Ibuprofen Abbott

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Ibuprofen

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Pacnex LP

Generic Name: benzoyl peroxide cleansing pads

Dosage Form: cloth
Pacnex(4.25% Benzoyl Peroxide)LP Cleansing Pads

DESCRIPTION: Pacnex (7% Benzoyl Peroxide) HP Cleansing Pads and Pacnex (4.25% Benzoyl Peroxide) LP Cleansing Pads are intended for topical administration and contain Benzoyl Peroxide for use in the treatment of acne vulgaris.

Benzoyl Peroxide is an oxidizing agent that possesses antibacterial properties and is classified as a keratolytic. Benzoyl Peroxide (C14H10O4) is represented by the following chemical structure:

Each pad of Pacnex HP Cleansing Pads contains 70 mg of Benzoyl Peroxide and Pacnex LP Cleansing Pads contains 42.5 mg of Benzoyl Peroxide in a formulation consisting of: aloe, carbomer interpolymer type A, cetyl alcohol, disodium oleamido MEA-sulfosuccinate, edetate disodium, glycerin, glyceryl stearate and PEG100 stearate, green tea, laureth-12, magnesium aluminum silicate, propylene glycol, purified water, sodium coco-sulfate, sodium lauroamphoacetate, xanthan gum.

CLINICAL PHARMACOLOGY: The mechanism of action of Benzoyl Peroxide is not totally understood but its antibacterial activity against Propionibacterium acnes is thought to be a major mode of action. In addition, patients treated with Benzoyl Peroxide show a reduction in lipids and free fatty acids, and mild desquamation (drying and peeling activity) with simultaneous reduction in comedones and acne lesions. Little is known about the percutaneous penetration, metabolism, and excretion of Benzoyl Peroxide, although it has been shown that Benzoyl Peroxide absorbed by the skin is metabolized to benzoic acid and then excreted as benzoate in the urine. There is no evidence of systemic toxicity caused by Benzoyl Peroxide in humans.

INDICATIONS AND USAGE:

Pacnex HP Cleansing Pads and Pacnex LP Cleansing Pads are indicated for the topical treatment of acne vulgaris.

CONTRAINDICATIONS: These preparations are contraindicated in patients with a history of hypersensitivity to any of their components.

WARNINGS: When using this product, avoid unnecessary sun exposure and use a sunscreen.

PRECAUTIONS: General: For external use only. If severe irritation develops, discontinue use and institute appropriate therapy. After reaction clears, treatment may often be resumed with less frequent application. These preparations should not be used in or near the eyes or on mucous membranes.

Information for Patients: Avoid contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water. Contact with any colored material (including hair and fabric) may result in bleaching or discoloration. If excessive irritation develops, discontinue use and consult your physician.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Data from several studies employing a strain of mice that is highly susceptible to developing cancer suggest that Benzoyl Peroxide acts as a tumor promoter. The clinical significance of these findings to humans is unknown. Benzoyl Peroxide has not been found to be mutagenic (Ames Test) and there are no published data indicating it impairs fertility.

Pregnancy: Teratogenic Effects: Pregnancy Category C: Animal reproduction studies have not been conducted with Benzoyl Peroxide. It is not known whether Benzoyl Peroxide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Benzoyl Peroxide should be used by a pregnant woman only if clearly needed. There are no available data on the effect of Benzoyl Peroxide on the later growth, development and functional maturation of the unborn child.

Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Benzoyl Peroxide is administered to a nursing woman.

Pediatric Use: Safety and effectiveness in children have not been established.

ADVERSE REACTIONS: Allergic contact dermatitis and dryness have been reported with topical Benzoyl Peroxide therapy.

OVERDOSAGE: If excessive scaling, erythema or edema occurs, the use of this preparation should be discontinued. To hasten resolution of the adverse effects, cool compresses may be used. After symptoms and signs subside, a reduced dosage schedule may be cautiously tried if the reaction is judged to be due to excessive use and not allergenicity.

DOSAGE AND ADMINISTRATION: Pacnex (7% Benzoyl Peroxide) HP and Pacnex (4.25% Benzoyl Peroxide) LP: Apply to affected areas once or twice a day, or as directed by your physician. Wet skin and liberally apply to areas to be cleansed. Massage gently into skin for 10-20 seconds, working into a full lather. Rinse thoroughly and pat dry. If excessive drying occurs, control by rinsing off cleanser sooner or using less often.

HOW SUPPLIED:

Pacnex HP Cleansing Pads contain 60 foil pouches, each with a single-use medicated pad (6 g each), NDC 43538-140-60.

Pacnex LP Cleansing Pads contain 60 foil pouches, each with a single-use medicated pad (6 g each), NDC 43538-150-60.

Store at controlled room temperature 15°-30° C (59°-86° F). Protect from freezing.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.


Manufactured for:


MEDIMETRIKS

PHARMACEUTICALS, INC.

363 Route 46 West

Fairfield, NJ 07004-2402 USA


www.medimetriks.com



Manufactured by:

Groupe PARIMA, Inc.

Montreal, QC H4S 1X6 CANADA

PACNEX  LP benzoyl peroxide  cloth

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 43538-150 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 42.5 mg  in 1 g

Inactive Ingredients Ingredient Name Strength ALOE   CARBOMER INTERPOLYMER TYPE A (55000 CP)   CETYL ALCOHOL   DISODIUM OLEAMIDO MEA-SULFOSUCCINATE   EDETATE DISODIUM   GLYCERIN   GLYCERYL MONOSTEARATE   POLYOXYL 100 STEARATE   GREEN TEA LEAF   LAURETH-12   MAGNESIUM ALUMINUM SILICATE   PROPYLENE GLYCOL   WATER   SODIUM COCO-SULFATE   SODIUM LAUROAMPHOACETATE   XANTHAN GUM

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 43538-150-60 60 POUCH In 1 CARTON contains a POUCH 1 6 g In 1 POUCH This package is contained within the CARTON (43538-150-60)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		07/09/2010

Labeler - Medimetriks Pharmaceuticals, Inc. (019903816)

Registrant - Groupe PARIMA, Inc. (252437850)

Establishment
Name	Address	ID/FEI	Operations
Groupe PARIMA, Inc.		252437850	manufacture

Revised: 07/2010Medimetriks Pharmaceuticals, Inc.

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Nature's Tears

Generic Name: hypromellose (Ophthalmic route)

hye-PROE-me-lose

Commonly used brand name(s)

In the U.S.

• Genteal


• Genteal Mild


• Gonak


• Goniosoft


• Goniovisc


• Isopto Tears


• Nature's Tears


• Tearisol


• Tears Again Mc

Available Dosage Forms:

• Solution


• Gel/Jelly

Therapeutic Class: Surgical Aid, Ocular

Uses For Nature's Tears

Hydroxypropyl methylcellulose belongs to the group of medicines known as artificial tears. It is used to relieve dryness and irritation caused by reduced tear flow. It helps prevent damage to the eye in certain eye diseases. Hydroxypropyl methylcellulose may also be used to moisten hard contact lenses and artificial eyes. In addition, it may be used in certain eye examinations.

Some of these preparations are available only with your doctor's prescription.

Before Using Nature's Tears

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Although there is no specific information comparing use of hydroxypropyl methylcellulose in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Many medicine have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of hydroxypropyl methylcellulose in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of hypromellose

This section provides information on the proper use of a number of products that contain hypromellose. It may not be specific to Nature's Tears. Please read with care.

To use:

• First, wash your hands. Then tilt the head back and pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close the eyes. Do not blink. Keep the eyes closed for 1 or 2 minutes to allow the medicine to be absorbed.


• To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed.

For patients wearing hard contact lenses:

• Take care not to float the lens from your eye when applying this medicine. If you have any questions about this, check with your health care professional.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For dry eyes:
  
  • For ophthalmic solution (eye drops) dosage form:
    
    • Adults and children—Use 1 drop three or four times a day.
    
    
  
  

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Nature's Tears

If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if your symptoms continue for more than 3 days or become worse, check with your doctor.

Nature's Tears Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• Eye irritation not present before use of this medicine

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common - more common with 1% solution

• Blurred vision


• matting or stickiness of eyelashes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

Voltarol Joint Pain 12.5mg Tablets

1. Name Of The Medicinal Product

Voltarol^® Joint Pain 12.5mg Tablets

Voltarol Pain-eze^® Tablets

2. Qualitative And Quantitative Composition

Each tablet contains 12.5 mg of diclofenac potassium.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

White capsule-shaped film-coated tablet

4. Clinical Particulars

4.1 Therapeutic Indications

Short term relief of headache, dental pain, period pain, rheumatic pain, muscular pain and backache and the symptoms of colds and flu, including fever.

4.2 Posology And Method Of Administration

Adults and children aged 14 years and over:

Initially two tablets, followed by one or two tablets every 4 to 6 hours as needed. No more than 6 tablets (75 mg) should be taken in any 24 hour period.

Voltarol Pain-eze Tablets should not be used for longer than 3 days. If symptoms persist or worsen consult your doctor.

The tablets should be swallowed whole with a drink of water.

Children and Adolescents:

Voltarol Pain-eze Tablets are not to be used in children and adolescents under 14 years of age.

4.3 Contraindications

• Known hypersensitivity to diclofenac or to any of the excipients. Patients in whom attacks of asthma, urticaria, angioedema, or acute rhinitis are precipitated by aspirin or other non-steroidal anti-inflammatory drugs such as ibuprofen.

• Gastric or intestinal ulcer, bleeding or perforation.

• Pregnancy or breastfeeding (see section 4.6 Pregnancy and lactation).

• Severe hepatic, renal or cardiac failure (see section 4.4 Special warnings and special precautions for use).

• Concomitant use of anticoagulants and antiplatelets (see section 4.5 Interactions)

• Use with concomitant NSAIDs including cyclo-oxygenase-2 specific inhibitors (see section 4.5 Interactions)

4.4 Special Warnings And Precautions For Use

Warnings

Gastrointestinal bleeding, ulceration or perforation, which can be fatal, have been reported with all NSAIDs and may occur at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events. They generally have more serious consequences in the elderly. If gastrointestinal bleeding or ulceration occur in patients receiving diclofenac, the medicinal product should be withdrawn.

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs, including diclofenac (see section 4.8 Undesirable effects). Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment. Diclofenac should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity.

As with other NSAIDs, allergic reactions, including anaphylactic/anaphylactoid reactions, can occur in rare cases without earlier exposure to diclofenac.

In common with other NSAIDs, diclofenac may mask the signs and symptoms of infection due to its pharmacodynamic properties.

Precautions

General

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see GI and Cardiovascular risks below).

The concomitant use of diclofenac with systemic NSAIDs, including cyclooxygenase-2 selective inhibitors, should be avoided due to the absence of any evidence demonstrating synergistic benefits and the potential for additive undesirable effects.

Caution is indicated in the elderly. In particular, it is recommended that the lowest effective dose be used in frail elderly patients or those with a low body weight.

Voltarol Pain-eze Tablets contain lactose and therefore are not recommended for patients with rare hereditary problems of galactose intolerance, of severe lactase deficiency or of glucose-galactose malabsorption.

Caution (discussion with doctor or pharmacist) is required prior to starting treatment in patients with a history of hypertension and/or heart failure as fluid retention, hypertension and oedema have been reported in association with NSAIDs therapy (see Renal effects below).

Pre-existing asthma

In patients with asthma, seasonal allergic rhinitis, swelling of nasal mucosa (i.e. nasal polypus), chronic obstructive pulmonary disease or chronic infection of the respiratory tract (especially if linked to allergic rhinitis-like symptoms), reactions to NSAIDs such as asthma exacerbations (so-called intolerance to analgesics / analgesics-asthma), angioedema or urticaria are more frequent than in other patients.

Gastrointestinal effects

As with all NSAIDs, close medical surveillance is imperative and caution should be exercised when prescribing diclofenac in patients with symptoms indicative of gastrointestinal (GI) disorders or with a history suggestive of gastric or intestinal ulceration, bleeding or perforation (see section 4.8 Undesirable effects). The risk of GI bleeding is higher with increasing NSAID doses and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation and in the elderly.

Patients with a history of GI toxicity, particularly the elderly, should report any unusual abdominal symptoms (especially GI bleeding). Caution is recommended in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as systemic corticosteroids, anticoagulants, anti-platelet agents or selective serotonin-reuptake inhibitors (see section 4.5 Interaction with other medicinal products and other forms of interaction).

Close medical surveillance should also be exercised in patients with ulcerative colitis or Crohn's disease, as their condition may be exacerbated (see section 4.8 Undesirable effects).

Cardiovascular and cerebrovascular effects

Clinical trial and epidemiological data suggest that use of diclofenac, particularly at high doses (150 mg daily) and in long-term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). Available data do not suggest an increased risk with use of low dose diclofenac (up to 75 mg/day) up to 3 days for relief of pain or fever.

Hepatic effects

Close medical surveillance is required when prescribing diclofenac to patients with impaired hepatic function, as their condition may be exacerbated.

As with other NSAIDs, values of one or more liver enzymes may increase. In the case of diclofenac being prescribed for a prolonged period, regular monitoring of hepatic function is indicated as a precautionary measure. If abnormal liver function tests persist or worsen, if clinical signs or symptoms consistent with liver disease develop, or if other manifestations occur (e.g. eosinophilia, rash), diclofenac should be discontinued. Hepatitis may occur without prodromal symptoms.

Caution is called for when using diclofenac in patients with hepatic porphyria, since it may trigger an attack.

Renal effects

Caution is called for in patiens with impaired renal function, particularly the elderly and patients receiving concomitant treatment with diuretics or medicinal products that can significantly impact renal function and in those patients with substantial extracellular volume depletion.

As fluid retention and oedema have been reported in association with NSAID therapy, particular caution is called for in elderly patients receiving concomitant treatment with diuretics or medicinal products that can significantly impact renal function, and in those patients with substantial extracellular volume depletion from any cause, e.g. before or after major surgery (see section 4.3 Contraindications). Monitoring of renal function is recommended as a precautionary measure when using diclofenac in such cases. Discontinuation of therapy is usually followed by recovery to the pre-treatment state.

Haematological effects

Like other NSAIDs, diclofenac may temporarily inhibit platelet aggregation. Patients with defects of haemostasis should be carefully monitored.

Dermatological effects

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at highest risk for these reactions early in the course of therapy: the onset of the reaction occurring in the majority of cases within the first month of treatment. Voltarol Pain-eze Tablets should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

The label will state:

Read the enclosed leaflet before taking this medicine.

Do not take if you:

• have or have ever had a stomach ulcer, perforation or bleeding

• are allergic to diclofenac or any other ingredient of the product, acetylsalicylic acid, ibuprofen or other related painkillers

• are taking other NSAID painkillers, or aspirin

• are pregnant or breastfeeding

Speak to a pharmacist or your doctor before taking this product if you:

• have or have had asthma, diabetes, high cholesterol, high blood pressure, a stroke, liver, heart, kidney or bowel problems

• are intolerant to some sugars

• are on a controlled potassium diet

• are a smoker

If symptoms persist or worsen, consult your doctor.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Lithium and digoxin: Diclofenac may increase plasma concentrations of lithium and digoxin.

Diuretics and antihypertensive agents: Like other NSAIDs, concomitant use of diclofenac with diuretics or antihypertensive agents (e.g. beta-blockers, angiotensin converting enzyme (ACE) inhibitors) may cause a decrease in their antihypertensive effect. Therefore, the combination should be administered with caution and patients, especially the elderly, should have their blood pressure periodically monitored. Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy and periodically thereafter, particularly for diuretics and ACE inhibitors due to the increased risk of nephrotoxicity. Concomitant treatment with potassium-sparing diuretics may be associated with increased serum potassium levels, which should therefore be monitored frequently (see section 4.4 Special warnings and special precautions for use).

Other NSAIDs including cyclooxygenase-2 selective inhibitors and corticosteroids:

Co-administration of diclofenac with aspirin or corticosteroids may increase the risk of gastrointestinal bleeding or ulceration. Avoid concomitant use of two or more NSAIDs (see section 4.4 Special warnings and special precautions for use).

Selective serotonin reuptake inhibitors (SSRIs) and anti-platelet agents: Increased risk of gastrointestinal bleeding (see section 4.4 Special warnings and special precautions for use).

Antidiabetics: Clinical studies have shown that diclofenac can be given together with oral antidiabetic agents without influencing their clinical effect. However, there have been isolated reports of both hypoglycaemic and hyperglycaemic effects necessitating changes in the dosage of the antidiabetic agents during treatment with diclofenac. Monitoring of the blood glucose level is recommended as a precautionary measure during concomitant therapy.

Methotrexate: Caution is recommended when NSAIDs are administered less than 24 hours before or after treatment with methotrexate, since blood concentrations of methotrexate may rise and the toxicity of this substance be increased.

Ciclosporin and tacrolimus: Diclofenac, like other NSAIDs, may increase the nephrotoxicity of ciclosporin due to the effect on renal prostaglandins. Therefore, it should be given at doses lower than those that would be used in patients not receiving ciclosporin or tacrolimus.

Quinolone antibacterials: There have been isolated reports of convulsions which may have been due to concomitant use of quinolones and NSAIDs.

4.6 Pregnancy And Lactation

Pregnancy

The use of diclofenac in pregnant women has not been studied. Therefore, Voltarol Pain-eze Tablets should not be used during pregnancy except on the advice of a doctor.

Lactation

Like other NSAIDs, diclofenac passes into the breast milk in small amounts. Therefore, Voltarol Pain-eze Tablets should not be administered during breast feeding in order to avoid undesirable effects in the infant.

Fertility

As with other NSAIDs, the use of diclofenac may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of diclofenac should be considered.

4.7 Effects On Ability To Drive And Use Machines

Usually there is no effect at the recommended low-dose and short duration of treatment. However patients experiencing visual disturbances, dizziness, vertigo, somnolence or other central nervous system disturbances while taking diclofenac should refrain from driving or using machines.

4.8 Undesirable Effects

Adverse reactions (Table 1) are ranked under heading of frequency, the most frequent first, using the following convention: common (

Available data do not suggest an increased risk with use of low dose diclofenac (up to 75 mg/day) for up to 3 days treatment for the relief of pain or fever.

Table 1

Blood and lymphatic system disorders
	Very rare:	Thrombocytopenia, leukopenia, anaemia (including haemolytic anaemia and aplastic anaemia), agranulocytosis.
Immune system disorders
	Rare:	Hypersensitivity, anaphylactic and anaphylactoid reaction (including hypotension and shock).
	Very rare:	Angioneurotic oedema (including face oedema).
Psychiatric disorders
	Very rare:	Disorientation, depression, insomnia, nightmare, irritability, psychotic disorder.
Nervous system disorders
	Common:	Headache, dizziness.
	Rare:	Somnolence.
	Very rare:	Paraesthesia, memory impairment, convulsion, anxiety, tremor, aseptic meningitis, taste disturbances, cerebrovascular accident.
Eye disorders
	Very rare:	Visual disturbance, vision blurred, diplopia.
Ear and labyrinth disorders
	Common:	Vertigo.
	Very rare:	Tinnitus, hearing impaired.
Cardiac disorders
	Very rare:	Palpitations, chest pain, cardiac failure, myocardial infarction.
Vascular disorders
	Very rare:	Hypertension, vasculitis.
Respiratory, thoracic and mediastinal disorders
	Rare:	Asthma (including dyspnoea).
	Very rare:	Pneumonitis.
Gastrointestinal disorders
	Common:	Nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, flatulence, anorexia.
	Rare:	Gastritis, gastrointestinal haemorrhage, Haematemesis, diarrhoea, hemorrhagic melaena, gastrointestinal ulcer (with or without bleeding or perforation).
	Very rare:	Colitis, (including haemorrhagic colitis and exacerbation of ulcerative colitis or Crohn's disease), constipation, stomatitis, glossitis, oesophageal disorder, diaphragm-like intestinal strictures, pancreatitis.
Hepatobiliary disorders
	Common:	Transaminases increased.
	Rare:	Hepatitis, jaundice, liver disorder.
	Very rare:	Fulminant hepatitis
Skin and subcutaneous tissue disorders
	Common:	Rash.
	Rare:	Urticaria.
	Very rare:	Bullous eruptions, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), dermatitis exfoliative, loss of hair, photosensitivity reaction, purpura, allergic purpura, pruritus.
Renal and urinary disorders
	Very rare:	Acute renal failure, haematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis.
General disorders and administration site conditions
	Rare:	Oedema.

Clinical trial and epidemiological data suggest that use of diclofenac (particularly at high doses 150 mg daily and in long-term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) ( see section 4.4 ).

4.9 Overdose

Symptoms

There is no typical clinical picture resulting from diclofenac overdosage. Overdose can cause symptoms such as vomiting, gastrointestinal haemorrhage, diarrhoea, dizziness, tinnitus or convulsions. In the event of significant poisoning, acute renal failure and liver damage are possible.

Therapeutic measures

Management of acute poisoning with NSAIDs essentially consists of supportive measures and symptomatic treatment. These should be given for complications such as hypotension, renal failure, convulsions, gastrointestinal disorder, and respiratory depression.

Special measures such as forced diuresis, dialysis or haemoperfusion are probably of no help in eliminating NSAIDs due to the high protein binding and extensive metabolism.

Activated charcoal may be considered in case of a potentially toxic overdose, and gastric decontamination (e.g. vomiting, gastric lavage) in case of a potentially life-threatening overdose.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids, acetic acid derivatives and related substances (ATC code M01A B05).

Voltarol Pain-eze Tablets contain diclofenac potassium, a non-steroidal anti-inflammatory drug (NSAID) with pronounced analgesic, anti-inflammatory and antipyretic properties. Inhibition of prostaglandin biosynthesis is considered fundamental to its mechanism of action. Prostaglandins play a major role in causing inflammation, pain and fever.

Diclofenac potassium in vitro does not suppress proteoglycan biosynthesis in cartilage at concentrations equivalent to those reached in humans.

5.2 Pharmacokinetic Properties

Absorption

Diclofenac is rapidly and completely absorbed. Following ingestion of two 12.5 mg coated tablets, mean peak plasma concentrations of 2.15 μmol/L are attained after approximately 30 minutes (median T_max).

The amount absorbed is in linear proportion to the size of the dose.

Since about half of diclofenac is metabolised during its first passage through the liver (“first pass” effect), the area under the concentration curve is about half as large following oral administration as it is following a parenteral dose of equal size.

Pharmacokinetic behaviour does not change after repeated administration. No accumulation occurs provided the recommended dosage intervals are observed.

Distribution

99.7% of diclofenac binds to serum proteins, mainly to albumin (99.4%). The apparent volume of distribution is 0.12 to 0.17 L/kg.

Diclofenac enters the synovial fluid, where maximum concentrations are measured 2 to 4 hours after peak plasma values have been reached. The apparent half-life for elimination from the synovial fluid is 3 to 6 hours. Two hours after reaching peak plasma levels, concentrations of the active substance are already higher in the synovial fluid than in the plasma, and they remain higher for up to 12 hours.

Biotransformation

Biotransformation of diclofenac takes place partly by glucuronidation of the intact molecule, but mainly by single and multiple hydroxylation and methoxylation, resulting in several phenolic metabolites, most of which are converted to glucuronide conjugates. Two of these phenolic metabolites are biologically active, but to a much lesser extent than diclofenac.

Elimination

Total systemic clearance of diclofenac from plasma is 263 ± 56 mL/min. The terminal half-life in plasma is 1 to 2 hours. Four of the metabolites, including the two active ones, also have short plasma half-lives of 1 to 3 hours. A fifth metabolite, 3'-hydroxy-4'-methoxy-diclofenac, has a much longer plasma half-life. This metabolite is virtually inactive.

About 60% of the administered dose is excreted in the urine as the glucuronide conjugate of the intact molecule and as metabolites, most of which are also converted to glucuronide conjugates. Less than 1% is excreted as unchanged substance. The rest of the dose is eliminated as metabolites through the bile in the faeces.

Characteristics in patients

No relevant age-dependent differences in the drug's absorption, metabolism, or excretion have been observed.

In patients suffering from renal impairment, no accumulation of the unchanged active substance can be inferred from the single dose kinetics when applying the usual dosage schedule. At a creatinine clearance of less than 10 mL/min, the calculated steady-state plasma levels of the hydroxy metabolites are about 4 times higher than in normal subjects. However, the metabolites are ultimately cleared through the bile.

In patients with chronic hepatitis or non-decompensated cirrhosis, the kinetics and metabolism of diclofenac are the same as in patients without liver disease.

5.3 Preclinical Safety Data

Preclinical data from acute and repeated dose toxicity studies, as well as from genotoxicity, mutagenicity, and carcinogenicity studies with diclofenac revealed no specific hazard for humans at the intended therapeutic doses. There was no evidence that diclofenac had a teratogenic potential in mice, rats or rabbits.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Core: silica, lactose, maize starch, sodium starch glycolate, polyvidone, microcrystalline cellulose, magnesium stearate.

Coating: hypromellose, titanium dioxide (E171), microcrystalline cellulose, stearic acid.

6.2 Incompatibilities

Not applicable

6.3 Shelf Life

3 years

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

PVC/Polychlorotrifluoroethylene/PVC – Alu blister packs.

Polyamide/ALU/PVC – Alu blister packs.

Pack size: 10 or 18 tablets, not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

No special requirements

7. Marketing Authorisation Holder

Novartis Consumer Health

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

8. Marketing Authorisation Number(S)

PL 00030/0073

9. Date Of First Authorisation/Renewal Of The Authorisation

17 June 2008

10. Date Of Revision Of The Text

29 September 2010.

LEGAL CATEGORY

P

micafungin Intravenous

mye-ka-FUN-jin

Commonly used brand name(s)

In the U.S.

• Mycamine

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antifungal

Pharmacologic Class: Glucan Synthesis Inhibitor

Chemical Class: Echinocandin

Uses For micafungin

Micafungin is an antifungal medicine. It is used to help the body overcome serious fungus infections, such as candidemia, acute disseminated candidiasis, candida peritonitis and abscess, and esophageal candidiasis. Micafungin is also used to prevent candida infections in patients having a stem cell transplant .

micafungin is available only with your doctor's prescription.

Before Using micafungin

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For micafungin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to micafungin or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of micafungin in the pediatric population. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of micafungin in the elderly .

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving micafungin, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using micafungin with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Itraconazole


• Nifedipine


• Sirolimus

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of micafungin. Make sure you tell your doctor if you have any other medical problems, especially:

• Bleeding problems (e.g., hemolysis or hemolytic anemia) or


• Kidney problems—Use with caution. May make these conditions worse .

• Liver disease, moderate to severe—Higher blood levels of micafungin may result, increasing the chance of side effects.

Proper Use of micafungin

A nurse or other trained health professional will give you micafungin. micafungin is given through a needle placed in one of your veins .

Precautions While Using micafungin

It is very important that your doctor check your progress at regular visits to make sure micafungin is working properly and to check for unwanted effects .

micafungin may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash; itching; swelling of the face, tongue, and throat; trouble breathing; or chest pain after you get the injection .

micafungin Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

• Bone pain


• chest pain


• chills


• convulsions


• cough


• decreased urine


• drowsiness


• dry mouth


• fever


• hoarseness


• increased thirst


• irregular heartbeat


• lab results that show problems with liver


• loss of appetite


• lower back or side pain


• mood or mental changes


• muscle pain or cramps


• muscle spasms or twitching


• nausea


• numbness or tingling in hands, feet, or lips


• painful or difficult urination


• seizures


• shortness of breath


• sore throat


• sores, ulcers, or white spots on lips or in mouth


• swollen glands


• trembling


• trouble breathing


• ulcers, sores, or white spots in mouth


• vomiting

Rare

• Abdominal cramps


• black, tarry stools


• bleeding gums


• blood in urine or stools


• blurred vision


• confusion


• dizziness


• headache


• nervousness


• pale skin


• pinpoint red spots on skin


• pounding in the ears


• slow or fast heartbeat


• tremor


• troubled breathing with exertion


• unusual bleeding or bruising


• unusual tiredness or weakness

Frequency unknown

• Cold, clammy skin


• difficulty swallowing


• fast, weak pulse


• hives


• itching


• lightheadedness


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• skin rash


• rash or redness


• sweating


• swelling of face, throat, or tongue


• tightness in chest


• wheezing

Observed during postmarketing trials

• Agitation


• back, leg, or stomach pains


• bleeding gums


• coma


• dark urine


• depression


• diarrhea


• general body swelling


• hostility


• increased blood pressure


• increased thirst


• irritability


• lethargy


• light-colored stools


• muscle twitching


• nosebleeds


• rapid weight gain


• seizures


• stomach pain


• swelling of face, ankles, or hands


• swelling of lower legs


• stupor


• troubled breathing


• unpleasant breath odor


• vomiting of blood


• white blood cell count decreased


• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Bluish color


• changes in skin color


• feeling unusually cold; shivering


• infusion site inflammation


• pain


• stomach pain


• swelling of foot or leg


• tenderness

Rare

• Acid or sour stomach


• belching


• change in taste


• confusion as to time, place, or person


• difficulty having a bowel movement (stool)


• feeling of warmth


• hallucinations


• heartburn


• hiccups


• holding false beliefs that cannot be changed by fact


• indigestion


• injection site pain


• loss of taste


• redness of the face, neck, arms and occasionally upper chest


• sleepiness or unusual drowsiness


• stomach discomfort, upset, or pain


• unusual excitement, nervousness, or restlessness


• upper stomach pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: micafungin Intravenous side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More micafungin Intravenous resources

• Micafungin Intravenous Side Effects (in more detail)
• Micafungin Intravenous Use in Pregnancy & Breastfeeding
• Micafungin Intravenous Drug Interactions
• Micafungin Intravenous Support Group
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Compare micafungin Intravenous with other medications

• Candida Infections, Systemic
• Esophageal Candidiasis
• Fungal Infection Prophylaxis

ProstaScint

Dosage Form: injection, suspension
ProstaScint® Kit

(capromab pendetide)


Kit for the Preparation of Indium In 111 Capromab Pendetide

For Intravenous Use Only

DESCRIPTION

ProstaScint® (capromab pendetide) is the murine monoclonal antibody, 7E11-C5.3, conjugated to the linker-chelator, glycyl-tyrosyl-(N, ε-diethylenetriaminepentaacetic acid)-lysine hydrochloride (GYK-DTPA-HCl). The 7E11-C5.3 antibody is of the IgG1, kappa subclass (IgG1κ). This antibody is directed against a glycoprotein expressed by prostate epithelium known as Prostate Specific Membrane Antigen (PSMA). The PSMA epitope recognized by monoclonal antibody (MAb) 7E11-C5.3 is located in the cytoplasmic domain. Expression of this glycoprotein has not been demonstrated on any other adenocarcinomas or transitional cell cancers tested. The antibody is produced by serum-free in vitro cultivation of cells, and purified by sequential protein isolation and chromatographic separation procedures.

Each ProstaScint® kit consists of two vials which contain all of the non-radioactive ingredients necessary to produce a single unit dose of Indium In 111 ProstaScint®, an immunoscintigraphic agent for administration by intravenous injection only. The ProstaScint® vial contains 0.5 mg of capromab pendetide in 1 mL of sodium phosphate buffered saline solution adjusted to pH 6; a sterile, pyrogen-free, clear, colorless solution that may contain some translucent particles. The vial of sodium acetate buffer contains 82 mg of sodium acetate in 2 mL of Water for Injection adjusted to pH 5-7 with glacial acetic acid; it is a sterile, pyrogen-free, clear, and colorless solution. Neither solution contains a preservative. Each kit also includes one sterile 0.22 μm Millex® GV filter, prescribing information, and two identification labels.

The sodium acetate solution must be added to the sterile, non-pyrogenic high purity Indium In 111 Chloride solution to buffer it prior to radiolabeling ProstaScint®. The immunoscintigraphic agent Indium In 111 Capromab Pendetide (Indium In 111 ProstaScint®) is formed after radiolabeling with Indium In 111.

Physical Characteristics of Indium In 111

Indium In 111 decays by electron capture with a physical half-life of 67.2 hours (2.8 days).1 The energies of the photons that are useful for detection and imaging studies are listed in TABLE 1.

TABLE 1 - INDIUM IN 111 PRINCIPAL RADIATION EMISSION DATA1
Radiation	Mean % per Disintegration	Mean Energy (keV)
Gamma 2	90.2	171.3
Gamma 3	94	245.4

External Radiation

The exposure rate constant for 37 MBq (1 mCi) of Indium In 111 is 8.3 x 10-4 C/kg/hr (3.21 R/hr). The first half-value thickness of lead (Pb) for Indium In 111 is 0.023 cm. A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from the interposition of various thicknesses of Pb is shown in TABLE 2. For example, the use of 0.834 cm of lead will decrease the external radiation exposure by a factor of about 1,000.

TABLE 2 - INDIUM IN 111 RADIATION ATTENUATION OF LEAD SHIELDING2
Shield Thickness (Pb) cm	Attenuation Factor
0.023	0.5
0.203	10-1
0.513	10-2
0.834	10-3
1.120	10-4

These estimates of attenuation do not take into consideration the presence of longer-lived contaminants with higher energy photons, namely Indium In 114m/114.

To allow correction for physical decay of Indium In 111, the fractions that remain at selected intervals before and after the time of calibration are shown in TABLE 3.

TABLE 3 - INDIUM IN 111 PHYSICAL DECAY CHART, HALF-LIFE 67.2 HOURS (2.8 DAYS)
* Calibration Time
Hours	Fraction Remaining
-48	1.64
-36	1.44
-24	1.28
-12	1.13
0*	1.00
12	0.88
24	0.78
36	0.69
48	0.61
60	0.54
72	0.48
84	0.42
96	0.37
108	0.33
120	0.29
132	0.26
144	0.23

CLINICAL PHARMACOLOGY

Pharmacodynamics

Prostate Specific Membrane Antigen is expressed in many primary and metastatic prostate cancer lesions, and in vitro immunohistologic studies have shown 7E11-C5.3 to be reactive with > 95% of the prostate adenocarcinomas evaluated. In general, PSMA expression by prostate cancer cells is either unchanged or increased in patients treated with hormonal therapy (see PRECAUTIONS, Drug Interactions). The 7E11-C5.3 antibody is immunoreactive with normal and hypertrophic adult prostate tissue. In clinical studies of patients with prostate cancer, Indium In 111 ProstaScint® (capromab pendetide) localized to the prostate, and some known primary and metastatic tumor sites.

Non-antigen-dependent localization, suspected to be secondary to catabolism, has been observed in the liver, spleen, and bone marrow. Although there is variation among individuals, there may also be localization and imaging activity in the bowel, blood pool, kidneys, urinary bladder, and genitalia. Intracellular localization of 7E11-C5.3 has been observed in histochemically prepared tissue sections from normal adult skeletal and cardiac muscle, although primate studies revealed no specific localization to these tissues.

Pharmacokinetics

Based on data obtained from clinical studies, Indium In 111 ProstaScint® demonstrated a monoexponential elimination pattern with a terminal-phase half life of 67 ± 11 hours (mean ± SD). Approximately 10% of the administered radioisotope dose is excreted in the urine during the 72 hours following intravenous infusion. The pharmacokinetics of Indium In 111 ProstaScint® are characterized by slow serum clearance rate (42 ± 22 mL/hr) and small volume of distribution (4 ± 2.1 L).

CLINICAL STUDIES

Indium In 111 ProstaScint® (capromab pendetide) has been administered in single doses to over 600 patients in clinical studies, and in repeat administrations (2 to 4 infusions) to 61 patients. A 0.5 mg dose was determined to be the lowest effective dose. The imaging performance of Indium In 111 ProstaScint® (capromab pendetide) was evaluated in a phase 2 and a phase 3 trial in each of two clinical settings: (1) patients with clinically-localized prostate cancer who were at high risk for metastases and (2) patients with a high clinical suspicion for occult recurrent or residual prostate cancer.

Imaging Performance in Newly-Diagnosed Patients

In one of two open label, multi-center, uncontrolled pivotal phase 3 trials, 160 patients with a tissue diagnosis of prostate cancer who were considered at high risk for lymph node metastases underwent Indium In 111 ProstaScint® immunoscintigraphy prior to scheduled staging pelvic lymphadenectomy. High risk was defined as at least one of the following: (1) prostate specific antigen (PSA) ≥10x the upper limit of normal & Gleason score ≥7; (2) prostatic acid phosphatase above the upper limit of normal; (3) equivocal evidence of lymph node metastases on CT or ultrasound & PSA ≥8x the upper limit of normal; (4) Gleason score ≥8; or (5) clinical stage C & Gleason score ≥6. All patients had been evaluated for metastatic disease using standard non-invasive imaging techniques, and were considered to have clinically-localized prostate cancer. The Indium In 111 ProstaScint® images were interpreted on-site, and the reader had access to all clinical data. The interpretations were correlated with the results of surgical staging; however, a correlation of specific areas of Indium In 111 ProstaScint® uptake to specific sites of tumor involvement was not performed.

One hundred fifty-two patients had an interpretable scan and surgical staging. Forty scans were classified as true positive, 25 as false positive, 63 as true negative, and 24 as false negative. The results for immunoscintigraphy are summarized in TABLE 4.

TABLE 4 - COMPARISON OF INDIUM IN 111 ProstaScint® AND HISTOPATHOLOGIC RESULTS FOR PRESURGICAL PATIENTS
	Number of Patients
	Indium In 111 ProstaScint®
	+	-
Biopsy +	40	24	Sensitivity = 62%
Biopsy -	25	63	Specificity = 72%
	Positive Predictive Value 62%	Negative Predictive Value 72%	Overall Accuracy 68%

Sixty-five patients (43%) had positive Indium In 111 ProstaScint® images for pelvic lymph node metastases: Of these 38% (25 patients) did not have metastatic prostate cancer at surgery. Eighty-seven patients (57%) had negative Indium In 111 ProstaScint® images: Of these 28% (24 patients) did have metastatic prostate cancer at surgery. The overall accuracy of Indium In 111 ProstaScint® immunoscintigraphy, as measured against pelvic lymph node dissection, was 68% (103/152).

A retrospective subset analysis suggested that a positive Indium In 111 ProstaScint® scan in patients with a Gleason score ≥ 7 and a PSA ≥ 40 contained additional information regarding the likelihood that tumor metastases would be found at the scheduled staging pelvic lymphadenectomy.

Imaging Performance in Patients with Occult Recurrent or Residual Disease

In the second open label, multi-center, uncontrolled pivotal phase 3 trial, 183 patients with a high clinical suspicion of residual or recurrent prostate cancer following radical prostatectomy were evaluated. Patients with a rising PSA, a negative bone scan, and negative or equivocal standard diagnostic techniques, (e.g. transrectal ultrasound, CT scan, or MRI) underwent Indium In 111 ProstaScint® immunoscintigraphy prior to biopsy of the prostatic fossa. The Indium In 111 ProstaScint® images were interpreted on-site, and the reader had access to all clinical data. The interpretations were correlated with the results of histopathologic analysis of the prostatic fossa biopsy specimens.

One hundred fifty-eight patients had an interpretable scan and prostatic fossa biopsy. Twenty-nine scans were classified as true positive, 29 as false positive, 70 as true negative, and 30 as false negative. The results are summarized in TABLE 5.

TABLE 5 - INDIUM IN 111 ProstaScint® AND HISTOPATHOLOGIC RESULTS FOR RECURRENT OR RESIDUAL DISEASE PATIENTS
	Number of Patients
	Indium In 111 ProstaScint®
	+	-
Biopsy +	29	30	Sensitivity 49%
Biopsy -	29	70	Specificity 71%
	Positive Predictive Value 50%	Negative Predictive Value 70%	Overall Accuracy 63%

Fifty-eight patients (37%) had positive Indium In 111 ProstaScint® images in the prostatic fossa: Of these 50% (29 patients) did not have recurrent prostate cancer on biopsy. One hundred patients (63%) had negative Indium In 111 ProstaScint® images: Of these 30% (30 patients) had recurrent prostate cancer on biopsy. The overall accuracy of Indium In 111 ProstaScint® immunoscintigraphy, as measured against prostatic fossa biopsy, was 63% (99/158).

Indium In 111 ProstaScint® localized to only the prostatic fossa in 29 (18%) patients, to prostatic fossa and extrafossa sites in 29 (18%) patients, and to only extrafossa sites in 39 (25%) patients. The study was not designed to evaluate extrafossa sites of uptake. Three extrafossa sites of uptake were biopsied, one of which was positive for metastatic prostate cancer.

ProstaScint® Results in Patients with Distant Metastases

Clinical trials have not specifically studied the ability of Indium In 111 ProstaScint® (capromab pendetide) to image distant (extra-pelvic) metastases, and a limited number of patients with distant (primarily bone) metastases were enrolled. Thirteen patients out of 16 (81%) with CT evidence of distant soft tissue disease had positive extrafossa Indium In 111 ProstaScint® scans. Thirty-five out of 61 patients (57%) with bone scan evidence of disease had positive Indium In 111 ProstaScint® skeletal uptake; however, Indium In 111 ProstaScint® imaging did not identify most sites of abnormal bone uptake on bone scan, nor did it demonstrate any new sites of metastasis that were not seen on bone scan. The Indium In 111 ProstaScint® scan did, however, demonstrate sites of bone marrow metastases that were not seen on bone scan in 2 of 43 patients in the phase 1 study.

Repeat Scans

Sixty-one patients received a total of 74 repeat infusions of Indium In 111 ProstaScint®. The incidence of adverse reactions upon repeat infusion (5%) was comparable to that observed after single infusion (4%). Human anti-mouse antibody (HAMA) levels were detected (at levels >8 ng/mL) by radioimmune assay (RIA) after single infusion in 8% (20/239) of patients while 1% of patients had levels greater than 100 ng/mL. Serum HAMA levels were detected by RIA after repeat infusion in 19% (5/27) of patients.

Biodistribution was unaltered on 65 of 70 (93%) evaluable repeat scans. The efficacy of repeat Indium In 111 ProstaScint® imaging was not evaluated.

INDICATIONS AND USAGE

Indium In 111 ProstaScint® (capromab pendetide) is indicated as a diagnostic imaging agent in newly-diagnosed patients with biopsy-proven prostate cancer, thought to be clinically-localized after standard diagnostic evaluation (e.g. chest x-ray, bone scan, CT scan, or MRI), who are at high-risk for pelvic lymph node metastases (see CLINICAL PHARMACOLOGY, Imaging Performance in Newly-Diagnosed Patients). It is not indicated in patients who are not at high risk.

Indium In 111 ProstaScint® is also indicated as a diagnostic imaging agent in post-prostatectomy patients with a rising PSA and a negative or equivocal standard metastatic evaluation in whom there is a high clinical suspicion of occult metastatic disease. The imaging performance of Indium In 111 ProstaScint® following radiation therapy has not been studied.

The information provided by Indium In 111 ProstaScint® imaging should be considered in conjunction with other diagnostic information. Scans that are positive for metastatic disease should be confirmed histologically in patients who are otherwise candidates for surgery or radiation therapy unless medically contraindicated. Scans that are negative for metastatic disease should not be used in lieu of histological confirmation.

ProstaScint® is not indicated as a screening tool for carcinoma of the prostate nor for readministration for the purpose of assessment of response to treatment.

CONTRAINDICATIONS

Indium In 111 ProstaScint® (capromab pendetide) should not be used in patients who are hypersensitive to this or any other product of murine origin or to Indium In 111 chloride.

WARNINGS

Patient management should not be based on Indium In 111 ProstaScint® (capromab pendetide) scan results without appropriate confirmatory studies since in the pivotal trials, there was a high rate of false positive and false negative image interpretations (See PRECAUTIONS).

Indium In 111 ProstaScint® images should be interpreted only by physicians who have had specific training in Indium In 111 ProstaScint® image interpretation (see PRECAUTIONS, Imaging Precautions).

Allergic reactions, including anaphylaxis, can occur in patients who receive murine antibodies. Although serious reactions of this type have not been observed in clinical trials after Indium In 111 ProstaScint® administration, medications for the treatment of hypersensitivity reactions should be available during administration of this agent.

Indium In 111 ProstaScint® may induce human anti-mouse antibodies which may interfere with some immunoassays, including those used to assay PSA and digoxin (see PRECAUTIONS, Drug/Laboratory Test Interactions).

PRECAUTIONS

General

There were high rates of false positive and false negative image interpretations in the pivotal trials (see Clinical Studies). False positive scan interpretations may result in: (1) inappropriate surgical intervention to confirm scan results; (2) inappropriate denial of curative therapy if results are not confirmed; or (3) inadequate surgical staging if only areas of uptake are sampled. Surgical sampling should not be limited to the areas of positive uptake, unless histologic examination of these areas is diagnostic. Due to the potential for false negative scan interpretations, negative images should not be used in lieu of histologic confirmation. Proper patient preparation is mandatory to obtain optimal images for interpretation (see Imaging Precautions, below).

Bone scans are more sensitive than ProstaScint® (capromab pendetide) for the detection of metastases to bone, and Indium In 111 ProstaScint® should not replace bone scan for the evaluation of skeletal metastases.

Imaging Precautions

Radiopharmaceuticals should be used only by physicians and other professionals who are qualified by training and experience in the safe use and handling of radionuclides. Indium In 111 ProstaScint® images should be interpreted only by physicians who have had specific training in the interpretation of Indium In 111 ProstaScint® images.

There may be Indium In 111 ProstaScint® clearance and imaging localization observed in the bowel, blood pool, kidneys, and urinary bladder. When obtaining all 72-120 hour planar and Single-Photon Emission Computed Tomography (SPECT) images, the bladder should be catheterized and irrigated. The administration of a cathartic is required the evening before imaging the patient, and a cleansing enema should be administered within an hour prior to each 72-120 hour imaging session.

The contents of the kit are not radioactive. However, after the Indium In 111 chloride is added, appropriate shielding of Indium In 111 ProstaScint® must be maintained. Care should be taken to minimize radiation exposure to patients and medical personnel, consistent with proper hospital and patient management procedures.

Each ProstaScint® kit is a unit of use package. The contents of the kit are to be used only to prepare Indium In 111 ProstaScint® -- unlabeled ProstaScint® should NOT be administered directly to the patient. After radiolabeling with Indium In 111, the entire Indium In 111 ProstaScint® dose must be administered to the patient for whom it was prescribed. Reducing the dose of Indium In 111, unlabeled ProstaScint®, or Indium In 111 ProstaScint® may adversely impact imaging results and is not recommended.

The components of the kit are sterile and pyrogen-free and contain no preservative. Indium In 111 ProstaScint® should be used within 8 hours after radiolabeling. It is essential to follow the directions for preparation carefully and to adhere to strict aseptic procedures during preparation of the radiolabeled product.

Information for Patients

Murine monoclonal antibodies (MAbs) are foreign proteins, and their administration can induce HAMA. While limited data exist concerning the clinical significance of HAMA, the presence of HAMA may interfere with murine-antibody based immunoassays, or could compromise the efficacy of diagnostic or therapeutic murine antibody-based agents and increase the risk of adverse reactions. For these reasons, patients should be informed that the use of this product could adversely affect the future ability to diagnose recurrence of their tumor, the ability to perform certain other laboratory tests, or to use other murine-based products. Patients should be advised to discuss prior use of murine-antibody based products with their physicians (see Heterologous Protein Administration, below).

Heterologous Protein Administration

Indium In 111 ProstaScint® (capromab penditide) has been shown to induce HAMA to murine IgG infrequently and with low peak levels after single administration. HAMA levels were detected (at >8 ng/mL) by RIA after single infusion in 8% (20/239) of patients, while 1% of patients had levels greater than 100 ng/mL. In addition, serum HAMA levels were detected by RIA after repeat infusion in 19% (5/27) of the patients.

While limited data exist concerning the clinical significance of HAMA, detectable serum levels can alter the clearance and tissue biodistribution of MAbs. The development of persistently elevated serum HAMA levels could compromise the efficacy of diagnostic or therapeutic murine antibody-based agents. In repeat administration trials, 93% (65/70) of the evaluable repeat infusions were associated with normal tissue distribution of the MAb conjugate. Pre-infusion serum HAMA levels were generally not predictive of altered distribution.

When considering the administration of Indium In 111 ProstaScint® to patients who have previously received other murine antibody-based products, physicians should be aware of the potential for assay interference and increased clearance and altered biodistribution, which may interfere with the quality or sensitivity of the imaging study. Prior to administration of murine antibodies, including Indium In 111 ProstaScint®, the physician should review the patient history to determine whether the patient has previously received such products.

Drug Interactions

The effect of surgical and/or medical androgen ablation on the imaging performance of Indium In 111 ProstaScint® has not been studied. Preliminary data suggest hormone ablation may increase PSMA expression, with concurrent decrease in tumor expression of PSA.3 The use of ProstaScint® in this patient population cannot be recommended at this time.

Drug/Laboratory Test Interactions

The presence of HAMA in serum as a result of ProstaScint® may interfere with some antibody-based immunoassays (such as PSA and digoxin). When present, this interference generally results in falsely high values. When following PSA levels, assay methods resistant to HAMA interference should be utilized. PSA assays which were found to be resistant to HAMA interference were Hybritech Tandem-R and Abbott IMX.

When patients have received Indium In 111 ProstaScint®, the clinical laboratory should be notified to take appropriate measures to avoid interference by HAMA with clinical laboratory testing procedures. These methods include the use of non-murine-based immunoassays, HAMA removal by adsorption, or sample pre-treatment to block HAMA activity.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic or mutagenic potential of Indium In 111 ProstaScint® or to evaluate its effect on fertility.

Pregnancy

ProstaScint® is not indicated for use in women.

Pediatric Use

The safety and effectiveness of Indium In 111 ProstaScint® in pediatric patients have not been established. ProstaScint® is not indicated for use in children.

ADVERSE REACTIONS

ProstaScint® (capromab pendetide) was generally well tolerated in the clinical trials. After administration of 529 single doses of Indium In 111 ProstaScint®, adverse reactions were observed in 4% of patients. The most commonly reported adverse reactions were increases in bilirubin, hypotension, and hypertension, which occurred in 1% of patients. Elevated liver enzymes and injection site reactions occurred in slightly less than 1% of patients. Other adverse reactions, listed in order of decreasing frequency, were: pruritus, fever, rash, headache, myalgia, asthenia, burning sensation in thigh, shortness of breath, and alteration of taste. Most adverse reactions were mild and readily reversible. Data from repeat administration in 61 patients revealed a similar incidence of adverse reactions (5%). No deaths were attributable to Indium In 111 ProstaScint® administration.

OVERDOSAGE

The maximum amount of Indium In 111 ProstaScint® (capromab pendetide) that can be safely administered has not been determined. In clinical studies, single doses of 10 mg of Indium In 111 ProstaScint® were administered to 20 patients with prostate cancer; the type and frequency of adverse reactions at this dose were similar to those observed with lower doses. The maximum Indium In 111 dose administered with ProstaScint® in a clinical study was 6.5 mCi.

DOSAGE AND ADMINISTRATION

The patient dose of the radiolabel must be measured in a dose calibrator prior to administration.

The recommended dose of ProstaScint® (capromab pendetide) is 0.5 mg radiolabeled with 5 mCi of Indium In 111 chloride. Each dose is administered intravenously over 5 minutes and should not be mixed with any other medication during its administration. Indium In 111 ProstaScint® may be readministered following infiltration or a technically inadequate scan; however, it is not indicated for readministration for the purpose of assessment of response to treatment (see INDICATIONS AND USAGE).

Each ProstaScint® kit is a unit dose package. After radiolabeling with Indium In 111, the entire Indium In 111 ProstaScint® dose should be administered to the patient. Reducing the dose of Indium In 111, unlabeled ProstaScint®, or Indium In 111 ProstaScint® may adversely impact imaging results and is, therefore, not recommended. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Radiation Dosimetry

The estimated absorbed radiation doses to an average adult patient from an intravenous injection of ProstaScint® labeled with 5 mCi of Indium In 111 are shown in TABLE 6. Total dose estimates include absorbed radiation doses from both Indium In 111 and the Indium In 114m radiocontaminant. A level of 0.06% of Indium In 114m was utilized for the dose estimates presented in TABLE 6.

TABLE 6 - ESTIMATED AVERAGE ABSORBED RADIATION DOSE IN ADULT PATIENTS FROM INTRAVENOUS ADMINISTRATION OF ProstaScint® LABELED WITH 5 mCi (185 MBq) OF INDIUM IN 111 CHLORIDEa
a Based on data from 21 patients who received doses of ProstaScint® labeled with a mean (± SD) Indium In 111 dose of 4.6 ± 1.0 mCi.
Organ	Average Dose (rad/5 mCi)	Average Dose (mGy/185 MBq)
Total body	2.7	27
Brain	1.1	11
Liver	18.5	185
Spleen	16.3	163
Kidneys	12.4	124
Lungs	5.6	56
Heart wall	7.8	78
Red marrow	4.3	43
Adrenals	5.2	52
Urine Bladder wall	2.2	22
Bone Surfaces	4.0	40
Stomach	3.1	31
Gall Bladder Wall	7.3	73
Small Intestine	3.3	33
Upper Large Intestine Wall	5.0	50
Lower Large Intestine Wall	7.6	76
Pancreas	5.1	51
Skin	1.1	11
Testes	5.6	56
Prostate	8.2	82
Thymus	2.6	26
Thyroid	1.4	14
Other Tissues	2.0	20

Directions for Radiolabeling ProstaScint® (capromab pendetide) with Indium In 111 Chloride

Proper aseptic techniques and precautions for handling radioactive materials should be employed. Waterproof gloves should be worn during the radiolabeling procedure. The preparation of the product should be done by the following procedure.

1. Required materials, not supplied:
   
   1. Indium In 111 Chloride from GE Healthcare, Inc. or Covidien, Inc.
   
   
   2. One sterile 1 mL syringe, one sterile 3 mL syringe
   
   
   3. Vial shield
   
   
   4. Dose calibrator set for Indium In 111
   
   
   5. Biodex Dark Green Chromatography strips
   
   
   6. Developing chamber for chromatography (e.g. scintillation vial)
   
   
   7. 21-23 gauge sterile needles
   
   
   8. Shield for 10 mL syringe
   
   
   9. Waterproof gloves
   
   
   10. Alcohol wipe
   
   
   11. Water-soluble marker
   
   
   12. 0.9% sodium chloride solution
   
   
   13. 0.05 M solution of diethylenetriamine pentaacetic acid (DTPA)
   
   
   14. Gamma ray detector
   
   


2. Sterile, pyrogen-free Indium In 111 Chloride solution must be utilized in the preparation of the Indium In 111 ProstaScint®. The use of high purity Indium In 111 Chloride manufactured by GE Healthcare, Inc. or by Covidien, Inc. is required. The Indium In 111 Chloride should be used only to radiolabel ProstaScint® and should not be injected directly into the patient. The Indium In 111 Chloride should not be utilized after its expiration date.


3. Before radiolabeling, bring the refrigerated ProstaScint® to room temperature. Note: ProstaScint® is a protein solution which may develop translucent particulates. These particulates will be removed by filtration.


4. Clean the rubber stopper of each vial with an alcohol wipe. With a sterile 1 mL syringe add 0.1 mL of sodium acetate solution to the shielded vial of Indium In 111 chloride and mix. Retain remaining sodium acetate for use in Step 7.


5. With the same 1 mL syringe, withdraw between 6 and 7 mCi of the buffered Indium In 111 chloride and add to the ProstaScint® vial. Flush the syringe to mix the preparation. Swirl gently to mix, and assay contents in a dose calibrator. On one of the labels provided, record the patient's identification, the date, time of preparation, and activity in the vial. Affix the label to the vial shield.


6. Allow the labeling reaction to proceed at room temperature for 30 minutes.


7. With a 3 mL syringe, add the remaining sodium acetate to the ProstaScint® reaction vial. To normalize pressure, withdraw an equal volume of air.


8. Aseptically attach the 0.22 μm Millex® GV sterile filter (provided) and a sterile hypodermic needle to a 10 mL sterile disposable syringe and withdraw the contents of the reaction vial through the filter into the syringe. Keep the needle immersed in the solution to avoid creating an air-lock in the filter.


9. Remove the filter and needle. Aseptically attach a fresh sterile hypodermic needle to the syringe. Assay syringe and contents in a dose calibrator. The syringe should contain not less than 4 mCi (148 MBq) of Indium In 111 ProstaScint®.


10. Radiochemical purity (RCP) by Instant Thin Layer Chromatography (ITLC) can be determined by the following procedure:
    
    1. Mix equal parts (several drops of each) of Indium In 111 ProstaScint® (Capromab Penditide) with DTPA solution. Allow the mixture to stand at room temperature for one minute. Spot a small drop of the mixture onto an ITLC strip at its origin.
    
    
    2. Add 0.9% sodium chloride solution to the developing chamber to a depth of about 0.5 cm. Place the strip in a chromatography chamber with the origin at the bottom (ensure the strip does not bend or touch the walls of the chamber) and allow the solvent to migrate to about 0.5 cm from the end of the strip. A small dot made with a felt tip pen at this distance can help indicate the arrival of the solvent front. Remove from the chamber and cut the strip in half and measure the counts per minute (CPM) of both halves with a gamma ray detector.
    
    
    3. Calculate the percent RCP as follows:
       
       %RCP =              CPM bottom half              x 100
       
                       CPM bottom half + CPM top half
    
    
    4. If the radiochemical purity is <90%, the ITLC procedure should be repeated. If repeat testing remains <90%, the preparation should not be administered.
    
    


11. On the second label provided in the kit, record the patient's identification, the date, time of assay, and activity in the syringe. Affix this label to the syringe shield.


12. Indium In 111 ProstaScint® should be used within 8 hours of radiolabeling.


13. Discard vials, needles, and syringes in accordance with local, state, and federal regulations governing radioactive and biohazardous waste.

Image Acquisition and Interpretation

Images should be acquired using a large field of view gamma camera equipped with a parallel hole medium energy collimator. The gamma camera should be calibrated using the 172 and 247 keV photopeaks for Indium In 111 with a 15-20% symmetric window.

Whole body or spot planar views of the pelvis, abdomen, and thorax should be performed between 72 and 120 hours following Indium In 111 ProstaScint® (capromab penditide) infusion. A cathartic is required the evening before imaging and a cleansing enema should be administered within an hour prior to each 72-120 hour imaging session. In addition, the bladder should be catheterized and irrigated.

Whole body acquisition should be carried out from skull through mid-femur. The total scan time over this area should be no less than 35 minutes using a 128x512 or 256x1024 matrix.

Planar images should be acquired in anterior and posterior views for 7.5 minutes per view using a 128x128 or 256x256 matrix. Due to uptake of Indium In 111 ProstaScint® by the liver, planar images obtained with the liver in the field of view must be acquired with adequate counts to allow the detection of lesions in the adjacent extrahepatic abdomen and pelvis. This may result in pixel overflow with image degradation in the region of the liver.

Two SPECT imaging sessions are necessary. The first SPECT session should be of the pelvis and be performed approximately 30 minutes after infusion to obtain a blood pool image. The second SPECT session should include both the pelvis and abdomen, including the lower liver margin through the prostatic fossa and be performed between 72 and 120 hours after infusion for detection of benign and malignant prostate tissue sites. Depending upon the capability of the camera field of view to include both pelvis and abdomen, either one or two separate acquisitions may be necessary during the second session.

To resolve imaging ambiguities possibly resulting from activity in blood pool, stool or urinary bladder, follow-up imaging sessions with full patient preparation should be performed.

The SPECT Images should be acquired using a 64x64 or 128x128 matrix for a minimum of 60 or 120 stops, respectively, over 360 degrees rotation for approximately 25 seconds per view at the first session and 50 seconds per view at the second session. Reconstruction should be performed using a Butterworth filter or equivalent in the transverse, coronal and sagittal views. An order of 5 and cut off of 0.5 may be used as a starting point. Slice thickness should be in the range of 6 to 12 mm.

Following Indium In 111 ProstaScint® (capromab penditide) administration, some of the radiolabel localizes in normal liver, spleen, bone marrow and genitalia.

It has been reported that Indium In 111 labeled antibodies may localize non-specifically in colostomy sites, degenerative joint disease, abdominal aneurysms, post-operative bowel adhesions, and local inflammatory lesions, including those typically associated with inflammatory bowel disease or secondary to surgery or radiation. Indium In 111 ProstaScint® can demonstrate apparent localization to sites of tortuous blood vessels. Careful review of the patient's medical history and other diagnostic information should aid in the interpretation of the images.

The diagnostic images acquired with Indium In 111 ProstaScint® should be interpreted in conjunction with other appropriate diagnostic tests.

HOW SUPPLIED

The ProstaScint® (capromab pendetide) kit (NDC No. 57902-817-01) for the preparation of Indium In 111 labeled Capromab Pendetide includes one vial containing 0.5 mg of ProstaScint® per 1 mL of sodium phosphate buffered saline and one 2 mL vial of sodium acetate solution, 0.5 M. These solutions are sterile and pyrogen free and contain no preservatives. Each kit also includes one sterile 0.22 μm Millex® GV filter, prescribing information, and two identification labels.

Storage

Store at 2° to 8°C (36° to 46°F). Do not freeze. Store upright.

REFERENCES

1. Kocher, DC: Radioactive decay data tables. DOE/TIC 115:11026, 1981.


2. Data supplied by Oak Ridge Associated Universities. Radiopharmaceutical Internal Dose Information Center, 1984.


3. Wright, GL, Jr; et al. Expression of Prostate-Specific Membrane Antigen in Normal, Benign, and Malignant Prostate Tissues. Urol Oncol. 1995; 1:18-28.

EUSA Pharma (USA) Customer Service: (800) 833-3533

Manufactured by EUSA Pharma (USA), Inc.

Langhorne, PA 19047

License 1829

ProstaScint® is a registered trademark of

2010 EUSA Pharma (USA), Inc.

Printed in USA   606-0870A   Rev F

Revised 12/2010

PRINCIPAL DISPLAY PANEL

ProstaScint® Kit for the Preparation of Indium In 111 Capromab Pendetide (NDC 57902-817-01)

ProstaScint®

Kit for the Preparation of Indium In 111 Capromab Pendetide

EUSAPharma

Rx Only

A murine monoclonal antibody conjugate. Single dose. For intravenous administration only after preparation according to instructions. See enclosed insert.

Package contents (one adult unit-dose):

1 vial ProstaScint® (capromab pendetide) 0.5mg/mL (1mL)*, in PBS pH 6

1 vial Sodium Acetate Buffer Solution 0.5M (2mL)*

1 Millex® GV Filter (0.22μm)

1 Package insert with two identification labels.

*Refer to enclosed package insert for quantitative composition and directions for use.

Sterile and pyrogen-free. Contains no preservative.

Caution: Federal law prohibits dispensing without prescription.

No U.S. standard of potency.

 

ProstaScint KIT FOR THE PREPARATION OF INDIUM IN 111 CAPROMAB PENDETIDE  capromab pendetide  kit

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 57902-817

Packaging # NDC Package Description Multilevel Packaging 1 57902-817-01 1 KIT In 1 BOX None

QUANTITY OF PARTS Part # Package Quantity Total Product Quantity Part 1 1 VIAL, SINGLE-DOSE   1 mL Part 2