Westcort

hydrocortisone valerate

Dosage Form: cream

For Dermatologic Use Only. Not for Ophthalmic Use.

Westcort Description

Westcort® (hydrocortisone valerate cream) Cream, 0.2% contains hydrocortisone valerate, 11,21-dihydroxy-17-[(1-oxopentyl)oxy]-(11β)-pregn-4-ene-3,20-dione, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, hydrocortisone valerate is C26H38O6. It has the following structural formula:

Hydrocortisone valerate has a molecular weight of 446.58. It is a white, crystalline solid, soluble in ethanol and methanol, sparingly soluble in propylene glycol and insoluble in water.

Each gram of Westcort Cream contains 2.0 mg hydrocortisone valerate in a hydrophilic base composed of amphoteric-9, carbomer 940, dried sodium phosphate, propylene glycol, sodium lauryl sulfate, sorbic acid, stearyl alcohol, water and white petrolatum.

Westcort - Clinical Pharmacology

Like other topical corticosteroids, hydrocortisone valerate has anti-inflammatory, antipruritic and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier. Occlusive dressings with hydrocortisone for up to 24 hours have not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.

Studies performed with Westcort Cream indicate that it is in the medium range of potency as compared with other topical corticosteroids.

Indications and Usage for Westcort

Westcort Cream is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in adult patients.

Contraindications

Westcort Cream is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Precautions

General

Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment.

Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. This may be done by using the ACTH stimulation, A.M. plasma cortisol, and urinary free cortisol tests.

Westcort Cream has produced mild, reversible adrenal suppression in adult patients when used under occlusion for 5 days, 15 grams twice a day over 25 to 60% body surface area or when used three times a day over 20 to 30% body surface area to treat psoriasis for 3-4 weeks.

If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for these products.

Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. (See PRECAUTIONS: Pediatric Use.)

If irritation develops, Westcort® (hydrocortisone valerate cream) Cream, 0.2% should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noting a clinical exacerbation, as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.

If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of Westcort Cream should be discontinued until the infection has been adequately controlled.

Information for Patients

Patients using topical corticosteroids should receive the following information and instructions:

1)

This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.

2)

This medication should not be used for any disorder other than that for which it was prescribed.

3)

The treated skin area should not be bandaged, otherwise covered or wrapped, so as to be occlusive unless directed by the physician.

4)

Patients should report to their physician any signs of local adverse reactions.

5)

Westcort Cream should not be applied in the diaper areas as diapers or plastic pants may constitute occlusive dressings. (See DOSAGE AND ADMINISTRATION.)

6)

This medication should not be used on the face, underarms, or groin areas unless directed by the physician.

7)

As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, contact the physician.

Laboratory Tests

The following tests may be helpful in evaluating patients for HPA axis suppression:

 

ACTH stimulation test

 

A.M. plasma cortisol test

 

Urinary free cortisol test

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential of hydrocortisone valerate. Westcort Cream was shown to be non-mutagenic in the Ames-Salmonella/Microsome Plate Test. There are no studies which assess the effects of hydrocortisone valerate on fertility and general reproductive performance.

Pregnancy: Teratogenic Effects, Pregnancy Category C

Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.

Dermal embryofetal developmental studies were conducted in rabbits and rats with hydrocortisone valerate cream, 0.2%. Hydrocortisone valerate cream, 0.2%, was administered topically for 4 hours/day, rather than the preferred 24 hours/day, during the period of organogenesis in rats (gestational days 5-16) and rabbits (gestational days 6-19). Topical doses of hydrocortisone valerate up to 9 mg/kg/day (54 mg/m2/day) were administered to rats and 5 mg/kg/day (60 mg/m2/day) were administered to rabbits. In the absence of maternal toxicity, a significant increase in delayed skeletal ossification in fetuses was noted at 9 mg/kg/day [2.5X the Maximum Recommended Human Dose (MRHD) based on body surface area (BSA) comparisons] in the rat study. No malformations in the fetuses were noted at 9 mg/kg/day (2.5X MRHD based on BSA comparisons) in the rat study. Indicators of embryofetal toxicity, significant decrease in fetal weight at 2 mg/kg/day (1X MRHD based on BSA) and a significant increase in post-implantation loss and embryo resorption at 5 mg/kg (3X MRHD based on BSA), were noted in the rabbit study. A significant increase in delayed skeletal ossification in fetuses was noted at 5 mg/kg/day (3X the MRHD based on BSA comparisons) in the rabbit study. Increased numbers of fetal malformations (e.g., cleft palate, omphalocele and clubbed feet) were noted at 5 mg/kg/day (3X MRHD based on BSA comparisons) in the rabbit study.

There are no adequate and well-controlled studies in pregnant women. Westcort® (hydrocortisone valerate cream) Cream, 0.2% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Westcort Cream is administered to a nursing woman.

Pediatric Use

Safety of this product in pediatric patients has not been established. There is no data on adrenal suppression and/or growth suppression.

Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing’s syndrome when they are treated with topical corticosteroids. They are therefore also at a greater risk of adrenal insufficiency during and/or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children. (See PRECAUTIONS.)

HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels, and an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Geriatric Use

Clinical studies of Westcort Cream did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

Adverse Reactions

The following local adverse reactions have been reported with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria.

In controlled clinical studies involving pediatric patients one month to 2 years of age (n=29), the incidence of adverse experiences, regardless of relationship to the use of Westcort Cream, was approximately 21%. Reported reactions included stinging (10%), eczema (7%), fungal infection (3%), and gastrointestinal disorder (3%).

In controlled clinical studies involving pediatric patients 2 to 12 years of age (n=153), the incidence of adverse experiences, regardless of relationship to the use of Westcort Cream, was approximately 10%. Reported reactions included stinging (3%), burning skin (2%), infection (Body as a Whole) (2%). Skin irritation, eczema, pruritus, application site reaction, rash, rash maculopapular, and dry skin were all reported at incidences of approximately 1%.

Overdosage

Topically applied Westcort Cream can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

Westcort Dosage and Administration

Westcort Cream should be applied to the affected area as a thin film two or three times daily depending on the severity of the condition.

As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.

Westcort Cream should not be used with occlusive dressings unless directed by a physician. Westcort Cream should not be applied in the diaper area if the patient requires diapers or plastic pants as these garments may constitute occlusive dressing.

How is Westcort Supplied

Westcort® (hydrocortisone valerate cream) Cream, 0.2%, is supplied in the following tube sizes:

 

15 g NDC 0072-8100-15: NSN 6505-01-093-9901

 

45 g NDC 0072-8100-45: NSN 6505-01-083-9395

 

60 g NDC 0072-8100-60: NSN 6505-01-121-0118

STORAGE

Store between 20° C-25° C (68° F-77° F); excursions permitted between 15° C and 30° C.

Distributed by:

Westwood-Squibb Pharmaceuticals, Inc.

A Bristol-Myers Squibb Company

Princeton, NJ 08543 USA


51-022263-01

Revised April 2006

Westcort  hydrocortisone valerate  cream

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0072-8100 Route of Administration TOPICAL DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength hydrocortisone valerate (hydrocortisone) Active 2 MILLIGRAM  In 1 GRAM amphoteric-9 Inactive   carbomer 940 Inactive   dried sodium phosphate Inactive   propylene glycol Inactive   sodium lauryl sulfate Inactive   sorbic acid Inactive   stearyl alcohol Inactive   water Inactive   white petrolatum Inactive

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0072-8100-15 1 TUBE In 1 CARTON contains a TUBE 1 15 g (GRAM) In 1 TUBE This package is contained within the CARTON (0072-8100-15) 2 0072-8100-45 1 TUBE In 1 CARTON contains a TUBE 2 45 g (GRAM) In 1 TUBE This package is contained within the CARTON (0072-8100-45) 3 0072-8100-60 1 TUBE In 1 CARTON contains a TUBE 3 60 g (GRAM) In 1 TUBE This package is contained within the CARTON (0072-8100-60)

Revised: 05/2007Bristol-Myers Squibb Company

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• Westcort Drug Interactions
• Westcort Support Group
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• Westcort Topical application Advanced Consumer (Micromedex) - Includes Dosage Information


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Xenical

Pronunciation: OR-li-stat
Generic Name: Orlistat
Brand Name: Xenical

Xenical is used for:

Managing obesity in adults and adolescents 12 years old and older. It is also used to reduce the risk of weight regain after previous weight loss. It is used along with a reduced-calorie diet.

Xenical is a gastrointestinal lipase inhibitor. It works by blocking the digestion of fats from the diet.

Do NOT use Xenical if:

• you are allergic to any ingredient in Xenical


• you constantly have problems absorbing food (chronic malabsorption)


• you have gallbladder problems


• you have cholestasis (a problem of bile flow from the liver to the intestines)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Xenical:

Some medical conditions may interact with Xenical. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have an underactive thyroid


• if you have a history of kidney stones, pancreas problems, liver problems, diabetes, or an eating disorder (eg, anorexia, bulimia)


• if you are taking another medicine for weight loss

Some MEDICINES MAY INTERACT with Xenical. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Anticoagulants (eg, warfarin) because the risk of their side effects, including the risk of bleeding, may be increased by Xenical


• Amiodarone, cyclosporine, or thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by Xenical

This may not be a complete list of all interactions that may occur. Ask your health care provider if Xenical may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Xenical:

Use Xenical as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Xenical. Talk to your pharmacist if you have questions about this information.


• Take Xenical by mouth with or up to 1 hour after each main meal that contains fat (up to 3 per day).


• If a meal is missed or contains no fat, do not take a dose of Xenical.


• You should take a multivitamin supplement containing vitamins A, D, E, and K to ensure good nutrition. The supplement should be taken at least 2 hours before or after you take Xenical, such as at bedtime.


• If you also take a thyroid hormone (eg, levothyroxine), do not take it within 4 hours before or after taking Xenical. Check with your doctor if you have questions.


• If you also take cyclosporine, do not take it within 2 hours before or after taking Xenical. Check with your doctor if you have questions.


• If you miss a dose of Xenical, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Xenical.

Important safety information:

• Do NOT take more than the recommended dose without checking with your doctor. Taking more than the recommended dose will not make you lose more weight and may increase side effects.


• Tell your doctor or dentist that you take Xenical before you receive any medical or dental care, emergency care, or surgery.


• Follow the diet program given to you by your health care provider. Your daily intake of fat should be divided evenly over 3 meals.


• Eating a meal high in fat while taking Xenical increases the risk of side effects involving the stomach and intestines.


• Diabetes patients - Xenical may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Rarely, some patients taking Xenical have developed severe liver problems. Contact your doctor right away if you experience yellowing of the skin or eyes, dark urine, pale stools, unusual weakness, loss of appetite, or severe or persistent nausea.


• Xenical should not be used in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Xenical while you are pregnant. It is not known if Xenical is found in breast milk. Do not breast-feed while taking Xenical.

Possible side effects of Xenical:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Bowel movement urgency; gas with discharge; inability to control bowel movements; increased number of bowel movements; oily discharge; oily or fatty stools; oily spotting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue); bloody urine; new or unusual back pain; severe or persistent stomach pain (with or without nausea and vomiting); symptoms of liver damage (eg, yellowing of the eyes or skin, dark urine, pale stools, loss of appetite, severe or persistent nausea).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Xenical side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Xenical:

Store Xenical below 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Xenical out of the reach of children and away from pets.

General information:

• If you have any questions about Xenical, please talk with your doctor, pharmacist, or other health care provider.


• Xenical is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is summary only. It does not contain all information about Xenical. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Xenical resources

• Xenical Side Effects (in more detail)
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• Xenical Drug Interactions
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• 27 Reviews for Xenical - Add your own review/rating

• Xenical Prescribing Information (FDA)


• Xenical Advanced Consumer (Micromedex) - Includes Dosage Information


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Hypercare

aluminum chloride hexahydrate and alcohol

Dosage Form: solution
Hypercare® SOLUTION

Rx only

Hypercare SOLUTION is a solution of: Aluminum Chloride (Hexahydrate) 20% w/v in Anhydrous Ethyl Alcohol (S.D. Alcohol 40) 93% v/v.

INDICATION:

An aid in the management of hyperhidrosis.

DIRECTIONS:

Apply Hypercare to the affected area once a day, only at bedtime. To help prevent irritation, the area should be completely dry prior to application. Do not apply Hypercare to broken, irritated or recently shaved skin.

This product is not intended to be used as a roll-on. Turn the bottle upside-down and apply a small amount of pressure to release the solution into the Dab-O-Matic™ applicator. Then apply the Dab-O-Matic™ applicator to the affected areas.

CAUTION:

Do not apply excessive pressure on the bottle. Excessive pressure will cause the Dab-O-Matic™ applicator to become dislodged and the solution could spill. DO NOT APPLY AS A ROLL-ON.

FOR MAXIMUM EFFECT:

Your doctor may instruct you to cover the treated area with saran wrap held in place by a snug fitting "T" or body shirt, mitten or sock (never hold saran in place with tape). Wash the treated area the following morning. Excessive sweating may be stopped after two or more treatments. Thereafter, apply Hypercare once or twice weekly or as needed.

NOTICE:

Hypercare may produce a burning or prickling sensation. Keep cap tighly closed when not in use to prevent evaporation.

WARNING:

For external use only. Keep out of reach of children. Avoid contact with eyes. If irritation or sensitization occurs, discontinue use or consult with a physician. Hypercare may be harmful to certain metals and fabrics. Do not use near open flame.

PACKAGE:

37.5 cc polyethylene bottle.

NDC 58980-150-10.

35 cc bottle with Dab-O-Matic™ applicator.

NDC 58980-150-11.

60 cc bottle with Dab-O-Matic™ applicator.

NDC 58980-150-20.

INSTRUCTIONS FOR THE USE OF Hypercare

APPLICATION:

Dab-O-Matic™ Bottle – Apply Hypercare from the convenient applicator to the affected area.

Plastic Bottle – Moisten a cotton ball with Hypercare and apply to the affected area.

Apply once a day, only at bedtime. To help prevent irritation, the area should be completely dry prior to application. Do not apply Hypercare to broken, irritated or recently shaved skin.

FOR MAXIMUM EFFECT:

Your doctor may instruct you to cover the treated area with a saran wrap held in place by a snug fitting "T" or body shirt, mitten or sock (never hold saran in place with tape).

Wash the treated area the following morning.

Excessive sweating may be stopped after two or more treatments. Thereafter, apply Hypercare once or twice a week or as needed.

WARNING:

For external use only. Avoid contact with eyes. If irritation or sensitization occurs, discontinue use or consult with a physician. Keep out of the reach of children. Hypercare may be harmful to certain metals or fabrics. Keep away from open flame.

STORAGE:

Store between 15°-30°C (59°-86°F).

Manufactured by:

Sonar Products Inc.

Carlstadt, NJ 07072

Exclusively for:

Stratus Pharmaceuticals Inc.

14377 Southwest 142nd Street

Miami, Florida 33186-6727

Customer Service: 800-442-7882

Fax: 305-254-6875

Distributed by

STRATUS

PHARMACEUTICALS INC.

JG-HCSINS-20060213

RECOMMENDED APPLICATION PROCEDURES FOR:

HYPERHIDROSIS OF UNDERARMS (Axillae)

Apply Hypercare evenly to dry skin of underarms. To minimize irritation let the alcohol evaporate (if needed, blow dry with a hair dryer on a cold air setting) leaving an evenly distribution film of the antiperspirant on the skin. Wear a T-shirt while sleeping to prevent the medication from being rubbed off on bed linens. Do not apply Hypercare to broken, irritation or recently shaved skin. Now check instructions under "Next Morning".

HYPERHIDROSIS OF PALMS (Hands)

Apply Hypercare evenly to both palms, let the alcohol evaporate, leaving a thin film of antiperspirant on the skin. To keep the medication from being rubbed off during sleep, cover each hand with a sheet of saran wrap, held in place with a mitten or a cotton glove. (Do not use adhesive tape). Now check instructions under "Next Morning".

HYPERHIDROSIS OF FEET (Bromhidrosis)

Apply Hypercare evenly to both soles, let the alcohol evaporate, leaving a thin film of antiperspirant on the skin. To keep the medication from being rubbed off during sleep, cover each sole with a sheet of saran wrap, held in place with a sock. (Do not use adhesive tape). Now check the instructions under "Next Morning".

HYPERHIDROSIS OF THE SCALP

Apply Hypercare evenly to the scalp. Avoid contact with eyes. Let the alcohol evaporate, leaving a thin film of antiperspirant on the scalp. To keep the medication from being rubbed off during sleep, wear a plastic shower cap. Now check instructions under "Next Morning".

NEXT MORNING (Upon Arising)

Depending on the area being treated: Remove the T-shirt, gloves, socks or shower cap. Remove and discard saran wrap. Wash the treated area thoroughly with soap and water or shampoo, to remove the residual antiperspirant and to prevent skin irritation as well as damage to dry clothing, then towel dry the skin or scalp. Do not apply other deodorants or antiperspirants while using Hypercare. Following these procedures, repeat applications of Hypercare for 2 or 3 nights, until the desired ANHIDROSIS (lack of sweating) is achieved. Generally, after that, an application once or twice a week should maintain needed controlled protection from hyperhidrosis. Occasionally, there is some tingling or itching after application. Any irritation it might produce is temporary and will subside if application is avoided for a few days. Hypercare is not absorbed but works locally on outer skin.

Distributed by

STRATUS

PHARMACEUTICALS INC.

PRINCIPAL DISPLAY PANEL - 35 cc Carton

NDC 58980-150-11

Hypercare™

Hypercare

SOLUTION

is a solution

of: Aluminum

Chloride

(Hexahydrate)

20% w/v in

Anhydrous

Ethyl Alcohol

(S.D. Alcohol

40) 93% v/v.

Rx only

Distributed by:

STRATUS

NET WT 35 cc

Hypercare  aluminum chloride hexahydrate and alcohol  solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 58980-150 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALUMINUM CHLORIDE HEXAHYDRATE (ALUMINUM CATION) ALUMINUM CHLORIDE HEXAHYDRATE 1 g  in 5 mL Alcohol (Alcohol) Alcohol 1.25 g  in 1 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 58980-150-10 1 CYLINDER In 1 BOX contains a CYLINDER 1 37.5 mL In 1 CYLINDER This package is contained within the BOX (58980-150-10) 2 58980-150-11 1 CYLINDER In 1 BOX contains a CYLINDER 2 35 mL In 1 CYLINDER This package is contained within the BOX (58980-150-11) 3 58980-150-20 1 CYLINDER In 1 BOX contains a CYLINDER 3 60 mL In 1 CYLINDER This package is contained within the BOX (58980-150-20)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved other		12/07/2001

Labeler - Stratus Pharamceuticals, Inc (789001641)

Establishment
Name	Address	ID/FEI	Operations
Sonar Products, Inc		104283945	MANUFACTURE

Revised: 10/2009Stratus Pharamceuticals, Inc

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• Hypercare Use in Pregnancy & Breastfeeding
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• 109 Reviews for Hypercare - Add your own review/rating

• Hypercare topical Concise Consumer Information (Cerner Multum)


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Proleukin

Proleukin 18 million IU powder for solution for injection or infusion

Aldesleukin

Read all of this leaflet carefully before you are given this medicine.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet

• 1. What Proleukin is and what it is used for


• 2. Before you are given Proleukin


• 3. How Proleukin is used


• 4. Possible side effects


• 5. How to store Proleukin


• 6. Further information

What Proleukin Is And What It Is Used For

Proleukin is the brand name of aldesleukin. It is a synthetic protein, very similar to a protein produced by the body called interleukin-2 (IL-2). This protein is part of the immune system. IL-2 activates certain white blood cells in the body called lymphocytes, which fight against diseases and infections. IL-2 stimulates the production of lymphocytes in the body, and enhances the body's defences.

Proleukin is used to treat kidney cancer which has spread to other organs (also called metastatic renal cell carcinoma).

Before You Are Given Proleukin

Follow carefully all instructions given to you by your doctor.

Your doctor may carry out tests before you are treated with Proleukin. He/she will check your response to the treatment at regular intervals and take any necessary action.

You should not be given Proleukin

• If you are allergic (hypersensitive) to adesleukin or any of the other ingredients of Proleukin.



• If you are confined to bed for more than half the day.



• If it is less than 24 months since your kidney cancer was diagnosed and you have cancer symptoms, even if the cancer has spread to other organs.



• If you have a history of heart disease.



• If you have an infection for which you are taking antibiotics.



• If you have a shortage of oxygen in your blood.



• If you have serious problems with your liver, kidneys or any other organs.



• If you suffer from seizures (convulsions or fits), or from brain cancer that has not been successfully treated.



• If you have had an organ transplant.



• If you currently use medicines called corticosteroids to treat inflammatory reactions or if you may require these during Proleukin therapy.



• If you have had rheumatoid arthritis, Crohn's disease or any other disease caused by your own immune system.

If any of the above applies to you, talk to your doctor. You should not be given Proleukin.

Also, Proleukin should not be given to you if blood tests show that:

You have a low level of white blood cells, platelets or red blood cells.

You have creatinine or bilirubin levels outside the normal range.

Take special care with Proleukin

• If you have chest pain or irregular heart beat. In some patients an electrocardiogram (ECG) will be carried out at regular intervals.



• If you become short of breath or you start breathing faster during treatment.



• If you feel extremely tired or sleepy, because this may be a signal that you are losing consciousness.

If you get any of the symptoms listed above, tell your doctor immediately.

You should also take special care:

• If you have a fever, shivers, chills, nausea and/or diarrhoea.



• If you feel dizzy. This may be a sign that you have low blood pressure, often seen within 2 to 12 hours after starting Proleukin administration.



• If you have a bacterial infection, since Proleukin treatment puts you at a higher risk of infection.



• If you notice mood changes. These in general return to normal after stopping therapy.



• If you have diabetes. Your blood sugar levels may increase or decrease more than usual.



• If you have a very itchy red rash or if your skin gets extremely dry during the treatment with Proleukin.

If any of the symptoms listed above gets severe, tell your doctor.

Using other medicines

Some medicines can decrease the effect of Proleukin, or increase side effects.

Tell your doctor or pharmacist if you are using any of the following medicines (or have recently used them).

• Chemotherapy medicines, called tamoxifen, interferon-alpha, cisplatin, vinblastine and/or dacarbazine, used to treat cancer.



• Medicines called glucocorticoids (a type of steroid), used to treat inflammatory reactions.



• Medicines called beta-blockers, used to treat high blood pressure.



• Medicines that affect the heart, central nervous system, liver, kidneys or bone marrow. Consult your doctor if you are not sure what these are.



• Contrast fluids used in Computerised Tomography (CT) scanning.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Children and adolescents (below 18 years)

Proleukin is not recommended for children and adolescents younger than 18 years.

Older people (65 years and over)

Older patients may be more susceptible to the side effects of Proleukin. Medical staff should take extra care when treating older people.

Pregnancy and breast-feeding

• Tell your doctor before starting treatment if you are pregnant, if you suspect that you are pregnant, or if you intend to become pregnant. Your doctor will discuss with you the risks and benefits of taking Proleukin during pregnancy.


• Both male and female patients should use effective contraception while being treated with Proleukin in order to prevent pregnancy. This is done with most other medicines used to treat cancer.


• Stop breast-feeding during treatment with Proleukin as there is a possibility that serious side effects could affect the baby.

Ask your doctor or pharmacist for advice before taking any medicine, while you are pregnant or breast-feeding.

Driving and using machines

Do not drive or use any tools or machines because Proleukin has side effects which may influence your ability to carry out these activities.

How Proleukin Is Used

Proleukin can be given to you:

• either as a drip into a vein (intravenous infusion). This should be carried out in the hospital, under supervision of a doctor or nurse experienced in the use of medicines to treat cancer,


• or by injection directly under the skin (subcutaneous injection). This can be administered in a hospital, in an outpatient's department or at home, under supervision of a doctor or nurse.

Before and during your Proleukin therapy, your doctor may perform regular blood tests and chest X-rays, to check your organs and your blood cell counts.

Follow all instructions given to you by your doctor or nurse carefully.

If you have been given more Proleukin than you should

If you have or think you have been given too much Proleukin, contact your doctor or nurse immediately. You might get some of the side effects described in section 4.

Proleukin Side Effects

Like all medicines, Proleukin can cause side effects, although not everybody gets them. The side effects of Proleukin usually disappear within two days after stopping treatment.

Your doctor may consider it necessary to treat the side effects of Proleukin with other medicines.

Some side effects can be serious

Very common (affecting more than 1 in 10 patients) or common (affecting less than 1 in 10 patients):

• Blood disorders: low levels of white blood cells (leucopenia) with symptoms of fever or increased risk of infections; low levels of platelets in your blood with bruises and spontaneous bleeding (thrombocytopenia); low levels of red blood cells (anaemia) with symptoms such as fatigue and pale skin; blood clotting disorders with sudden onset of shortness of breath, bloody sputum, leg pain or easy bleeding.


• Heart and circulation problems: oppressive chest pain (angina); low blood pressure (hypotension) or high blood pressure (hypertension) associated with dizziness, blurred vision or constant headache; irregular heart beat (arrhythmia); fast heart beat (tachycardia); blue colour to the lips, tongue and skin due to oxygen deficiency in the blood (cyanosis).


• Breathing and lung problems: coughing; shortness of breath (dyspnoea) or chest discomfort.


• Kidney and urine problems: low urine production (oliguria), with high levels of urea and creatinine in the blood with symptoms such as vomiting, sleepiness, poor muscle tone or difficult breathing; blood in the urine (haematuria).


• Digestive and organ problems: stomach, intestine and rectal bleeding (resulting in black stools); vomiting blood (haematemesis); swelling of the belly (ascites); difficulty in swallowing (dysphagia).


• Nerve problems: sudden unconsciousness or fainting (syncope); loss of ability to speak.


• Feeling cold due to low body temperature (hypothermia); low level of calcium (hypocalcaemia) with possible muscle weakness, twitching or tingling of fingers; high level of potassium (hyperkalaemia) associated with cramps, abnormal heart rhythm, dizziness and headache.

If you experience any of the effects listed above, contact your doctor immediately or go to the nearest emergency unit.

Uncommon (affecting less than 1 in 100 patients) or rare (affecting less than 1 in 1,000 patients):

• Blood disorders: low levels of white blood cells with signs and symptoms of sudden high fever, severe sore throat, and more frequent infections (agranulocytosis); formation of blood clot (thrombosis); bleeding (haemorrhage).


• Heart problems: heart attack (myocardial infarction, myocardial ischemia); disorders of heart and blood vessels, such as abnormal or insufficient pumping force of the heart (heart failure); irregular heart beat; disease of the heart muscle with symptoms such as chest pain, fever or malaise; awareness of an abnormal heart beat (palpitations).


• Lung problems: sudden onset of breathing difficulty due to blood clots in the lung (pulmonary embolism); extreme difficulty in breathing (adult respiratory distress syndrome); coughing up blood (haemoptysis).


• Serious allergic reactions: anaphylaxis, leading to swelling of the face and throat and difficulty breathing (Quincke's oedema); high fever, skin rash with small blisters, joint pain and/or eye inflammation (Stevens Johnson syndrome.


• Digestive and organ problems: recurring (severe) inflammation of the bowels (Crohn's disease) accompanied with diarrhoea, pain in lower abdomen, fever, and weight loss; inflammation of the pancreas (pancreatitis) accompanied with severe pain in upper abdomen radiating to the back; constipation, swollen abdomen, abdominal pain (intestinal obstruction); upper abdominal pain (cholecystitis); liver failure with abdominal pain, fatigue, yellowish skin and eyes or dark yellow urine.


• Kidney failure associated with fatigue, sleepiness, loss of appetite, vomiting or swollen legs.


• Nerve problems: seizures (convulsions or fits); paralysis; coma; disturbances of the sight (optic neuropathy); central nervous lesion with tingling, numbness (paraesthesia) or loss of control of movement.


• Decreased or increased thyroid activity (hypo- or hyperthyroidism) with symptoms such as weight gain, weight loss, sweating or hearing loss; low glucose level (hypoglycaemia) associated with symptoms such as feeling hungry, sweating, dizziness, heart palpitations; high blood calcium level (hypercalcaemia) with symptoms such as feeling sick (nausea), vomiting or constipation.

If you experience any of the effects listed above, contact your doctor immediately or go to the nearest emergency unit.

Other side effects

Very common (affecting more than 1 in every 10 patients):

• Loss of appetite (anorexia).


• Anxiety; confusion; dizziness; headache; drowsiness (somnolence).


• Cough.


• Feeling sick (nausea) with or without vomiting; diarrhoea; mouth sores with inflammation (stomatitis).


• Redness of the skin (erythema), skin rash; peeling; itching.


• Reactions at injection site, such as pain and inflammation.


• Flu-like symptoms (fever, chills, malaise, fatigue); pain; weight loss, weight gain.

If any of these gets severe, tell your doctor or pharmacist.

Common (affecting less than 1 in 10 patients):

• Nose, throat and pulmonary infections; stuffed nose (nasal congestion).


• Dehydration with signs such as dryness of the mouth or feeling thirsty.


• Mood changes, e.g. irritability, excitement and restlessness (agitation), depression, observation of things which are not there (hallucinations); difficulty in sleeping (insomnia).


• Loss of control of movements, observation of itching and tingling of fingers or toes without cause (paraesthesia, neuropathy).


• Stomach discomfort after meal (dyspepsia); constipation.


• Sweating; loss of hair (alopecia).


• Muscle pain; joint pain.


• Eye inflammations (conjunctivitis) with itching redness and swelling.


• Swelling and reddening of a vein (phlebitis).


• Fluid accumulation (oedema); inflammation of mucous membranes (mucositis); swelling with nodes (nodules) at site of injection.


• High level of blood glucose (hyperglycaemia) with signs such as excessive thirst, hunger, urination or fatigue.


• Blood tests indicating a change in liver function e.g. high level of bilirubin (hyperbilirubinaemia) or liver enzymes in the blood (liver transaminase, alkaline phosphatase and lactate dehydrogenase).

If any of these gets severe, tell your doctor or pharmacist.

Uncommon (affecting less than 1 in 100 patients):

• Allergy reactions (hypersensitivity) leading to runny eyes, runny nose, skin rash or distress.


• Muscle weakness (myasthenia)


• Loss of taste.


• Nose bleeding (epistaxis).


• Inflammation of the lips (cheilitis); inflammation of the stomach resulting in stomach ache and nausea (gastritis).


• Skin discolouration (vitiligo).

If any of these gets severe, tell your doctor or pharmacist.

Rare (affecting less than 1 in 1,000 patients):

• Diabetes.


• Lethargy with signs of luck of energy, tiredness and sleepiness.


• Skin rash with small blisters filled with fluid (vesiculobullous rash).


• Tissue damage (necrosis) at injection site.

If any of these gets severe, tell your doctor or pharmacist.

Inflammation of the blood vessels (vasculitis) in the skin, brain, and rest of the body, has also been reported.

If any of the side effects gets severe, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How To Store Proleukin

Keep out of reach and sight of children.

Do not use Proleukin after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.

Store the unopened vials in a refrigerator (2°C-8°C). Do not freeze.

Store in the original package.

Your doctor, nurse or pharmacist knows how to store Proleukin properly.

Further Information

What Proleukin contains

• The active substance is aldesleukin, providing 18 million International Units (IU) (1.1 mg) per millilitre of solution reconstituted as recommended.


• The other ingredients are mannitol (E421), sodium laurylsulfate, sodium dihydrogen phosphate and disodium hydrogen phosphate.

What Proleukin looks like and contents of the pack

Proleukin is a sterile, white powder available in packs containing 1 or 10 vials.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

Manufacturer

Novartis Pharmaceuticals UK Ltd

Wimblehurst Road

Horsham West Sussex

RH12 5AB

UK

This leaflet was last approved in August 2008.

Laxative Gentle Suppositories

Generic Name: bisacodyl (bis AK oh dil)

Brand Names: Alophen, Bisac-Evac, Bisco-Lax, Carters Little Pills, Correctol, Doxidan Tablet, Dulcolax Laxative, Evac-U-Gen, Ex-lax Ultra, Feen-A-Mint, Fleet Bisacodyl, Gen Lax, Gentlax Tablet, Gentle Laxative, Laxative Gentle Suppositories, Magic Bullet, Modane, Veracolate

What is Laxative Gentle Suppositories (bisacodyl)?

Bisacodyl is a laxative that stimulates bowel movements.

Bisacodyl is used to treat constipation or to empty the bowels before surgery, colonoscopy, x-rays, or other intestinal medical procedure.

Bisacodyl may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Laxative Gentle Suppositories (bisacodyl)?

Do not use bisacodyl if you have stomach (abdominal) pain, nausea, or vomiting, unless directed by a doctor.

If you notice a sudden change in bowel habits that persists over a period of 2 weeks, consult your healthcare provider before using a laxative.

Bisacodyl products should not be used for longer than one week, unless otherwise directed by your healthcare provider.

Rectal bleeding or failure to have a bowel movement after use of a laxative may indicate a more serious condition. Stop using bisacodyl and contact your healthcare provider.

What should I discuss with my healthcare provider before using Laxative Gentle Suppositories (bisacodyl)?

You should not use this medication if you are allergic to bisacodyl, or if you have:

• 
  

  severe stomach pain, nausea, or vomiting;

  
  


• 
  

  a perforated bowel;

  
  


• 
  

  a blockage in your intestines;

  
  


• 
  

  fructose or galactose intolerance;

  
  


• 
  

  an allergy to yellow food dye;

  
  


• 
  

  severe constipation or dehydration;

  
  


• 
  

  inflammatory bowel disease, toxic megacolon; or

  
  


• 
  

  a sudden change in bowel habits lasting 2 weeks or longer.

  
  

People with eating disorders (such as anorexia or bulimia) should not use this medication without the advice of a doctor.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use bisacodyl:

• 
  

  kidney disease;

  
  


• 
  

  trouble swallowing;

  
  


• 
  

  a history of bowel obstruction, diverticulitis, ulcerative colitis, or other intestinal disorder; or

  
  


• 
  

  if you are taking a diuretic ("water pill").

  
  

Do not use bisacodyl without telling your doctor if you are pregnant. Do not use bisacodyl without telling your doctor if you are breast-feeding a baby. Do not give this medication to a child without the advice of a doctor.

When used to treat constipation, bisacodyl is only part of a complete program of treatment that may also include diet and exercise. Follow your doctor's instructions very closely.

How should I use Laxative Gentle Suppositories (bisacodyl)?

Use this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.

For best results, take bisacodyl on an empty stomach, or at bedtime. Do not crush, chew, or break the enteric-coated tablet. Swallow it whole. The enteric-coated pill has a special coating to protect your stomach. Breaking the pill could damage this coating. Do not take a bisacodyl rectal (enema or suppository) by mouth. It is for use only in your rectum.

Try to use the rectal form of this medicine at a time when you can lie down afterward and hold the medicine in. Avoid using the bathroom during this time.

If you are using bisacodyl before surgery or a medical procedure, follow your doctor's instructions about the timing of your dose (the number of days or hours) before your procedure.

Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands.

Lie on your side and gently insert the suppository pointed end first. For best results, hold in the suppository for a 15 to 20 minutes. The suppository will melt quickly once inserted and you should feel little or no discomfort while holding it in. Avoid using the bathroom just after you have inserted the suppository.

Shake the rectal enema gently just before use. Remove the protective cap from the applicator tip. You may use the enema lying down or seated on a toilet. Gently insert the tip into your rectum and lightly squeeze the bottle to release the enema. Hold the enema in for a few minutes and then release into the toilet.

The rectal forms of bisacodyl should produce a bowel movement within 15 minutes to 1 hour.

The tablet form of bisacodyl should produce a bowel movement within 6 to 12 hours, or overnight when taken at bedtime.

Call your doctor if you do not have a bowel movement after using this medication. Do not use bisacodyl for more than 7 days in a row unless your doctor tells you to. Store bisacodyl at room temperature away from moisture and heat.

What happens if I miss a dose?

Since bisacodyl is used only once or as needed, you are not likely to be on a dosing schedule.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include watery diarrhea, stomach cramps, muscle weakness, or urinating less than usual.

What should I avoid while using Laxative Gentle Suppositories (bisacodyl)?

Avoid using any other medications within 2 hours before or after using bisacodyl.

Avoid drinking milk within 1 hour after using bisacodyl.

Laxative Gentle Suppositories (bisacodyl) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

• 
  

  urinating less than usual or not at all;

  
  


• 
  

  drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting;

  
  


• 
  

  swelling, weight gain, feeling short of breath;

  
  


• 
  

  rectal bleeding;

  
  


• 
  

  severe stomach pain or cramps, severe or ongoing diarrhea or vomiting; or

  
  


• 
  

  low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling).

  
  

Less serious side effects may include:

• 
  

  dizziness, weakness;

  
  


• 
  

  increased thirst;

  
  


• 
  

  mild stomach pain, gas, indigestion;

  
  


• 
  

  diarrhea or loose stools;

  
  


• 
  

  mild nausea; or

  
  


• 
  

  skin rash.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Laxative Gentle Suppositories (bisacodyl)?

There may be other drugs that can interact with bisacodyl. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Laxative Gentle Suppositories resources

• Laxative Gentle Suppositories Side Effects (in more detail)
• Laxative Gentle Suppositories Use in Pregnancy & Breastfeeding
• Laxative Gentle Suppositories Drug Interactions
• 0 Reviews for Laxative Gentle - Add your own review/rating

• Bisacodyl Prescribing Information (FDA)


• Bisacodyl Professional Patient Advice (Wolters Kluwer)


• Bisacodyl Monograph (AHFS DI)


• Bisacodyl MedFacts Consumer Leaflet (Wolters Kluwer)


• Evac-u-gen Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Laxative Gentle Suppositories with other medications

• Bowel Preparation
• Constipation

Where can I get more information?

• Your pharmacist can provide more information about bisacodyl.

See also: Laxative Gentle side effects (in more detail)

ViATIM

1. Name Of The Medicinal Product

ViATIM, Suspension and solution for injection in a pre-filled dual chamber syringe.

Hepatitis A (inactivated, adsorbed) and Typhoid polysaccharide vaccine

2. Qualitative And Quantitative Composition

The dual chamber syringe contains 0.5 millilitre of purified Vi polysaccharide typhoid vaccine and 0.5 millilitre of inactivated hepatitis A vaccine which are mixed prior to administration.

After reconstitution, 1 dose (1ml) contains:

Originally contained in the suspension:

Hepatitis A virus, GBM strain (inactivated)^1,2………….160 U³

¹ produced in human diploid (MRC-5) cells

² adsorbed on aluminium hydroxide, hydrated (0.3 milligrams Al)

³ In the absence of an international standardised reference, the antigen content is expressed using an in-house reference

Originally contained in the solution:

Salmonella typhi (Ty 2 strain) capsular Vi polysaccharide………25 micrograms

Excipient(s):

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Suspension and solution for suspension for injection in a pre-filled dual chamber syringe.

The vaccine is presented in a dual-chamber syringe.

The purified Vi polysaccharide typhoid vaccine (solution for injection) is contained in the chamber of the syringe closest to the needle, and the inactivated hepatitis A vaccine (suspension for injection) in the chamber closest to the plunger.

The component Hepatitis A (inactivated, adsorbed) is a cloudy and white suspension and the component Typhoid polysaccharide is a clear and colourless solution.

4. Clinical Particulars

4.1 Therapeutic Indications

ViATIM is indicated for simultaneous active immunisation against typhoid fever and hepatitis A virus infection in subjects from 16 years of age.

ViATIM should be given in accordance with official recommendations.

4.2 Posology And Method Of Administration

Posology

The recommended dosage for subjects of at least 16 years of age is 1 millilitre of the mixed vaccine.

Initial protection is achieved with one single dose of ViATIM. Protective levels of antibody may not be reached until 14 days after administration of the vaccine.

In order to provide long-term protection against infection caused by the hepatitis A virus, a second dose (booster) of an inactivated hepatitis A vaccine should be given. ViATIM may be be used to provide one or both doses of hepatitis A vaccine as follows:

• In subjects who have received one dose of ViATIM:

- either a dose of monovalent hepatitis A vaccine should be given within 36 months and preferably within 6 to 12 months (see section 5.1)

- or, if continued protection against typhoid is also required, a second dose of ViATIM may be given provided that approximately 36 months have elapsed since the first dose.

• In subjects who have received one dose of monovalent hepatitis A vaccine:

- ViATIM may be used to provide the second dose (booster) of hepatitis A vaccine if protection against typhoid fever is also desirable. It should be given within 36 months of the hepatitis A vaccine and preferably within 6 to 12 months.

It is predicted that HAV antibodies persist for many years (beyond 10 years) after the second dose (booster).

In subjects who remain at risk of typhoid fever, revaccination against typhoid fever should be carried out with a single dose of a purified Vi polysaccharide typhoid vaccine every 3 years, (see section 5.1).

Method of administration

ViATIM should be administered by slow intramuscular injection in the deltoid region.

ViATIM must not be administered intravascularly.

ViATIM should not be administered into the buttocks due to the varying amount of fatty tissue in this region, nor by the intradermal route, since these methods of administration may induce a weaker immune response. ViATIM may be administered by the subcutaneous route in patients with thrombocytopenia or in those at risk of haemorrhage.

See section 6.6 for instructions for preparation.

4.3 Contraindications

Hypersensitivity to the active substance(s) or to any of the excipients or to neomycin (present in trace amounts as a residual of the manufacturing process).

Vaccination should be delayed in subjects with an acute severe febrile illness.

4.4 Special Warnings And Precautions For Use

As with all vaccines, appropriate facilities and medication such as epinephrine (adrenaline) should be readily available for immediate use in case of anaphylaxis or hypersensitivity following injection.

Immunogenicity of ViATIM could be impaired by immunosuppressive treatment or in immunodeficient subjects. It is recommended to delay vaccination until the completion of any immunosuppressive treatment. Subjects with chronic immunodeficiency such as HIV infection may be vaccinated if the underlying immunodeficiency allows the induction of an antibody response, even if limited.

Because of the incubation period of hepatitis A disease, infection may be present but not clinically apparent at the time of vaccination. It is not known whether ViATIM will prevent hepatitis A in this case.

ViATIM does not protect against infection caused by other known liver pathogens including hepatitis B, hepatitis C and hepatitis E viruses.

ViATIM does not protect against infection by Salmonella enterica other than serotype typhi.

As with any vaccine, a protective immune response may not be elicited in all vaccinees.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

ViATIM must not be mixed with any other vaccine in the same syringe.

ViATIM is a combination of purified Vi polysaccharide typhoid vaccine and inactivated hepatitis A vaccine. Although concomitant administration with other inactivated vaccines using different syringes and at different injection sites has not been specifically studied, it is anticipated that no interaction will be observed.

Concomitant administration of yellow fever vaccine with ViATIM has not been specifically assessed. However, based on data obtained from the concomitant administration of the monovalent vaccines (purified Vi polysaccharide typhoid vaccine and inactivated hepatitis A vaccine) with yellow fever vaccine, no interference with the immune responses to any of these antigens would be expected.

The effect of concomitant administration of immunoglobulins on the immunogenicity of ViATIM has not been assessed. Therefore, interference with the immune response of ViATIM cannot be ruled out. Data obtained from concomitant administration of immunoglobulins with the monovalent inactivated hepatitis A vaccine showed that anti-HAV seroconversion rates were not modified whereas anti-HAV antibody titres could be lower than after vaccination with the monovalent vaccine alone.

4.6 Pregnancy And Lactation

Pregnancy

Data on a limited number (more than 150 cases with monovalent Vi polysaccharide typhoid vaccine, more than 40 cases with monovalent inactivated hepatitis A vaccine and more than 10 cases with ViATIM or the two components given simulatenously) of exposed pregnancies indicate no adverse effects of ViATIM on pregnancy or on the health of the foetus/new born child. To date no other relevant epidemiological data are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or post-natal development (see section 5.3).

Caution should be exercised when prescribing to pregnant women.

When the patient is considered to be at risk of only one of hepatitis A or typhoid fever, the monovalent vaccine should be used.

Lactation

It is unknown whether ViATIM is excreted in human breast milk. The excretion of ViATIM in milk has not been studied in animals. A decision on whether to continue/discontinue breast-feeding or to administer or not administer ViATIM should be made taking into account the benefit of breast-feeding to the child and the benefit of ViATIM to the woman.

4.7 Effects On Ability To Drive And Use Machines

No studies on the effects on the ability to drive and use machines have been performed. Dizziness has been observed as an uncommon reaction (>1/1000, <1/100) following administration of this vaccine (see section 4.8).

4.8 Undesirable Effects

Adverse event data are derived from clinical trials and worldwide post marketing experience.

Within each system organ class the adverse events are ranked under headings of frequency, most frequent reactions first, using the following convention:

Very common (>1/10), Common (>1/100, <1/10), Uncommon (>1/1000, <1/100), Rare (>1/10000, <1/1000), Very rare (<1/10000), including isolated reports.

Within each frequency grouping, adverse reactions are ranked in order of decreasing seriousness.

Clinical Studies

The safety profile of ViATIM was evaluated in nearly 1100 subjects included in 5 clinical studies. The most commonly reported reactions were those occurring at the injection site.

The adverse reactions observed with ViATIM were as follows:

Nervous system disorders

Very common: headache.

Uncommon: dizziness.

Gastrointestinal disorders

Common: nausea, diarrhoea.

Skin and subcutaneous tissue disorders

Uncommon: pruritus, rash.

Musculoskeletal and connective tissue disorders

Very common: myalgia.

Common: arthralgia.

General disorders and administration site conditions

Very common: malaise, asthenia, injection site disorders (pain, induration, oedema, erythema).

Common: fever.

Pain at the ViATIM injection site was reported in 89.9% of subjects (severe in 4.5%). For subjects who received the two monovalent vaccines concomitantly at separate injection sites, pain was reported in 83.2% of subjects (severe in 5.0%) for both vaccine sites combined. Pain was reported by 79.3% of subjects (severe in 5.0%) at the Vi vaccine site and by 50.3% of subjects (severe in 0.6%) at the hepatitis A vaccine site.

Pain at the injection site lasting more than 3 days was reported by 17.4% of subjects after ViATIM, by 2.8% of subjects for the monovalent Vi vaccine site and by 0.6% of subjects for the monovalent hepatitis A vaccine site.

Severe oedema/induration (> 5 cm) was reported in 7.9% of subjects at the ViATIM site. For subjects who received the two monovalent vaccines concomitantly at separate injection sites, severe oedema/induration was reported in 1.7% of subjects for both vaccine sites combined (in 1.1% of subjects at the Vi vaccine site and in 0.6% of subjects at the hepatitis A vaccine site).

The overall incidence of systemic reactions was similar between subjects who were vaccinated with ViATIM and subjects who received the two monovalent vaccines concomitantly at separate injection sites.

All reactions resolved without any sequelae.

Post marketing experience

Based on spontaneous reporting, the following additional adverse events have been reported during the commercial use of each monovalent vaccine.

Adverse reactions reported following the use of the monovalent purified Vi polysaccharide vaccine (and not listed above for ViATIM) include:

Immune system disorders

Very rare: anaphylactic/anaphylactoid reactions, including shock; serum sickness.

Nervous system disorders

Very rare: paraesthesia.

Respiratory, thoracic and mediastinal disorders

Very rare: aggravation of asthma.

Gastrointestinal disorders

Rare: vomiting, abdominal pain.

Skin and subcutaneous tissue disorders

Very rare: urticaria.

Adverse reactions reported following use of the monovalent inactivated hepatitis A vaccine (and not listed above for ViATIM) include:

Skin and subcutaneous tissue disorders

Very rare: urticaria.

General disorders and administration site conditions

Very rare: injection site nodule.

Investigations

Rare: transaminases increased (mild and reversible).

4.9 Overdose

No case of overdose has been reported.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Bacterial and viral vaccines combined, ATC code: J07C (combined) / P03 (Typhoid purified polysaccharide antigen) / C02 (Hepatitis A, inactivated, whole virus).

Four clinical studies provided useful data on immune responses to ViATIM. A total of 1090 subjects were included, with 179, 610, 243 and 58 subjects vaccinated in each study.

After the primary vaccination the seroprotection rate for HAV (%

The seroprotection rate for Vi (%

In one study that evaluated anti-Vi antigen seroprotection rates at years 1, 2 and 3 after the first dose of ViATIM and after re-vaccination with ViATIM at year 3, results were as follows:

	ViATIM
	Year 1	Year 2	Year 3	28 days after Re-vaccination at Year 3
Number of vaccinees	139	124	112	46
% of vaccinees seroprotected (95% CI)	44.6 (36.2-53.3)	40.3 (31.6-49.5)	32.1 (23.6-41.6)	69.6 (54.2-82.3)

Serological data show continuing protection against hepatitis A for up to 36 months in subjects who responded to the first dose of ViATIM. Anti-HAV antigen seroprotection rates at years 1, 2 and 3 after the first dose of ViATIM and after re-vaccination with ViATIM at year 3 were as follows:

	ViATIM
	Year 1	Year 2	Year 3	28 days after Re-vaccination at Year 3
Number of vaccinees	140	124	112	46
% (95% CI)	99.3 (96.1-100)	98.4 (94.3-99.8)	99.1 (95.1-100)	100 (92.3-100)

Similar results were seen at all timepoints in the control group who received concomitant monovalent purified Vi polysaccharide and inactivated hepatitis A vaccines.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

Non-clinical data obtained with this vaccine, or with the monovalent vaccines contained within this combined vaccine, reveal no special hazard for humans based on single, repeated dose and local tolerance toxicity studies.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Purified Vi polysaccharide typhoid vaccine component:

Phosphate buffer solution:

Sodium chloride

Disodium phosphate dihydrate

Sodium dihydrogen phosphate dihydrate

Water for Injections

Inactivated hepatitis A vaccine component:

2-Phenoxyethanol solution

Formaldehyde

Medium 199 Hanks (without phenol red)* supplemented with polysorbate 80

*Medium 199 Hanks (without phenol red) is a complex mixture of amino acids (including phenylalanine), mineral salts, vitamins and other components (including glucose), diluted in water for injections and pH adjusted with hydrochloric acid or sodium hydroxide

6.2 Incompatibilities

In the absence of compatibility studies, this vaccine must not be mixed with other vaccines or medicinal products.

6.3 Shelf Life

3 years

6.4 Special Precautions For Storage

Store in a refrigerator (2°C - 8°C). Do not freeze. If frozen, the vaccine should be discarded.

Keep the vaccine in the outer carton in order to protect from light.

6.5 Nature And Contents Of Container

A prefilled syringe (type I glass) with a dual-chamber (0.5 millilitre of vaccine in each chamber) with elastomer (chlorobutyl and bromobutyl rubber blend) plunger-stopper, elastomer tip cap and elastomer by-pass stopper.

Pack of 1 or 10 prefilled syringes supplied with or without needle.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

The two vaccine components should only be mixed immediately prior to injection.

Shake before mixing and again prior to injection to obtain a homogeneous suspension. The contents of the two compartments are mixed by slowly advancing the plunger. The final volume to be injected is 1 millilitre.

The vaccine should be visually inspected before administration for any foreign particulate matter. The mixed vaccine is a cloudy, whitish suspension.

Any unused product or waste material should be disposed of in accordance with local requirements.

7. Marketing Authorisation Holder

Sanofi Pasteur MSD Ltd

Mallards Reach

Bridge Avenue

Maidenhead

Berkshire SL6 1QP

8. Marketing Authorisation Number(S)

PL 06745/0114

9. Date Of First Authorisation/Renewal Of The Authorisation

02/09/06

10. Date Of Revision Of The Text

09/2010