IMMUNOHBs: Side Effects & Dosing

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Thai FDA Category Presentation/Packing

Concise Prescribing Info

Contents

Human hepatitis B Ig

Indications/Uses

Prevention of HBV re-infection after liver transplantation for hepatitis B induced liver failure. Immunoprophylaxis of hepatitis B in case of accidental exposure in non-immunised subjects (including persons whose vaccination is incomplete or status unknown); in haemodialysed patients; newborn of a HBV carrier-mother; in subjects who did not show an immune response after vaccination & for whom a continuous prevention is necessary due to the continuous risk of being infected w/ hepatitis B.

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Dosage/Direction for Use

IM Prevention of HBV re-infection after liver transplantation for hepatitis B-induced liver failure Adult 2,000 IU every 15 days. Immunoprophylaxis of hepatitis B: Prevention in accidental exposure in non-immunised subjects At least 500 IU w/in 24-72 hr. Immunoprophylaxis in haemodialysed patients 8-12 IU/kg w/ a max of 500 IU every 2 mth until seroconversion following vaccination. Prevention in newborns of a HBV carrier-mother 30-100 IU/kg at birth or as soon as possible. May be repeated until seroconversion following vaccination. Subjects w/ no known response after vaccination or require continuous prevention Adult 500 IU. Childn 8 IU/kg every 2 mth to achieve Ab titre at least 10 mIU/mL.

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Overdosage

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Contraindications

Hypersensitivity to human Ig.

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Special Precautions

Do not administer into blood vessel. Patients who are HBsAg-carrier, IgA-deficient, or on controlled Na diet. Discontinue if allergic or anaphylactic type reactions occur. May interfere w/ some serological tests for red cell Abs eg, Coombs' test. Pregnancy & lactation.

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Use In Pregnancy & Lactation

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Adverse Reactions

Inj site pain. Vomiting. Hypersensitivity, anaphylactic shock; headache; tachycardia; hypotension; nausea; skin reaction, erythema, pruritus; arthralgia; fever, malaise, chill, swelling, induration, warmth, pruritus, rash, & itching at inj site.

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Drug Interactions

Live attenuated virus vaccines.

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Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view IMMUNOHBs detailed prescribing information

Storage

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Description

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Action

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MIMS Class

Vaccines, Antisera & Immunologicals

ATC Classification

J06BB04 - hepatitis B immunoglobulin ; Belongs to the class of specific immunoglobulins. Used in passive immunizations.

Thai FDA Category

Presentation/Packing

Form

IMMUNOHBs inj 180 IU

Packing/Price

(vial) 1 mL x 1's

Form

IMMUNOHBs inj 540 IU

Packing/Price

(vial) 3 mL x 1's

IMMUNOHBs

hepatitis b immunoglobulin

Manufacturer:

Kedrion

Distributor:

Biogenetech