Twinrix Dosage & Drug Information

Concise Prescribing Info Bahasa 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 Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Per 1 mL Inactivated HAV 720 ELISA u, recombinant HBsAg 20 mcg (adsorbed)

Indications/Uses

Non-immune adults, adolescents & childn 2-15 yr who are at risk of both hepatitis A & B infection & never or incompletely vaccinated w/ hepatitis B vaccine.

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Dosage/Direction for Use

IM in deltoid region in adult, adolescents & childn; anterolateral thigh in infants Primary dose Adult & adolescent ≥16 yr 3 doses: 1st dose at elected date, 2nd dose 1 mth later & 3rd dose 6 mth after 1st dose. If insufficient time is available to complete 0, 1, 6 mth schedule when travel is anticipated w/in ≥1 mth after initiating vaccination course, use 3 inj schedule at 0, 7 & 21 days + 4th dose at 12 mth after 1st dose. Childn 2-15 yr 2 doses: 1st dose at elected date & 2nd dose between 6 & 12 mth after 1st dose. Booster dose General guideline can be drawn from experience w/ the monovalent vaccines.

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Overdosage

View Twinrix overdosage for action to be taken in the event of an overdose.

Contraindications

Hypersensitivity to any constituent of Twinrix or after previous administration of Twinrix or the monovalent hepatitis A or hepatitis B vaccines.

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Special Precautions

Do not administer intravascularly. Avoid intradermal inj or IM administration into the gluteal muscle. Administer SC to patients w/ thrombocytopenia or bleeding disorders since bleeding may occur following IM administration. Postpone vaccination in patients w/ acute severe febrile illness. Syncope (fainting) can occur. Prevention of hepatitis A & B is unknown if the infection is in the incubation period at the time of vaccine. Not recommended for post-exposure prophylaxis (needle stick injury). Patients w/ impaired immune system & undergoing haemodialysis may require additional doses. Does not prevent infection caused by other agents eg, hepatitis C & E & other pathogens known to infect the liver. Pregnancy & lactation.

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Use In Pregnancy & Lactation

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Adverse Reactions

Headache; fatigue, pain & redness at the inj site. GI symptoms eg, diarrhoea, nausea, vomiting; swelling at the inj site. Adult & adolescent ≥16 yr: Inj site reaction, malaise. Childn 1-15 yr: Loss of appetite; irritability, fussiness. Drowsiness; fever.

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Drug Interactions

Adequate response may not be achieved in patients receiving immunosuppressants or w/ immunodeficiency.

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Caution For Usage

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

Storage

View Twinrix storage conditions for details to ensure optimal shelf-life.

Description

View Twinrix description for details of the chemical structure and excipients (inactive components).

Action

View Twinrix mechanism of action for pharmacodynamics and pharmacokinetics details.

MIMS Class

Vaccines, Antisera & Immunologicals

ATC Classification

J07BC20 - combinations ; Belongs to the class of hepatitis viral vaccines.

Regulatory Classification

Presentation/Packing

Form

Twinrix susp for inj

Packing/Price

(pre-filled syringe) 1 mL x 1's

Twinrix

hepatitis a and hepatitis b vaccine

Manufacturer:

GlaxoSmithKline Indonesia