Avaxim 80 U Pediatric/Avaxim Adult 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 Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Inactivated adsorbed HAV

Indications/Uses

Avaxim 80 U Pediatric Prevention of infection induced by HAV in childn 12 mth-15 yr. Avaxim Adult Prevention of infection caused by HAV in adults >16 yr.

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Dosage/Direction for Use

Avaxim 80 U Pediatric 0.5 mL IM inj into the deltoid region followed by booster dose preferably 6-36 mth after the initial dose. Avaxim Adult 0.5 mL IM into the deltoid region followed by booster dose preferably 6-12 mth later for adult >16 yr & can be administered up to 36 mth after the first vaccination.

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Overdosage

View Avaxim 80 U Pediatric/Avaxim Adult overdosage for action to be taken in the event of an overdose.

Contraindications

Hypersensitivity to the vaccine, neomycin & previous inj of vaccine. Postpone vaccination in patients suffering from fever, acute illness or chronic progressive disease.

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Special Precautions

Anaphylactic reaction. Not to be inj intravascularly, intradermally or into the buttocks. Not a protection against infection caused by HBV, HCV, hepatitis E virus or other known liver pathogens. Immunodeficient patients or on immunosuppressive treatment. Syncope. Not to be mixed w/ other vaccines. Liver disease. Not to be used during pregnancy. Not recommended during lactation.

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Use In Pregnancy & Lactation

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Adverse Reactions

Cephalalgia; nausea, vomiting, diarrhoea, abdominal pain; decreased appetite; fever; myalgia, arthralgia; asthenia. Avaxim 80 U Pediatric Abnormal crying; malaise. Local inj site reaction eg, pain, redness, haematoma, oedema or induration; irritability, insomnia; somnolence. Avaxim Adult Mild inj site pain.

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Drug Interactions

Simultaneous administration of Ig may lower Ab titers. Not to be mixed w/ other vaccines in the same syringe.

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Storage

View Avaxim 80 U Pediatric/Avaxim Adult storage conditions for details to ensure optimal shelf-life.

Description

View Avaxim 80 U Pediatric/Avaxim Adult description for details of the chemical structure and excipients (inactive components).

Action

View Avaxim 80 U Pediatric/Avaxim Adult mechanism of action for pharmacodynamics and pharmacokinetics details.

MIMS Class

Vaccines, Antisera & Immunologicals

ATC Classification

J07BC02 - hepatitis A, inactivated, whole virus ; Belongs to the class of hepatitis viral vaccines.

Regulatory Classification

Presentation/Packing

Form

Avaxim 80 U Pediatric pre-filled syringe 80 IU/0.5 mL

Packing/Price

1's (Rp220,000/pre-filled syringe)

Form

Avaxim Adult pre-filled syringe 160 IU/0.5 mL

Packing/Price

1's (Rp346,500/pre-filled syringe)

Avaxim 80 U Pediatric/Avaxim Adult

vaccine, hepatitis a

Manufacturer:

Kalventis Sinergi Farma