Avaxim 80 U Pediatric/Avaxim Adult

Avaxim 80 U Pediatric/Avaxim Adult

vaccine, hepatitis a

Manufacturer:

Kalventis Sinergi Farma
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.
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 primary vaccination & may be administered up to 7 yr after primary vaccination. 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 1st vaccination. Can also be administered as a booster dose of hepatitis A vaccine after receiving combined typhoid fever & hepatitis A vaccine 6-36 mth earlier.
Contraindications
Hypersensitivity to the vaccine, neomycin & previous inj of vaccine. Postpone vaccination in patients suffering from fever, acute illness, chronic progressive disease.
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; phenylketonuria. Not to be mixed w/ other vaccines. Liver disease. Not to be used during pregnancy. Not recommended during lactation.
Adverse Reactions
Anaphylactic reaction; cephalalgia; vasovagal syncope in response to inj; decreased appetite; abdominal pain, diarrhoea, nausea, vomiting; arthralgia, myalgia; fever, asthenia. Avaxim 80 U Pediatric Abnormal crying; seizures w/ or w/o fever; local inj site pain; malaise. Irritability, insomnia; local inj site reaction eg, redness, induration or oedema, haematoma; somnolence. Avaxim Adult Mild inj site pain.
Drug Interactions
Avaxim 80 U Pediatric Concomitant immunosuppressive treatment may diminish immunological response. Simultaneous administration of Ig may lower Ab titers. Not to be mixed w/ other vaccines in the same syringe.
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J07BC02 - hepatitis A, inactivated, whole virus ; Belongs to the class of hepatitis viral vaccines.
Presentation/Packing
Form
Avaxim 80 U Pediatric pre-filled syringe 80 IU/0.5 mL
Packing/Price
1's (Rp266,805/pre-filled syringe)
Form
Avaxim Adult pre-filled syringe 160 IU/0.5 mL
Packing/Price
1's (Rp379,077/pre-filled syringe)
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