Finished product reference
Hepatitis B Virus
Injection · Parenteral · 10 dose · 5 mL
- List code
- 7058
- Pharmacologic class
- Vaccine (hepatitis B, recombinant surface antigen)
What it is and how it works
Contains purified hepatitis B surface antigen (HBsAg), produced by recombinant DNA technology and usually adsorbed on an aluminium adjuvant. It induces protective anti-HBs antibodies against hepatitis B virus infection.
Indications
Active immunisation against hepatitis B virus infection in infants, children and adults, particularly those at increased risk of exposure.
Dosage and administration (summary)
Given by intramuscular injection (deltoid in adults, anterolateral thigh in infants) according to the national schedule, typically a 3-dose primary course (e.g. 0, 1 and 6 months); dose volume depends on age and product.
Contraindications
Hypersensitivity to any component (including yeast where relevant) or a severe reaction to a previous dose; postpone in acute severe febrile illness.
Warnings and precautions
Appropriate treatment for anaphylaxis should be available. Response may be reduced in immunocompromised, dialysis, older or obese patients, and post-vaccination anti-HBs testing may be needed. Avoid gluteal injection; do not give intravenously.
Pregnancy
May be used in pregnancy when there is a clear risk of hepatitis B infection.
Storage and supply
Store at 2–8 °C; do not freeze.
Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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