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Genvac-B

Genvac-B

hepatitis b vaccine

Manufacturer:

Serum Institute of India

Distributor:

Genpharm
Concise Prescribing Info
Contents
Hepatitis B (rDNA) vaccine
Indications/Uses
Active immunisation against HBV infection in subjects of all ages considered at risk of exposure to HBV.
Dosage/Direction for Use
IM Deltoid region in adult & childn; anterolateral thigh in young childn, infant, neonate. Primary immunisation schedule 0, 1 & 6 mth or a rapid schedule at 0, 1, 2 mth. Infant: 6, 10, 14 wk. Adult ≥20 yr 20 mcg dose. Adolescent ≤19 yr, childn, infant & neonate 10 mcg dose. Known or presumed exposure to HBV Follow rapid immunisation schedule (0, 1, 2 mth). Administer 1st dose w/ HBIg (separate inj site). Neonate born of HBV-carrier mother Recommended schedule: 0, 1, 2 mth, starting at birth. Chronic hemodialysis or immunocompromised patient 4 dose of 40 mcg at 0, 1, 2 & 6 mth after 1st dose. Booster dose is recommended.
Contraindications
Hypersensitivity to any component of the vaccine, or after previous Genvac-B administration.
Special Precautions
Not to be administered in gluteal muscle or intradermally. Administer by SC in patients w/ thrombocytopenia or bleeding disorders. Booster dose is recommended when Ab titres fall <10 IU/L for all people at risk. Appropriate medication (eg, adrenaline) should be readily available in case of rare anaphylactic reactions following vaccination. Vaccine will not prevent infection caused by other agents eg, hepatitis A, C & E & other pathogens known to infect the liver. Additional doses required for haemodialysis patients & persons w/ impaired immune system. Adults >40 yr may have less immune response.
Adverse Reactions
Mild soreness, erythema, induration, fatigue, fever, malaise, flu-like symptoms.
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J07BC01 - hepatitis B, purified antigen ; Belongs to the class of hepatitis viral vaccines.
Presentation/Packing
Form
Genvac-B susp for inj 10 mcg/0.5 mL (multidose)
Packing/Price
(ped dose) 5 mL x 50 × 1's
Form
Genvac-B susp for inj 10 mcg/0.5 mL (single dose)
Packing/Price
(ped dose) 0.5 mL x 50 × 1's
Form
Genvac-B susp for inj 20 mcg/mL (multidose)
Packing/Price
(adult dose) 10 mL x 50 × 1's
Form
Genvac-B susp for inj 20 mcg/mL (single dose)
Packing/Price
(adult dose) 1 mL x 50 × 1's
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