Hepatitis B Vaccine (rDNA) BP

Indications

Hepatitis B Vaccine (rDNA) BP is used for: To prevent Hepatiis B virus

Adult Dose

Intramuscular Active immunisation against hepatitis B Adult: 1 mL (20 mcg) IM at 0, 1, and 6 months More rapid immunization 3rd dose can be given 2 months after initial dose with booster at 12 months. Adults receiving dialysis or other immunocompromising conditions 40 mcg IM at 0, 1, and 6 months

Child Dose

Intramuscular Active immunisation against hepatitis B Adult: 0.5 mL (10 mcg) IM at 0, 1, and 6 months More rapid immunization 3rd dose can be given 2 months after initial dose with booster at 12 months. Routine vaccination First dose: Administer first dose to all newborns before hospital discharge Infants born to HBsAg-positive mothers: 0.5 mL IM within 12 hr of birth PLUS hepatitis B immune globulin (HBIG); test for HBsAg and antibody to HBsAg (anti-HBs) 1-2 months after completion of hepatitis B vaccination series, at age 9 through 18 months Mother's HBsAg status unknown: 0.5 mL IM within 12 hr of birth PLUS give HBIG if newborn wt <2 kg; determine mother's HBsAg status as soon as possible and, if she is HBsAg-positive, also administer HBIG for infants weighing 2 kg or more (no later than age 1 week) Second dose: Administered at age 1-2 months Infants who did not receive a birth dose should receive 3 doses of vaccine on a schedule of 0, 1 to 2 months, and 6 months starting as soon as feasible Minimum interval between dose 1 and dose 2 is 4 weeks, and between dose 2 and 3 is 8 weeks Final (3rd or 4th) dose vaccine series should be administered no earlier than age 24 weeks, and at least 16 weeks after the first dose A total of 4 doses of vaccine is recommended when a combination vaccine containing HepB is administered after the birth dose

Renal Dose

Administration

Administer in deltoid muscle for older children and adolescents; anterolateral thigh preferred for neonates/infants/small children Do not give IV/intradermal

Contra Indications

Previous confirmed anaphylactic reaction to a previous dose of a vaccine containing the same antigens. Hypersensitivity. Vaccines prepared in egg cultures are contraindicated in patients with hypersensitivity reactions to egg. Severe immunodeficiency. Malignant disease being treated with chemotherapy or radiotherapy and for at least 6 mth after stopping treatment. Patients with compromised immune system such as those on high-dose systemic corticosteroids, immunosuppressants or HIV positive.

Precautions

If any alcohol or disinfectant is used for cleansing the skin it should be allowed to evaporate before vaccination otherwise inactivation of live vaccines may occur. Lactation: not known if excreted in breast milk

Pregnancy-Lactation

Interactions

Reduced response to vaccination when used concurrently with immunosuppressants such as corticosteroids or antineoplastics.

Adverse Effects

Side effects of Hepatitis B Vaccine (rDNA) BP : >10% Pain (10-29%),Pruritus (10-29%),Erythema (10-29%),Burning (10-29%),Nodules (10-29%),Fatigue (15%),Headache (15%),Fever (15%),Vertigo (15%) 1-10% Lightheadedness,Flushinig,Insomnia,Irritability,Arthralgia,Constipation,Pruritus,Lupus-like syndrome,Lymphadenopathy,Tachycardia

Mechanism of Action

Hepatitis B vaccines are used for active immunisation against hepatitis B infection. Two types of vaccine have been available each containing hepatitis B surface antigen (HBsAg) adsorbed onto aluminium hydroxide or a similar adsorbent.