HyperHEP B S/D

HyperHEP B S/D

hepatitis b immunoglobulin

Manufacturer:

Grifols

Distributor:

Grifols Asia Pacific
Concise Prescribing Info
Contents
Hepatitis B Ig (human)
Indications/Uses
In combination w/ hepatitis B vaccine as post-exposure prophylaxis in acute exposure to blood containing HBsAG, perinatal exposure of infants born to HBsAG-positive mothers, sexual exposure to an HBsAG-positive person, household exposure to persons w/ acute HBV infection.
Dosage/Direction for Use
IM Acute exposure to blood containing HBsAG 0.06 mL/kg as soon as possible after exposure & w/in 24 hrs if possible. If hepatitis B vaccine is refused, give 2nd dose of hepatitis B Ig (human) 1 mth after 1st dose. Prophylaxis of infant born to HBsAG & HBeAG mothers 0.5 mL after physiologic stabilization of the infant & preferably w/in 12 hr after birth. Administer hepatitis B vaccine IM in 3 doses of 0.5 mL each. Give the 1st dose w/in 7 days of birth & may be given concurrently w/ hepatitis B Ig (human) but at a separate site. Give 2nd & 3rd doses of vaccine 1 & 6 mth respectively after the 1st. If administration of the 1st dose of hepatitis B vaccine is delayed for as long as 3 mth, a 0.5 mL dose of hepatitis B Ig (human) should be repeated after 3 mth. If hepatitis B vaccine is refused, the 0.5 mL dose of hepatitis B Ig (human) should be repeated at 3 & 6 mth. Sexual exposure to an HBsAG-positive person 0.06 mL/kg single dose & should begin the hepatitis B vaccine series if prophylaxis can be started w/in 14 days of the last sexual contact or if sexual contact w/ the infected person will continue. Household exposure to person w/ acute HBV infection Infant <12 mth 0.5 mL w/ hepatitis B vaccine. May be administered at the same time (at different site) or up to 1 mth preceding hepatitis B vaccination w/o impairing the active immune response from hepatitis B vaccination.
Special Precautions
Administration at birth for prophylaxis of infants born to HBsAG & HBeAG positive mothers should not interfere w/ oral polio & DPT vaccine administered at 2 mth. Do not administer IV & at the gluteal region. May contain disease-causing infectious agents eg, viruses, & theoretically, the Creutzfeldt-Jakob Disease (CJD) agent. Patients w/ history of prior systemic allergic reactions following administration of human Ig prep. Epinephrine should be available. Patients w/ severe thrombocytopenia or any coagulation disorder that would contraindicate IM inj. Pregnancy & lactation. Childn.
Adverse Reactions
Local pain & tenderness at the inj site, urticaria, angioedema, anaphylactic reactions.
Drug Interactions
Defer from using other live vaccines until approx 3 mth after hepatitis B Ig administration.
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J06BB04 - hepatitis B immunoglobulin ; Belongs to the class of specific immunoglobulins. Used in passive immunizations.
Presentation/Packing
Form
HyperHEP B S/D inj ≥200 IU/mL
Packing/Price
0.5 mL x 1's;1 mL x 1's;5 mL x 1's
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