Hepatitis B Immunoglobulin (IM)
Presentation
Single vials containing 100 IU or 400 IU hepatitis B antibody.
Indications for Use
For maximum protective effect, hepatitis B Immunoglobulin should be given within three days of exposure. Efficacy is greatly reduced if it is given after a longer interval. If serological tests reveal that the subject is not already immune, (negative for hepatitis B surface antibody) and is not a chronic carrier of hepatitis B surface antigen (HBsAg), then a course of hepatitis B vaccination should be commenced simultaneously with the passive immunoglobulin, given at a different site.
Issues are restricted to the following circumstances:
- Post-exposure prophylaxis in persons who did not receive prior vaccination or whose vaccination regimen is incomplete or when the hepatitis B antibody level is inadequate (less than 10 IU/L). Post-exposure prophylaxis should be considered following percutaneous or permucosal exposure to HBsAg positive or suspected positive material, for example, by needle stick, oral ingestion or sexual exposure.
- Infants born to HBsAg positive mothers, either chronic carriers or those who contract hepatitis B during pregnancy.
Contraindications
Individuals with:
- IgA deficiency – unless they have no circulating anti IgA antibodies.
- Severe thrombycytopenia or coagulation disorder that would contraindicate IM injections.
- Who are HSsAg-positive.
Precautions
Administer by intramuscular injection.
MUST NOT be administered intravenously.
Care should be taken to draw back plunger of syringe before injection to be certain needle is not in a vessel.
Give with caution to patients with a history of prior systemic allergic reactions to human immunoglobulin preparations.
Availability
Requests to ARCBS. Issued in accordance with product information sheet.
Dosage and Administration
Dosage varies and is dependent on the clinical indication.
Bring to room temperature prior to administration.
Hepatitis B immunoglobulin should be given slowly by intramuscular injection.
The product s does not contain antimicrobial preservative; it must be used immediately after opening the vial.
Refer to the current product information sheet for further information.