Description:

Hepatitis B Immunoglobulin I.P. 100 IU  is a human plasma-derived immunoglobulin preparation containing high titers of antibodies to hepatitis B surface antigen (anti-HBs). It provides immediate passive immunization against hepatitis B virus (HBV) for post-exposure prophylaxis (PEP) in susceptible individuals exposed to HBV (e.g., needle stick injury, sexual contact with infected person, perinatal exposure in newborns of HBV-positive mothers). It is used in combination with hepatitis B vaccine for long-term protection but offers rapid, short-term immunity (typically 3-6 months) while active immunity from vaccine develops. It is not for treatment of active HBV infection.

Prescription: Prescription-only (Rx). Administered by healthcare professionals (intramuscular or intravenous in some formulations); requires medical oversight for post-exposure scenarios, with HBV status testing and vaccination coordination.

Therapeutic Category:

Immunoglobulin / Specific immune globulin (passive immunizing agent for hepatitis B post-exposure prophylaxis).

Active Ingredients/Composition:

Human Hepatitis B Immunoglobulin (HBIG) derived from screened human plasma donors with high anti-HBs titers. Potency: 100 IU/ml (or 100 IU per vial/ampoule; total 100 IU in standard 1 ml presentation). Contains no less than 100 IU of anti-HBs per ml. Excipients: Glycine (stabilizer), sodium chloride, water for injection (sterile solution); no preservatives in many formulations.

Vitamins: None.

Minerals: None.

Variant: 100 IU/ml solution for injection (standard 1 ml vial/ampoule for single-dose use; 200 IU/ml variants exist but 100 IU is common for PEP; intramuscular formulation primary).

Consume Type:

Parenteral (intramuscular injection; some formulations allow intravenous use under specialist supervision; not oral).

Directions/Usage: Administered only by trained healthcare professionals.

• Post-exposure prophylaxis (e.g., needle stick, sexual exposure): 0.06 ml/kg body weight (approximately 100-200 IU total for adults) as a single intramuscular dose as soon as possible (ideally within 24 hours, up to 7-14 days post-exposure).
• Newborns of HBsAg-positive mothers: 0.5 ml (100 IU) intramuscularly within 12 hours of birth (combined with hepatitis B vaccine at separate site).
• Other exposures: Dose based on body weight and exposure type (consult guidelines). Administer IM in deltoid or anterolateral thigh; do not give IV unless specified. Combine with HBV vaccine for active immunity.

Common Side Effects:

• Local: Pain, redness, swelling, tenderness at injection site
• Systemic: Mild fever, headache, fatigue, malaise, chills
• Gastrointestinal: Nausea, vomiting (rare)
• Rare: Allergic reactions (rash, itching, anaphylaxis in hypersensitive individuals) Most mild and transient; serious adverse events uncommon.

Package Type:

Single-dose glass vial or ampoule of 1 ml (containing 100 IU); often in individual carton with administration instructions (sterile, for IM use).

Storage Advice: Store at 2-8°C (refrigerator); do not freeze. Protect from light. Keep in original packaging. Use immediately after opening; discard unused portion.

Safety Advice:

• Administer only by qualified personnel; verify HBV status of source and recipient.
• Contraindicated in IgA deficiency with anti-IgA antibodies (anaphylaxis risk).
• Caution in thrombocytopenia or coagulation disorders (IM injection risk).
• Not for active HBV infection treatment—use for prophylaxis only.
• Pregnancy/breastfeeding: Safe for PEP (Category C equivalent; benefits outweigh risks in exposure).
• Monitor for allergic reactions (have epinephrine available).
• Combine with HBV vaccine at separate site; do not mix in same syringe.
• Report adverse events (e.g., severe allergy, fever) to healthcare provider.
• Derived from human plasma—screened but theoretical risk of transmission (very low with modern processing).

Product Substitutes: Other Hepatitis B Immunoglobulin (HBIG) 100 IU/ml: HepaRel (Reliance), Nabi-HB, HepaGam B, Human Hepatitis B Immunoglobulin-VF (CSL Behring), or generics from importers. Alternatives: Hepatitis B vaccine alone (if prior immunity) or no PEP if low-risk exposure—consult infectious disease specialist per guidelines (e.g., WHO or Ghana protocols for PEP).

Manufacturer/Marketer:

Reliance Life Sciences Pvt. Ltd.

Country of Origin:

India.