Description:

BEVAC is a recombinant hepatitis B vaccine (rDNA) used for active immunization against hepatitis B virus (HBV) infection and its common subtypes. It prevents acute and chronic HBV infection, which can lead to liver disease, cirrhosis, and hepatocellular carcinoma. The vaccine contains purified hepatitis B surface antigen (HBsAg) produced by recombinant DNA technology in yeast cells (Pichia pastoris or similar), adsorbed on aluminium hydroxide to enhance immunogenicity. It stimulates the immune system to produce protective antibodies (anti-HBs) without causing infection. It is suitable for all ages, including infants, children, adolescents, and adults at risk (e.g., healthcare workers, newborns of HBV-positive mothers, travelers to endemic areas, or those with chronic liver disease).

Prescription:

Prescription-only (Rx).

Therapeutic Category:

Vaccine / Hepatitis B vaccine (recombinant) (prophylactic immunizing agent against hepatitis B virus).

Active Ingredients/Composition:

• Purified hepatitis B surface antigen (HBsAg) produced by recombinant DNA technology:
  • Paediatric dose (0.5 ml): 10 μg HBsAg
  • Adult dose (1 ml): 20 μg HBsAg
• Adjuvant: Aluminium hydroxide gel equivalent to aluminium ≤ 1.25 mg per dose
• Preservative: Thiomersal (mercury-containing) 0.025-0.05 mg per dose (some multi-dose vials)
• Other excipients: Sodium chloride, phosphate buffer, water for injection (sterile suspension; ready-to-use liquid).

Variant:

• Paediatric (0.5 ml dose, 10 μg HBsAg)
• Adult (1 ml dose, 20 μg HBsAg)
• Single-dose vials (0.5 ml or 1 ml) or multi-dose vials (e.g., 5 ml/10 doses or 10 ml) The queried “BEVAC” is typically the paediatric or adult suspension; 100 IU is not standard for BEVAC (that may refer to HBIG, not vaccine).

Consume Type:

Parenteral (intramuscular injection; administered by healthcare professionals; not oral).

Directions/Usage: Administered by intramuscular injection (usually anterolateral thigh in infants, deltoid in older children/adults). Standard WHO-recommended schedule (3-dose series):

• Dose 1: At birth (within 24 hours, especially if mother HBsAg-positive)
• Dose 2: At 1 month
• Dose 3: At 6 months (or as per national schedule, e.g., combined with pentavalent vaccine at 6, 10, 14 weeks in some programs)
• Catch-up or adult: 0, 1, 6 months
• Post-exposure prophylaxis (with HBIG if high-risk): Vaccine + HBIG within 24 hours Dose: 0.5 ml (paediatric) or 1 ml (adult) per injection. Shake well before use. Complete series for full protection; no booster routinely needed in immunocompetent individuals.

Common Side Effects:

• Local: Pain, redness, swelling at injection site
• Systemic: Mild fever, fatigue, headache, irritability (especially infants)
• Gastrointestinal: Nausea, vomiting (rare)
• Rare: Allergic reactions (rash, anaphylaxis) Most mild and transient; serious adverse events very rare (e.g., anaphylaxis in hypersensitive individuals).

Package Type:

Single-dose vial (0.5 ml or 1 ml) or multi-dose vial (e.g., 5 ml/10 doses or 10 ml); sterile glass vials with rubber stopper and aluminium seal; supplied with or without diluent (ready-to-use suspension).

Storage Advice: Store at 2-8°C (refrigerator); do not freeze (discard if frozen). Protect from light. Keep in original packaging. Opened multi-dose vials: Use within 28 days if handled aseptically (per WHO prequalification).

Safety Advice:

• For active immunization only; not for post-exposure alone (combine with HBIG if indicated).
• Contraindicated in severe allergic reaction to previous dose or vaccine components (e.g., yeast hypersensitivity).
• Caution in moderate/severe acute illness (delay vaccination); preterm/low birth weight infants (monitor).
• Safe in pregnancy (recommended for at-risk women); breastfeeding: Safe.
• No evidence of harm from thiomersal in vaccines (low risk).
• Report adverse events (e.g., severe allergy) to healthcare provider.
• Combine with hepatitis B vaccine schedule; test for anti-HBs response if high-risk.
• Not for treatment of active HBV infection.

Manufacturer/Marketer:

Biological E. Limited.

Country of Origin:

India.