Infanrix Hexa 0.5ml Injection

Infanrix Hexa 0.5ml Injection is a hexavalent combination vaccine designed for the primary and booster vaccination of infants and toddlers. It provides active immunization against six major infectious diseases: diphtheria, tetanus, pertussis (whooping cough), hepatitis B, poliomyelitis, and infections caused by Haemophilus influenzae type b (Hib). This vaccine is indicated for infants from 6 weeks of age and toddlers.

The vaccine is presented in two components: a 0.5ml pre-filled syringe containing the DTPa-HBV-IPV suspension and a vial with a lyophilized Hib pellet. Prior to administration, the entire contents of the pre-filled syringe must be added to the Hib pellet vial and shaken until completely dissolved. Infanrix Hexa 0.5ml Injection is administered via deep intramuscular injection, preferably into the anterolateral aspect of the thigh for infants. The vaccine requires cold-chain storage between +2°C and +8°C and must not be frozen.

The primary vaccination schedule typically consists of two or three doses of 0.5ml, with common schedules including administration at 2, 3, 4 months; 3, 4, 5 months; or 2, 4, 6 months of age. A booster dose may be given at least 6 months after the last priming dose, ideally before 18 months of age. Infanrix Hexa received marketing approval from the European Commission in October 2000 and is marketed by GlaxoSmithKline.

Key Features : 

Antigen Composition: Each 0.5ml reconstituted dose contains Diphtheria toxoid (≥30 IU), Tetanus toxoid (≥40 IU), Pertussis toxoid (25 µg), Filamentous Haemagglutinin (25 µg), Pertactin (8 µg), Hepatitis B surface antigen (10 µg), Inactivated Poliovirus Type 1 (40 D-antigen units), Type 2 (8 D-antigen units), Type 3 (32 D-antigen units), and Haemophilus influenzae type b polysaccharide (10 µg) conjugated to tetanus toxoid protein.
Approved Indications and Target Population: Indicated for primary and booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and Haemophilus influenzae type b disease in infants from 6 weeks of age and toddlers.
Cold-chain Storage Temperature: Store between +2°C and +8°C; do not freeze.
Route of Administration: Administered by deep intramuscular injection, typically into the anterolateral aspect of the thigh for infants.
Schedule / Dosing Intervals: Primary vaccination consists of two or three 0.5ml doses with at least a 1-month interval between doses, followed by a booster dose at least 6 months after the last primary dose.
Reconstitution Requirements: Requires reconstitution by adding the liquid component from the 0.5ml pre-filled syringe to the lyophilized Hib pellet in the vial, then shaking until dissolved. The reconstituted vaccine is stable for up to eight hours at room temperature (21°C) but should be injected promptly.
Regulatory Approval: Received marketing approval from the European Commission in October 2000 and is marketed by GlaxoSmithKline.