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Hexaxim 0.5ml PFS Injection
Hexaxim 0.5ml PFS Injection: Image 1
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Brand Sanofi

Hexaxim 0.5ml PFS Injection is a hexavalent combination vaccine developed by Sanofi India Pvt. Ltd. for the primary and booster vaccination of infants and toddlers from six weeks of age. This vaccine provides comprehensive protection against diphtheria, tetanus, pertussis (whooping cough), hepatitis B, poliomyelitis, and invasive diseases caused by Haemophilus influenzae type b (Hib). Supplied as a 0.5ml pre-filled syringe (PFS), Hexaxim is a fully liquid, ready-to-use formulation, eliminating the need for reconstitution prior to administration and thereby enhancing convenience for healthcare professionals.

The vaccine is administered via intramuscular (IM) injection, with recommended sites typically being the antero-lateral aspect of the upper thigh in infants and toddlers. Primary vaccination schedules consist of either 2 doses (with an interval of at least 8 weeks) or 3 doses (with an interval of at least 4 weeks), in accordance with official recommendations. A booster dose is recommended at least six months after the last priming dose, preferably during the second year of life. Hexaxim 0.5ml PFS Injection requires strict cold-chain storage at 2-8°C and must be protected from freezing to maintain its stability and efficacy.

Hexaxim received a positive scientific opinion from the European Medicines Agency (EMA) in June 2012, following an assessment conducted in cooperation with the World Health Organization (WHO) for medicinal products intended for markets outside the European Union. The vaccine is also WHO Prequalified, affirming its quality, safety, and efficacy for global immunization programs.

Key Features : 

Antigen composition includes Diphtheria Toxoid, Tetanus Toxoid, Pertussis Toxoid, Inactivated Poliomyelitis Virus Types 1, 2, and 3, Hepatitis B Vaccine (rDNA), and Haemophilus influenzae type b Capsular Polysaccharide.
Approved for primary and booster vaccination of infants and toddlers from six weeks of age against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and invasive Hib diseases.
Requires cold-chain storage at 2-8°C and must not be frozen.
Administered by intramuscular injection, with flexible primary and booster dosing schedules in accordance with official recommendations.
Holds a positive scientific opinion from the European Medicines Agency (EMA) and is WHO Prequalified.

Antigen CompositionDiphtheria Toxoid 20Iu + Tetanus Toxoid 40Iu + Pertussis Toxoid 25mcg + Poliomyelitis Virus Type 1 40Dantigenunit + Poliomyelitis Virus Type 2 8Dantigenunit + Poliomyelitis Virus Type 3 32Dantigenunit + Hepatitis B Vaccine Rdna 10mcg + Haemophilus Influenzae Type B Capsular Polysaccharide 12mcg
Approved Indications and Target PopulationPrimary and booster vaccination of infants and toddlers from six weeks of age against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and invasive diseases caused by Haemophilus influenzae type b (Hib).
Cold-chain Storage Temperature2-8°C, do not freeze.
Route of AdministrationIntramuscular (IM) injection.
Regulatory ApprovalEMA positive scientific opinion (June 2012), WHO Prequalified.
Schedule / Dosing IntervalsPrimary vaccination: 2 or 3 doses (at least 4-8 weeks apart). Booster: at least 6 months after last priming dose, preferably in second year of life.
Reconstitution RequirementsNot required (fully liquid, ready-to-use).
WHO PrequalificationYes.
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