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Pentaxim Injection
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Brand Sanofi

Pentaxim Injection is a pentavalent combination vaccine designed for active immunization against diphtheria, tetanus, pertussis (whooping cough), poliomyelitis (polio), and invasive infections caused by Haemophilus influenzae type b (Hib). This vaccine is indicated for primary vaccination in infants from two months of age and for booster vaccination during the second year of life.



The vaccine is formulated as a powder and suspension for injection, requiring reconstitution prior to administration. It is administered via the intramuscular route, preferably in the anterolateral side of the thigh for infants and the deltoid area for children.



Key Features : 

Provides active immunization against diphtheria, tetanus, pertussis, poliomyelitis, and invasive Haemophilus influenzae type b infections, including meningitis and septicaemia.
Approved for primary vaccination in infants from two months of age and for booster vaccination one year after primary vaccination during the second year of life.
Requires cold-chain storage, maintaining a temperature between 2°C and 8°C, and must not be frozen.
Administered intramuscularly, with recommended injection sites being the anterolateral thigh for infants and the deltoid area for children.
First licensed in Sweden in 1997 and approved by regulatory bodies such as the Ministry of Food and Drug Safety (MFDS) in South Korea and registered in the Russian Federation.

Antigen CompositionDiphtheria toxoid (≥30 IU), Tetanus toxoid (≥40 IU), Bordetella pertussis antigens (Pertussis toxoid 25 micrograms, Filamentous haemagglutinin 25 micrograms), Inactivated Poliomyelitis virus (Type 1: 29-40 D antigen units, Type 2: 7-8 D antigen units, Type 3: 26-32 D antigen units), Haemophilus influenzae type b polysaccharide (10 micrograms) conjugated with tetanus protein (18-30 micrograms).
Approved Indications and Target PopulationJoint prevention of diphtheria, tetanus, pertussis, poliomyelitis, and invasive infections caused by Haemophilus influenzae type b (e.g., meningitis, septicaemia, cellulitis, arthritis, epiglottitis). Indicated for primary vaccination in infants from 2 months of age and for booster vaccination one year after primary vaccination during the second year of life.
Cold-chain Storage TemperatureStore in a refrigerator between 2°C and 8°C. Do not freeze.
Route of AdministrationIntramuscular (IM) route. Preferably in the anterolateral side of the thigh (middle third) in infants and in the deltoid area in children. Not for intradermal or intravascular administration.
Regulatory ApprovalFirst licensed in Sweden in 1997. Approved by the Ministry of Food and Drug Safety (MFDS) in South Korea on May 9, 2016. Registered in the Russian Federation since 2008. Meets European Union Pharmacopoeia requirements. Marketing Authorization Holder: Sanofi Winthrop Industrie, France.
Schedule / Dosing IntervalsPrimary immunization typically involves three doses at 1-2 month intervals, starting at 2 months of age (e.g., 2, 3, 4 months or 2, 4, 6 months). A booster dose is recommended one year after primary vaccination, usually between 16 and 18 months of age, or within the second year of life.
Reconstitution RequirementsReconstitute by injecting the suspension of the combined diphtheria, tetanus, acellular pertussis, and poliomyelitis vaccine into the vial containing the Haemophilus type b conjugate vaccine powder. Shake until complete dissolution. The reconstituted suspension is cloudy and whitish. Use immediately after reconstitution.
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