- Approval Id
- 2f63a1c925ba7969
- Drug Name
- Tetraxim Vaccine
- Product Name
- Tetraxim Vaccine
- Approval Number
- SIN15026P
- Approval Date
- 2016-06-06
- Registrant
- SANOFI-AVENTIS SINGAPORE PTE. LTD.
- Licence Holder
- SANOFI-AVENTIS SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INJECTION, SUSPENSION
- Dosage
- **4.2 Posology and method of administration**
TETRAXIM (DTaP-IPV) is a full dose formulation.
**Posology**
Primary vaccination: Primary immunization can be given as 3 doses at an interval of 1–2 months starting at the age of 2 or 3 months i.e., according to the official schedule, at the age of 2, 3, 4 months or 3, 4, 5 months or 2, 4, 6 months.
Booster vaccination: 1 injection in the second year of life, i.e., usually, between 16 and 18 months.
Tetraxim can also be administered to children aged 4 through 13 years who were previously immunized with an acellular vaccine or a whole-cell pertussis vaccine. Tetraxim is a high dose diphtheria vaccine. A low dose diphtheria vaccine is usually recommended at this age as per official recommendation.
Booster doses in 4 through 13 years old individuals should be given in accordance with official recommendation.
For primary vaccination and for the first booster dose, this vaccine may be administered by reconstituting the _Haemophilus influenzae_ type b conjugate vaccine (Act-HIB) or administered at the same time as this vaccine, but at two separate injection sites.
**Method of administration**
Administer via the intramuscular route.
Administration should preferably be performed in the antero-lateral side of the thigh (middle third) in infants and in the deltoid area in children aged between 4 through 13 years.
- Route Of Administration
- INTRAMUSCULAR
- Indication Info
- **4.1 Therapeutic indications**
This vaccine is indicated in the joint prevention of diphtheria, tetanus, pertussis and poliomyelitis according to official recommendations:
- for primary vaccination in infants from the age of 2 months,
- for booster vaccination
- Contraindications
- **4.3 Contraindications**
- Hypersensitivity:
- to any of the active substances of TETRAXIM,
- to any of the excipients listed in section 6.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_,
- to glutaraldehyde, neomycin, streptomycin, or polymyxin B (used during the manufacturing process and which may be present in trace amounts)
- to a pertussis vaccine (acellular or whole cell).
- Life-threatening reaction after previous administration of the same vaccine or a vaccine containing the same substances.
- Vaccination must be postponed in case of febrile or acute disease.
- Evolving encephalopathy.
- Encephalopathy within 7 days of administration of a previous dose of any vaccine containing pertussis antigens (whole cell or acellular pertussis vaccines).
- Atc Code
- J07CA02
- Atc Item Name
- diphtheria-pertussis-poliomyelitis-tetanus
- Pharma Manufacturer Name
- SANOFI-AVENTIS SINGAPORE PTE. LTD.
- Company Detail Path
- /organization/sanofi-aventis-singapore-pte-ltd
