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HSA Approval

Tetraxim Vaccine

SIN15026P

Tetraxim Vaccine

Tetraxim Vaccine

June 6, 2016

SANOFI-AVENTIS SINGAPORE PTE. LTD.

SANOFI-AVENTIS SINGAPORE PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantSANOFI-AVENTIS SINGAPORE PTE. LTD.
Licence HolderSANOFI-AVENTIS SINGAPORE PTE. LTD.

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification

Formulation Information

INJECTION, SUSPENSION

**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.

INTRAMUSCULAR

Medical Information

**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

**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).

J07CA02

diphtheria-pertussis-poliomyelitis-tetanus

Manufacturer Information

SANOFI-AVENTIS SINGAPORE PTE. LTD.

Sanofi Pasteur S.A., MLE

Sanofi Pasteur S.A., VDR

Active Ingredients

Diphtheria Toxoid

Minimum 30 IU/0.5ml

Tetanus Toxoid

Minimum 40 IU/0.5ml

Pertussis Toxoid

25 μg/0.5ml

Poliovirus (inactivated) Type 3 (Saukett)

32 DU/0.5ml

Filamentous haemagglutinin

25 μg/0.5ml

Poliovirus (inactivated) Type 1 (Mahoney)

40 DU/0.5ml

Poliovirus (inactivated) Type 2 (MEF-1)

8 DU/0.5ml

Documents

Package Inserts

Tetraxim Vaccine PI.pdf

Approved: April 13, 2023

Download

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