MedPath
HSA Product

INFANRIX HEXA VACCINE

Product approved by Health Sciences Authority (SG)

Basic Information

INFANRIX HEXA VACCINE

INJECTION

Regulatory Information

SIN12288P

May 7, 2003

Prescription Only

Therapeutic

INTRAMUSCULAR

August 10, 2023

June 3, 2025

XJ07CA09

Company Information

GLAXOSMITHKLINE PTE LTD

GLAXOSMITHKLINE PTE LTD

Active Ingredients

DIPHTHERIA TOXOID

Strength: min 30 iu/0.5 ml

PERTACTIN (69 kDa OMP)

Strength: 8 mcg/0.5 ml

POLIOVIRUS TYPE 1 (INACTIVATED)

Strength: 40 du/0.5 ml

FILAMENTOUS HAEMAGGLUTININ

Strength: 25 mcg/0.5 ml

PERTUSSIS TOXOID

Strength: 25 mcg/0.5 ml

POLIOVIRUS TYPE 3 (INACTIVATED)

Strength: 32 du/0.5 ml

POLIOVIRUS TYPE 2 (INACTIVATED)

Strength: 8 du/0.5 ml

Detailed Information

Contraindications

**Contraindications** Hypersensitivity to the active substances or to any of the excipients or residues such as formaldehyde, neomycin and polymyxin (see _Qualitative and quantitative composition_ and _List of Excipients_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Hypersensitivity after previous administration of diphtheria, tetanus, pertussis, hepatitis B, polio or Hib vaccines. Infanrix hexa is contraindicated if the child has experienced an encephalopathy of unknown aetiology, occurring within 7 days following previous vaccination with pertussis-containing vaccine. In these circumstances, pertussis vaccination should be discontinued and the vaccination course should be continued with diphtheria-tetanus, hepatitis B, inactivated polio and Hib vaccines.

Indication Information

**Indications** Infanrix hexa is indicated for primary and booster vaccination of infants and toddlers against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and _Haemophilus influenzae_ type b. The use of Infanrix hexa should be in accordance with official recommendations.

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