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National Drug Formulary

PERTAGEN® SUSPENSION FOR INJECTION 0.5 ML/DOSE [SIN16283P]

Active ingredients: PERTAGEN® SUSPENSION FOR INJECTION 0.5 ML/DOSE

View product's general information
Last updated 24 April 2026

Product Info

PERTAGEN® SUSPENSION FOR INJECTION 0.5 ML/DOSE

[SIN16283P]

Product information

Active Ingredient and Strength

FILAMENTOUS HAEMAGGLUTININ (FHA) - 5 MCG/0.5 ML
RECOMBINANT PERTUSSIS TOXIN (RPT) - 5 MCG/0.5 ML

Dosage Form

INJECTION, SUSPENSION

Manufacturer and Country

BIONET-ASIA CO., LTD. - THAILAND

Registration Number

SIN16283P

Licence Holder

NOVEM HEALTHCARE PTE LTD

Forensic Classification

PRESCRIPTION ONLY MEDICINES

Anatomical Therapeutic Chemical (ATC) code

J07AJ02

Prescription-only Medicines with Exemptions for Supply without Prescription

NA

Indication

4.1. Therapeutic indications

Pertagen® is indicated for active booster immunization against pertussis in individuals from the age of 3 years onwards.

Pertagen® is indicated for maternal immunization in pregnant women for the prevention of pertussis in infants too young to be vaccinated.

Pertagen® should be used in accordance with official recommendations for booster vaccination and maternal immunization against pertussis only.

Dosing

4.2. Posology and method of administration

Posology

A single 0.5 mL dose of Pertagen® is recommended.

Pertagen® should be given in accordance with WHO and national recommendations or medical practices for booster vaccination and for maternal immunization in the second and third trimester preferably at least 15 days before the end of pregnancy, for protection of infants against pertussis.

Pertagen® may be considered as an alternative to acellular pertussis combinations (DTaP or Tdap-based vaccines) for pertussis booster immunization in subjects with known hypersensitivity to tetanus (Arthus-type hypersensitivity reaction) or diphtheria vaccines and in individuals who have received multiple and frequent tetanus or diphtheria vaccine doses.

Method of administration

Pertagen® should be administered by intramuscular injection, preferably in the deltoid region.

Shake well before use. Do not use if resuspension does not occur after vigorous shaking or foreign particles or discoloration are observed. Administer the total volume of 0.5 mL intramuscularly (IM) (see Section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Contraindications

4.3. Contraindications

Hypersensitivity to the active substance(s) or 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 or formaldehyde.

Pertagen® should not be administered to individuals with past experience or signs of:

  • severe allergic reaction or any encephalopathy with unknown origin following administration of pertussis vaccines or to any components of the vaccine,

  • neurological disorders, uncontrolled epilepsy or progressive encephalopathy.