Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
INJECTION, SUSPENSION
**POSOLOGY** A single 0.5 mL dose of **Pertagen®** is recommended. **Pertagen®** should be given following the current local recommendation for booster vaccination against pertussis. In accordance with 2019 WHO recommendations for routine immunization of pertussis-containing vaccine, the use of **Pertagen®** may be considered in the second or third trimester and preferably at least 15 days before the end of pregnancy. See **PREGNANCY AND LACTATION** section – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.
INTRAMUSCULAR
Medical Information
**INDICATION** **Pertagen®** is indicated for active booster immunization against pertussis in individuals from the age of 11 years onwards. **Pertagen®** may be considered as an alternative to combined tetanus, diphtheria and acellular pertussis vaccines in persons having received multiple and frequent tetanus and diphtheria vaccine doses including persons with known hypersensitivity to tetanus (Arthus-type hypersensitivity reaction) or diphtheria vaccines.
**CONTRAINDICATION** **Pertagen®** should not be administered to individuals having shown signs of hypersensitivity or life-threatening reaction following administration of pertussis vaccines or to any components of the vaccine. Hypersensitivity to diphtheria and tetanus vaccines are not contraindication to the use of **Pertagen®**. **Pertagen®** should not be administered to individuals having experienced any encephalopathy with unknown aetiology such as coma, prolonged seizures, or decreased level of consciousness within 7 days following previous vaccination with any whooping cough vaccine. **Pertagen®** should not be administered to individuals with progressive or unstable neurological disorders, uncontrolled epilepsy or progressive encephalopathy.
J07AJ02
pertussis, purified antigen
Manufacturer Information
NOVEM HEALTHCARE PTE LTD
Bionet-Asia Co., Ltd.
Active Ingredients
Recombinant Pertussis Toxin (rPT)
5 ug/0.5 ml
Filamentous Haemagglutinin (FHA)
5 ug/0.5 ml
Documents
Package Inserts
Pertagen Suspension for Injection PI.pdf
Approved: June 28, 2022