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 **Boostagen** ® is recommended. **Boostagen** ® should be given in accordance with WHO and national recommendations or medical practices for booster vaccination and for maternal immunization in the second or third trimester preferably at least 15 days before the end of pregnancy, for protection of infants against pertussis. **Boostagen** ® can be used for tetanus prophylaxis in wound management. Tetanus immunoglobulin should be administered in accordance with existing recommendations.
INTRAMUSCULAR
Medical Information
**INDICATION** **Boostagen** ® is indicated for: - active booster immunization against tetanus, diphtheria and pertussis in individuals from the age of 3 years onwards. - maternal immunization in pregnant women for the prevention of pertussis in infants too young to be vaccinated. **Boostagen** ® is not indicated for primary immunization.
**CONTRAINDICATION** **Boostagen** ® should not be administered to individuals with past experience or signs of: - hypersensitivity or life-threatening reaction following administration of diphtheria, tetanus or pertussis vaccines or to any components of the vaccine (see Section COMPOSITION – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_); - 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; - progressive or unstable neurological disorders, uncontrolled epilepsy or progressive encephalopathy.
J07AJ52
pertussis, purified antigen, combinations with toxoids
Manufacturer Information
NOVEM HEALTHCARE PTE LTD
BioNet-Asia Co., Ltd
Active Ingredients
Diphtheria Toxoid (DT)
2.0 Lf/0.5 ml
Filamentous Haemagglutinin (FHA)
5 ug/0.5 ml
Recombinant Pertussis Toxin (rPT)
5 ug/0.5 ml
Documents
Package Inserts
Boostagen Suspension For Injection PI.pdf
Approved: December 7, 2022