BOOSTAGEN SUSPENSION FOR INJECTION [SIN16493P]
Active ingredients: BOOSTAGEN SUSPENSION FOR INJECTION
Product Info
BOOSTAGEN SUSPENSION FOR INJECTION
[SIN16493P]
Product information
Active Ingredient and Strength | DIPHTHERIA TOXOID (DT) - 2 LF/0.5 ML |
Dosage Form | INJECTION, SUSPENSION |
Manufacturer and Country | BIONET-ASIA CO., LTD - THAILAND |
Registration Number | SIN16493P |
Licence Holder | NOVEM HEALTHCARE PTE LTD |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | J07AJ52 |
Prescription-only Medicines with Exemptions for Supply without Prescription | NA |
Indication
4.1. Therapeutic indications
Boostagen® is indicated for active booster immunization against tetanus, diphtheria and pertussis in individuals from the age of 3 years onwards.
Boostagen® is indicated for maternal immunization in pregnant women for the prevention of pertussis in infants too young to be vaccinated
Boostagen® is not indicated for primary immunisation.
Dosing
4.2. Posology and method of administration
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.
Method of administration
Boostagen® 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 or formaldehyde or thiomersal – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
Boostagen® should not be administered to individuals with past experience or signs of:
severe allergic reaction or any encephalopathy with unknown origin following administration of diphtheria, tetanus or pertussis vaccines or to any components of the vaccine,
neurological disorders, uncontrolled epilepsy or progressive encephalopathy.
