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PERTAGEN® SUSPENSION FOR INJECTION 0.5 ML/DOSE [SIN16283P]
Active ingredients: PERTAGEN® SUSPENSION FOR INJECTION 0.5 ML/DOSE
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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 |
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 |
INDICATION
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.
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.
CONTRAINDICATION
Pertagen® should not be administered to individuals with past experience or signs of:
servere 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.
Hypersensitivity, thrombocytopenia or neurological complications following an earlier immunization against diphtheria and/or tetanus are not contraindication to the use of Pertagen®.
