Synflorix – GSK
Indication and Usage –
- SYNFLORIX is indicated for active immunization of infants and children from 6 weeks up to 5 years of age against diseases caused by Streptococcus pneumoniae serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F and cross-reactive 19A
- invasive disease (including sepsis, meningitis, bacteraemia pneumonia, pleural empyema and bacteraemia)
- pneumonia
- acute otitis media
Dosage and Administration –
- Synflorix should be given by intramuscular injection. The preferred sites are anterolateral aspect of the thigh in infants or the deltoid muscle of the upper arm in children.
- Infants from 6 weeks to 6 months of age:
Three-dose primary series
- The recommended immunization series to ensure optimal protection consists of four doses, each of 0.5 mL.
Dose
|
Dose 1
|
Dose 2
|
Dose 3
|
Dose 4
|
Age at Dose
|
2 months
|
4 months
|
6 months
|
12-15 months
|
- Vaccine Schedule for Infants from 2 to 6 months of age
Two-dose primary series alternatively,
Dose
|
Dose 2
|
Dose 3
|
Dose 4
|
Age at Dose
|
2 months
|
4 months
|
11-12 months
|
- Previously unvaccinated older infants and children:
Age at First Dose
|
Total Number of 0.5 mL Doses
|
7-11 months of age
|
3
|
12 months to 5 years of age
|
2
|
Contraindications –
- Synflorix should not be administered to subjects with known hypersensitivity to any component of the vaccine. For a complete listing, see the dosage forms, composition and packaging section of the product monograph.
Adverse reactions –
- The most common adverse reactions observed after primary vaccination were redness at the injection site and irritability which occurred after approximately 41% and 55% of all doses respectively.
- Following booster vaccination, the most common adverse reactions were pain at the injection site and irritability, which occurred at approximately 51% and 53% respectively.
- The majority of these reactions were of mild to moderate severity and were not long lasting.
Drug interactions and other interactions –
- Synflorix can be given concomitantly with any of the following
- monovalent or combination vaccines [including DTPa-HBV-IPV/Hib]:
- diphtheria-tetanus-acellular pertussis vaccine (DTPa),
- hepatitis B vaccine (HBV),
- inactivated polio vaccine (IPV),
- Haemophilus influenzae type b vaccine (Hib),
- measles-mumps-rubella vaccine (MMR),
- varicella vaccine,
- meningococcal
- rotavirus vaccine.
- Different injectable vaccines should always be given at different injections sites.