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.
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Dose
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Dose 1
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Dose 2
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Dose 3
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Dose 4
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Age at Dose
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2 months
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4 months
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6 months
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12-15 months
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- Vaccine Schedule for Infants from 2 to 6 months of age
Two-dose primary series alternatively,
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Dose
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Dose 2
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Dose 3
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Dose 4
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Age at Dose
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2 months
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4 months
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11-12 months
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- Previously unvaccinated older infants and children:
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Age at First Dose
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Total Number of 0.5 mL Doses
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7-11 months of age
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3
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12 months to 5 years of age
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2
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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.
