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.

• Vaccine Schedule for Infants from 2 to 6 months of age

Two-dose primary series alternatively,

• Previously unvaccinated older infants and children:

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

1. monovalent or combination vaccines [including DTPa-HBV-IPV/Hib]:
2. diphtheria-tetanus-acellular pertussis vaccine (DTPa),
3. hepatitis B vaccine (HBV),
4. inactivated polio vaccine (IPV),
5. Haemophilus influenzae type b vaccine (Hib),
6. measles-mumps-rubella vaccine (MMR),
7. varicella vaccine,
8. meningococcal
9. rotavirus vaccine.

• Different injectable vaccines should always be given at different injections sites.