Prevenar 13 Suspension For Injection

INJECTION, SUSPENSION

**4.2 Posology and method of administration** **Method of administration** The vaccine should be given by intramuscular injection only. The dose is 0.5 mL given intramuscularly, with care to avoid injection into or near nerves and blood vessels. The preferred sites are the anterolateral aspect of the thigh (vastus lateralis muscle) in infants or the deltoid muscle of the upper arm in older children and adult. The vaccine should not be injected in the gluteal area. Do not administer Prevenar 13 intravascularly. The vaccine should not be injected intradermally, subcutaneously or intravenously, since the safety and immunogenicity of these routes have not been evaluated. Parenteral products should be inspected visually for particulate matter or discoloration prior to use. Data on the interchangeability of pneumococcal 7-valent conjugate vaccine or Prevenar 13 with other pneumococcal conjugate vaccines containing a protein carrier different from CRM197 are not available. **Pediatric population** The safety and effectiveness of Prevenar 13 in children below the age of 6 weeks have not been established. **Posology** The immunisation schedules for Prevenar 13 should be based on official recommendations. Infants and children aged 6 weeks to 5 years It is recommended that infants who receive a first dose of Prevenar 13 complete the vaccination course with Prevenar 13. _Infants aged 6 weeks–6 months_ _Three-dose primary series_ The recommended immunisation series consists of four doses, each of 0.5 mL. The primary infant series consists of three doses, with the first dose usually given at 2 months of age and with an interval of at least 1 month between doses. The first dose may be given as early as six weeks of age. The fourth (booster) dose is recommended between 12 and 15 months of age. Unvaccinated children ≥7 months of age _Infants aged 7–11 months_ Two doses, each of 0.5 mL, with an interval of at least 1 month between doses. A third dose is recommended in the second year of life. _Children aged 12–23 months_ Two doses, each of 0.5 mL, with an interval of at least 2 months between doses. _Children aged 2–17 years_ One single dose of 0.5 mL. Prevenar 13 schedule for preterm infants (<37 weeks gestation) In preterm infants, the recommended immunisation series consists of 4 doses, each of 0.5 mL. The primary infant series consists of 3 doses, with the first dose given at 2 months of age and with an interval of at least 1 month between doses. The first dose may be given as early as 6 weeks of age. The fourth (booster) dose is recommended at approximately 12 months of age. Prevenar 13 vaccine schedule for infants and children previously vaccinated with Pneumococcal 7-valent conjugate vaccine ( _S. pneumoniae_ serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) Prevenar 13 contains the same 7 serotypes contained in pneumococcal 7-valent conjugate vaccine, using the same carrier protein CRM197. Infants and children who have begun immunisation with pneumococcal 7-valent conjugate vaccine may switch to Prevenar 13 at any point in the schedule. _Young children (12–59 months) completely immunized with pneumococcal 7-valent conjugate vaccine_ Young children who are considered completely immunised with pneumococcal 7-valent conjugate vaccine should receive one dose of 0.5 mL of Prevenar 13 to elicit immune responses to the 6 additional serotypes. This dose of Prevenar 13 should be administered at least 8 weeks after the final dose of pneumococcal 7-valent conjugate vaccine (see section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Children 5–17 years Children 5 to 17 years of age may receive a single dose of Prevenar 13 if they have been previously vaccinated with one or more doses of pneumococcal 7-valent conjugate vaccine. This dose of Prevenar 13 should be administered at least 8 weeks after the final dose of pneumococcal 7-valent conjugate vaccine (see section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Adults ≥18 years of age, and the elderly Prevenar 13 is to be administered as a single dose to adults 18 years and older including those previously vaccinated with a pneumococcal polysaccharide vaccine. The need for re-vaccination with a subsequent dose of Prevenar 13 has not been established. For specific guidelines, please refer to local recommendations. Special populations Individuals who may be at higher risk of pneumococcal infection (e.g., individuals with sickle cell disease or HIV infection) including those previously vaccinated with 1 or more doses of 23-valent pneumococcal polysaccharide vaccine (PPSV23) may receive at least 1 dose of Prevenar 13. In individuals with a hematopoietic stem cell transplant (HSCT), the recommended immunisation series consists of 4 doses of Prevenar 13, each of 0.5 mL. The primary series consists of 3 doses, with the first dose given 3 to 6 months after HSCT and with an interval of at least 1 month between doses. A booster dose is recommended 6 months after the third dose (see section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).