Prevnar 13

Prevnar 13 Manufacturers

• Wyeth Pharmaceutical Division Of Wyeth Holdings Corporation, A Subsidiary Of Pfizer Inc.
  

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  Prevnar 13 | Wyeth Pharmaceutical Division Of Wyeth Holdings Corporation, A Subsidiary Of Pfizer Inc.

  

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  2.1 Preparation for Administration

  Since this product is a suspension containing an adjuvant, shake vigorously immediately prior to use to obtain a homogenous, white suspension in the vaccine container. Do not use the vaccine if it cannot be resuspended. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration [see Description (11)]. This product should not be used if particulate matter or discoloration is found.

  Do not mix Prevnar 13 with other vaccines/products in the same syringe.

  2.2 Administration Information

  For intramuscular injection only.

  Each 0.5 mL dose is to be injected intramuscularly using a sterile needle attached to the supplied prefilled syringe. The preferred sites for injection are the anterolateral aspect of the thigh in infants and the deltoid muscle of the upper arm in toddlers, children and adults. The vaccine should not be injected in the gluteal area or areas where there may be a major nerve trunk and/or blood vessel.

  2.3 Vaccination Schedule for Infants and Toddlers

  Prevnar 13 is to be administered as a four-dose series at 2, 4, 6, and 12–15 months of age.

  Table 1: Vaccination Schedule for Infants and Toddlers Dose Dose 1*,† Dose 2† Dose 3† Dose 4‡ * Dose 1 may be given as early as 6 weeks of age. † The recommended dosing interval is 4 to 8 weeks. ‡ The fourth dose should be administered at approximately 12–15 months of age, and at least 2 months after the third dose. Age at Dose 2 months 4 months 6 months 12–15 months 2.4 Vaccination Schedule for Unvaccinated Children 7 Months Through 5 Years of Age

  For children 7 months through 5 years of age who have not received Prevnar® or Prevnar 13, the catch-up schedule in Table 2 applies:

  Table 2: Vaccination Schedule for Unvaccinated Children 7 Months of Age Through 5 Years of Age Age at First Dose Total Number of 0.5 mL Doses * The first 2 doses at least 4 weeks apart; third dose after the one-year birthday, separated from the second dose by at least 2 months. † Two doses at least 2 months apart. 7–11 months of age 3* 12–23 months of age 2† 24 months through 5 years of age (prior to the 6th birthday) 1

  The immune responses induced by this catch-up schedule may result in lower antibody concentrations for some serotypes, compared to antibody concentrations following 4 doses of Prevnar 13 (given at 2, 4, 6, and 12–15 months). In children 24 months through 5 years of age, lower antibody concentrations were observed for some serotypes, compared to antibody concentrations following 3 doses of Prevnar 13 (given at 2, 4, and 6 months).

  2.5 Vaccination Schedule for Children Previously Vaccinated With Prevnar Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)

  Children 15 months through 5 years of age who are considered completely immunized with Prevnar may receive one dose of Prevnar 13 to elicit immune responses to the 6 additional serotypes. This catch-up (supplemental) dose of Prevnar 13 should be administered with an interval of at least 8 weeks after the final dose of Prevnar. The immune responses induced by this Prevnar 13 schedule may result in lower antibody concentrations for the 6 additional serotypes (types 1, 3, 5, 6A, 7F, and 19A), compared to antibody concentrations following 4 doses of Prevnar 13 (given at 2, 4, 6, and 12–15 months).

  2.6 Vaccination Schedule for Children 6 Years Through 17 Years of Age

  In children 6 years through 17 years of age, Prevnar 13 is administered as single dose. If Prevnar was previously administered, then at least 8 weeks should elapse before receiving Prevnar 13.

  2.7 Vaccination Schedule for Adults 50 years of Age and Older

  Prevnar 13 is administered as a single dose.

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