DOSAGE AND ADMINISTRATION
For intramuscular injection only. Do not inject intravenously.
The dose is 0.5 mL to be given intramuscularly.
Since this product is a suspension containing an adjuvant, shake vigorously immediately prior to use to obtain a uniform suspension in the vaccine container. The vaccine should not be used if it cannot be resuspended.
After shaking, the vaccine is a homogeneous, white suspension.
The vaccine is not to be mixed with other vaccines/products in the same syringe.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration (see DESCRIPTION ). This product should not be used if particulate matter or discoloration is found.
The vaccine should be injected intramuscularly. The preferred sites are the anterolateral aspect of the thigh in infants or the deltoid muscle of the upper arm in toddlers and young children. The vaccine should not be injected in the gluteal area or areas where there may be a major nerve trunk and/or blood vessel. Before injection, the skin at the injection site should be cleansed and prepared with a suitable germicide. After insertion of the needle, aspirate and wait to see if any blood appears in the syringe, which will help avoid inadvertent injection into a blood vessel. If blood appears, withdraw the needle and prepare for a new injection at another site.
For infants, the immunization series of Prevnar® consists of three doses of 0.5 mL each, at approximately 2-month intervals, followed by a fourth dose of 0.5 mL at 12-15 months of age. The customary age for the first dose is 2 months of age, but it can be given as young 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.
|Vaccination schedule for infants and toddlers |
| Dose: ||Dose 1*† ||Dose 2† ||Dose 3† ||Dose 4‡ |
| Age at Dose: ||2 months ||4 months ||6 months ||12-15 months |
|* 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.
Previously Unvaccinated Older Infants and Children
For previously unvaccinated older infants and children, who are beyond the age of the routine infant schedule, the following schedule applies: 31
|Vaccine schedule for previously unvaccinated children ≥7 months of age |
| Age at First Dose || Total Number of 0.5 mL Doses |
|7-11 months of age ||3* |
|12-23 months of age ||2† |
|≥24 months through 9 years of age ||1 |
|* 2 doses at least 4 weeks apart; third dose after the one-year birthday, separated from the second dose by at least 2 months. |
† 2 doses at least 2 months apart.
(See CLINICAL PHARMACOLOGY section for the limited available immunogenicity data and ADVERSE REACTIONS section for limited safety data corresponding to the previously noted vaccination schedule for older children).
Safety and immunogenicity data are either limited or not available for children in specific high risk groups for invasive pneumococcal disease (eg, persons with sickle cell disease, asplenia, HIV-infected).