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Prevnar

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Prevnar

Prevnar

INDICATIONS

Prevnar (pneumococcal 7-valent conjugate) ® is indicated for active immunization of infants and toddlers against invasive disease caused by S. pneumoniae due to capsular serotypes included in the vaccine (4, 6B, 9V, 14, 18C, 19F, and 23F). The routine schedule is 2, 4, 6, and 12-15 months of age.

The decision to administer Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein), Prevnar (pneumococcal 7-valent conjugate) ® should be based primarily on its efficacy in preventing invasive pneumococcal disease. As with any vaccine, Prevnar (pneumococcal 7-valent conjugate) ® may not protect all individuals receiving the vaccine from invasive pneumococcal disease.

Prevnar (pneumococcal 7-valent conjugate) ® is also indicated for active immunization of infants and toddlers against otitis media caused by serotypes included in the vaccine. However, for vaccine serotypes, protection against otitis media is expected to be substantially lower than protection against invasive disease. Additionally, because otitis media is caused by many organisms other than serotypes of S. pneumoniae represented in the vaccine, protection against all causes of otitis media is expected to be low.

(See CLINICAL PHARMACOLOGY for estimates of efficacy against invasive disease and otitis media).

For additional information on usage, see DOSAGE AND ADMINISTRATION.

This vaccine is not intended to be used for treatment of active infection.

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.

Vaccine Schedule

For infants, the immunization series of Prevnar (pneumococcal 7-valent conjugate) ® 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).

HOW SUPPLIED

Syringe, 1 Dose (10 per package) - NDC 0005-1970-50

CPT Code 90669

Storage

DO NOT FREEZE. STORE REFRIGERATED, AWAY FROM FREEZER COMPARTMENT, AT 2°C TO 8°C (36°F TO 46°F).

This product's label may have been updated. For current package insert and further product information, please visit www.wyeth.com or call our medical communications department toll-free at 1-800-934-5556. Manufactured by: Wyeth Pharmaceuticals Inc. Philadelphia, PA 19101. FDA Rev date: n/a

Last reviewed on RxList: 2/4/2009
This monograph has been modified to include the generic and brand name in many instances.

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