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Daptacel

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Daptacel

Daptacel

INDICATIONS

DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) ® is a vaccine indicated for active immunization against diphtheria, tetanus and pertussis as a five-dose series in infants and children 6 weeks through 6 years of age (prior to seventh birthday).

DOSAGE AND ADMINISTRATION

Immunization Series

DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine is to be administered as a 5 dose series at 2, 4 and 6 months of age (at intervals of 6-8 weeks), at 15-20 months of age and at 4-6 years of age. The first dose may be given as early as 6 weeks of age. Four doses of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine constitute a primary immunization course for pertussis. The fifth dose is a booster for pertussis immunization. Three doses of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine constitute a primary immunization course for diphtheria and tetanus. The fourth and fifth doses are boosters for diphtheria and tetanus immunization. [See Clinical Studies.]

Data are not available on the safety and immunogenicity of using mixed sequences of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine and DTaP vaccines from different manufacturers for successive doses of the DTaP vaccination series. DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine may be used to complete the immunization series in infants who have received 1 or more doses of whole-cell pertussis DTP. However, the safety and efficacy of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine in such infants have not been fully demonstrated.

If a decision is made to withhold any recommended dose of pertussis vaccine, [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS], Diphtheria and Tetanus Toxoids Adsorbed For Pediatric Use (DT) should be administered.

Administration

Just before use, shake the vial well, until a uniform, white, cloudy suspension results. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If these conditions exist, the product should not be administered.

When withdrawing a dose from a rubber-stoppered vial, do not remove either the rubber stopper or the metal seal holding it in place.

Each 0.5 mL dose of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine is to be administered intramuscularly. In infants younger than 1 year, the anterolateral aspect of the thigh provides the largest muscle and is the preferred site of injection. In older children, the deltoid muscle is usually large enough for injection. The vaccine should not be injected into the gluteal area or areas where there may be a major nerve trunk.

Do not administer this product intravenously or subcutaneously.

DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine should not be combined through reconstitution or mixed with any other vaccine.

HOW SUPPLIED

Dosage Forms And Strengths

DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine is a suspension for injection in 0.5 mL single dose vials. Each 0.5 mL dose contains 15 Lf diphtheria toxoid, 5 Lf tetanus toxoid and acellular pertussis antigens [10 g detoxified pertussis toxin (PT), 5 g filamentous hemagglutinin (FHA), 3 g pertactin (PRN), and 5 g fimbriae types 2 and 3 (FIM)]. [See DESCRIPTION]

Vial, 1 Dose (1 per package) - NDC No. 49281-286-01
Vial, 1 Dose (5 per package) - NDC No. 49281-286-05
Vial, 1 Dose (10 per package) - NDC No. 49281-286-10

DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine should be stored at 2° to 8°C (35° to 46°F). DO NOT FREEZE. Product which has been exposed to freezing should not be used. Do not use after expiration date shown on the label.

Manufactured by: Sanofi Pasteur Limited, Toronto, Ontario, Canada. Distributed by: Sanofi Pasteur Inc. Swiftwater PA 18370 USA. Product information as of March 2008.

Last reviewed on RxList: 10/30/2009
This monograph has been modified to include the generic and brand name in many instances.

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