Generic name: BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED) 10ug in 0.5mL, BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) 5ug in 0.5mL, BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN 5ug in 0.5mL, BORDETELLA PERTUSSIS PERTACTIN ANTIGEN 3ug in 0.5mL, CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 15ug in 0.5mL, CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 5ug in 0.5mL
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DAPTACEL 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 vaccine constitute a primary immunization course for pertussis. The fifth dose is a booster for pertussis immunization. Three doses of DAPTACEL 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 (14.1, 14.2, 14.3).]
Data are not available on the safety and immunogenicity of using mixed sequences of DAPTACEL vaccine and DTaP vaccines from different manufacturers for successive doses of the DTaP vaccination series. DAPTACEL 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 vaccine in such infants have not been fully demonstrated.
If a decision is made to withhold any recommended dose of pertussis vaccine, [see Contraindications (4.2), (4.3) and Warnings and Precautions (5.2)], Diphtheria and Tetanus Toxoids Adsorbed For Pediatric Use (DT) should be administered.
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 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 vaccine should not be combined through reconstitution or mixed with any other vaccine.