DAPTACEL- corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated), clostridium tetani toxoid antigen (formaldehyde inactivated), bordetella pertussis toxoid antigen (glutaraldehyde inactivated), bordetella pertussis filamentous hemagglutinin antigen (formaldehyde inactivated), bordetella pertussis pertactin antigen and bordetella pertussis fimbriae 2/3 antigen injection, suspension
Sanofi Pasteur Inc.
1 INDICATIONS AND USAGE
DAPTACEL® 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).
2 DOSAGE AND ADMINISTRATION
2.1 Immunization Series
DAPTACEL 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 constitute a primary immunization course for pertussis. The fifth dose is a booster for pertussis immunization. Three doses of DAPTACEL 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).]
DAPTACEL should be used as the fifth dose of the DTaP series in children who initially received 4 doses of Pentacel® [(Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) vaccine, Sanofi Pasteur Limited]. Pentacel and DAPTACEL contain the same pertussis antigens, manufactured by the same process, although Pentacel contains twice the amount of detoxified pertussis toxin (PT) and four times the amount of filamentous hemagglutinin (FHA) as DAPTACEL.
Data are not available on the safety and effectiveness of using mixed sequences of DAPTACEL and DTaP vaccines from different manufacturers for successive doses of the DTaP vaccination series. DAPTACEL 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 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.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exist, the product should not be administered.
After removing the "flip-off" cap, cleanse the vaccine vial stopper with a suitable germicide. Do not remove either the rubber stopper or the metal seal holding it in place. Just before use, shake the vial well, until a uniform, white, cloudy suspension results.
Using a sterile needle and syringe and aseptic technique, withdraw and administer a single 0.5 mL dose of DAPTACEL intramuscularly. Use a separate sterile needle and syringe for each injection. Changing needles between withdrawing the vaccine from the vial and injecting it into a recipient is not necessary unless the needle has been damaged or contaminated. 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 should not be combined through reconstitution or mixed with any other vaccine.
3 DOSAGE FORMS AND STRENGTHS
DAPTACEL is a suspension for injection in 0.5 mL single dose vials. See Description (11) for a complete listing of ingredients.