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RX ITEM-Daptacel Dtap 15 10 5 .5 Vial 10X0.5Ml By Sanofi Pasteur Refrigerated

NDC 49281-0286-10 UPC/GTIN No.3-49281-28610-0 Mfg.Part No.28610  vial , cloudy , white  Brand Name	DAPTACEL 0.5ML SDV Rx itemBrand Name ProductRefrigerated Item
Generic Name	DTAP DAPTACEL 0.5/ML
ProBRAND: DAPTACEL NDC: 49281-0286-10,49281028610 UPC: 3-49281-28610-0,349281286100 Sanofi Pasteur Daptacel 15 10 5 .5 Vial 10X0.5ml by Sanofi Pasteur RefrigeratedOnly Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

RX ITEM-Daptacel Dtap 15 10 5 .5 Vial 10X0.5Ml By Sanofi Pasteur Refrigerated

$343.10$329.99

item No.:RX997820/a NDC No.49281028610 UPC No.:349281286100 NDC No. 49281-0286-10 UPC/GTIN No. 3-49281-28610-0 MPN 28610 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX item. Rx Item No. Rx997820 Daptacel DTaP 15/10/5/.5 Vial 10X0.5ml by Sanofi Pasteur Item No. 3997820 NDC No. 49281028610 UPC No. 349281286100 Other

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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.

2.2 Administration
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.

NDC 49281-0286-10 UPC/GTIN No.3-49281-28610-0 Mfg.Part No.28610  vial , cloudy , white  Brand Name	DAPTACEL 0.5ML SDV Rx itemBrand Name ProductRefrigerated Item
Generic Name	DTAP DAPTACEL 0.5/ML
Pro
RX ITEM-Daptacel Dtap 15 10 5 .5 Vial 10
NDC 49281-0286-10 UPC/GTIN No.3-49281-28610-0 Mfg.Part No.28610 vial , cloudy , white Brand Name DAPTACEL 0.5ML SDV Rx itemBrand Name ProductRefrigerated Item Generic Name DTAP DAPTACEL 0.5/ML Pro

BRAND: DAPTACEL NDC: 49281-0286-10,49281028610 UPC: 3-49281-28610-0,349281286100 Sanofi Pasteur Daptacel 15 10 5 .5 Vial 10X0.5ml by Sanofi Pasteur Refrigerated
Daptacel 15 10 5 .5 Vial 10X0.
BRAND: DAPTACEL NDC: 49281-0286-10,49281028610 UPC: 3-49281-28610-0,349281286100 Sanofi Pasteur Daptacel 15 10 5 .5 Vial 10X0.5ml by Sanofi Pasteur Refrigerated

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
DIPH,PERTUSS(ACELL),TET P
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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