Rx Item-Infanrix Dtap 25 58 10 Syringe 10X0.5Ml By Glaxosmithkline Vaccines Refr

INFANRIX- clostridium tetani toxoid antigen (formaldehyde inactivated), corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated), bordetella pertussis toxoid antigen (formaldehyde, glutaraldehyde inactivated), bordetella pertussis filamentous hemagglutinin antigen (formaldehyde inactivated) and bordetella pertussis pertactin antigen (formaldehyde inactivated) suspension
GlaxoSmithKline Biologicals SA

1 INDICATIONS AND USAGE

INFANRIX� is indicated for active immunization against diphtheria, tetanus, and pertussis as a 5-dose series in infants and children 6 weeks to 7 years of age (prior to seventh birthday).

2 DOSAGE AND ADMINISTRATION

2.1 Preparation for Administration


Shake vigorously to obtain a homogeneous, turbid, white suspension. Do not use if resuspension does not occur with vigorous shaking. 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 exists, the vaccine should not be administered.

For the prefilled syringes, attach a sterile needle and administer intramuscularly.

For the vials, use a sterile needle and sterile syringe to withdraw the 0.5?mL dose and administer intramuscularly. Changing needles between drawing vaccine from a vial and injecting it into a recipient is not necessary unless the needle has been damaged or contaminated. Use a separate sterile needle and syringe for each individual.

Do not administer this product intravenously, intradermally, or subcutaneously.

2.2 Dose and Schedule
A 0.5-mL dose of INFANRIX is approved for intramuscular administration in infants and children 6 weeks to 7 years of age (prior to the seventh birthday) as a 5-dose series. The series consists of a primary immunization course of 3 doses administered at 2, 4, and 6 months of age (at intervals of 4 to 8 weeks), followed by 2 booster doses, administered at 15 to 20 months of age and at 4 to 6 years of age. The first dose may be given as early as 6 weeks of age.

The preferred administration site is the anterolateral aspect of the thigh for most infants younger than 12 months of age and the deltoid muscle of the upper arm for most children 12 months of age to 7 years of age.

RX ITEM-Infanrix Dtap 25 58 10 Syringe 1
NDC 58160-0810-52 UPC/GTIN No.3-58160-81052-7 Mfg.Part No.81052 solution , white Turbid appearance Brand Name INFANRIX 0.5ML PFS Rx itemBrand Name ProductRefrigerated Item Generic Name DTAP INFANRIX

Infanrix Dtap 25 58 10 Syringe 10X0.5Ml
BRAND: INFANRIX-VACCINE NDC: 58160-0810-52,58160081052 UPC: 3-58160-81052-7,358160810527 Glaxosmithkline/Vaccines

DIPH,PERTUSS(ACELL),TET P
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