November 27, 2015
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How Supplied


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).


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.

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 months of age to 7 years of age.

Use Of INFANRIX With Other DTaP Vaccines

Sufficient data are not available on the safety and effectiveness of interchanging INFANRIX and Diphtheria and Tetanus Toxoids and Acellular Pertussis (DTaP) vaccines from different manufacturers for successive doses of the DTaP vaccination series. Because the pertussis antigen components of INFANRIX and PEDIARIX® [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine] are the same, INFANRIX may be used to complete a DTaP vaccination series initiated with PEDIARIX.

Additional Dosing Information

If any recommended dose of pertussis vaccine cannot be given [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS], Diphtheria and Tetanus Toxoids Adsorbed (DT) For Pediatric Use should be given according to its prescribing information.


Dosage Forms And Strengths

INFANRIX is a suspension for injection available in 0.5-mL single-dose vials and prefilled TIP-LOK® syringes.

Storage And Handling

INFANRIX is available in 0.5-mL single-dose vials and disposable prefilled TIP-LOK syringes (packaged without needles):

NDC 58160-810-01 Vial in Package of 10: NDC 58160-810-11
NDC 58160-810-43 Syringe in Package of 10: NDC 58160-810-52

Store refrigerated between 2° and 8°C (36° and 46°F). Do not freeze. Discard if the vaccine has been frozen.

Manufactured by : GlaxoSmithKline Biologicals, Rixensart, Belgium. Novartis Vaccines and Diagnostics GmbH, Marburg, Germany. Distributed by GlaxoSmithKline Research Triangle Park, NC 27709

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 11/13/2015

How Supplied

Report Problems to the Food and Drug Administration


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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