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Infanrix

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Infanrix

Indications
Dosage
How Supplied

INDICATIONS

INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) is indicated for active immunization against diphtheria, tetanus, and pertussis (whooping cough) as a 5-dose series in infants and children 6 weeks to 7 years of age (prior to seventh birthday). Because of the substantial risks of complications from pertussis disease in infants, completion of the primary series of 3 doses of vaccine early in life is strongly recommended (see DOSAGE AND ADMINISTRATION).2 INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) should not be administered to any infant before the age of 6 weeks, or to individuals 7 years of age or older.

As with any vaccine, INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) may not protect 100% of individuals receiving the vaccine, and is not recommended for treatment of actual infections.

DOSAGE AND ADMINISTRATION

Preparation for Administration

INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) is an adjuvanted vaccine; therefore shake vigorously to obtain a homogeneous, turbid, white suspension. DO NOT USE IF RESUSPENSION DOES NOT OCCUR WITH VIGOROUS SHAKING. Inspect visually for particulate matter or discoloration prior to administration. After removal of the dose, any vaccine remaining in the vial should be discarded.

Before injection, the skin at the injection site should be cleaned and prepared with a suitable germicide.

Recommended Schedule

A 0.5 mL dose of INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) is approved for administration in infants and children 6 weeks to 7 years of age (prior to the seventh birthday) as a 5 dose series. INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) should be administered by intramuscular injection. The series consists of a primary immunization course of 3 doses administered at 2, 4, and 6 months of age, followed by 2 booster doses, administered at 15 to 20 months of age and at 4 to 6 years of age. The customary age for the first dose is 2 months of age, but it may be given as early as 6 weeks of age. The recommended interval between the first three doses is 8 weeks, with a minimum interval of 4 weeks.5,12 The recommended interval between the third and fourth dose is 6 to 12 months.5,12 The fifth dose is recommended before entry into kindergarten or elementary school, and is not needed if the fourth dose was given after the fourth birthday.12

The preferred administration sites are the anterolateral aspects of the thigh or the deltoid muscle of the upper arm. The vaccine should not be injected in the gluteal area or areas where there may be a major nerve trunk.

Do not administer this product subcutaneously or intravenously.

Use of INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) with Other DTaP Vaccines

Interchanging INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) and DTaP vaccines from different manufacturers for successive doses of the vaccination series is not recommended because data are limited regarding the safety and efficacy of such regimens.

INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) may be used to complete a DTaP immunization series initiated with PEDIARIX™ [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined, manufactured by GlaxoSmithKline Biologicals], because the diphtheria, tetanus, and pertussis components of INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) are the same as those in PEDIARIX. However, the safety and efficacy of INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) in such infants and children have not been evaluated.

Additional Dosing Information

If any recommended dose of pertussis vaccine cannot be given, DT (For Pediatric Use) should be given as needed to complete the series.

Interruption of the recommended schedule with a delay between doses should not interfere with the final immunity achieved with INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) . There is no need to start the series over again, regardless of the time elapsed between doses.

The use of reduced volume (fractional doses) is not recommended. The effect of such practices on the frequency of serious adverse events and on protection against disease has not been determined.5

Preterm infants should be vaccinated according to their chronological age from birth.5

Concomitant Vaccine Administration

In clinical trials, INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) was routinely administered, at separate sites, concomitantly with 1 or more of the following vaccines: poliovirus vaccine live oral (OPV), hepatitis B vaccine, and Haemophilus influenzae type b vaccine (Hib) (see CLINICAL PHARMACOLOGY). Safety data are available following the first dose of INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) when administered concomitantly at separate sites with Hib and pneumococcal conjugate vaccines, hepatitis B vaccine, and IPV (see ADVERSE REACTIONS). No immunogenicity data are available on the simultaneous administration of INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) with pneumococcal conjugate vaccine or IPV.

No immunogenicity or safety data are available on the simultaneous administration of INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) with measles, mumps, and rubella vaccine (MMR) or varicella vaccine.

When concomitant administration of other vaccines is required, they should be given with separate syringes and at different injection sites.

Storage

Store INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) refrigerated between 2° and 8°C (36° and 46°F). Do not freeze. Discard if the vaccine has been frozen. Do not use after expiration date shown on the label.

HOW SUPPLIED

INFANRIX (diphtheria and tetanus toxoids and acellular pertussis) is supplied as a turbid white suspension in single-dose (0.5 mL) vials and disposable prefilled TIP-LOK® syringes.

Single-Dose Vials and Prefilled Syringes (Preservative Free Formulation)

NDC 58160-810-11 Package of 10 Single-Dose Vials

NDC 58160-810-46 Package of 5 Single-Dose Prefilled Disposable TIP-LOK Syringes (packaged without needles)

REFERENCES

2. Centers for Disease Control. Diphtheria, tetanus, and pertussis: Recommendations for vaccine use and other preventive measures — Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 1991;40(RR-10):1-28.

5. Centers for Disease Control and Prevention. General recommendations on immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the American Academy of Family Physicians (AAFP). MMWR 2002;51(RR-2):1-35.

12. Centers for Disease Control and Prevention. Update: Vaccine side effects, adverse reactions, contraindications, and precautions — Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 1996;45(RR-12):1-35.

Manufactured by GlaxoSmithKline Biologicals. Rixensart, Belgium. Distributed by GlaxoSmithKline Research Triangle Park, NC 27709. March 2008.

Last reviewed on RxList: 3/6/2009
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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