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Kinrix

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Kinrix

INDICATIONS

A single dose of KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) is indicated for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis as the fifth dose in the diphtheria, tetanus, and acellular pertussis (DTaP) vaccine series and the fourth dose in the inactivated poliovirus vaccine (IPV) series in children 4 through 6 years of age whose previous DTaP vaccine doses have been with INFANRIX® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) and/or PEDIARIX® [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined] for the first three doses and INFANRIX for the fourth dose.

DOSAGE AND ADMINISTRATION

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. After removal of the dose, any vaccine remaining in the vial should be discarded.

Recommended Dose and Schedule

KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) is to be administered as a 0.5-mL dose by intramuscular injection. The preferred site of administration is the deltoid muscle of the upper arm. Do not administer this product intravenously, intradermally, or subcutaneously.

KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) may be used for the fifth dose in the DTaP immunization series and the fourth dose in the IPV immunization series in children 4 through 6 years of age (prior to the seventh birthday) whose previous DTaP vaccine doses have been with INFANRIX and/or PEDIARIX for the first three doses and INFANRIX for the fourth dose [see INDICATIONS].

HOW SUPPLIED

Dosage Forms And Strengths

KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) is available in 0.5-mL single-dose vials and prefilled TIP-LOK® syringes. Each 0.5-mL dose contains a suspension for injection of diphtheria and tetanus toxoids, acellular pertussis antigens, and inactivated poliovirus types 1, 2, and 3. See DESCRIPTION for the complete listing of ingredients.

Storage And Handling

KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) is available in 0.5-mL single-dose vials and disposable prefilled TIP-LOK syringes.

Single-Dose Vials

NDC 58160-812-11 (package of 10)

Single-Dose Prefilled Disposable TIP-LOK Syringes (packaged without needles)

NDC 58160-812-46 (package of 5)

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, US License 1617 and Novartis Vaccines and Diagnostics GmbH & Co. KG Marburg, Germany, US License 1754. Distributed by GlaxoSmithKline Research Triangle Park, NC 27709. FDA Rev date: 6/24/2008

Last reviewed on RxList: 7/23/2008
This monograph has been modified to include the generic and brand name in many instances.

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