May 31, 2016
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Kinrix

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Kinrix




Indications
Dosage
How Supplied

INDICATIONS

A single dose of KINRIX® 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] 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. 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.

Recommended Dose And Schedule

KINRIX 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.

KINRIX 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 AND USAGE].

HOW SUPPLIED

Dosage Forms And Strengths

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

Storage And Handling

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

NDC 58160-812-01 Vial in Package of 10: NDC 58160-812-11
NDC 58160-812-43 Syringe in Package of 10: NDC 58160-812-52

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 and Novartis Vaccines and Diagnostics GmbH, Marburg, Germany. Distributed by :GlaxoSmithKline Research Triangle Park, NC 27709. Revised: July 2014

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

Last reviewed on RxList: 10/19/2015

Indications
Dosage
How Supplied

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