Rx Item-Kinrix Dtap+Polio .5Ml Single Dose Vials 10 By Glaxosmithkline Vaccines

KINRIX- corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated), clostridium tetani toxoid antigen (formaldehyde inactivated), bordetella pertussis filamentous hemagglutinin antigen (formaldehyde inactivated), bordetella pertussis pertactin antigen (formaldehyde inactivated), bordetella pertussis toxoid antigen (formaldehyde, glutaraldehyde inactivated), poliovirus type 1 antigen (formaldehyde inactivated), poliovirus type 2 antigen (formaldehyde inactivated) and poliovirus type 3 antigen (formaldehyde inactivated) injection, suspension
GlaxoSmithKline Biologicals SA

1 INDICATIONS AND USAGE



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.

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 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 (1)].

3 DOSAGE FORMS AND STRENGTHS

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

RX ITEM-Kinrix Dtap+Polio .5Ml Single Do
NDC 58160-0812-11 UPC/GTIN No.3-58160-81211-8 Mfg.Part No.81211

Kinrix Dtap+Polio .5Ml Single Dose Vials
BRAND: KINRIX NDC: 58160-0812-11,58160081211 UPC: 3-58160-81211-8,358160812118 Glaxosmithkline/Vaccines

DIPH,PERTUS(ACEL),TET,POL
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