Rx Item-Kinrix (Dtap+Polio) .5Ml Syrup By Glaxosmithkline Vaccines

Clinical Information
Gen. Code and Des.
64122 diph,pertus(acel),tet,polio/PF INTRAMUSC SYRINGE 25-25-10
GCN and Des.
99831 diph,pertus(acel),tet,polio/PF INTRAMUSC SYRINGE 25-25-10
Strength
0.5ML
Dose Form
SYRINGE (ML)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
80120000 VACCINES
Active Ingredients
7715 diphtheria,pertussis (acell),tetanus,polio vaccine
9870 preservative free
Inactive Ingredients
2551 polysorbates 9005645
8921 latex
9283 beef derived (bovine)




These highlights do not include all the information needed to use KINRIX safely and effectively. See full prescribing information for KINRIX.

KINRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine) Suspension for Intramuscular Injection
Initial U.S. Approval: 2008
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 aged 4 through 6 years (prior to the seventh birthday) whose previous DTaP vaccine doses have been with INFANRIX and/or PEDIARIX for the first 3 doses and INFANRIX for the fourth dose. (1)
DOSAGE AND ADMINISTRATION

A single intramuscular injection (0.5 mL). (2.2)
DOSAGE FORMS AND STRENGTHS

Single-dose, prefilled syringes containing a 0.5�'mL suspension for injection. (3)
CONTRAINDICATIONS

•
Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, pertussis- or poliovirus-containing vaccine, or to any component of KINRIX, including neomycin and polymyxin B. (4.1)
•
Encephalopathy within 7 days of administration of a previous pertussis-containing vaccine. (4.2)
•
Progressive neurologic disorders. (4.3)

WARNINGS AND PRECAUTIONS

•
If Guillain-Barré syndrome occurs within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the decision to give KINRIX should be based on potential benefits and risks. (5.1)
•
The tip caps of the prefilled syringes contain natural rubber latex which may cause allergic reactions. (5.2)
•
Syncope (fainting) can occur in association with administration of injectable vaccines, including KINRIX. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope. (5.3)
•
If temperature ≥105°F, collapse or shock-like state, or persistent, inconsolable crying lasting ≥3 hours have occurred within 48 hours after receipt of a pertussis-containing vaccine, or if seizures have occurred within 3 days after receipt of a pertussis-containing vaccine, the decision to give KINRIX should be based on potential benefits and risks. (5.4)
•
For children at higher risk for seizures, an antipyretic may be administered at the time of vaccination with KINRIX. (5.5)

ADVERSE REACTIONS

•
The most frequently reported solicited local reaction (>50%) was injection site pain. Other common solicited local reactions (≥25%) were redness, increase in arm circumference, and swelling. (6.1)
•
Common solicited general adverse reactions (≥15%) were drowsiness, fever (≥99.5°F), and loss of appetite. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.
DRUG INTERACTIONS

Do not mix KINRIX with any other vaccine in the same syringe. (7.1)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 7/2023

Kinrix (Dtap+Polio) .5Ml Syrup By Glaxos
Item No.:RX028478/a, Item No. RX028478, 028478, NDC No.: 58160-0812-52, 58160-812-52, 5816081252, 58160081252, 0812-52, 081252 UPC No. 3-58160-81252-1, 358160-812521, 358160812521, Rx Item-Kinrix (Dta

DIPH,PERTUS(ACEL),TET,POL
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

RX ITEM-Kinrix (Dtap+Polio) .5Ml Syrup B
Item No.:RX028478/a, Item No. RX028478, 028478, NDC No.: 58160-0812-52, 58160-812-52, 5816081252, 58160081252, 0812-52, 081252 UPC No. 3-58160-81252-1, 358160-812521, 358160812521, Rx Item-Kinrix (Dta

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