KINRIX- diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine injection, suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: IRH51QN26H) (CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:IRH51QN26H), CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: K3W1N8YP13) (CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:K3W1N8YP13), BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: 8C367IY4EY) (BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:8C367IY4EY), BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: I05O535NV6) (BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:I05O535NV6), BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED) (UNII: QSN5XO8ZSU) (BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED) - UNII:QSN5XO8ZSU), POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: 0LVY784C09) (POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:0LVY784C09), POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: 23JE9KDF4R) (POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:23JE9KDF4R), POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: 459ROM8M9M) (POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:459ROM8M9M)

Available from:

GlaxoSmithKline Biologicals SA

INN (International Name):

CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN - UNII:IRH51QN26H)

Composition:

CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 25 [iU] in 0.5 mL

Administration route:

INTRAMUSCULAR

Therapeutic 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 aged 4 through 6 years (prior to the seventh birthday) 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 3 doses and INFANRIX for the fourth dose. 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, is a contraindication to administration of KINRIX [see Description (11)] . Because of the uncertainty as to which component of the vaccine might be responsible, no further vaccination with any of these components should be given. Alternatively, such individuals may be referred to an allergist for evaluation if immunization with any of these components is considered. Encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of administration of a previous dose of a pertussis-containing vaccine that is not attributable to another identifiable cause is a contraindication to administration of any pertussis-containing vaccine, including KINRIX. Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy, is a contraindication to administration of any pertussis-containing vaccine, including KINRIX. Pertussis vaccine should not be administered to individuals with such conditions until a treatment regimen has been established and the condition has stabilized. Safety and effectiveness of KINRIX in children younger than 4 years and children aged 7 to 16 years have not been evaluated. KINRIX is not approved for use in persons in these age groups.

Product summary:

KINRIX is available in 0.5-mL single-dose, disposable, prefilled TIP‑LOK syringes (Luer Lock syringes) packaged without needles. TIP-LOK syringes are to be used with Luer Lock compatible needles. The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex. 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.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

KINRIX- DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS
ADSORBED AND
INACTIVATED POLIOVIRUS VACCINE INJECTION, SUSPENSION
GLAXOSMITHKLINE BIOLOGICALS SA
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HIGHLIGHTS OF PRESCRIBING INFORMATION
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
RECENT MAJOR CHANGES
Warnings and Precautions, Latex (5.2) - Removed
10/2023
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
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
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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)
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)
If Guillain-Barré syndrome occurs within 6 weeks of receipt of a
prior vac