INFANRIX- diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: K3W1N8YP13) (CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:K3W1N8YP13), CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: IRH51QN26H) (CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:IRH51QN26H), BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED) (UNII: QSN5XO8ZSU) (BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED) - UNII:QSN5XO8ZSU), 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)

Available from:

GlaxoSmithKline Biologicals SA

INN (International Name):

CLOSTRIDIUM TETANI TOXOID ANTIGEN - UNII:K3W1N8YP13)

Composition:

CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 10 [iU] in 0.5 mL

Administration route:

INTRAMUSCULAR

Therapeutic indications:

INFANRIX is indicated for active immunization against diphtheria, tetanus, and pertussis as a 5-dose series in infants and children aged 6 weeks through 6 years (prior to the seventh birthday). Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, or pertussis-containing vaccine, or to any component of INFANRIX is a contraindication [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 being 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 INFANRIX. Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy, is a contraindication to administration of any pertussis-containing vaccine, including INFANRIX. Pertussis vaccine should not be administered to individuals with these conditions until a treatment regimen has been established and the condition has stabilized. Safety and effectiveness of INFANRIX in infants aged younger than 6 weeks and children aged 7 to 16 years have not been established. INFANRIX is not approved for use in these age groups.

Product summary:

INFANRIX 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 58160-810-43 Syringe in Package of 10: NDC 58160-810-52 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

INFANRIX- DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS
VACCINE
ADSORBED SUSPENSION
GLAXOSMITHKLINE BIOLOGICALS SA
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
INFANRIX SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR INFANRIX.
INFANRIX (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS
VACCINE ADSORBED)
SUSPENSION FOR INTRAMUSCULAR INJECTION
INITIAL U.S. APPROVAL: 1997
RECENT MAJOR CHANGES
Warnings and Precautions, Latex (5.2) - Removed
10/2023
INDICATIONS AND USAGE
INFANRIX is a vaccine indicated for active immunization against
diphtheria, tetanus, and pertussis as a 5-
dose series in infants and children aged 6 weeks through 6 years
(prior to the seventh birthday). (1)
DOSAGE AND ADMINISTRATION
A 0.5-mL intramuscular injection given as a 5-dose series: (2.2)
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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
Rates of injection site reactions (pain, redness, swelling) ranged
from 10% to 53%, depending on reaction
and dose number, and were highest following Doses 4 and 5. Fever was
common (20% to 30%) following
Doses 1-3. Other common solicited adverse reactions were drowsiness,
irritability/fussiness, and loss of
appetite, reported in approximately 15% to 60% of subjects, depending
on reaction and dose number.
(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.
One dose each at 2, 4, and 6 months of age.
One booster dose at 15 to 20 months of age and another booster dose at
4 to 6 years of age.
Severe allergic reaction (e.g., anaphylaxis) after a previous dose of
any diphtheria toxoid-, tetanus
toxoid-, or pertussis-containing vaccine, or to any component of
INFANRIX. (4.1)
Encephalopathy within 7 days of administration of a previous
pertussis-containing vaccine. (4.2)
Progressi