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 IN

Available from:

A-S Medication Solutions

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 7th 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 IN

Product summary:

Product: 50090-2883

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

INFANRIX- DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS
VACCINE ADSORBED SUSPENSION
A-S MEDICATION SOLUTIONS
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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
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 7th
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 vials and 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 reactions 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.
DRUG INTERACTIONS
Do not mix INFANRIX with any other vaccine in the same syringe or
vial. (7.1)
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 1/2020
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)
Encephalopa