DAPTACEL (corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated), clostridium tetani toxoid antigen (formaldehyde

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 TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED) (UNII: F4TN0IPY37) (BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED) - UNII:F4TN0IPY37

Available from:

Sanofi Pasteur Inc.

INN (International Name):

CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN - UNII:IRH51QN26H)

Composition:

CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 15 [Lf] in 0.5 mL

Administration route:

INTRAMUSCULAR

Therapeutic indications:

DAPTACEL® is a vaccine indicated for active immunization against diphtheria, tetanus and pertussis as a five-dose series in infants and children 6 weeks through 6 years of age (prior to seventh birthday). A severe allergic reaction (e.g., anaphylaxis) after a previous dose of DAPTACEL or any other tetanus toxoid, diphtheria toxoid, or pertussis-containing vaccine, or any other component of this vaccine is a contraindication to administration of DAPTACEL. [See Description (11). ] Because of uncertainty as to which component of the vaccine may be responsible, none of the components should be administered. Alternatively, such individuals may be referred to an allergist for evaluation if further immunizations are to be considered. Encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days 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, inclu

Product summary:

The vial stopper for this product is not made with natural rubber latex. DAPTACEL is supplied in a single-dose vial (NDC No. 49281-286-58): in packages of 1 vial: NDC No. 49281-286-01; in packages of 5 vials: NDC No. 49281-286-05; in packages of 10 vials: NDC No. 49281-286-10. DAPTACEL should be stored at 2° to 8°C (35° to 46°F). DO NOT FREEZE. Product which has been exposed to freezing should not be used. Do not use after expiration date shown on the label.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

DAPTACEL- CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE
INACTIVATED), CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE
INACTIVATED),
BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED),
BORDETELLA
PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE
INACTIVATED),
BORDETELLA PERTUSSIS PERTACTIN ANTIGEN, AND BORDETELLA PERTUSSIS
FIMBRIAE 2/3
ANTIGEN INJECTION, SUSPENSION
SANOFI PASTEUR INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DAPTACEL SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DAPTACEL.
DAPTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS
VACCINE ADSORBED)
SUSPENSION FOR INTRAMUSCULAR INJECTION
INITIAL U.S. APPROVAL: 2002
INDICATIONS AND USAGE
DAPTACEL is a vaccine indicated for active immunization against
diphtheria, tetanus and pertussis as a
five-dose series in infants and children 6 weeks through 6 years of
age (prior to 7 birthday). (1)
DOSAGE AND ADMINISTRATION
The five dose immunization series consists of a 0.5 mL intramuscular
injection administered at 2, 4, 6
and 15-20 months of age, and at 4-6 years of age. (2.1, 2.2)
DOSAGE FORMS AND STRENGTHS
Suspension for injection, supplied in single-dose (0.5 mL) vials (3)
CONTRAINDICATIONS
Severe allergic reaction (e.g., anaphylaxis) after a previous dose of
any diphtheria toxoid, tetanus
toxoid, or pertussis-containing vaccine, or any component of DAPTACEL.
(4.1)
Encephalopathy within 7 days of a previous pertussis-containing
vaccine with no other identifiable
cause. (4.2)
Progressive neurologic disorder until a treatment regimen has been
established and the condition has
stabilized. (4.3)
WARNINGS AND PRECAUTIONS
Carefully consider benefits and risks before administering DAPTACEL to
persons with a history of:
-
-
If Guillain-Barré syndrome occurred within 6 weeks of receipt of a
prior vaccine containing tetanus
toxoid, the risk for Guillain-Barré syndrome may be increased
following DAPTACEL. (5.3)
For infants and children with