ADACEL TDAP (clostridium tetani toxoid antigen (formaldehyde inactivated), corynebacterium diphtheriae toxoid antigen (formaldeh

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Sanofi Pasteur Inc.

INN (mednarodno ime):

CLOSTRIDIUM TETANI TOXOID ANTIGEN - UNII:K3W1N8YP13)

Sestava:

CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 5 [Lf] in 0.5 mL

Pot uporabe:

INTRAMUSCULAR

Terapevtske indikacije:

Adacel® is a vaccine indicated for: - Active booster immunization against tetanus, diphtheria and pertussis. Adacel is approved for use in individuals 10 through 64 years of age. Immunization during the third trimester of pregnancy to prevent pertussis in infants younger than 2 months of age. A severe allergic reaction (e.g., anaphylaxis) after a previous dose of any tetanus toxoid, diphtheria toxoid or pertussis containing vaccine or any other component of this vaccine is a contraindication to administration of Adacel. [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, prolonged seizures, or decreased level of consciousness) within 7 days of a previous dose of a pertussis containing vaccine not attributable to another identifiable cause is a contraindicatio

Povzetek izdelek:

Syringe, without needle, single-dose – NDC 49281-400-89 (not made with natural rubber latex); in package of 5 syringes, NDC 49281-400-20. Vial, single-dose – NDC 49281-400-58; in package of 5 vials; NDC 49281-400-05. The vial stopper is not made with natural rubber latex. Discard unused portion in vial. Vial, single-dose – NDC 49281-400-58; in package of 10 vials; NDC 49281-400-10. The vial stopper is not made with natural rubber latex. Discard unused portion in vial. Not all pack sizes may be marketed. Adacel should be stored at 2°C to 8°C (35°F 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.

Status dovoljenje:

Biologic Licensing Application

Lastnosti izdelka

ADACEL TDAP- CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE
INACTIVATED),
CORYNEBACTERIUM DIPHTHERIAE 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.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ADACEL SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ADACEL.
ADACEL (TETANUS TOXOID, REDUCED DIPHTHERIA TOXOID AND ACELLULAR
PERTUSSIS VACCINE
ADSORBED), SUSPENSION FOR INTRAMUSCULAR INJECTION
INITIAL U.S. APPROVAL: 2005
RECENT MAJOR CHANGES
Indications and Usage (1)
01/2023
Dosage and Administration (2.2)
01/2023
INDICATIONS AND USAGE
Adacel is a vaccine indicated for:
active booster immunization against tetanus, diphtheria and pertussis.
Adacel is approved for use in
persons 10 through 64 years of age. (1)
immunization during the third trimester of pregnancy to prevent
pertussis in infants younger than 2
months of age. (1)
DOSAGE AND ADMINISTRATION
FOR INTRAMUSCULAR INJECTION ONLY.
Each dose of Adacel is administered as a 0.5 mL injection. (2.1)
For routine booster vaccination, a first dose of Adacel is
administered 5 years or more after the last
dose of Diphtheria and Tetanus Toxoids and Acellular Pertussis (DTaP)
series or 5 years or more after
vaccination with Tetanus and Diphtheria Toxoids Adsorbed (Td). A
second dose of Adacel may be
administered 8 years or more after the first dose with Tetanus Toxoid,
Reduced Diphtheria Toxoid and
Acellular Pertussis Vaccine Adsorbed (Tdap).
Adacel may be administered for tetanus prophylaxis for wound
management. For management of a
tetanus prone wound, a booster dose of Adacel may be administered if
at least 5 years have elapsed
since previous receipt of a tetanus toxoid containing vaccine. (2.2)
To provide protection against p