DIPHTHERIA AND TETANUS TOXOIDS ADSORBED (corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) and clostridium t

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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)

Fáanlegur frá:

Sanofi Pasteur Inc.

INN (Alþjóðlegt nafn):

CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN - UNII:IRH51QN26H)

Samsetning:

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

Stjórnsýsluleið:

INTRAMUSCULAR

Ábendingar:

Diphtheria and Tetanus Toxoids Adsorbed is a vaccine indicated for active immunization against diphtheria and tetanus. Diphtheria and Tetanus Toxoids Adsorbed is approved for use in children from 6 weeks through 6 years of age (prior to 7th birthday). Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine (DTaP) or a DTaP-containing vaccine is recommended for immunization of infants and children 6 weeks through 6 years of age. Diphtheria and Tetanus Toxoids Adsorbed should be used in instances where the pertussis vaccine component is contraindicated. Diphtheria and Tetanus Toxoids Adsorbed is not to be used for treatment of diphtheria or tetanus infection. A severe allergic reaction (e.g., anaphylaxis) after a previous dose of Diphtheria and Tetanus Toxoids Adsorbed or any other diphtheria toxoid or tetanus toxoid-containing vaccine, or any other component of this vaccine is a contraindication to administration of Diphtheria and Tetanus Toxoids Adsorbed. [See Description (11). ] Diphtheria and Tetanu

Vörulýsing:

Diphtheria and Tetanus Toxoids Adsorbed is supplied in: a 0.5 mL single-dose vial: NDC No. 49281-225-58; in packages of 10 vials: NDC No. 49281-225-10. The vial stopper is not made with natural rubber latex. Diphtheria and Tetanus Toxoids Adsorbed 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 vaccine beyond the expiration date. Discard unused portion.

Leyfisstaða:

Biologic Licensing Application

Vara einkenni

DIPHTHERIA AND TETANUS TOXOIDS ADSORBED- CORYNEBACTERIUM DIPHTHERIAE
TOXOID
ANTIGEN (FORMALDEHYDE INACTIVATED) AND CLOSTRIDIUM TETANI TOXOID
ANTIGEN (FORMALDEHYDE
INACTIVATED) INJECTION, SUSPENSION
SANOFI PASTEUR INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DIPHTHERIA AND TETANUS TOXOIDS ADSORBED
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
DIPHTHERIA AND TETANUS TOXOIDS ADSORBED.
DIPHTHERIA AND TETANUS TOXOIDS ADSORBED
SUSPENSION FOR INTRAMUSCULAR INJECTION
INITIAL U.S. APPROVAL: 1997
INDICATIONS AND USAGE
Diphtheria and Tetanus Toxoids Adsorbed is a vaccine indicated for
active immunization against diphtheria and tetanus.
Diphtheria and Tetanus Toxoids Adsorbed is approved for use in
children from 6 weeks through 6 years of age (prior to
7
birthday). (1)
DOSAGE AND ADMINISTRATION
The five dose immunization series consists of an injection
administered at 2, 4, 6, 15-18 months and between 4 and 6 years
of age. (2.1)
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
Diphtheria and Tetanus Toxoids Adsorbed or any other
diphtheria toxoid or tetanus toxoid-containing vaccine, or any other
component of this vaccine. (4)
WARNINGS AND PRECAUTIONS
If Guillain-Barré syndrome occurred within 6 weeks of receipt of
prior vaccine containing tetanus toxoid, the risk for
Guillain-Barré syndrome may be increased following Diphtheria and
Tetanus Toxoids Adsorbed vaccine. (5.2)
Apnea following intramuscular vaccination has been observed in some
infants born prematurely. The decision about
when to administer an intramuscular vaccine, including Diphtheria and
Tetanus Toxoids Adsorbed, to an infant born
prematurely should be based on consideration of the individual
infant's medical status and the potential benefits and
possible risks of vaccination. (5.5)
Syncope (fainting) has been reported following vaccinati