TENIVAC (clostridium tetani toxoid antigen (formaldehyde inactivated) and corynebacterium diphtheriae toxoid antigen- formaldehy

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)

Available from:

A-S Medication Solutions

Administration route:

INTRAMUSCULAR

Therapeutic indications:

TENIVAC® is a vaccine indicated for active immunization for the prevention of tetanus and diphtheria in persons 7 years of age and older. A severe allergic reaction (e.g., anaphylaxis) after a previous dose of TENIVAC or any other tetanus toxoid or diphtheria toxoid-containing vaccine or any other component of this vaccine is a contraindication to administration of TENIVAC. [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. Risk Summary All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. There are no adequate and well-controlled studies of TENIVAC administration in pregnant women in t

Product summary:

Product: 50090-2062 NDC: 50090-2062-0 .5 mL in a SYRINGE / 10 in a PACKAGE

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

TENIVAC- CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)
AND
CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE
INACTIVATED) INJECTION, SUSPENSION
A-S MEDICATION SOLUTIONS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TENIVAC SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TENIVAC.
TENIVAC (TETANUS AND DIPHTHERIA TOXOIDS ADSORBED)
SUSPENSION FOR INTRAMUSCULAR INJECTION
INITIAL U.S. APPROVAL: 2003
RECENT MAJOR CHANGES
WARNINGS AND PRECAUTIONS (5.8)
12/2022
INDICATIONS AND USAGE
TENIVAC is a vaccine indicated for active immunization for the
prevention of tetanus and diphtheria in
persons 7 years of age and older. (1)
DOSAGE AND ADMINISTRATION
Each 0.5 mL dose should be administered intramuscularly. (2.5)
Primary immunization with TENIVAC consists of 3 doses. The first 2
doses are administered 2 months
apart and the third dose is administered 6-8 months after the second
dose. (2.1)
TENIVAC may be used for booster immunization against tetanus and
diphtheria. Routine booster
immunization against tetanus and diphtheria is recommended at 11-12
years of age and every 10
years thereafter. (2.2)
For post-exposure diphtheria prophylaxis and for management of a
tetanus prone wound, a booster
dose of TENIVAC may be administered if at least 5 years have elapsed
since previous receipt of a
diphtheria toxoid and tetanus toxoid containing vaccine. (2.3) (2.4)
DOSAGE FORMS AND STRENGTHS
Suspension for injection supplied in 0.5 mL single-dose vials or
syringes. (3)
CONTRAINDICATIONS
Severe allergic reaction (e.g., anaphylaxis) to a previous dose of
TENIVAC, or any other tetanus or
diphtheria toxoid-containing vaccine, or any component of this
vaccine. (4.1)
WARNINGS AND PRECAUTIONS
The tip caps of the prefilled syringes may contain natural rubber
latex which may cause allergic
reactions in latex sensitive individuals. (5.2)
More frequent administration of TENIVAC than described in Dosage and
Administration (2.1, 2.2, 2.3,
2.4) may b