TENIVAC (clostridium tetani toxoid antigen (formaldehyde inactivated) and corynebacterium diphtheriae toxoid antigen- formaldehyde inactivated injection, suspension

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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)

থেকে পাওয়া:

Sanofi Pasteur Inc.

INN (আন্তর্জাতিক নাম):

CLOSTRIDIUM TETANI TOXOID ANTIGEN - UNII:K3W1N8YP13)

রচনা:

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

প্রশাসন রুট:

INTRAMUSCULAR

থেরাপিউটিক ইঙ্গিত:

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 the U.S. There are insufficient human data from TENIVAC administered during pregnancy to establish the presence or absence of a vaccine-associated risk. A developmental toxicity study has been performed in female rabbits administered a single human dose of TENIVAC prior to mating and during gestation. This study revealed no evidence of harm to the fetus due to TENIVAC. (See Animal data ) Data Animal data In a developmental toxicity study, female rabbits received a single human dose (0.5 mL) of TENIVAC by intramuscular injection 17 and 10 days prior to mating, and on gestation days 6 and 29. No adverse effects on pre-weaning development up to post-natal day 35 were observed. There were no vaccine-related fetal malformations or variations observed. It is not known whether TENIVAC components are excreted in human milk. Data are not available to assess the effect of administration of TENIVAC on breastfed infants or on milk production/excretion. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for TENIVAC and any potential adverse effects on the breastfed child from TENIVAC or from the underlying maternal condition. For preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine. TENIVAC is not approved for use in infants and children younger than 7 years of age. Safety and effectiveness of TENIVAC in this age group have not been established. In one clinical study, (TDC01) 449 participants 65 years of age and over, including 192 participants who were 75 years of age and over received a dose of TENIVAC. A lower proportion of participants 65 years of age and over had a pre-vaccination seroprotective level of antibody to tetanus toxoid and diphtheria toxin compared to adolescents and adults less than 65 years of age. The proportion of participants 65 years of age and over with a seroprotective level of antibody following TENIVAC was marginally lower for tetanus and lower for diphtheria compared to younger participants. In general, rates of solicited adverse events were not higher in participants 65 years of age and over compared to younger participants. [See Adverse Reactions (6) , Clinical Pharmacology (12.1), and Clinical Studies (14.2) .]

পণ্য সারাংশ:

Single-dose Vial, NDC No. 49281-215-58; in package of 10 vials, NDC No. 49281-215-10. Contains no latex. Single-dose Syringe, NDC No. 49281-215-88; in package of 10 syringes, NDC No. 49281-215-15. The tip caps of the prefilled syringes may contain natural rubber latex. No other components contain latex. TENIVAC 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.

অনুমোদন অবস্থা:

Biologic Licensing Application

পণ্য বৈশিষ্ট্য

TENIVAC- CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)
AND
CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE
INACTIVATED) INJECTION, SUSPENSION
SANOFI PASTEUR INC.
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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
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 be associated with increased incidence and severity of
adverse rea