ADENOVIRUS TYPE 4 AND TYPE 7 VACCINE, LIVE kit

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

HUMAN ADENOVIRUS E SEROTYPE 4 STRAIN CL-68578 (UNII: FKD3DUK39I) (HUMAN ADENOVIRUS E SEROTYPE 4 STRAIN CL-68578 - UNII:FKD3DUK39I)

Disponible depuis:

Teva Women's Health, Inc.

DCI (Dénomination commune internationale):

HUMAN ADENOVIRUS E SEROTYPE 4 STRAIN CL-68578

Composition:

HUMAN ADENOVIRUS E SEROTYPE 4 STRAIN CL-68578 32000 [TCID_50]

indications thérapeutiques:

Adenovirus Type 4 and Type 7 Vaccine, Live, Oral is a vaccine indicated for active immunization for the prevention of febrile acute respiratory disease caused by Adenovirus Type 4 and Type 7. Adenovirus Type 4 and Type 7 Vaccine, Live, Oral is approved for use in military populations 17 through 50 years of age. Adenovirus Type 4 and Type 7 Vaccine, Live, Oral should not be administered to pregnant females [See Pregnancy (8.1)] . It is not known whether Adenovirus Type 4 and Type 7 Vaccine, Live, Oral can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Naturally occurring infection with adenoviruses has been associated with fetal harm. Pregnancy should be avoided for 6 weeks following receipt of vaccine. Severe allergic reaction (e.g., anaphylaxis) to any component of Adenovirus Type 4 and Type 7 Vaccine, Live, Oral is a Contraindication [See Description (11)]. Adenovirus Type 4 and Type 7 Vaccine, Live, Oral should not be administered to individuals incapable of swa

Descriptif du produit:

Adenovirus Type 4 and Type 7 Vaccine, Live, Oral Enteric Coated Tablets is packaged in a carton of two bottles of 100 tablets of each component of the vaccine:  Store refrigerated between 2° and 8° C (35° and 46° F). Do not freeze. Keep bottle tightly closed and protect from moisture. Do not remove desiccant canister from bottle.

Statut de autorisation:

Biologic Licensing Application

Résumé des caractéristiques du produit

ADENOVIRUS TYPE 4 AND TYPE 7 VACCINE, LIVE- ADENOVIRUS TYPE 4 AND TYPE
7 VACCINE, LIVE
TEVA WOMEN'S HEALTH, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ADENOVIRUS TYPE 4 AND
TYPE 7 VACCINE, LIVE, ORAL SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
ADENOVIRUS TYPE 4 AND TYPE 7 VACCINE, LIVE, ORAL.
ADENOVIRUS TYPE 4 AND TYPE 7 VACCINE, LIVE, ORAL
ENTERIC COATED TABLETS FOR ORAL ADMINISTRATION
INITIAL U.S. APPROVAL: 2011
INDICATIONS AND USAGE
Adenovirus Type 4 and Type 7 Vaccine, Live, Oral is a vaccine
indicated for active immunization for the
prevention of febrile acute respiratory disease caused by Adenovirus
Type 4 and Type 7. Adenovirus Type
4 and Type 7 Vaccine, Live, Oral is approved for use in military
populations 17 through 50 years of age. (1)
DOSAGE AND ADMINISTRATION
A single vaccine dose is administered orally as two tablets: one
tablet of Adenovirus Type 4 and one
tablet of Adenovirus Type 7. (2)
Each of the two tablets should be swallowed whole. The tablets should
not be chewed or crushed to
avoid releasing the live adenovirus in the upper respiratory tract.
Postpone administration in vaccinees with vomiting and/or diarrhea.
DOSAGE FORMS AND STRENGTHS
A single oral dose consists of one Adenovirus Type 4 tablet and one
Adenovirus Type 7 tablet. (3)
CONTRAINDICATIONS
Pregnancy (4.1, 8.1).
Severe allergic reaction (e.g., anaphylaxis) to any component of
Adenovirus Type 4 and Type 7 Vaccine,
Live, Oral is a Contraindication. (4.2, 11)
Inability to swallow the tablets whole without chewing. (4.3)
WARNINGS AND PRECAUTIONS
Safety and effectiveness have not been evaluated in persons with
primary or acquired
immunodeficiency states. (5.1)
Vaccinees and individuals who come in close contact with vaccinees may
be exposed to the vaccine
viruses shed in the stool for up to 28 days. Proper personal hygiene
can minimize this risk. (5.2)
Vaccinees should exercise caution when in close contact with children
less than 7 years of a