Adenovirus Type 4 and Type 7

Adenovirus Type 4 and Type 7 Vaccine, Live, Oral, Barr Labs, Ltd.
Approuvé par les pays
Maladies ciblées: 
Adenovirus
Dénomination commerciale du vaccin: 
Adenovirus Type 4 and Type 7 Vaccine, Live, Oral, Barr Labs, Ltd.
Type de vaccin: 

Adenovirus Type 4 and Type 7 Vaccine, Live, Oral contains viable selected strains of human adenovirus Type 4 and human adenovirus Type 7 prepared in human-diploid fibroblast cell cultures (strain WI-38). The virus stains have not been attenuated.

Fabricant: 
Barr Labs, Ltd.
Pays de fabrication: 
United States
Date de la pré-qualification ou de l’approbation: 
Wednesday, March 16, 2011
Autorité de régulation nationale de l’enregistrement: 
U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), United States
Présentation(s): 

Single vaccine dose administered orally as two tablets: one table of Adenovirus Type 4 and one table of Adenovirus Type 7

Formulation pharmaceutique: 
Enteric-Coated Tablet
Voie d’administration: 
Oral
Durée de vie: 
24 months at 2 - 8 °C
Conservateur: 
Not provided
Pastille de contrôle du vaccin: 
None
Volume de la chaîne du froid par dose (cm3): 

Not provided

Emballage secondaire: 

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:

  • Adenovirus Type 4 Component, a white to off-white, round, coated tablet with stylized b imprinted on one side, for oral administration
  • Adenovirus Type 7 Component, a white to off-white, round, coated tablet with stylized b imprinted on one side, for oral administration
  • Available as a single carton containing 1 x 100 tablets Adenovirus Type 4 Component and 1 x 100 tablets Adenovirus Type 7 Component
Traitement des flacons multi-doses entamés: 

N/A