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Adenovirus Type 4 and Type 7 Vaccine, Live, Oral Enteric Coated Tablets for Oral Administration


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 strains have not been attenuated. The cells are grown and the virus growth maintained in Dulbecco's Modified Eagle's Medium, fetal bovine serum, and sodium bicarbonate. The virus is harvested, freed of particulate cellular material by filtration, formulated and dried by lyophilization. The dried virus material includes monosodium glutamate, sucrose, D-mannose, D-fructose, dextrose, human serum albumin, potassium phosphate and plasdone C.

The final vaccine is composed of two tablets (one tablet of Adenovirus Type 4 and one tablet of Adenovirus Type 7) designed to pass intact through the stomach and release the live virus in the intestine. Each entericcoated tablet contains an inner core tablet containing anhydrous lactose, micro crystalline cellulose, polacrilin potassium, magnesium stearate, and live adenovirus, either Type 4 or Type 7, at a potency of no fewer than 32,000 tissue-culture infective doses (4.5 log10 TCID50) per tablet. The outer tablet layer contains microcrystalline cellulose, magnesium stearate, and anhydrous lactose, with an enteric coating consisting of cellulose acetate phthalate, alcohol, acetone, and castor oil. The Type 7 tablet also contains FD&C Yellow #6 aluminum lake dye.

Last reviewed on RxList: 12/28/2016
This monograph has been modified to include the generic and brand name in many instances.

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