VIVOTIF Typhoid vaccine capsule Ref.[10259] Active ingredients: Typhoid, live attenuated

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product description

Vivotif (Typhoid Vaccine Live Oral Ty21a) is a live attenuated vaccine for oral administration only. The vaccine contains the attenuated strain Salmonella typhi Ty21a (1, 2).

Vivotif is manufactured by the PaxVax Berna GmbH, Switzerland. The vaccine strain is grown in fermenters under controlled conditions in medium containing a digest of yeast extract, an acid digest of casein, dextrose and galactose. The bacteria are collected by centrifugation, mixed with a stabilizer containing sucrose, ascorbic acid and amino acids, and lyophilized. The lyophilized bacteria are mixed with lactose and magnesium stearate and filled into gelatin capsules which are coated with an organic solution to render them resistant to dissolution in stomach acid. The enteric-coated, salmon/white capsules are then packaged in 4-capsule blisters for distribution. The contents of each enteric-coated capsule are shown in Table 1.

Table 1. Contents of one enteric-coated capsule of Vivotif (Typhoid Vaccine Live Oral Ty21a):

Viable S. typhi Ty21a 2.0–10.0x109 colony-forming units*
Non-viable S. typhi Ty21a 5‑50x109 bacterial cells
Sucrose 3.3 – 34.2 mg
Ascorbic acid 0.2 – 2.4 mg
Amino acid mixture 0.3 – 3.0 mg
Lactose up to 180 – 200 mg
Magnesium stearate 3.6–4.0 mg

==*= Vaccine potency (viable cell counts per capsule) is determined by inoculation of agar plates with appropriate dilutions of the vaccine suspended in physiological saline.

How Supplied

Product: 50090-2292

Manufactured by: PaxVax Berna GmbH, Oberriedstrasse 68, Thoerishaus, CH-3174 Switzerland

US-License No. 2015

Distributed by: PaxVax, Inc. 555 Twin Dolphin Dr., Ste. 360 Redwood City, CA 94065

Drugs

Drug Countries
VIVOTIF Austria, Canada, Spain, Finland, Hong Kong, New Zealand, Poland, Singapore, United Kingdom, United States, South Africa

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