|
Indication |
Induction of active immunity against typhoid
fever |
|
Proprietary Name |
Typhim Vi |
Vivotif Berna |
|
Manufacturers |
sanofi pasteur |
Berna |
|
Viability |
Inactivated |
Live, attenuated |
|
Microorganism |
Salmonella enterica serovar typhi, S typhi
Ty2 strain |
Salmonella typhi
Ty21a |
|
Approved Ages |
2 years and older |
6
years and older |
|
Dose |
0.5 mL |
One enteric-coated capsule |
|
Route |
Adults -
Intramuscular in Deltoid
Children - Intramuscular in Deltoid or vastus
lateralis |
Oral |
|
Dose form |
Liquid solution |
Capsule |
|
Appearance |
Clear, colorless |
Salmon/white capsule |
|
Concentration (per 0.5 mL Typhim VI or one
capsule for Vivotif) |
Purified Vi polysaccharide, 25 mcg |
Salmonella typhi
Ty21a, 2-6x109 colony-forming units |
|
Excipients |
Sodium chloride, 4.150 mg
Disodium phosphate, 0.065 mg
Monosodium phosphate, 0.023 mg
Sterile Water, 0.5mL
Polydimethylsilozane-based antifoam agents,
residual |
Sucrose, 26–130 mg
Ascorbic acid, 1–5 mg
Amino acid mixture, 1.4–7 mg
Lactose, 100–180 mg
Magnesium stearate 3.6–4.4 mg |
|
Adjuvant |
None
|
None |
|
Allergens |
None |
Lactose, 100–180 mg
Yeast extract from media |
|
Preservatives |
Phenol, 0.25% |
None |
|
Media |
Semi-synthetic medium without animal proteins |
Yeast extract (consisting of casein, dextrose
and galactose) |
|
Packaging |
Syringe without needle
Vial,
20-dose |
Single foil blister contains 4 doses of vaccine |
|
Routine Storage |
2 to 8° C (36 to 46°
F)
Do not freeze |
2 to 8° C (36 to 46°
F)
Do not freeze |
|
Package Insert date |
December 2005 |
August 2006 |
|
updated January 2012 |