All the Active Ingredient Drugs
Rota Virus Diarrhea Vaccine. Rotavirus live, attenuated: not less than 10^6.0 CCID50. ORAL APPLICATOR: 1, 10 x 1.5 ml.
TUBE: 1, 10, 50 x 1.5 ml.
Oral use only. Vaccinat. course
consists of 2 doses. 1st dose: From
age of 6 wks., with interval of min. 4
wks. betw. doses. Vaccinat. course
must be completed by age of 24 wks.
Recommend. that both doses of
regim. be with Rotarix.
Active immunisat. infants from 6 wks. for
prevent. gastro-enterit. due to rotavirus
infect.{ types G1P[8], G2P[4], G3P[8],
G4P[8] and G9P[8]}.
C/I: Hypersens., prev. history
intussuscept., pts. with uncorrect.
congen. malform. of GI tract that
would predispose for intussuscept., pts
with Severe Combined
Immunodeficiency (SCID). Acute
severe febrile illness, diarr. or vomit. –
postpone vaccin. Not for inject. Not for
children> 24 wks of age.
Rotavirus G1 has a minimum dose level (106 infectious units) of 2.2; G2 has a minimum dose level (106 infectious units) of 2.8; G3 has a minimum dose level (106 infectious units) of 2.2; G4 has a minimum dose level (106 infectious units) of 2.0; P1 has a minimum dose level (106 infectious units) of 2.3.. SINGLE-DOSE TUBE: 1 x 2 ml. Oral
vaccine: 3 dose series to infants 6-32
wks. 1st dose: 6-12 wks. old.
Subsequent doses: 4-10 wk. intervals.
3rd dose: Not after 32 wks. old.
Prevent rotavirus gastroenterit. caused
by serotypes G1, G2, G3, G4.
C/I: Known hypersens.
