Rotasiil-Liquid Special Precautions

No safety or efficacy data of ROTASIIL-Liquid is available in immunocompromised infants, infants infected with HIV or infants with chronic gastroenteritis. Administration of ROTASIIL-Liquid may be considered with caution in immunocompromised infants and infants in close contact with immunodeficient persons if in the opinion of the physician the benefits far outweigh the risks of vaccine. Similarly, acute infection or febrile illness may be a reason for delaying the administration of ROTASIIL-Liquid, if in the opinion of the physician the benefits far outweigh the risks of vaccine. Low-grade fever and mild upper respiratory tract infection are not contraindications to ROTASIIL-Liquid.
Available published data shows a small increased incidence of intussusception (IS) following other live oral Rotavirus vaccines especially after the first dose. The safety data from the clinical trials of ROTASIIL (already licensed lyophilized formulation of BRV-PV) did not show any increased risk of IS when compared with placebo. In Phase III trial, no intussusception was reported in ROTASIIL-Liquid and ROTASIIL groups. However, health care providers should carefully evaluate cases with symptoms suggestive of IS.
Similar to other rotavirus vaccines, vaccination with ROTASIIL-Liquid may not protect all vaccine recipients against rotavirus infection. Also, ROTASIIL-Liquid will not provide protection against gastroenteritis caused by the other pathogens.
Use in Pregnancy: ROTASIIL-Liquid is not indicated for adults, including women of child-bearing age and should not be administered to pregnant females. Animal reproduction studies have not been conducted with ROTASIIL-Liquid.