Rotasiil – Serum International Institute
Indication and Usage –
- ROTASIIL-Liquid is indicated for active immunization of healthy infants from the age of 6 weeks for the prevention of gastroenteritis due to rotavirus infection when administered as a 3-dose series.
- The three-dose regimen should be completed by one year of age.
Dosage and Administration –
- ROTASIIL-Liquid is for oral administration only and must not be administered parenterally.
- ROTASIIL-Liquid should be administered as a 3-dose regimen, 4 weeks apart, beginning at 6 weeks of age. The three dose regimen should be completed by one year of age.
- It is recommended that infants who receive ROTASIIL-Liquid as the first dose should complete the three dose series with ROTASIIL-Liquid.
Contraindications –
- Hypersensitivity to any component of the vaccine is a contraindication to vaccine.
- Individuals who develop symptoms suggestive of hypersensitivity after receiving a dose of Rotasiil liquid should not receive further doses.
- Individuals with Severe Combined Immunodeficiency Disease (SCID). Cases of gastroenteritis associated with live rotavirus vaccines have been reported in infants with SCID.
- History of intussusception (IS) is a contraindication to vaccine administration.
Adverse reactions –
- The common adverse events after Rotasiil vaccination are –
- Fever
- Irritability
- Decreased appetite
- Decreased activity level
- Vomiting
- Diarrhea
Drug interactions and other interactions –
- Immunosuppressive therapies including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids, may reduce the immune response to vaccines.
- Rotasiil liquid can be administered concomitantly with other vaccines of the infant immunization programme, including combined diphtheria, tetanus toxoid and pertussis vaccine, inactivated polio vaccine, oral polio vaccine, influenza type b conjugate, hepatitis B vaccine.
- No interaction studies have been performed woth Rotasiil liquid in infants with other medicinal products.
