Nchi: Indonesia
Lugha: Kiindonesia
Chanzo: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DUS, 1 TUBE @ 1,5 ML
2022-05-12
FAW_leaROTOA_PI update GDS18 IPI13_circ2_24Oct22- for submission _Page 1 of 10 _ ROTARIX ROTAVIRUS VACCINE ORAL SUSPENSION QUALITATIVE AND QUANTITATIVE COMPOSITION 1 dose (1.5 mL) contains: Live attenuated human rotavirus RIX4414 strain not less than 10 6.0 CCID 50 The vaccine is a clear and colourless liquid. CLINICAL INFORMATION INDICATIONS _ROTARIX_ is indicated for the prevention of gastroenteritis caused by rotavirus (_see sections Warnings _ _and Precautions and Pharmacodynamics_). DOSAGE AND ADMINISTRATION POSOLOGY The vaccination course consists of two doses. The first dose may be administered from the age of 6 weeks. There should be an interval of at least 4 weeks between doses. The vaccination course should be completed by the age of 24 weeks. _ROTARIX_ may be given to preterm infants with the same posology (_see sections Adverse Reactions _ _and Pharmacodynamics_). In clinical trials, spitting or regurgitation of the vaccine has rarely been observed and, under such circumstances, a replacement dose was not given. However, in the unlikely event that an infant sp its out or regurgitates most of the vaccine dose, a single replacement dose may be given at the same vaccination visit. It is strongly recommended that infants who receive a first dose of _ROTARIX_ complete the 2-dose regimen with _ROTARIX_. METHOD OF ADMINISTRATION _ROTARIX_ is for ORAL use only. _ROTARIX_ SHOULD UNDER NO CIRCUMSTANCES BE INJECTED. There are no restrictions on the infant’s consumption of food or liquid, including breast -milk, either before or after vaccination. Based on evidence generated in clinical trials, breast-feeding does not reduce the protection against rotavirus gastroenteritis afforded by _ROTARIX_. Therefore, breast-feeding may be continued during the vaccination schedule. For information on instructions for administration _see section Use and Handling_. CONTRAINDICATIONS _ROTARIX_ should not be administered to subjects with known hypersensitivity after previous administration of _ROTARIX_ vaccine or to any compon Soma hati kamili