البلد: سنغافورة
اللغة: الإنجليزية
المصدر: HSA (Health Sciences Authority)
HUMAN ROTAVIRUS, LIVE, ATTENUATED, RIX 4414 STRAIN
GLAXOSMITHKLINE PTE LTD
J07BH01
Not less than 10⁶ CCID₅₀/dose (1.5 ml)
SUSPENSION
HUMAN ROTAVIRUS, LIVE, ATTENUATED, RIX 4414 STRAIN Not less than 10⁶ CCID₅₀/dose (1.5 ml)
ORAL
Prescription Only
GlaxoSmithKline Biologicals s.a.
ACTIVE
2010-06-01
- 1 - ROTARIX TM ROTAVIRUS VACCINE QUALITATIVE AND QUANTITATIVE COMPOSITION 1 dose (1.5 ml) contains: Live attenuated human rotavirus RIX4414 strain* of the G1P[8] type: not less than 10 6.0 CCID 50 *Produced on Vero cells PHARMACEUTICAL FORM ORAL suspension. The vaccine is a clear and colourless liquid. CLINICAL PARTICULARS INDICATIONS _ROTARIX_ _TM_ is indicated for the active immunisation of infants from the age of 6 weeks for prevention of gastro-enteritis due to rotavirus infection (_see sections Dosage and _ _Administation 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 preferably be given before 16 weeks of age, but must be completed by the age of 24 weeks. 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 spits out or regurgitates most of the vaccine dose, a single replacement dose may be given at the same vaccination visit. It is recommended that infants who receive a first dose of _ROTARIX_ _TM_ complete the 2-dose regimen with _ROTARIX_ _TM_ . There are no data on safety, immunogenicity or efficacy when _ROTARIX_ _TM_ is administered for the first dose and another rotavirus vaccine is administered for the second dose or vice versa. METHOD OF ADMINISTRATION _ROTARIX_ _TM_ is for ORAL use only. Administer the entire content (1.5 mL) of the tube ORALLY on the inside of the cheek. _ROTARIX_ _TM_ SHOULD UNDER NO CIRCUMSTANCES BE INJECTED. There are no restrictions on the اقرأ الوثيقة كاملة
- 1 - ROTARIX ROTAVIRUS VACCINE ORAL SUSPENSION QUALITATIVE AND QUANTITATIVE COMPOSITION 1 dose (1.5 ml) contains: Live attenuated human rotavirus RIX4414 strain* of the G1P[8] type: not less than 10 6.0 CCID 50 *Produced on Vero cells The vaccine is a clear and colourless liquid. CLINICAL INFORMATION INDICATIONS _ROTARIX_ is indicated for the active immunisation of infants from the age of 6 weeks for prevention of gastro-enteritis due to rotavirus infection (_see sections Dosage and _ _Administration, 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 preferably be given before 16 weeks of age, but must be completed by the age of 24 weeks. 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 spits out or regurgitates most of the vaccine dose, a single replacement dose may be given at the same vaccination visit. It is recommended that infants who receive a first dose of _ ROTARIX_ complete the 2-dose regimen with _ROTARIX_. There are no data on safety, immunogenicity or efficacy when _ROTARIX_ is administered for the first dose and another rotavirus vaccine is administered for the second dose or vice versa. METHOD OF ADMINISTRATION _ROTARIX_ is for ORAL use only. Administer the entire content (1.5 mL) of the tube ORALLY on the inside of the cheek. _ _ _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. - 2 - Based on evidence generated in clinical trials, breast-feeding does not reduce the protection against rotavirus gastro-enteritis afforded by _ROTARIX_. Therefore, breast-feeding may be continued during the v اقرأ الوثيقة كاملة