Țară: Indonezia
Limbă: indoneziană
Sursă: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DUS, 1 VIAL @ 1 DOSIS (0,5 ML) + 1 AMPUL PELARUT @ 0,5 ML
2022-01-03
ERS_leaVARinj_Update PI GDS 015 IPI 017_circ2_09Aug22 _Page 1 of 8_ VARILRIX VARICELLA VACCINE POWDER AND SOLVENT FOR SOLUTION FOR INJECTION QUALITATIVE AND QUANTITATIVE COMPOSITION _VARILRIX_ is a lyophilised preparation of the live attenuated Oka-strain of varicella-zoster virus, obtained by propagation of the virus in MRC-5 human diploid cell culture. _ _ _VARILRIX_ meets the World Health Organization requirements for biological substances and for varicella vaccines. Each dose of the reconstituted vaccine contains not less than 10 3.3 plaque-forming units (PFU) of the attenuated varicella-zoster virus. The powder is slightly cream to yellowish or pinkish. The solvent is clear and colourless. CLINICAL INFORMATION INDICATIONS Healthy subjects _VARILRIX_ is indicated for active immunization against varicella of healthy subjects from the age of 12 months onwards. Vaccination of susceptible healthy close contacts of subjects at risk of severe varicella is recommended, in order to reduce the risk of transmission of wild-type virus to these patients. Close contacts include parents and siblings of high-risk patients, and medical and paramedical personnel. Patients at high risk of severe varicella Patients suffering from leukaemia, patients under immunosuppressive treatment (including corticosteroid therapy) for malignant solid tumour, for serious chronic diseases (such as chronic renal failure, autoimmune diseases, collagen diseases, severe bronchial asthma) or following organ transplantation, are predisposed to severe natural varicella. Vaccination with the Oka-strain has been shown to reduce the complications of varicella in these patients. There is only limited data from clinical trials available for _ VARILRIX_ _ _ in patients at high risk of severe varicella; should vaccination be considered, it is advised that: • Maintenance chemotherapy should be withheld one week before and one week after immunization of patients in the acute phase of leukaemia. Patients under radiotherapy should normally not be vaccinated d Citiți documentul complet