Country: Израел
Језик: Енглески
Извор: Ministry of Health
AGALSIDASE ALFA
TAKEDA ISRAEL LTD
A16AB03
CONCENTRATE FOR SOLUTION FOR INFUSION
AGALSIDASE ALFA 1 MG/ML
I.V
Required
SHIRE HUMAN GENETIC THERAPIES INC., USA
AGALSIDASE ALFA
AGALSIDASE ALFA
Replagal is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of fabry disease (alfa-galactosidase A deficiency).
2021-11-30
העדוה העדוה לע לע הרמחה הרמחה ( ( עדימ עדימ ןולעב )תוחיטב ןולעב )תוחיטב ל ל אפור אפור ןכדועמ( ןכדועמ( 05.2013 05.2013 ) ) ךיראת __ 11/09/2014 _____ םש רישכת תילגנאב רפסמו םושירה _ 124-32-30382-00 REPLAGAL __ םש לעב םושירה ___ ןוסידמ המראפ מ"עב ____ ספוט הז דעוימ טורפל תורמחהה דבלב ! תורמחהה תושקובמה קרפ ןולעב טסקט יחכונ טסקט שדח 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Paediatric Population_ The experience in children is limited. No dosage regimen in children (0-6 years) can presently be recommended as safety and efficacy have not yet been sufficiently established. Limited clinical data in children (7-18 years) do not permit to recommend an optimal dosage regimen presently (see sections 5.1 and 5.2). Because no unexpected safety issues were encountered in the 6 month study with Replagal administered at 0.2 mg/kg in this population, this dose regimen is suggested for children between 7- 18 years of age. _Paediatric Population_ The experience in children is limited. No dosage regimen in children (0-6 years) can presently be recommended as safety and efficacy haveof Replagal in children aged 0- 6 years has not yet been sufficiently established. Currently available data are described in section 5.1 but no recommendation on posology can be made. LimitedIn clinical data instudies of children (7-18 years) do not permit to recommend an optimal dosage regimen presently (see sections 5.1 and 5.2). Becausewho received Replagal 0.2 mg/kg every other week, no unexpected safety issues were encountered in the 6 month study with Replagal administered at 0.2 mg/kg in this population, this dose regimen is suggested for children between 7- 18 years of age.(see section 5.1). 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE _Allergic-type hypersensitivity reactions_ As with any intravenous protein product, allergic-type hypersensitivity react Прочитајте комплетан документ
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Replagal Concentrate for solution for infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of concentrate for solution for infusion contains 1 mg of agalsidase alfa*. Each vial of 3.5 ml of concentrate contains 3.5 mg of agalsidase alfa. *agalsidase alfa is the human protein α-galactosidase A produced in a human cell line by genetic engineering technology. Excipient(s) with known effect This medicinal product contains 14.2 mg sodium per vial. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion. A clear and colourless solution. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Replagal is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry Disease (α-galactosidase A deficiency). 4.2 Posology and method of administration Replagal treatment should be supervised by a physician experienced in the management of patients with Fabry Disease or other inherited metabolic diseases. Posology Replagal is administered at a dose of 0.2 mg/kg body weight every other week by intravenous infusion over 40 minutes. _Special populations _ _Elderly patients_ _ _ Studies in patients over the age of 65 years have not been performed and no dosage regimen can presently be recommended in these patients as safety and efficacy have not yet been established. _Patients with hepatic impairment_ _ _ No studies have been performed in patients with hepatic impairment. _Patients with renal impairment_ _ _ No dose adjustment is necessary in patients with renal impairment. The presence of extensive renal damage (eGFR <60mL/min) may limit the renal response to enzyme replacement therapy. Limited data are available in patients on dialysis or post-kidney transplantation, no dose adjustment is recommended. _Paediatric Population_ _ _ The safety and efficacy of Replagal in children aged 0-6 years has not yet been established. Currently available data are described in section Прочитајте комплетан документ