País: Israel
Idioma: inglés
Fuente: Ministry of Health
ELOSULFASE ALFA
MEDISON PHARMA LTD
A16AB12
CONCENTRATE FOR SOLUTION FOR INFUSION
ELOSULFASE ALFA 1 MG/ML
I.V
Required
BIOMARIN INTERNATIONAL LIMITED, IRELAND
ELOSULFASE ALFA
Vimizim is indicated for the treatment of mucopolysaccharidosis, type IVA (Morquio A Syndrome ,MPS IVA) in patients of all ages.
2020-06-30
,םידבכנ ת/חקור ,ה/אפור ולעה יכ םכעידוהל ינירה ן רישכתה לש ןכדוע : VIMIZIM םיזימיו CONCENTRATE FOR SOLUTION FOR INFUSION Q UALITATIVE AND Q UANTITATIVE C OMPOSITION : Each ml of solution contains 1 mg elosulfase alfa*. Each vial of 5 ml contains 5 mg elosulfase alfa. *Elosulfase alfa is a recombinant form of human N-acetylgalactosamine-6-sulfatase (rhGALNS) and is produced in Chinese Hamster Ovary cell culture by recombinant DNA technology. תרשואמ היוותה - Vimizim is indicated for the treatment of mucopolysaccharidosis, type IVA (Morquio A Syndrome, MPS IVA) in patients of all ages. ןוכדע השענ אפורל ןולעב :אבה ףיעסב 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Sodium restricted diet This medicinal product contains 8 mg sodium per vial, equivalent to 0.4% of the WHO recommended maximum daily intake of 2 g sodium for an adult, and is administered in sodium chloride 9 mg/ml (0.9%) solution for infusion (see section 6.6). Sorbitol This medicinal product contains 100 mg sorbitol in each vial which is equivalent to 40 mg/kg. Patients with hereditary fructose intolerance (HFI) must not be given this medicinal product unless strictly necessary. Babies and young children (below 2 years of age) may not yet be diagnosed with hereditary fructose intolerance (HFI). Medicinal products (containing sorbitol/fructose) given intravenously may be life- threatening. The treatment benefit to the child compared to the associated risks must be fully evaluated prior to treatment. A detailed history with regard to HFI symptoms has to be taken for each patient prior to being given this medicinal product. ןולעה אצמנ אפורל ןכו רושיקב לעבל הינפ ידי לע ספדומ ולבקל ןתינו תואירבה דרשמ רתאב תופורתה רגאמב םסרופמ .םושירה ,הכרבב וילש היח 'רגמ הנוממ תחקור Leer el documento completo
1 פ רשואו קדבנ ונכותו תואירבה דרשמ י"ע עבקנ הז ןולע טמרו ראתב תואירבה דרשמ י"ע ךי 07/2015 ןכדועו ראתב תואירבה דרשמ תוארוהל םאתהב ךי 9 201 / 5 0 1. NAME OF THE MEDICINAL PRODUCT Vimizim concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 1 mg elosulfase alfa*. Each vial of 5 ml contains 5 mg elosulfase alfa. *Elosulfase alfa is a recombinant form of human N-acetylgalactosamine-6-sulfatase (rhGALNS) and is produced in Chinese Hamster Ovary cell culture by recombinant DNA technology. Excipients with known effect: Each 5 ml vial contains 8 mg sodium and 100 mg sorbitol (E420). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion A clear to slightly opalescent and colourless to pale yellow solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vimizim is indicated for the treatment of mucopolysaccharidosis, type IVA (Morquio A Syndrome, MPS IVA) in patients of all ages. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be supervised by a physician experienced in the management of patients with MPS IVA or other inherited metabolic diseases. Administration of Vimizim should be carried out by an appropriately trained healthcare professional with the ability to manage medical emergencies. Home administration under the supervision of an appropriately trained healthcare professional may be considered for patients who are tolerating their infusions well. _ _ Posology The recommended dose of elosulfase alfa is 2 mg/kg of body weight administered once a week. The total volume of the infusion should be delivered over approximately 4 hours (see Table 1). Because of the potential for hypersensitivity reactions with elosulfase alfa, patients should receive antihistamines with or without antipyretics 30 to 60 minutes prior to start of infusion (see section 4.4). 2 _Special populations _ _ _ _Elderly patien Leer el documento completo