Država: Izrael
Jezik: engleski
Izvor: Ministry of Health
IDURSULFASE
TAKEDA ISRAEL LTD
A16AB09
CONCENTRATE FOR SOLUTION FOR INFUSION
IDURSULFASE 2 MG/ML
I.V
Required
TAKEDA PHARMACEUTICALS INTERNATIONAL AG IRELAND BRANCH, IRELAND
IDURSULFASE
IDURSULFASE
Long term treatment of patients with Hunter syndrome (MPS II).
2023-07-31
רשוא – 61 . 2 ךיראת : 61 02. 2 0. 22 תילגנאב רישכת םש םושירה רפסמו ELAPRASE 138 94 31772 00 םושירה לעב םש : מ"עב המראפ ןוסידמ ה טורפל דעוימ הז ספוט דבלב תורמחה ! לע העדוה לע העדוה לע העדוה ( הרמחה ( הרמחה ( הרמחה עדימ עדימ עדימ ל ןולעב )תוחיטב ל ןולעב )תוחיטב ל ןולעב )תוחיטב אפור אפור אפור תושקובמה תורמחהה ןולעב קרפ יחכונ טסקט שדח טסקט 5.PHARMACO LOGICAL PROPERTIES 5.1 PHARMACODYNAM IC PROPERTIES 5.1 PHARMACODYNAMIC PROPERTIES Among all patients, statistically significant mean increases from treatment baseline (TKT024 baseline for TKT024 idursulfase patients and Week 53 baseline for TKT024 placebo patients) were seen in the distance walked 6MWT at the majority of time points tested, with significant mean and percent increases ranging from 13.7m to 41.5m and from 6.4% to 11.7% (maximum at Month 20). At most time points tested, patients who were from the original TKT024 weekly treatment group improved their walking distance to a greater extent that patients in the other 2 treatment groups. Among all patients, mean % predicted FVC was significantly increased at Month 16, although by Month 36, it was similar to the baseline. Patients with the most severe pulmonary impairment at baseline (as measured by % predicted FVC) tended to show the least improvement. Statistically significant increases from treatment baseline in absolute FVC volume were seen at most visits for each of the prior TKT024 treatment groups. Mean changes from 0.07 l to 0.31 l and percent ranged from 6.3% to 25.1% (maximum at Month 30). The mean and percent changes from treatment baseline were greatest in the group of patients from the TKT024 study who had received the weekly dosing, across all time points. 5.1 PHARMACODYNAMIC PROPERTIES Among all patients, statistically significant mean increases from treatment baseline (TKT024 bas Pročitajte cijeli dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Elaprase Concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ Each vial contains 6 mg of idursulfase. Each ml contains 2 mg of idursulfase*. Excipient with known effect Each vial contains 0.482 mmol of sodium. For the full list of excipients, see section 6.1. * idursulfase is produced by recombinant DNA technology in a continuous human cell line. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate). A clear to slightly opalescent, colourless solution. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Elaprase is indicated for the long-term treatment of patients with Hunter syndrome (Mucopolysaccharidosis II, MPS II). Heterozygous females were not studied in the clinical trials. 4.2 Posology and method of administration This treatment should be supervised by a physician or other healthcare professional experienced in the management of patients with MPS II disease or other inherited metabolic disorders. Posology Elaprase is administered at a dose of 0.5 mg/kg body weight every week by intravenous infusion over a 3 hour period, which may be gradually reduced to 1 hour if no infusion-associated reactions are observed (see section 4.4). For instructions for use, see section 6.6. Infusion at home may be considered for patients who have received several months of treatment in the clinic and who are tolerating their infusions well. Home infusions should be performed under the surveillance of a physician or other healthcare professional. Special populations _Elderly patients _ There is no clinical experience in patients over 65 years of age. _Patients with renal or hepatic impairment_ _ _ There is no clinical experience in patients with renal or hepatic insufficiency ( s ee section 5.2). _Paediatric population _ The dose for children and adolescents is the same as for adults, 0.5 mg/kg body weight weekly. Method of administration For instructions on dilution of the medicinal product before a Pročitajte cijeli dokument