Land: Israel
Sprog: engelsk
Kilde: Ministry of Health
GALSULFASE
MEDISON PHARMA LTD
A16AB08
CONCENTRATE FOR SOLUTION FOR INFUSION
GALSULFASE 1 MG/ML
I.V
Required
BIOMARIN PHARMACEUTICAL INC, USA
GALSULFASE
GALSULFASE
Naglazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of MPSVI (N-acetylglactosamine 4 sulfatase deficiency Maroteaux-Lamy syndrome).
2015-04-30
_אפורל ןולעב )תוחיטב עדימ ( הרמחה לע העדוה_ _אפורל ןולעב )תוחיטב עדימ ( הרמחה לע העדוה_ _ ןכדועמ(_ _ ןכדועמ(_ _05.2013_ _05.2013_ _)_ _)_ ________ ךיראת _ 04.2015 _____ ____________ םושירה רפסמו תילגנאב רישכת םש 143-48-3176-700 _ Reg .No: __ NAGLAZYME ____ _______________ םושירה לעב םש MEDISON PHARMA LTD _____________________ ! דבלב תורמחהה טורפל דעוימ הז ספוט תושקובמה תורמחהה ןולעב קרפ יחכונ טסקט שדח טסקט EXCIPIENTS Each 5 ml vial contains 0.8 mmol (18.4 mg) of sodium THERAPEUTIC INDICATIONS Naglazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Mucopolysaccharidosis VI (MPS VI; N- acetylgalactosamine 4-sulfatase deficiency; Maroteaux-Lamy syndrome) (see section 5.1). Naglazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Mucopolysaccharidosis VI (MPS VI; N-acetylgalactosamine 4- sulfatase deficiency; Maroteaux-Lamy syndrome) (see section 5.1). A key issue is to treat children aged <5 years suffering from a severe form of the disease, even though children <5 years were not included in the pivotal phase 3 study. Limited data are available in patients < 1 year of age (see section 5.1). POSOLOGY AND METHOD OF ADMINISTRATION Naglazyme treatment should be supervised by a physician experienced in the management of patients with MPS VI or other inherited metabolic diseases. Administration of Naglazyme should be carried out in an appropriate clinical setting where resuscitation equipment to manage medical emergencies would be readily available. The recommended dosage regimen for galsulfase is 1 mg/kg body weight administered once every week as an intravenous infusion over 4 hours. The initial infusion rate is adjusted so that approximately 2.5% of the total solution is infused during the first hour, with infusion of the remaining volume (ap Læs hele dokumentet
1. NAME OF THE MEDICINAL PRODUCT Naglazyme 1 mg/ml concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 1 mg galsulfase. One vial of 5 ml contains 5 mg galsulfase. Galsulfase is a recombinant form of human N-acetylgalactosamine 4-sulfatase and is produced by recombinant DNA technology using mammalian Chinese Hamster Ovary (CHO) cell culture. _Excipients _ Each 5 ml vial contains 0.8 mmol (18.4 mg) of sodium. For a 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 Naglazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Mucopolysaccharidosis VI (MPS VI; N-acetylgalactosamine 4-sulfatase deficiency; Maroteaux-Lamy syndrome) (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION A key issue is to treat children aged <5 years suffering from a severe form of the disease, even though children <5 years were not included in the pivotal phase 3 study. Limited data are available in patients < 1 year of age (see section 5.1). As for all lysosomal genetic disorders, it is of primary importance, especially in severe forms, to initiate treatment as early as possible, before appearance of non-reversible clinical manifestations of the disease. Naglazyme treatment should be supervised by a physician experienced in the management of patients with MPS VI or other inherited metabolic diseases. Administration of Naglazyme should be carried out in an appropriate clinical setting where resuscitation equipment to manage medical emergencies would be readily available _. _ _ _ Posology The recommended dose regimen for galsulfase is 1 mg/kg body weight administered once every week as an intravenous infusion over 4 hours. _Special populations _ _ _ _Elderly _ The safety and efficacy of Naglazyme in patients older than 65 years has not been established, an Læs hele dokumentet