Country: Европска Унија
Језик: Енглески
Извор: EMA (European Medicines Agency)
Migalastat hydrochloride
Amicus Therapeutics Europe Limited
A16AX
migalastat
migalastat
Fabry Disease
Galafold is indicated for long-term treatment of adults and adolescents aged 16 years and older with a confirmed diagnosis of Fabry disease (α-galactosidase A deficiency) and who have an amenable mutation.
Revision: 16
Authorised
2016-05-25
50 B. PACKAGE LEAFLET 51 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT GALAFOLD 123 MG HARD CAPSULES migalastat READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist, or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Galafold is and what it is used for 2. What you need to know before you take Galafold 3. How to take Galafold 4. Possible side effects 5. How to store Galafold 6. Contents of the pack and other information 1. WHAT GALAFOLD IS AND WHAT IT IS USED FOR Galafold contains the active substance migalastat. This medicine is used for the long-term treatment of Fabry disease in adults and adolescents aged 12 years and older who have certain genetic mutations (changes). Fabry disease is caused by the lack of or a faulty enzyme called alpha-galactosidase A (α-Gal A). Depending upon the kind of mutation (change) in the gene that produces α-Gal A, the enzyme does not work properly or is completely absent. This enzyme defect leads to abnormal deposits of a fatty substance known as globotriaosylceramide (GL-3) in kidneys, heart, and other organs, leading to the symptoms of Fabry disease. This medicine works by stabilising the enzyme that your body produces naturally, so that it can work better to reduce the amount of GL-3 that has accumulated in your cells and tissues. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GALAFOLD DO NOT TAKE GALAFOLD IF YOU: • are allergic to migalastat or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS 123 mg migalastat capsules are not for children (≥12 years) weig Прочитајте комплетан документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Galafold 123 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains migalastat hydrochloride equivalent to 123 mg migalastat. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. Size 2 hard capsule (6.4x18.0 mm) with an opaque blue cap and opaque white body with “A1001” printed in black, containing white to pale brown powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Galafold is indicated for long-term treatment of adults and adolescents aged 12 years and older with a confirmed diagnosis of Fabry disease (α-galactosidase A deficiency) and who have an amenable mutation (see the tables in section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Galafold should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of Fabry disease. Galafold is not intended for concomitant use with enzyme replacement therapy (see section 4.4). Posology The recommended dosage regimen is 123 mg migalastat (1 capsule) taken once every other day at the same time of the day. _ _ _Missed dose _ Galafold should not be taken on 2 consecutive days. If a dose is missed entirely for the day, the patient should take the missed dose of Galafold only if it is within 12 hours of the normal time the dose is taken. If more than 12 hours has passed the patient should resume taking Galafold at the next planned dosing day and time according to the every other day dosing schedule. 3 Special populations _ _ _Elderly population _ No dosage adjustment is required based on age (see section 5.2). _ _ _ _ _Renal impairment _ Galafold is not recommended for use in patients with Fabry disease who have estimated GFR less than 30 mL/min/1.73 m 2 (see section 5.2). _ _ _Hepatic impairment_ No dosage adjustment of Galafold is required in patients with hepatic impairment (see section 5.2). _Paediatric population _ _Adolescents aged ≥ 12 to < 18 years and Прочитајте комплетан документ