Riik: Iisrael
keel: inglise
Allikas: Ministry of Health
MIGALASTAT AS HYDROCHLORIDE
TRUEMED LTD, ISRAEL
HARD CAPSULE
MIGALASTAT AS HYDROCHLORIDE 123 MG
PER OS
Required
AMICUS THERAPEUTICS UK LTD, UK
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.
2022-05-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a doctor’s prescription only GALAFOLD 123 MG HARD CAPSULES Each hard capsule contains the ACTIVE INGREDIENT : Migalastat 123 mg (as migalastat hydrochloride 150 mg). The list of inactive and allergenic ingredients is detailed in section 6. READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed to treat your ailment. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. The medicine is intended for adults and adolescents aged 16 years and older with certain genetic changes (mutations). 1. WHAT IS THE MEDICINE INTENDED FOR? Galafold 123 mg is intended for the long-term treatment of adults and adolescents aged 16 years and older, with a confirmed diagnosis of Fabry disease (impaired alpha-galactosidase A enzyme activity) and who have “amenable mutations”. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: • You are sensitive (allergic) to the active ingredient migalastat or to any of the additional ingredients contained in the medicine (see section 6 in the leaflet). SPECIAL WARNINGS REGARDING USE OF THE MEDICINE: BEFORE TREATMENT WITH GALAFOLD 123 MG, TELL YOUR DOCTOR if you are currently taking enzyme replacement therapy. Do not use Galafold 123 mg if you are currently receiving enzyme replacement therapy. While you are being treated with Galafold 123 mg, every 6 months your doctor will monitor your medical condition and whether the medicine is working. If your condition worsens, your doctor may perform an additional evaluation or may stop your treatment with Galafold 123 mg. Talk to your doctor before taking Galafold if you have severely reduced kidney function as Galafold is not recommended for use in patients with severe renal insufficiency ( Lugege kogu dokumenti
1 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 with an opaque blue cap and opaque white body printed with “A1001”. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Galafold 123 mg 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 (see the table in section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Galafold 123mg should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of Fabry disease. Galafold 123mg is not intended for concomitant use with enzyme replacement therapy (see section 4.4). Posology The recommended dosage regimen in adults and adolescents 16 years and older is 123 mg migalastat (1 capsule) once every other day at the same time of day. _Missed dose _ _ _ Galafold 123mg 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 123mg 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 123mg at the next planned dosing day and time according to the every other day dosing schedule. Special populations _ _ _Elderly population _ _ _ No dosage adjustment is required based on age (see section 5.2). _Renal impairment _ _ _ Galafold 123mg 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). 2 _Hepatic impairment _ _ _ No dosage adjustment of Galafold 123mg is required in patients with hepatic impairment (see section 5.2). _Paediatric population _ _ _ The safety and efficacy of Galafold 123mg in children aged less than 16 years have Lugege kogu dokumenti