Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
panobinostat lactate anhydrous
pharmaand GmbH
L01XH03
panobinostat
Antineoplastic agents
Multiple Myeloma
Farydak, in combination with bortezomib and dexamethasone, is indicated for the treatment of adult patients with relapsed and/or refractory multiple myeloma who have received at least two prior regimens including bortezomib and an immunomodulatory agent.Farydak, in combination with bortezomib and dexamethasone, is indicated for the treatment of adult patients with relapsed and/or refractory multiple myeloma who have received at least two prior regimens including bortezomib and an immunomodulatory agent.
Revision: 13
Authorised
2015-08-28
38 B. PACKAGE LEAFLET 39 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT FARYDAK 10 MG HARD CAPSULES FARYDAK 15 MG HARD CAPSULES FARYDAK 20 MG HARD CAPSULES panobinostat 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 Farydak is and what it is used for 2. What you need to know before you take Farydak 3. How to take Farydak 4. Possible side effects 5. How to store Farydak 6. Contents of the pack and other information 1. WHAT FARYDAK IS AND WHAT IT IS USED FOR WHAT FARYDAK IS Farydak is an anti-cancer medicine that contains the active substance panobinostat, which belongs to a group of medicines called pan-deacetylase inhibitors. WHAT FARYDAK IS USED FOR Farydak is used to treat adult patients with a rare type of blood cancer called multiple myeloma. Multiple myeloma is a disorder of plasma cells (a type of blood cell) that grow out of control in the bone marrow. Farydak blocks the growth of cancerous plasma cells and reduces the number of cancer cells. Farydak is always used together with two other medicines: bortezomib and dexamethasone. If you have any questions about how Farydak works or why you have been given it, ask your doctor or pharmacist. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FARYDAK DO NOT TAKE FARYDAK: - if you are allergic to panobinostat or any of the other ingredients of this medicine (listed in section 6). - if you are breast-feeding WARNINGS AND PRECAUTIONS Follow all your doctor’s instructions carefully. 40 Talk to your doctor or pharmacist before taking Farydak: Прочетете целия документ
1 SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Farydak 10 mg hard capsules Farydak 15 mg hard capsules Farydak 20 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Farydak 10 mg hard capsules Each hard capsule contains panobinostat lactate anhydrous equivalent to 10 mg panobinostat. Farydak 15 mg hard capsules Each hard capsule contains panobinostat lactate anhydrous equivalent to 15 mg panobinostat. Farydak 20 mg hard capsules Each hard capsule contains panobinostat lactate anhydrous equivalent to 20 mg panobinostat. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule (capsule). Farydak 10 mg hard capsules Light green opaque hard gelatin capsule (15.6–16.2 mm) containing white to almost white powder, with radial marking “LBH 10 mg” in black ink on cap and two radial bands in black ink on body. Farydak 15 mg hard capsules Orange opaque hard gelatin capsule (19.1–19.7 mm) containing white to almost white powder, with radial marking “LBH 15 mg” in black ink on cap and two radial bands in black ink on body. Farydak 20 mg hard capsules Red opaque hard gelatin capsule (19.1–19.7 mm) containing white to almost white powder, with radial marking “LBH 20 mg” in black ink on cap and two radial bands in black ink on body. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Farydak, in combination with bortezomib and dexamethasone, is indicated for the treatment of adult patients with relapsed and/or refractory multiple myeloma who have received at least two prior regimens including bortezomib and an immunomodulatory agent. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Farydak should be initiated by a physician experienced in the use of anti-cancer 3 therapies. Posology The recommended starting dose of panobinostat is 20 mg, taken orally once a day, on days 1, 3, 5, 8, 10 and 12 of a 21-day cycle. Patients should be treated initially for eight cycles. It is recommended that patients with clinical benefit continue the treatment Прочетете целия документ