Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
ruxolitinib (as phosphate)
Novartis Europharm Limited
L01EJ01
ruxolitinib
Antineoplastic agents
Myeloproliferative Disorders; Polycythemia Vera; Graft vs Host Disease
Myelofibrosis (MF)Jakavi is indicated for the treatment of disease related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis.Polycythaemia vera (PV)Jakavi is indicated for the treatment of adult patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea.Graft versus host disease (GvHD)Jakavi is indicated for the treatment of patients aged 12 years and older with acute graft versus host disease or chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5.1).
Revision: 28
Authorised
2012-08-23
68 B. PACKAGE LEAFLET 69 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT JAKAVI 5 MG TABLETS JAKAVI 10 MG TABLETS JAKAVI 15 MG TABLETS JAKAVI 20 MG TABLETS ruxolitinib 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 or pharmacist. - 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Jakavi is and what it is used for 2. What you need to know before you take Jakavi 3. How to take Jakavi 4. Possible side effects 5. How to store Jakavi 6. Contents of the pack and other information 1. WHAT JAKAVI IS AND WHAT IT IS USED FOR Jakavi contains the active substance ruxolitinib. Jakavi is used to treat adult patients with an enlarged spleen or with symptoms related to myelofibrosis, a rare form of blood cancer. Jakavi is also used to treat adult patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea. Jakavi is also used to treat patients 12 years of age and older and adults with graft-versus-host disease (GvHD). There are two forms of GvHD: an early form called acute GvHD that usually develops soon after the transplantation and can affect skin, liver and gastrointestinal tract, and a form called chronic GvHD, which develops later, usually weeks to months after the transplantation. Almost any organ can be affected by chronic GvHD. 70 HOW JAKAVI WORKS Enlargement of the spleen is one of the characteristics of myelofibrosis. Myelofibrosis is a disorder of the bone marrow, in which the marrow is replaced by scar tissue. The abnormal marrow can no longer produce enough normal blood cells and as a result the spleen becomes significantly enlarged. By block Læs hele dokumentet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Jakavi 5 mg tablets Jakavi 10 mg tablets Jakavi 15 mg tablets Jakavi 20 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Jakavi 5 mg tablets Each tablet contains 5 mg ruxolitinib (as phosphate). _Excipient with known effect _ Each tablet contains 71.45 mg lactose monohydrate. Jakavi 10 mg tablets Each tablet contains 10 mg ruxolitinib (as phosphate). _Excipient with known effect_ Each tablet contains 142.90 mg lactose monohydrate. Jakavi 15 mg tablets Each tablet contains 15 mg ruxolitinib (as phosphate). _Excipient with known effect_ Each tablet contains 214.35 mg lactose monohydrate. Jakavi 20 mg tablets Each tablet contains 20 mg ruxolitinib (as phosphate). _Excipient with known effect_ Each tablet contains 285.80 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. Jakavi 5 mg tablets Round curved white to almost white tablets of approximately 7.5 mm in diameter with “NVR” debossed on one side and “L5” debossed on the other side. Jakavi 10 mg tablets Round curved white to almost white tablets of approximately 9.3 mm in diameter with “NVR” debossed on one side and “L10” debossed on the other side. Jakavi 15 mg tablets Ovaloid curved white to almost white tablets of approximately 15.0 x 7.0 mm with “NVR” debossed on one side and “L15” debossed on the other side. Jakavi 20 mg tablets Elongated curved white to almost white tablets of approximately 16.5 x 7.4 mm with “NVR” debossed one one side and “L20” debossed on the other side. 3 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Myelofibrosis (MF) Jakavi is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis. Polycythaemia vera (PV) Jakavi is indicated for the treatment of adult patients with Læs hele dokumentet