Maa: Israel
Kieli: englanti
Lähde: Ministry of Health
RUXOLITINIB AS PHOSPHATE
NOVARTIS ISRAEL LTD
L01XE18
TABLETS
RUXOLITINIB AS PHOSPHATE 10 MG
PER OS
Required
NOVARTIS PHARMA STEIN AG, SWITZERLAND
RUXOLITINIB
* 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
2022-04-30
JAK SPL NOV22 V3 EU PIL April 2022 1 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor's prescription only JAKAVI ® 5 MG JAKAVI ® 10 MG JAKAVI ® 15 MG JAKAVI ® 20 MG TABLETS TABLETS TABLETS TABLETS Each tablet contains: ruxolitinib phosphate 6.60 mg corresponding to ruxolitinib 5 mg Each tablet contains: ruxolitinib phosphate 13.20 mg corresponding to ruxolitinib 10 mg Each tablet contains: ruxolitinib phosphate 19.80 mg corresponding to ruxolitinib 15 mg Each tablet contains: ruxolitinib phosphate 26.40 mg corresponding to ruxolitinib 20 mg INACTIVE INGREDIENTS AND ALLERGENS: SEE SECTION 2 "IMPORTANT INFORMATION ABOUT SOME OF THE MEDICINE’S INGREDIENTS", AND SECTION 6 "ADDITIONAL INFORMATION". READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE, BECAUSE IT CONTAINS INFORMATION THAT IS IMPORTANT FOR YOU. This leaflet contains concise information about this medicine. If you have any further questions, refer to your doctor or pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. 1. WHAT IS THE MEDICINE INTENDED FOR? Jakavi is used to treat: • Adult patients with an enlarged spleen or with symptoms related to myelofibrosis, a rare type of blood cancer. • Adult patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea. • Adults and children aged 12 years and older with acute or chronic graft-versus- host disease (GvHD), who have inadequate response to corticosteroids or other systemic therapies. THERAPEUTIC GROUP: Jakavi belongs to a group of antineoplastic medicines that inhibit protein-kinase. 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 Lue koko asiakirja
1 JAK API FEB23 V6 EU SmPC April 2022 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 : Each tablet contains 6.60 mg ruxolitinib phosphate, corresponding to 5 mg ruxolitinib free base. _Excipient with known effect_ : _ _ Each tablet contains 71.45 mg lactose monohydrate. Jakavi 10 mg : Each tablet contains 13.20 mg ruxolitinib phosphate, corresponding to 10 mg ruxolitinib free base. _Excipient with known effect_ : Each tablet contains 142.90 mg lactose monohydrate. Jakavi 15 mg : Each tablet contains 19.8 0 mg ruxolitinib phosphate, corresponding to 15 mg ruxolitinib free base. _Excipient with known effect_ : Each tablet contains 214.35 mg lactose monohydrate. Jakavi 20 mg : Each tablet contains 26.40 mg ruxolitinib phosphate, corresponding to 20 mg ruxolitinib free base. _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 : Tablet. 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 : Tablet. 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 : Tablet. 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 : Tablet. Elongated curved white to almost white tablets of approximately 16.5 x 7.4 mm with “NVR” debossed on one side and “L20” debossed on the other side. 2 JAK API FEB23 V6 EU SmPC April 2022 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 Lue koko asiakirja