Kraj: Malezja
Język: angielski
Źródło: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
RUXOLITINIB PHOSPHATE
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
RUXOLITINIB PHOSPHATE
56tablet Tablets; 14tablet Tablets
NOVARTIS PHARMA STEIN AG
_Customer Medication Indication Leaflet (RiMUP) _ JAKAVI ® RUXOLITINIB (5MG, 10MG, 15MG, 20MG TABLETS) 1 WHAT IS IN THIS LEAFLET 1. What Jakavi is used for 2. How Jakavi works 3. Before you use Jakavi 4. How to use Jakavi 5. While you are using Jakavi 6. Side effects 7. Storage and Disposal of Jakavi 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT JAKAVI 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. 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 blocking the action of certain enzymes (called Janus Associated Kinases), Jakavi can reduce the size of the spleen in patients with myelofibrosis and relieve symptoms such as fever, night sweats, bone pain and weight loss. Jakavi can help reduce the risk of serious blood or vascular complications. Polycythaemia vera is a disorder of the bone marrow, in which the marrow produce too many red blood cells. The blood becomes thicker as a result of the increased red blood cells. Jakavi can relieve the symptoms, reduce spleen size and the volume of red Przeczytaj cały dokument
1 Regulatory Affairs JAKAVI ® (RUXOLITINIB) 5mg, 10mg, 15 mg and 20 mg tablets MALAYSIA PACKAGE INSERT (AUG 2021; EU SMPCJUL 2021APR 2022) Effective date: 26-Oct-202012-Jan-2021 Safety Label Change (SLC) Tracking Number: 2020-PSB/GLC-1155-sNA Document status: Final Novartis Page 2 Malaysia Package Insert 26-Oct-202012-Jan-2021 Jakavi 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 Novartis Page 3 Malaysia Package Insert 26-Oct-202012-Jan-2021 Jakavi 3 on one side and “L20” debossed on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Myelofib Przeczytaj cały dokument