Šalis: Didžioji Britanija
kalba: anglų
Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ruxolitinib phosphate
Novartis Pharmaceuticals UK Ltd
L01XE18
Ruxolitinib phosphate
15mg
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 08010500; GTIN: 5010678910025 5010678910056
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 patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea. 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 in patients with myelofibrosis. 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 Perskaitykite visą dokumentą
OBJECT 1 JAKAVI 15MG TABLETS Summary of Product Characteristics Updated 13-Jun-2018 | Novartis Pharmaceuticals UK Ltd • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Fertility, pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text 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. Perskaitykite visą dokumentą