Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
SUNITINIB MALATE
RANBAXY (MALAYSIA) SDN. BHD.
SUNITINIB MALATE
4 x 7 Capsules
Sun Pharmaceutical Industries Limited
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ NIBINASE 12.5, 25 AND 50 Sunitinib Malate Hard Gelatin Capsule (12.5mg, 25mg and 50mg) Page 1 WHAT IS IN THIS LEAFLET 1. What NIBINASE is used for 2. How NIBINASE work 3. Before you use NIBINASE 4. How to use NIBINASE 5. While you are using it 6. Side effects 7. Storage and Disposal of NIBINASE 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial Number WHAT NIBINASE IS USED FOR NIBINASE is used to treat adults with the following types of cancer: • Gastrointestinal stromal tumour (GIST), a type of cancer of the stomach and bowel, where imatinib (another anticancer medicine) no longer works or you cannot take imatinib. • Metastatic renal cell carcinoma (MRCC), a type of kidney cancer that has spread to other parts of the body. • Pancreatic neuroendocrine tumours (pNET) (tumours of the hormone- producing cells in the pancreas) that have progressed or cannot be removed with surgery. HOW NIBINASE WORK NIBINASE contains the active substance sunitinib, which is a protein kinase inhibitor. It is used to treat cancer by preventing the activity of a special group of proteins which are known to be involved in the growth and spread of cancer cells. BEFORE YOU USE NIBINASE ‑ _When you must not use it _ Do not take NIBINASE if: You are allergic to sunitinib or to any of the other ingredients of NIBINASE (See the end of this leaflet for a complete list of ingredients in NIBINASE ). Talk to your doctor or pharmacist before taking NIBINASE if you: • have high blood pressure. NIBINASE can raise blood pressure. Your doctor may check your blood pressure during treatment with NIBINASE, and you may be treated with medicines to reduce the blood pressure, if needed. • have or have had blood disease, bleeding problems, or bruising. Treatment with NIBINASE may lead to a higher risk of bleeding or lead to changes in the number of certain cells in the blood which may lead to anaemia or affect the ability of your blood to clo Baca dokumen lengkap
_For the use of a Registered Medical Practitioner only _ PRESCRIBING INFORMATION NIBINASE 12.5 / NIBINASE 25 / NIBINASE 50 (Sunitinib Hard Gelatin Capsule 12.5 mg /25 mg / 50 mg) COMPOSITION NIBINASE 12.5MG Each hard gelatin capsule contains: Sunitinib malate equivalent to Sunitinib……. 12.5 mg NIBINASE 25MG Each hard gelatin capsule contains: Sunitinib malate equivalent to Sunitinib……. 25 mg NIBINASE 50MG Each hard gelatin capsule contains: Sunitinib malate equivalent to Sunitinib……. 50 mg _Excipients:_ Mannitol, Croscarmellose Sodium, Povidone (K 30), Magnesium Stearate, Purified Water, Iron oxide black, Iron oxide red, Iron oxide yellow, Titanium dioxide, Gelatin. DESCRIPTION NIBINASE 12.5MG Hard gelatin capsule Size 4 with opaque reddish brown cap and opaque reddish brown body, self-lock capsule, imprinted with 'RM53' on cap and 'RM53' on body in white ink, containing Yellow to orange colored powder.. NIBINASE 25MG Hard gelatin capsule “Size 3” with opaque caramel cap and opaque reddish brown body, self-lock capsule, imprinted with 'RM54' on cap and 'RM54' on body in white ink, containing Yellow to orange colored powder NIBINASE 50MG Hard gelatin capsule “Size 1” with opaque caramel cap and opaque caramel body, self-lock capsule, imprinted with 'RM56' on cap and 'RM56' on body in white ink, containing Yellow to orange colored powder.. NIBINASE contains Sunitinib. Sunitinib is an indolinone derivative and tyrosine kinase inhibitor with potential antineoplastic activity. It is described chemically as N-[2-(diethylamino)ethyl]-5-[(Z)-(5-fluoro-2-oxo-1H-indol- 3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide. Sunitinib has molecular formulae C 22 H 27 FN 4 O 2 and molecular weight is 398.5 g/mol. Sunitinib has the following structural formula: STRUCTURAL FORMULAE OF SUNITINIB PHARMACODYNAMIC AND PHARMACOKINETIC PROPERTIES PHARMACODYNAMICS Sunitinib inhibits multiple receptor tyrosine kinases (RTKs) that are implicated in tumor growth, pathologic angiogenesis, and metastatic progressi Baca dokumen lengkap