Ország: Malajzia
Nyelv: angol
Forrás: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
SUNITINIB MALATE
PFIZER (MALAYSIA) SDN. BHD.
SUNITINIB MALATE
30Capsule Capsules; 28 Capsule Capsules
PFIZER ITALIA S.R.L.
Pfizer Confidential _CONSUMER MEDICATION INFORMATION LEAFLET _ _(RIMUP) _ SUTENT ® CAPSULE Sunitinib Malate (12.5 mg, 25 mg) PLD Title : Sunitinib Malate (SUTENT) PLD Date : 03 May 20190316 NovemberJuly 2020 Country : Malaysia Reference Document : 12.5 mg and 25 mg capsules of Malaysia LPD dated 06 February 202018 July 2018 Reason for Changechange : To Update PRH address To add Serial NumberPfLEET Numbero- 2020-0062522 (S 1) To update as per latest CLD : To amend serial number Pfizer Confidential _ _ _ _ _ _ _ _ _ _ _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ SUTENT ® CAPSULE _ _ Sunitinib Malate (12.5 mg, 25 mg) _ _ 1 WHAT IS IN THIS LEAFLET 1. What SUTENT is used for 2. How SUTENT works 3. Before you use SUTENT 4. How to use SUTENT 5. While you are using it 6. Side Effects 7. Storage and Disposal of SUTENT 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT SUTENT IS USED FOR SUTENT is used to treat adults with the following types of cancer: Gastrointestinal stromal tumour (GIST), a type of cancer of the stomach and bowel,. Aafter disease progression on or, where imatinib (another anticancer medicine) no longer works or you cannot take imatinib. Advanced renal cell carcinoma, 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 SUTENT WORKS SUTENT 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 SUTENT - _When you must not use it _ DO NOT TAKE SUTENT If you are allergic to sunitinib or any of the other ingredients of SUTENT. _Pregnancy and lactation _ There are no studies in pregnant women using sunitinib. If you are pregnant or think you may be pregnant, tell your doctor. SUTENT is not to be used during pregnancy unless clearly necessary. Your doctor Olvassa el a teljes dokumentumot
Pfizer Confidential SUTENT SUNITINIB MALATE 1. NAME OF THE MEDICINAL PRODUCT SUTENT 2. QUALITATIVE AND QUANTITATIVE COMPOSITION SUTENT 12.5 MG Each capsule contains sunitinib malate equivalent to 12.5 mg of sunitinib. SUTENT 25 MG Each capsule contains sunitinib malate equivalent to 25 mg of sunitinib. 3. PHARMACEUTICAL FORM 12.5 MG CAPSULES Hard gelatin capsule with orange cap and orange body, printed with white ink “Pfizer” on the cap and “STN 12.5 mg” on the body. 25 MG CAPSULES Hard gelatin capsule with caramel cap and orange body, printed with white ink “Pfizer” on the cap and “STN 25 mg” on the body. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATION 4.1.1 GASTROINTESTINAL STROMAL TUMOR (GIST) SUTENT is indicated for the treatment of gastrointestinal stromal tumor after disease progression on or intolerance to imatinib mesylate. 4.1.2 ADVANCED RENAL CELL CARCINOMA (RCC) SUTENT is indicated for the treatment of advanced renal cell carcinoma. 4.1.3. PANCREATIC NEUROENDOCRINE TUMOUR (PNET)_ _ SUTENT is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours (pNET) with disease progression in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 4.2.1 RECOMMENDED DOSE For _GIST _ and Advanced _RCC_ , the recommended dose of sunitinib is 50 mg taken orally once daily for 4 consecutive weeks, followed by a 2-week off period (Schedule 4/2) to comprise a complete cycle of 6 weeks. Pfizer Confidential 1 For _pNET, _ the recommended dose of sunitinib is 37.5 mg taken orally once daily without a scheduled rest period. Sunitinib may be taken with or without food. If a dose is missed, the patient should not be given an additional dose. The patient should take the usual prescribed dose on the following day. 4.2.2 DOSE MODIFICATIONS _Safety and Tolerability_ For GIST and Advanced RCC, dose modifications in 12.5 mg increments or decrements may be applied based on individual safety and tolerability up to 75 mg or down to 25 mg. For _pNET_ , dose modificati Olvassa el a teljes dokumentumot