Country: মাল্যাশিয়া
ভাষা: ইংরেজি
সূত্র: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Oteracil potassium; TEGAFUR; Gimeracil
ZUELLIG PHARMA SDN BHD
Oteracil potassium; TEGAFUR; Gimeracil
2 x 2 X 14tablet Tablets
Taiho Pharmaceutical Co.,Ltd.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ TS-ONE ® OD TABLET Tegafur/Gimeracil/Oteracil Potassium (20mg/5.8mg/19.6mg, 25mg/7.25mg/24.5mg) 1 WHAT IS IN THIS LEAFLET 1. What TS-ONE ® OD Tablet is used for 2. How TS-ONE ® OD Tablet works 3. Before you use TS-ONE ® OD Tablet 4. How to use TS-ONE ® OD Tablet 5. While you are using it 6. Side effects 7. Storage and Disposal of TS-ONE ® OD Tablet 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST . KEEP THIS LEAFLET. You may need to read it again. WHAT TS-ONE ® OD TABLET IS USED FOR This medicine is used to treat adults with: • Advanced gastric (stomach) cancer when given in combination with cisplatin (another anticancer medicine). • Locally advanced (stage II (excluding T1), IIIA or IIIB) gastric (stomach) cancer as post operative adjuvant chemotherapy. • Locally advanced or metastatic pancreatic cancer when given as monotherapy. • Locally advanced or metastatic non- small cell lung cancer when given in combination with carboplatin (another anticancer medicine). • Metastatic colorectal cancer when given in combination with oxaliplatin (another anticancer medicine) as first-line treatment or in combination with irinotecan (another anticancer medicine) as second-line treatment. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason . HOW TS-ONE ® OD TABLET WORKS TS-ONE ® OD Tablet belongs to the fluoropyrimidine class of medicine known as “antineoplastic agents” which stop the growth of cancer cells. BEFORE YOU USE TS-ONE ® OD TABLET - _When you must not use it _ Do not take TS-ONE ® OD Tablet if you: • are allergic (hypersensitive) to tegafur, gimeracil, oteracil or any of the other ingredients of TS-ONE ® OD Tablet • are taking other fluoropyrimidine anti- cancer medicine such as fluorouracil and capecitabine, or have সম্পূর্ণ নথি পড়ুন
1 1. NAME OF THE MEDICINAL PRODUCT TS -ONE ® OD Tablet 20 TS -ONE ® OD Tablet 25 2. QUALITATIVE AND QUANTITATIVE COMPOSITION TS -ONE ® OD Tablet 20 Each tablet contains 20 mg tegafur, 5.8 mg gimeracil and 19.6 mg oteracil potassium (equivalent to 15.8mg oteracil f ree acid) TS -ONE ® OD Tablet 25 Each tablet contains 25 mg tegafur, 7.25 mg gimeracil and 24.5 mg oteracil potassium (equivalent to 19.7mg oteracil free acid) For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM TS -ONE ® OD Tablet 20: an orally disintegrating , p ale blue -green tablet with a white disc inset centrally in one face, having a characteristic odor. TS -ONE ® OD Tablet 25 : an orally disintegrating, pale orange tablet with a white disc inset centrally in one face, having a charact eristic odor. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications TS -ONE ® is indic ated in adults • For the treatment of advanced gastric cancer when given in combination with cisplatin. • For post operative adjuvant chemotherapy for locally advanced (stage II (excluding T1), IIIA or IIIB) gastric cancer . • For the treatment of locally advanced or metastatic pancreatic cancer when given as monotherapy. • For the treatment of locally advanced or metastatic non -small cell lung cancer when given in combination with carboplatin. • For the treatment of metastatic colorectal cancer when given in combination with oxaliplatin as first -line treatment or in combination with irinotecan as second -line treatment. 4.2 Posology and method of administration TS -ONE ® should only be prescribed by a qualified physician experienced in treating cancer patients with anti -neoplastic medicinal products. Posology The recommended standard dose is based on studies performed in an Asian population and differs from the dosing recommended in Caucasian patients. সম্পূর্ণ নথি পড়ুন