Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
TEGAFUR; Gimeracil; Oteracil potassium
ZUELLIG PHARMA SDN BHD
TEGAFUR; Gimeracil; Oteracil potassium
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 . • For the treatment of HER2-negative metastatic breast cancer when given as monotherapy. 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 Baca dokumen lengkap
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 15.8 mg oteracil free acid). TS-ONE ® OD Tablet 25 Each tablet contains 25 mg tegafur, 7.25 mg gimeracil and 24.5 mg oteracil potassium (equivalent to 19.7 mg oteracil free acid). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM TS-ONE ® OD Tablet 20: an orally disintegrating, pale 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 characteristic odor. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TS-ONE ® is indicated 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. • For the treatment of HER2-negative metastatic breast cancer when given as monotherapy. 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. 2 The standard TS-ONE ® doses when given as monotherapy or combination therapy are provided in Table 1. _Table 1: Baca dokumen lengkap