Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
tegafur, gimeracil, oteracil
Nordic Group B.V.
L01BC53
tegafur, gimeracil, oteracil
Antineoplastic agents
Stomach Neoplasms
Teysuno is indicated in adults:- for the treatment of advanced gastric cancer when given in combination with cisplatin (see section 5.1).- as monotherapy or in combination with oxaliplatin or irinotecan, with or without bevacizumab, for the treatment of patients with metastatic colorectal cancer for whom it is not possible to continue treatment with another fluoropyrimidine due to hand-foot syndrome or cardiovascular toxicity that developed in the adjuvant or metastatic setting.
Revision: 21
Authorised
2011-03-14
62 B. PACKAGE LEAFLET 63 PACKAGE LEAFLET: INFORMATION FOR THE USER TEYSUNO 15 MG/4.35 MG/11.8 MG HARD CAPSULES tegafur/gimeracil/oteracil 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If you get any side effects, talk to your doctor. This includes any possible any side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What Teysuno is and what it is used for 2. What you need to know before you take Teysuno 3. How to take Teysuno 4. Possible side effects 5. How to store Teysuno 6. Contents of the pack and other information 1. WHAT IS TEYSUNO AND WHAT IS IT USED FOR Teysuno contains the active substances tegafur gimeracil and oteracil. Teysuno belongs to the fluoropyrimidine class of medicines known as “antineoplastic agents” which stop the growth of cancer cells. Teysuno is prescribed by doctors for: - The treatment of adults with advanced stomach (gastric) cancer and is taken with cisplatin, another anti-cancer medicine. - The treatment of cancer of the large intestines and rectum which has spread (metastasized) and where it is not possible to continue with another fluoropyrimidine (anti-cancer treatments from the same group of medicines as Teysuno) due to side effects on the skin of hands or feet (hand-foot syndrome) or on the heart. In these patients, Teysuno is used alone or in combination with other anticancer medicines. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TEYSUNO DO NOT TAKE TEYSUNO IF YOU: - are allergic to tegafur, gimeracil, oteracil or any of the other ingredients of this medicine (listed in section 6). - are taking other fluoropyrimidine anti-cancer medicine such as fluorouracil and capecitabine, or have had severe and unexpected reac Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Teysuno 15 mg/4.35 mg/11.8 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 15 mg tegafur, 4.35 mg gimeracil and 11.8 mg oteracil (as monopotassium). Excipient with known effect Each hard capsule contains 70.2 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule (capsule). The capsule has an opaque white body and opaque brown cap imprinted “TC448” in grey. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Teysuno is indicated in adults: - for the treatment of advanced gastric cancer when given in combination with cisplatin (see section 5.1). - as monotherapy or in combination with oxaliplatin or irinotecan, with or without bevacizumab, for the treatment of patients with metastatic colorectal cancer for whom it is not possible to continue treatment with another fluoropyrimidine due to hand-foot syndrome or cardiovascular toxicity that developed in the adjuvant or metastatic setting. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Teysuno should only be prescribed by a qualified physician experienced in treating cancer patients with anti-neoplastic medicinal products. Patients should be provided with outpatient prescriptions for anti-emetic and anti-diarrhoeal medicinal products. The patient's BSA must be recalculated and the Teysuno dose adjusted accordingly if a patient’s weight increases or decreases by ≥10% from the one used for the previous calculation of BSA and the change is clearly not related to fluid retention. Posology _Advanced gastric cancer when given in combination with cisplatin _ The recommended standard dose of Teysuno when administered in combination with cisplatin is 25 mg/m 2 (expressed as tegafur content) twice daily, morning and evening, for 21 consecutive days followed by 7 days rest (1 treatment cycle). This treatment cycle is repeated every 4 weeks. The standard and reduced Teysuno and cisplatin doses and calcula Прочетете целия документ