Maa: Israel
Kieli: englanti
Lähde: Ministry of Health
TIPIRACIL AS HYDROCHLORIDE; TRIFLURIDINE
MEDISON PHARMA LTD
L01BC59
FILM COATED TABLETS
TIPIRACIL AS HYDROCHLORIDE 8.19 MG; TRIFLURIDINE 20 MG
PER OS
Required
ANDERSONBRECON (UK) LTD
TRIFLURIDINE, COMBINATIONS
Colorectal cancerLonsurf is indicated as monotherapy for the treatment of adult patients with metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents.Gastric cancerLonsurf is indicated as monotherapy for the treatment of adult patients with metastatic gastric cancer including adenocarcinoma of the gastroesophageal junction, who have been previously treated with at least two prior systemic treatment regimens for advanced disease.
2020-03-10
LONS-PIL-0121 -V2 Page 1 of 9 Lonsurf_PIL_ENG-D18-F Patient leaflet in accordance with the Pharmacists' Regulations (Preparations) - 1986 This medicine is dispensed with a doctor’s prescription only Lonsurf 15 mg / 6.14 mg Lonsurf 20 mg / 8.19 mg Film-coated tablets Name and quantity of active ingredients: Lonsurf 15 mg / 6.14 mg Each film-coated tablet contains: trifluridine 15 mg tipiracil (as hydrochloride) 6.14 mg Lonsurf 20 mg / 8.19 mg Each film-coated tablet contains: trifluridine 20 mg tipiracil (as hydrochloride) 8.19 mg Inactive ingredients and allergens in this medicine: see section 6 ‘Additional information’. See also ‘Important information about some of this medicine’s ingredients’ in section 2. Read the entire leaflet carefully before you start using this medicine. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar to yours. 1. What is this medicine intended for? Lonsurf is intended as monotherapy for the treatment of adult patients with: metastatic colon or rectal cancer (colorectal cancer (CRC)) who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF (vascular endothelial growth factor) agents, and anti-EGFR (epidermal growth factor receptor) agents metastatic stomach cancer, including cancer of the junction between the oesophagus and the stomach, who have been previously treated with at least two prior systemic treatment regimens for advanced disease Therapeutic group: anticancer, antimetabolites. Lonsurf contains 2 different active ingredients: Trifluridine and Tipiracil. Trifluridine stops the growth of cancer cells. Tipiracil stops the trifluridine from being broken down by the body, helping trifluridin Lue koko asiakirja
LONS-SPC-0121-V1 Page 1 of 21 PHYSICIAN’S PRESCRIBING INFORMATION 1. NAME OF THE MEDICINAL PRODUCT Lonsurf 15 mg/ 6.14 mg Lonsurf 20 mg/ 8.19 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Lonsurf 15 mg/ 6.14 mg: Each film-coated tablet contains 15 mg trifluridine and 6.14 mg tipiracil (as hydrochloride). _Excipient with known effect _ Each film-coated tablet contains 90.735 mg of lactose monohydrate. Lonsurf 20 mg/ 8.19 mg: Each film-coated tablet contains 20 mg trifluridine and 8.19 mg tipiracil (as hydrochloride). _Excipient with known effect _ Each film-coated tablet contains 120.980 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Lonsurf 15 mg/ 6.14 mg The tablet is a white, biconvex, round, film-coated tablet, with a diameter of 7.1 mm and a thickness of 2.7 mm, imprinted with ‘15’ on one side, and ‘102’ and ’15 mg’ on the other side, in grey ink. Lonsurf 20 mg/ 8.19 mg The tablet is a pale red, biconvex, round, film-coated tablet, with a diameter of 7.6 mm and a thickness of 3.2 mm, imprinted with ‘20’ on one side, and ‘102’ and ‘20 mg’ on the other side, in grey ink. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Colorectal cancer Lonsurf is indicated as monotherapy for the treatment of adult patients with metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents. Gastric cancer Lonsurf is indicated as monotherapy for the treatment of adult patients with metastatic gastric cancer including adenocarcinoma of the gastroesophageal junction, who have been previously treated with at least two prior systemic treatment regimens for advanced disease (see section 5.1). LONS-SPC-0121-V1 Page 2 of 21 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Lonsurf should be prescribed by physicians experienced in the administration Lue koko asiakirja