Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
irinotecan anhydrous free-base
Les Laboratoires Servier
L01CE02
irinotecan hydrochloride trihydrate
Antineoplastic agents
Pancreatic Neoplasms
Treatment of metastatic adenocarcinoma of the pancreas, in combination with 5 fluorouracil (5 FU) and leucovorin (LV), in adult patients who have progressed following gemcitabine based therapy.
Revision: 11
Authorised
2016-10-14
30 B. PACKAGE LEAFLET 31 PACKAGE LEAFLET: INFORMATION FOR THE USER ONIVYDE PEGYLATED LIPOSOMAL 4.3 MG/ML CONCENTRATE FOR DISPERSION FOR INFUSION irinotecan READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 nurse. - If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What ONIVYDE pegylated liposomal is and what it is used for 2. What you need to know before you use ONIVYDE pegylated liposomal 3. How ONIVYDE pegylated liposomal is used 4. Possible side effects 5. How to store ONIVYDE pegylated liposomal 6. Contents of the pack and other information 1. WHAT ONIVYDE PEGYLATED LIPOSOMAL IS AND WHAT IT IS USED FOR WHAT ONIVYDE PEGYLATED LIPOSOMAL IS AND HOW IT WORKS ONIVYDE pegylated liposomal is a cancer medicine that contains the active substance irinotecan. This active substance is held in tiny lipid (fatty) particles called liposomes. Irinotecan belongs to a group of cancer medicines called ‘topoisomerase inhibitors’. It blocks an enzyme called topoisomerase I, which is involved in the division of cell DNA. This prevents the cancer cells from multiplying and growing, and they eventually die. The liposomes are expected to accumulate within the tumour and release the medicine slowly over time, thereby allowing it to act for longer. WHAT ONIVYDE PEGYLATED LIPOSOMAL IS USED FOR ONIVYDE pegylated liposomal is used to treat adult patients with metastatic pancreatic cancer (cancer of the pancreas that has already spread elsewhere in the body) whose previously cancer treatment included a medicine called gemcitabine. ONIVYDE pegylated liposomal is used in combination with other cancer medicines, called 5-fluorouracil and leucovorin. If you have any questions about how ONIVYDE pegylated liposomal works or why this medicine has b Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT ONIVYDE pegylated liposomal 4.3 mg/ml concentrate for dispersion for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One 10 ml vial of concentrate contains 43 mg irinotecan anhydrous free base (as irinotecan sucrosofate salt in a pegylated liposomal formulation). One ml of concentrate contains 4.3 mg irinotecan anhydrous free base (as irinotecan sucrosofate salt in a pegylated liposomal formulation). Excipient with known effect One ml of concentrate contains 0.144 mmol (3.31 mg) sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for dispersion for infusion. White to slightly yellow opaque isotonic liposomal dispersion. The concentrate has a pH of 7.2 and an osmolality of 295 mOsm/kg. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of metastatic adenocarcinoma of the pancreas, in combination with 5-fluorouracil (5-FU) and leucovorin (LV), in adult patients who have progressed following gemcitabine based therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ONIVYDE pegylated liposomal must only be prescribed and administered to patients by healthcare professionals experienced in the use of anti-cancer therapies. ONIVYDE pegylated liposomal is not equivalent to non-liposomal irinotecan formulations and should not be interchanged. Posology ONIVYDE pegylated liposomal, leucovorin and 5-fluorouracil should be administered sequentially. The recommended dose and regimen of ONIVYDE pegylated liposomal is 70 mg/m 2 intravenously over 90 minutes, followed by LV 400 mg/m 2 intravenously over 30 minutes, followed by 5-FU 2,400 mg/m 2 intravenously over 46 hours, administered every 2 weeks. ONIVYDE pegylated liposomal should not be administered as a single agent. A reduced starting dose of ONIVYDE pegylated liposomal of 50 mg/m 2 should be considered for patients known to be homozygous for the UGT1A1*28 allele (see sections 4.8 and 5.1). A dose increase of ONIVYDE pegylated liposomal to 70 m Прочетете целия документ