Země: Indonésie
Jazyk: indonéština
Zdroj: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DUS, 1 VIAL @ 10 ML @ 43 MG
2022-06-10
1 SUMMARY OF PRODUCT CHARACTERISTICS DISETUJUI OLEH BPOM: 11/01/2022 EREG10023812000068 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 ONIVYDE (irinotecan liposome for injection) is indicated for the 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. DO NOT SUBSTITUTE ONIVYDE for or with other drug products containing irinotecan. (See Warnings and Precautions, General, Other Formulations of lrinotecan). ONIVYDE is not indicated as a single agent for the treatment of patients with metastatic adenocarcinoma of the pancreas. ONIVYDE should be administered only under the supervision of a physician who is experienced in the use of cancer chemotherapeutic agents. ONIVYDE should not be used in patients who have already received Irinotecan. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ONIVYDE pegylated liposomal (irinotecan) must only be prescribed and administered to patients by healthcare professionals experienced in the use of anti-cancer therapies. ONIVYDE pegylated liposomal (irinotecan) is not equivalent to non-liposomal irinotecan formulations and should not be interchanged. Posology ONIVYDE pegylated liposomal, Přečtěte si celý dokument