देश: आर्मेनिया
भाषा: अंग्रेज़ी
स्रोत: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
etoposide
EBEWE Pharma Ges. m.b.H. Nfg. KG
L01CB01
etoposide
20mg/ml
concentrate for solution for infusion
glass vial 5ml
Prescription
Registered
2015-05-15
m12 - en-spc-pl-w - 12 1 PRESCRIBING INFORMATION 1. NAME OF THE MEDICINAL PRODUCT Etoposid Ebewe ® 20mg/ml Concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION International nonproprietary name: etoposide 1 ml of concentrate contains 20 mg of etoposide. Excipient(s) with known effect: 1 ml of concentrate contains 260.60 mg of Ethanol and 20 mg of Benzyl alcohol. For the full list of excipients see section 6.1 3. PHARMACEUTICAL FORM Concentrate for solution for infusion. Clear light yellow solution. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS TESTICULAR CANCER - is indicated in combination with other approved chemotherapeutic agents for the first-line treatment of recurrent or refractory testicular cancer in adults. SMALL CELL LUNG CANCER - is indicated in combination with other approved chemotherapeutic agents for the treatment of small-cell lung cancer in adults. HODGKIN’S LYMPHOMA - is indicated in combination with other approved chemotherapeutic agents for the treatment of Hodgkin's lymphoma in adult and paediatric patients. NON-HODGKIN’S LYMPHOMA - is indicated in combination with other approved chemotherapeutic agents for the treatment of non-Hodgkin's lymphoma in adult and paediatric patients. ACUTE MYELOID LEUKAEMIA - is indicated in combination with other approved chemotherapeutic agents for the treatment of acute myeloid leukaemia in adult and paediatric patients. GESTATIONAL TROPHOBLASTIC NEOPLASIA - is indicated for first-line and second-line therapy in combination with other approved chemotherapeutic agents for the treatment of high-risk gestational trophoblastic neoplasia in adults. OVARIAN CANCER m12 - en-spc-pl-w - 12 2 - is indicated in combination with other approved chemotherapeutic agents for the treatment of non-epithelial ovarian cancer in adults. - is indicated for the treatment of platinum-resistant/refractory epithelial ovarian cancer in adults. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Etoposid Ebewe should only be administered and monitored und पूरा दस्तावेज़ पढ़ें