Negara: Israel
Bahasa: Inggris
Sumber: Ministry of Health
ETOPOSIDE
ABIC MARKETING LTD, ISRAEL
L01CB01
CONCENTRATE FOR SOLUTION FOR INFUSION
ETOPOSIDE 20 MG/ML
I.V
Required
PHARMACHEMIE B.V., (TEVA GROUP) ,THE NETHERLANDS
ETOPOSIDE
ETOPOSIDE
Hodgkin's disease. Malignant (non-Hodgkin's) Lymphomas, especially of the Histiocytic variety.Acute Non-Lymphocytic leukemia. Management of refractory testicular tumors and of small cell lung cancer.
2014-12-31
העדוה העדוה לע לע הרמחה הרמחה ( ( עדימ עדימ ןולעב )תוחיטב ןולעב )תוחיטב ל ל אפור אפור ןכדועמ( ןכדועמ( 05.2013 05.2013 ) ) ךיראת _______ OCTOBER 21, 2014 __ םש רישכת תילגנאב רפסמו םושירה ETOPOSIDE CONCENTRATE FOR SOLUTION FOR INFUSION 106 48 28897 05 םש לעב םושירה SALOMON, LEVIN, & ELSTEIN LTD.; POBOX 3696, PETACH TIKVA 49133 ספוט הז דעוימ טורפל תורמחהה דבלב ! תורמחהה תושקובמה קרפ ןולעב טסקט יחכונ טסקט שדח INDICATION CONTRAINDICATIONS Severe myelosuppression, unless when this is caused by the underlying disease. Liver impairment. Hypersensitivity to etoposide or one of the other constituents. Breastfeeding Patients with severe renal impairment (creatinine clearance < 15 ml/min) Severe myelosuppression, unless when this is caused by the underlying disease. Severe hepatic Liver impairment. Hypersensitivity to etoposide or one of the other constituents. Breastfeeding (see section 4.6) Concomitant use of yellow fever vaccine or other live vaccines is contraindicated in immunosuppressed patients (see section "Interaction with other medicinal products and other forms of interaction") Patients with severe renal impairment (creatinine clearance < 15 ml/min) POSOLOGY, DOSAGE & ADMINISTRATION ETOPOSIDE SHOULD NOT BE ADMINISTERED BY RAPID INTRAVENOUS INJECTION. Hypotension following rapid intravenous administration of etoposide has been reported. Therefore, it is recommended that the etoposide injection be administered by slow i. v. infusion over a 30 to 60- minute period or longer if it is not tolerated. Generally 3 or 4 treatment cycles are carried out. Dosage of etoposide should be modified to take into account the myelosuppressive effects of other drugs in the combination or the effects of prior X-ray therapy or chemotherapy which may have compromised bone marrow reserve. Etoposide is administered by slow intravenous infusion. ETOPOSIDE SHOU Baca dokumen lengkapnya
Etoposide Teva NA Notification 06/23 SUMMARY OF PRODUCT CHARACTERISTICS Etoposide Teva Concentrate for solution for infusion For I.V. Infusion 1. NAME OF THE MEDICINAL PRODUCT Etoposide Teva 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of Etoposide Teva concentrate for solution for infusion contains 20 mg etoposide. 1 vial with 5 ml concentrate for solution for infusion contains 100 mg etoposide. 1 vial with 10 ml concentrate for solution for infusion contains 200 mg etoposide. 1 vial with 50 ml concentrate for solution for infusion contains 1000 mg etoposide. Excipient with known effect: Each 5 ml vial contains up to 1.2 g of alcohol. Each 10 ml vial contains up to 2.4 g of alcohol. Each 50 ml vial contains up to 12 g of alcohol. Each ml of concentrate for solution contains 241 mg ethanol absolute. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion. Clear, yellowish, slightly viscous solution, essentially free from visible particles. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications - Hodgkin’s disease - Malignant (non-Hodgkin’s) lymphomas, especially of the histiocytic variety - Acute non-lymphocytic leukemia - Management of refractory testicular tumours and of small cell lung cancer. 4.2 Posology and method of administration _Etoposide must not be given by intra-cavity injection_. _Dose adjustments _ Dosage of etoposide should be modified to take into account the myelosuppressive effects of other drugs in the combination or the effects of prior X-ray therapy or chemotherapy which may have compromised bone marrow reserve. Etoposide is administered by slow intravenous infusion. ETOPOSIDE SHOULD NOT BE ADMINISTERED BY RAPID INTRAVENOUS INJECTION. Hypotension following rapid intravenous administration of etoposide has been reported. Therefore, it is recommended that the etoposide injection be administered by slow I.V. infusion over a 30 to 60-minute period. Longer infusion times may be required based on patient tolerance. As with other potent Baca dokumen lengkapnya