Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
Etoposide
Fresenius Kabi Oncology Plc
L01CB; L01CB01
Etoposide
20 milligram(s)/millilitre
Concentrate for solution for infusion
Product subject to prescription which may not be renewed (A)
Podophyllotoxin derivatives; etoposide
Marketed
2014-05-16
ETOPOSIDE - PACK INSERT - IRELAND+UK (Travesh Sharma) \\fre-kp-fp01\PDD-Artworks\EU\Etoposide\Ireland+UK\2018 SEP\Etoposide - Pack Insert - Ireland+UK.indd Black xxxxxxxx V002 FONT SIZE: TIMES NEW ROMAN 10 PT. DATE: 15 JANUARY 2019 10:20 AM VERSION: 08 FINAL PACKAGING SITE: BORDON MFG. SITE: BADDI-2 DIMENSION: 592 X 300 MM FOLDING SIZE: 60 X 33 MM (OUTLINE OF FOLDING SIZE FOR INDICATION PURPOSE ONLY, IT SHOULD BE REMOVED BEFORE FINAL PRINTING.) Form No.: SOP/PDD/014-02 Rev. 00 THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE PROFESSIONALS ONLY: Cytotoxic agent INSTRUCTIONS ON HOW TO DILUTE, STORE AND DISPOSE OF ETOPOSIDE DILUTION Etoposide 20 mg/ml concentrate for solution for infusion must be diluted immediately prior to use with either 50 mg/ ml (5%) dextrose in water, or 9 mg/ ml (0.9%) sodium chloride solution to give a final concentration of 0.2 mg/ml to 0.4 mg/ml. At higher concentrations precipitation of etoposide may occur. Etoposide is administered by slow intravenous infusion (usually over a 30 to 60 minute period). Etoposide SHOULD NOT BE GIVEN BY RAPID INTRAVENOUS INJECTION. STORAGE OF THE PREPARED SOLUTION After dilution Chemical and physical in-use stability of the solution diluted to a concentration of 0.2 mg/ml or 0.4 mg/ml has been demonstrated up to 24 hours at 15°C to 25°C. From a microbiological point of view, the diluted product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 12 hours at 15°C to 25°C, unless dilution has taken place in controlled and validated aseptic conditions. HANDLING AND DISPOSAL The normal procedures for proper handling and disposal of anti-cancer medicinal products should be adopted: • Staff should be trained to reconstitute the medicinal product. • Pregnant staff should be excluded from working with this medicinal product. • Staff handling this medicinal product during dilution should wear protective clothing including mask, gogg Lesen Sie das vollständige Dokument
Health Products Regulatory Authority 05 July 2019 CRN008HJG Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Etoposide 20 mg/ml concentrate for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml concentrate for solution for infusion contains 20 mg of etoposide. Each 5 ml vial contains 100 mg of etoposide. Each 10 ml vial contains 200 mg of etoposide. Each 25 ml vial contains 500 mg of etoposide. Each 50 ml vial contains 1000 mg of etoposide. Excipients with known effect: Benzyl alcohol 30 mg/ml Ethanol: 241.4 mg/ml For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for solution for infusion. A clear, light yellow to pale yellow solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TESTICULAR CANCER Etoposide is indicated in combination with other approved chemotherapeutic agents for the treatment of first line, recurrent or refractory testicular cancer in adults. SMALL CELL LUNG CANCER Etoposide is indicated in combination with other approved chemotherapeutic agents for the treatment of small-cell lung cancer in adults HODGKIN'S LYMPHOMA Etoposide 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 Etoposide 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 Etoposide is indicated in combination with other approved chemotherapeutic agents for the treatment of acute myeloid leukaemia in adult and paediatric patients. GESTATIONAL TROPHOBLASTIC NEOPLASIA Etoposide 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 Etoposide is indicated in combination with other approved chemotherapeutic agents for the treatment of non-epithelial ovarian Lesen Sie das vollständige Dokument