Страна: Кипър
Език: гръцки
Източник: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας
ΔΟΞΟΡΟΥΒΙΚΊΝΗ
T.C.CHRISTOFOROU LTD
L01DB01
DOXORUBICIN
2MG/ML
SOLUTION FOR INFUSION, CONCENTRATE FOR
0023214928 - DOXORUBICIN - 2 MG
Με Ιατρική Συνταγή
DOXORUBICIN
01 - 5x5ML - 5 - MILLILITRE - 940018401 - Εγκεκριμένο; - 02 - 1 VIAL X 50MG/25ML - 1 - VIAL - 940018402 - Εγκεκριμένο; - 03 - 1 VIAL X 100MG/50ML - 1 - VIAL - 940018403 - Εγκεκριμένο; - 04 - 1 VIAL X 200MG/100ML - 1 - VIAL - 940018404 - Εγκεκριμένο
PACKAGE LEAFLET DOXORUBICIN "EBEWE" 2MGLML- CONCENTRATE FOR SOLUTION FOR INFUSION READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or your pharmacist. This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours. IN THIS LEAFLET: 1. What Doxorubicin is and what it is used for 2. Before you take Doxorubicin 3. How to take use Doxorubicin 4. Possible side effects 5. Storing Doxorubicin 6. Further information The vials contain either 10 mg doxorubicin hydrochloride in 5 ml sodium chloride solution 50 mg doxorubicin hydrochloride in 25 ml sodium chloride solution. 100 mg doxorubicin hydrochloride in 50ml sodium chloride solution. 200mg doxorubicin hydrochloride in 100 ml sodium chloride solution. The vials also contain hydrochloric acid. The active substance is doxorubicin hydrochloride The other ingredients are hydrochloric acid, sodium chloride and water for injection. Marketing Authorisation Holder and Manufacturer: Marketing Authorisation Holder: T.C. Christoforou Ltd., 7 KJeovoulouPapakyrlacou street, CHRISEVA Court Flat 11, 6018 Lamaka, Cyprus Manufacturer: Ebewe Pharma Ges.m.b.H. Nfg. KG, A-4866 Unterach, Austria 1. WHAT DOXORUBICIN "EBEWE" IS AND WHAT IT IS USED FOR Doxorubicin is used to treat a wide range of tumors, and also leukaemias, which are diseases of the blood. Your doctor will be able to explain how doxorubicin might help in your particular condition. Doxorubicin is used in the following indications: soft tissue and osteogenicsarcomas, Hodgkin's disease and non-Hodgkin's lymphoma, acute lymphoblastic leukaemia, acute myeloblasticleukaemia, carcinomas of the thyroid, breast, ovary, bladder, small cell bronchogenic carcinoma and neuroblastoma. Some reports have shown that Doxorubicin may be used intravesically. Benefits are evident in: multiple Прочетете целия документ
1. NAME OF THE MEDICINAL PRODUCT Doxorubicin "Ebewe" 2 mg/ml concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains 2 mg doxorubicinhydrochloride. Each 5 ml vial contains 10 mg of doxorubicin hydrochloride. Each 25 ml vial contains 50 mg of doxorubicin hydrochloride Each 50 ml vial contains 100 mg of doxorubicin hydrochloride Each 100 ml vial contains 200 mg of doxorubicin hydrochloride For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion. Clear, red coloured solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Doxorubicin is used in the following indications: soft tissue and osteogenic sarcomas, Hodgkin's disease and non-Hodgkin's lymphoma, acute lymphoblastic leukaemia, acute myeloblasticleukaemia, carcinomas of the thyroid, breast, ovary, bladder, small cell bronchogenic carcinoma and neuroblastoma. Doxorubicin is used intravesicallyfor the treatment of transitional cell carcinoma, papillary bladder tumours and carcinoma in situ. It should not be used for invasive tumours of the bladder which have penetrated the bladder wall, patients with urinary tract infections or inflammatory conditions of the bladder. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Doxorubicin may be given by • intravenous (bolus) injection over 2-5 minutes or as continuous infusion into a running infusion of sodium chloride 0.9% w/v intravenous injection, dextrose intravenous injection 5% w/v or sodium chloride and dextrose intravenous injection. Bolus injection causes higher peak plasma-concentrations and therefore is probably more cardiotoxic. Adult dosage Monotherapy Dosage depends on tumor type, hepatic function, and concurrent chemotherapy. The recommended dose as single agent: The commonly recommended dosageschedule as single agent is 60-75 mg/m 2 by intravenous injection, once every three weeks. An alternative dose schedule is 20 mg/m 2 intravenously, for three consecutive days, once every three weeks. The maximum cumulative dos Прочетете целия документ