देश: आर्मेनिया
भाषा: अंग्रेज़ी
स्रोत: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
doxorubicin (doxorubicin hydrochloride)
EBEWE Pharma Ges. m.b.H. Nfg. KG
L01DB01
doxorubicin (doxorubicin hydrochloride)
2mg/ml
concentrate for solution for infusion
glass vial 25ml
Prescription
Registered
2019-06-05
Doxorubicin Ebewe®- Concentrate for Solution for Infusion CIS - Prescribing Information (Package Leaflet) Doxorubicin Ebewe_SmPC.doc Page 1 of 18 PRESCRIBING INFORMATION 1. NAME OF THE MEDICINAL PRODUCT Doxorubicin Ebewe® concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial with 5 ml solution contains 10 mg of doxorubicin hydrochloride (2 mg/ml). One vial with 25 ml solution contains 50 mg of doxorubicin hydrochloride (2 mg/ml). Other excipients with known effect: 1 ml contains 9 mg of sodium chloride. For a complete list of excipients, see Section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion Clear red solution 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Therapeutic indications foradults, adolescents and children: breast cancer neoadjuvant and adjuvant therapy of osteosarcoma advanced soft tissue sarcoma in adults small cell lung cancer (SCLC) Hodgkin’s lymphoma. highly malignant non-Hodgkin’s lymphoma Induction and consolidation therapy in acute lymphatic leukaemia acute myeloblastic leukaemia advanced multiple myeloma advanced or recurrent papillary endometrial carcinoma advanced or recurrent papillary/follicular thyroid carcinoma anaplastic thyroid carcinoma systemic treatment of local advanced or metastasised bladder carcinoma intravesical prophylaxis of recurrences of surface bladder carcinoma after transurethral resection recurring ovarian cancer Wilms’ tumour advanced neuroblastoma Ewing’s sarcoma Doxorubicin is often used in combined chemotherapy dosing regimens with other cytostatic agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION: For intravenous and intravesical administration only. The ampoule should be heated to room temperature before puncturing it with a needle. Doxorubicin must only be administered under the supervision of a qualified physician experienced in treatment with cytostatic agents. Furthermore, the patient must be carefully and frequently पूरा दस्तावेज़ पढ़ें