Country: Armenia
Language: English
Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
epirubicin (epirubicin hydrochloride)
Actavis Italy S.p.A.
L01DB03
epirubicin (epirubicin hydrochloride)
10mg
powder lyophilized for solution for infusion
glass vial and solvent in ampoule 5ml
Prescription
Registered
2019-12-24
1 _ _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT FARMORUBICIN ® rapid dissolution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ _Each vial _contains_: _ _ _ _Active ingredient_: epirubicin hydrochloride — 10 mg or 50 mg (equivalent to 9.36 or 46.8 mg of epirubicin, respectively); For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lyophilisate for solution for intravenous and intravesical administration. _Lyophilisate: _red lyophilized powder or cake. _Diluent: _clear, colourless liquid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Transitional cell carcinoma of the bladder, breast cancer (including early stage cancer and metastatic/advanced cancer), stomach and oesophageal cancer, cancer of the head and neck, primary hepatocellular cancer, acute leukaemia, non-small cell and small cell lung cancer, non-Hodgkin's lymphoma, Hodgkin's lymphoma, multiple myeloma, ovarian cancer, pancreatic cancer, cancer of the rectum, soft tissue and bone sarcoma. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Intravenous, intravesical or intraarterial administration. It is recommended that the reconstituted solution of the medicinal product be immediately used after preparation. The safety and efficacy of administration of epirubicin in children has not been established. Intravenous administration The recommended standard dose as monotherapy per cycle for adults is 60–120 mg/m 2 . During administration of Farmorubicin ® rapid dissolution as a component of adjuvant treatment in breast cancer patients with axillary lymph nodes involvement, the recommended starting dose is 100–120 mg/m 2 . During administration of combined treatment, a starting high dose (up to 120 mg/m 2 ) should be administered on the first day every 3–4 weeks. The total dose of the medicinal product per cycle (every 3–4 weeks) may also be administered as a single dose or it may be divided for multiple administration over 2–3 days in a row. If Farmorubicin ® rapid dissolution is administered Read the complete document