국가: 아르메니아
언어: 영어
출처: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
epirubicin (epirubicin hydrochloride)
Corden Pharma Latina S.p.A
L01DB03
epirubicin (epirubicin hydrochloride)
10mg
powder lyophilized for solution for infusion
glass vial
Prescription
Registered
2023-04-08
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. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Farmorubicin has been found to be capable of inducing useful responses in a wide spectrum of neoplastic diseases including carcinoma of the breast; malignant lymphomas; sarcomas of the soft tissues; gastric carcinoma; carcinoma of the liver, pancreas, sigmoid rectum; carcinoma of the cervical-facial area; carcinoma of the lung; carcinoma of the ovary; leukaemia. By intravesical instillation, Farmorubicin is indicated in the treatment of surface carcinomas of the bladder (transitional cell carcinoma, carcinoma in situ) and as prophylaxis against recurrence after transurethral resection. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY INTRAVENOUS ADMINISTRATION Dosage plan for standard doses When Farmorubicin is used as the sole antiblastic agent, the recommended dose for adults is 60-90 mg/m² of body surface area, to be administered by intravenous injection over 5-10 minutes at intervals of 21 days, compatibly with blood/bone marrow conditions. Dosage plan for high doses • CARCINOMA OF THE LUNG When used as a single agent at high doses in the treatment of pulmonary carcinoma, Farmorubicin should be administered according to the following regimens: 3 - small cell lung cancer in previously untreated patients: 120 mg/m² on day 1, every three weeks. - non small cell lung cancer (epidermoid, squamous and adenocarcinoma) in previously untreated patients: 135 mg/m² on day 1 or 45 mg/m² on Days 1,2,3, every three weeks. • CARCINOMA OF THE BREAST Doses of 전체 문서 읽기