Država: Izrael
Jezik: angleščina
Source: Ministry of Health
DOXORUBICIN HYDROCHLORIDE
ABIC MARKETING LTD, ISRAEL
L01DB01
CONCENTRATE FOR SOLUTION FOR INFUSION
DOXORUBICIN HYDROCHLORIDE 2 MG/ML
I.V
Required
PHARMACHEMIE B.V., THE NETHERLANDS
DOXORUBICIN
DOXORUBICIN
To produce regression in disseminated neoplastic conditions such as: - acute lymphoblastic leukemia, - acute myeloblastic leukemia, - Wilms' tumor neuroblastoma, - soft tissue and bone sarcomas, - breast carcinoma, - lymphomas of both Hodgkin's and non-Hodgkin's types, - bronchogenic carcinoma in which the small cell histologic type is the most responsive compared to other cell types, - gastric carcinoma.
2023-10-31
DOXORUBICIN TEVA MF 12/2023 Notification CLEAN 1 SUMMARY OF PRODUCT CHARACTERISTICS DOXORUBICIN TEVA Concentrate for solution for infusion For I.V. infusion 1. NAME OF THE MEDICINAL PRODUCT Doxorubicin Teva 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of Doxorubicin Teva contains 2 mg doxorubicin hydrochloride. 5 ml of Doxorubicin Teva contains 10 mg doxorubicin hydrochloride. 10 ml of Doxorubicin Teva contains 20 mg doxorubicin hydrochloride. 25 ml of Doxorubicin Teva contains 50 mg doxorubicin hydrochloride. 100 ml of Doxorubicin Teva contains 200 mg doxorubicin hydrochloride. Excipients with known effect Each ml of Doxorubicin Teva contains 3.54 mg sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion. Clear, red solution. pH = 2.7-3.3. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Doxorubicin Teva is indicated for producing regression in disseminated neoplastic conditions such as: acute lymphoblastic leukaemia, acute myeloblastic leukaemia, Wilms` tumour, neuroblastoma, soft tissue and bone sarcomas, breast carcinoma, lymphomas of both Hodgkin’s and non-Hodgkin’s types, bronchogenic carcinoma in which the small cell histologic type is the most responsive compared to other cell types, and gastric carcinoma. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Doxorubicin is frequently used in combination chemotherapy regimens with other cytotoxic drugs. Doxorubicin hydrochloride should be administered only under the supervision of a qualified physician experienced in cytotoxic therapy. Also, patients must be carefully and frequently monitored during the treatment. Due to the risk of an often lethal cardiomyopathy, the risks and benefits to the individual patient should be assessed before each application. Prior to start of the treatment it is recommended to measure the liver function by using conventional tests such as AST, ALT, ALP and bilirubin, as well as measuring renal function (see section 4.4). DOXORUBICIN TEVA MF 12/2023 Notification C Preberite celoten dokument