DOXORUBICIN TEVA

Država: Izrael

Jezik: engleski

Izvor: Ministry of Health

Aktivni sastojci:

DOXORUBICIN HYDROCHLORIDE

Dostupno od:

ABIC MARKETING LTD, ISRAEL

ATC koda:

L01DB01

Farmaceutski oblik:

CONCENTRATE FOR SOLUTION FOR INFUSION

Sastav:

DOXORUBICIN HYDROCHLORIDE 2 MG/ML

Administracija rute:

I.V

Tip recepta:

Required

Proizveden od:

PHARMACHEMIE B.V., THE NETHERLANDS

Terapijska grupa:

DOXORUBICIN

Područje terapije:

DOXORUBICIN

Terapijske indikacije:

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.

Datum autorizacije:

2023-10-31

Svojstava lijeka

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