DOXORUBICIN EBEWE 2 MGML

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

DOXORUBICIN HYDROCHLORIDE

Available from:

NOVARTIS ISRAEL LTD

ATC code:

L01DB01

Pharmaceutical form:

SOLUTION FOR INJECTION/ CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

DOXORUBICIN HYDROCHLORIDE 2 MG/ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

EBEWE PHARMA GES.M.B.H NFG.KG, AUSTRIA

Therapeutic group:

DOXORUBICIN

Therapeutic area:

DOXORUBICIN

Therapeutic indications:

Soft tissue and bone sarcomas, Hodgkin's and non-Hodgkin's lymphoma, acute lymphoblastic leukemia, acute myeloblastic leukemia, Wilms` tumor, carcinomas of the thyroid, breast, ovary, bladder, small cell bronchogenic carcinoma and neuroblastoma.

Authorization date:

2014-04-30

Summary of Product characteristics

PRESCRIBING INFORMATION
DOXORUBICIN “EBEWE”
2 mg/ml concentrate for solution for infusion
COMPOSITION
1 vial of 5 ml contains:
10 mg Doxorubicin HCl
1 vial of 25 ml contains:
50 mg Doxorubicin HCl
1 vial of 100 ml contains: 200 mg Doxorubicin HCl
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Doxorubicin is used for the following indications: soft tissue and
bone sarcomas, Hodgkin's and non-Hodgkin's lymphoma, acute
lymphoblastic leukaemia, acute myeloblastic leukaemia, Wilm's
tumor, carcinomas of the thyroid, breast, ovary, bladder, small-cell
bronchogenic carcinoma and neuroblastoma.
PHARMACOTHERAPEUTIC GROUP
Anthracyclines and related substances
ATC Code: L01DB
DOSAGE AND METHOD OF ADMINISTRATION
Doxorubicin may be given by intravenous (bolus) injection over 2-5
minutes or as continuous infusion into a running infusion of sodium
chloride 0.9% w/v intravenous injection, dextrose intravenous
injection
5% w/v or sodium chloride and dextrose intravenous injection.
Bolus injection causes higher peak plasma concentrations and therefore
is probably more cardiotoxic.
_ADULT DOSAGE_
Dosage depends on tumour type, cardiac or hepatic function, and
concurrent chemotherapy.
THE RECOMMENDED DOSE AS SINGLE AGENT
The commonly recommended dosage schedule as single agent is
60-75 mg/m
2
by intravenous injection, once every three weeks.
An alternative dose schedule is 20 mg/m
2
intravenously, for three
consecutive days, once every three weeks.
_The maximum cumulative dose_: 550 mg/m
2
should not be
exceeded.
Administration of doxorubicin in a weekly regimen has been shown to
be as effective as the 3-weekly regimen whilst reducing cardiac
toxicity.
The recommended dosage is 20 mg/m
2
weekly, although objective
responses have been seen with doses between 6 and 12 mg/m
2
.
COMBINATION THERAPY
Dosage should be decreased when combination with other cytostatic
drugs with any similar toxicity is used.
_The maximum cumulative dose_: If a patient received mediastinal
irradiation, has concomitant heart disease, or is also treated with
o