DOXORUBICIN-EBEWE 2MG/ML SOLUTION FOR INFUSION, CONCENTRATE FOR

Země: Kypr

Jazyk: řečtina

Zdroj: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Aktivní složka:

ΔΟΞΟΡΟΥΒΙΚΊΝΗ

Dostupné s:

T.C.CHRISTOFOROU LTD

ATC kód:

L01DB01

INN (Mezinárodní Name):

DOXORUBICIN

Dávkování:

2MG/ML

Léková forma:

SOLUTION FOR INFUSION, CONCENTRATE FOR

Složení:

0023214928 - DOXORUBICIN - 2 MG

Druh předpisu:

Με Ιατρική Συνταγή

Terapeutické oblasti:

DOXORUBICIN

Přehled produktů:

01 - 5x5ML - 5 - MILLILITRE - 940018401 - Εγκεκριμένο; - 02 - 1 VIAL X 50MG/25ML - 1 - VIAL - 940018402 - Εγκεκριμένο; - 03 - 1 VIAL X 100MG/50ML - 1 - VIAL - 940018403 - Εγκεκριμένο; - 04 - 1 VIAL X 200MG/100ML - 1 - VIAL - 940018404 - Εγκεκριμένο

Informace pro uživatele

PACKAGE LEAFLET
DOXORUBICIN "EBEWE" 2MGLML- CONCENTRATE FOR SOLUTION FOR INFUSION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.

Keep this leaflet. You may need to read it again.

If you have further questions, please ask your doctor or your
pharmacist.

This medicine has been prescribed for you personally and you should
not pass it on to
others. It may harm them, even if their symptoms are the same as
yours.
IN THIS LEAFLET:
1.
What Doxorubicin is and what it is used for
2.
Before you take Doxorubicin
3.
How to take use Doxorubicin
4.
Possible side effects
5.
Storing Doxorubicin
6.
Further information
The vials contain either

10 mg doxorubicin hydrochloride in 5 ml sodium chloride solution

50 mg doxorubicin hydrochloride in 25 ml sodium chloride solution.

100 mg doxorubicin hydrochloride in 50ml sodium chloride solution.

200mg doxorubicin hydrochloride in 100 ml sodium chloride solution.
The vials also contain hydrochloric acid.

The active substance is doxorubicin hydrochloride

The other ingredients are hydrochloric acid, sodium chloride and water
for injection.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder: T.C. Christoforou Ltd., 7
KJeovoulouPapakyrlacou street,
CHRISEVA Court Flat 11, 6018 Lamaka, Cyprus
Manufacturer: Ebewe Pharma Ges.m.b.H. Nfg. KG, A-4866 Unterach,
Austria
1.
WHAT DOXORUBICIN "EBEWE" IS AND WHAT IT IS USED FOR
Doxorubicin is used to treat a wide range of tumors, and also
leukaemias, which are diseases
of the blood. Your doctor will be able to explain how doxorubicin
might help in your
particular condition.
Doxorubicin is used in the following indications: soft tissue and
osteogenicsarcomas,
Hodgkin's disease and non-Hodgkin's lymphoma, acute lymphoblastic
leukaemia, acute
myeloblasticleukaemia, carcinomas of the thyroid, breast, ovary,
bladder, small cell
bronchogenic carcinoma and neuroblastoma.
Some reports have shown that Doxorubicin may be used intravesically.
Benefits are evident in: multiple

Charakteristika produktu

1.
NAME OF THE MEDICINAL PRODUCT
Doxorubicin "Ebewe" 2 mg/ml concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 2 mg doxorubicinhydrochloride.
Each 5 ml vial contains 10 mg of doxorubicin hydrochloride.
Each 25 ml vial contains 50 mg of doxorubicin hydrochloride
Each 50 ml vial contains 100 mg of doxorubicin hydrochloride
Each 100 ml vial contains 200 mg of doxorubicin hydrochloride
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear, red coloured solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Doxorubicin is used in the following indications: soft tissue and
osteogenic sarcomas, Hodgkin's disease
and non-Hodgkin's lymphoma, acute lymphoblastic leukaemia, acute
myeloblasticleukaemia, carcinomas
of the thyroid, breast, ovary, bladder, small cell bronchogenic
carcinoma and neuroblastoma.
Doxorubicin is used intravesicallyfor the treatment of transitional
cell carcinoma, papillary bladder
tumours and carcinoma in situ. It should not be used for invasive
tumours of the bladder which have
penetrated the bladder wall, patients with urinary tract infections or
inflammatory conditions of the
bladder.
4.2
POSOLOGY 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
Monotherapy
Dosage depends on tumor type, hepatic function, and concurrent
chemotherapy.
The recommended dose as single agent: The commonly recommended
dosageschedule 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 dos