Dacarbazine medac

Land: Armenien

Sprache: Englisch

Quelle: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Wirkstoff:

dacarbazine

Verfügbar ab:

Medac GmbH

INN (Internationale Bezeichnung):

dacarbazine

Dosierung:

200mg

Darreichungsform:

powder for solution for injection or infusion

Verschreibungstyp:

Prescription

Gebrauchsinformation

pal (common) Dacarbazine medac 100 mg/200 mg, powder for solution for
injection or infusion
1
Version date:03/2015
PACKAGE LEAFLET: INFORMATION FOR THE USER
DACARBAZINE MEDAC 100 MG POWDER FOR SOLUTION FOR INJECTION OR
INFUSION
DACARBAZINE MEDAC 200 MG POWDER FOR SOLUTION FOR INJECTION OR
INFUSION
Dacarbazine (as dacarbazine citrate)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if
their symptoms are the same as yours.
•
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET
:
1.
What DACARBAZINE MEDAC is and what it is used for
2.
Before you are given DACARBAZINE MEDAC
3.
How to use DACARBAZINE MEDAC
4.
Possible side effects
5.
How to store DACARBAZINE MEDAC
6.
Further information
1.
WHAT DACARBAZINE MEDAC IS AND WHAT IT IS USED FOR
Dacarbazine belongs to the group of medicines known as cytostatic
agents. These agents influence the
growth of cancer cells.
DACARBAZINE MEDAC has been prescribed by your doctor for the treatment
of cancer, such as
advanced malignant melanoma (skin cancer), Hodgkin’s disease (cancer
of the lymph tissue) or soft tissue
sarcoma (cancer of muscles, fat, fibrous tissue, blood vessels or
other supporting tissue of the body).
DACARBAZINE MEDAC can be used in combination with other cytostatic
agents.
2.
BEFORE YOU ARE GIVEN DACARBAZINE MEDAC
YOU SHOULD NOT BE GIVEN DACARBAZINE MEDAC
•
if you are
ALLERGIC
(hypersensitive) to dacarbazine or any of the other ingredients of
DACARBAZINE MEDAC (please refer to section 6 for more detailed
information).
•
if the number of white blood cells and/or platelets in your blood is
too low
(LEUKOPENIA
and/or
THROMBOCYTOPENIA)
.
•
if you have a severe
LIVER OR KIDNEY DISEASE
.
•
if you are
PREGNANT O

Fachinformation

_________________________________________________________________________________________
Summary of Product Characteristics (date of revision: 01.03.2015)
1
Dacarbazine medac 100 mg (-200 mg, -500 mg, -1000 mg)
DACARBAZINE
MEDAC 100 MG (-200 MG, -500 MG, -1000 MG)
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Dacarbazine medac 100 mg, Powder for solution for injection or
infusion
Dacarbazine medac 200 mg, Powder for solution for injection or
infusion
Dacarbazine medac 500 mg, Powder for solution for infusion
Dacarbazine medac 1000 mg, Powder for solution for infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single-dose vial of Dacarbazine medac 100 mg (-200 mg, -500 mg,
-1000 mg) contains
100 mg (200 mg, 500 mg, 1000 mg) dacarbazine (as dacarbazine citrate,
formed in situ).
After reconstitution Dacarbazine medac 100 mg (-200 mg) contains 10
mg/ml dacarbazine
(see 6.6. a).
After reconstitution and final dilution Dacarbazine medac 500 mg
(-1000 mg) contains
1.4 – 2.0 mg/ml (2.8 – 4.0 mg/ml) dacarbazine (see 6.6. b).
For excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Dacarbazine medac 100 mg (-200 mg): Powder for solution for injection
or infusion.
Dacarbazine medac 500 mg (-1000 mg): Powder for solution for infusion.
Dacarbazine medac is a white or pale yellow powder.
CLINICAL PARTICULARS
_4.1 THERAPEUTIC INDICATIONS _
Dacarbazine
is indicated for the treatment of patients with metastasized malignant
melanoma.
Further indications for dacarbazine as part of a combination
chemotherapy are:
- advanced Hodgkin’s disease,
- advanced adult soft tissue sarcomas (except mesothelioma, Kaposi
sarcoma).
_4.2 POSOLOGY AND METHOD OF ADMINISTRATION _
_ _
The use of dacarbazine should be confined to physicians experienced in
oncology or hematology
respectively.
Dacarbazine is sensitive to light exposure. All reconstituted
solutions should be suitably protected
from light also during administration (light-resistant infusion set).
Care should be taken of administration of the injection to a