Dacarbazine medac

Riik: Armeenia

keel: inglise

Allikas: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Toimeaine:

dacarbazine

Saadav alates:

Medac GmbH

INN (Rahvusvaheline Nimetus):

dacarbazine

Annus:

100mg

Ravimvorm:

powder lyophilized for solution for injection

Retsepti tüüp:

Prescription

Toote omadused

_________________________________________________________________________________________
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