Dacarbazine medac powder for solution for injection or infusion

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

dacarbazine (dacarbazine citrate)

Available from:

Medac GmbH

ATC code:

L01AX04

INN (International Name):

dacarbazine (dacarbazine citrate)

Dosage:

200mg

Pharmaceutical form:

powder for solution for injection or infusion

Units in package:

(10) glass vial

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2019-09-06

Patient Information leaflet

Dacarbazine medac 200 mg · 80120-VPIL · FA · 01.17 · Pharma-Code:
1389
Format: 592 x 150 mm · HKS 44 · Corrective action: KV01_osc_25.10.16
/ KV02_uma_17.01.17 / KV03_uma_17.01.17
Package leaflet: Information for the patient
Dacarbazine medac 200 mg
powder for solution for injection/infusion
Dacarbazine
Read all of this leaflet carefully before you start
using this medicine because it contains important
information for you.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or
pharmacist.
•
If you get any side effects talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.
What is in this leaflet
1. What Dacarbazine medac is and what it is used for
2. What you need to know before you are given
Dacarbazine medac
3. How to use Dacarbazine medac
4. Possible side effects
5. How to store Dacarbazine medac
6. Contents of the pack and other 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 lymphatic tissue),
•
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. What you need to know before you are given
Dacarbazine medac
You will not be given Dacarbazine medac
•
if you are allergic to dacarbazine or any of the other
ingredients of this medicine (listed in section 6),
•
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 or breastfeeding.
Warnings and precautions
Talk to your doctor or pharmacist before y

Summary of Product characteristics

spc (IE) Dacarbazine medac 200 mg/500 mg/1000 mg, Powder for solution
for (injection/) infusion
National version: 01/2017
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Dacarbazine medac 200 mg, powder for solution for injection/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 200 mg contains 200 mg
dacarbazine (as dacarbazine
citrate, formed in situ). After reconstitution Dacarbazine medac 200
mg contains 10 mg/ml
dacarbazine.
Each single-dose vial of Dacarbazine medac 500 mg contains 500 mg
dacarbazine (as dacarbazine citrate,
formed in situ). After reconstitution and final dilution Dacarbazine
medac 500 mg contains
1.4 – 2.0 mg/ml dacarbazine.
Each single-dose vial of Dacarbazine medac 1000 mg contains 1000 mg
dacarbazine (as dacarbazine
citrate, formed in situ). After reconstitution and final dilution
Dacarbazine medac 1000 mg contains 2.8 -
4.0 mg/ml dacarbazine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Dacarbazine medac 200 mg: Powder for solution for injection/infusion.
Dacarbazine medac 500 mg (1000 mg): Powder for solution for infusion.
Dacarbazine medac is a white or pale yellow powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Dacarbazine
is indicated for the treatment of patients with metastasised 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
_ _
Posology
The use of dacarbazine should be confined to physicians experienced in
oncology or haematology.
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 when administering the injecti