Dacarbazine medac 200 mg, powder for solution for injection/infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Dacarbazine

Available from:

medac Gesellschaft für klinische Spezialpräparate mbH

ATC code:

L01AX; L01AX04

INN (International Name):

Dacarbazine

Dosage:

200 milligram(s)

Pharmaceutical form:

Powder for solution for injection/infusion

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Other alkylating agents; dacarbazine

Authorization status:

Marketed

Authorization date:

1997-11-14

Patient Information leaflet

pal (IE) Dacarbazine medac 200 mg, Powder for solution for
injection/infusion
National version: 08/2023
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 you are given Dacarbazine
medac.
Before each administration you will have blood

Summary of Product characteristics

Health Products Regulatory Authority
04 March 2024
CRN00DGSC
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dacarbazine medac 200 mg, powder for solution for injection/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.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for injection/infusion.
Dacarbazine medac is a white or pale yellow powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Dacarbazineis 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.
The following regimes may be used. For further details see current
scientific literature.
_Malignant melanoma_
Dacarbazine can be administered as single agent in doses of 200 to 250
mg/m² body surface area/day as an i.v. injection for
5 days every 3 weeks.
As an alternative to an intravenous bolus injection dacarbazine can be
administered as a short-term infusion (over 15 –
30 minutes).
It is also possible to give 850 mg/m² body surface area on day 1 and
then once every 3 weeks as intravenous infusion.
HODGKIN'S DISEASE
Dacarbazine is administered in a daily dose of 375 mg/m² body surface
area i.v. every 15 days in combination with doxorubicin,
bleomycin and vinblastine (ABVD regimen).
_Adult soft-tissue sarcoma_
For adult soft tissue sarcomas dacarbazine is given in daily doses of
250 mg/m² body surface area i.v. (days 1‑5) in
combination with doxorubicin every 3 weeks (ADIC regimen).
During dacarbazine treatment frequent moni