Dacarbazine Lipomed 500 mg powder for solution for infusion
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
28-09-2022
Summary of Product characteristics
(SPC)
11-08-2022
Active ingredient:
Dacarbazine
Available from:
Lipomed GmbH
ATC code:
L01AX; L01AX04
INN (International Name):
Dacarbazine
Dosage:
500 milligram(s)
Pharmaceutical form:
Powder for solution for infusion
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Other alkylating agents; dacarbazine
Authorization status:
Marketed
Authorization date:
2017-08-18
Patient Information leaflet
1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
DACARBAZINE LIPOMED 500 MG POWDER FOR SOLUTION FOR INFUSION
Dacarbazine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START RECEIVING 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 Lipomed is and what it is used for
2.
What you need to know before you receive Dacarbazine Lipomed
3.
How to use Dacarbazine Lipomed
4.
Possible side effects
5.
How to store Dacarbazine Lipomed
6.
Contents of the pack and other information
1.
WHAT DACARBAZINE LIPOMED 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 Lipomed has been prescribed by your doctor for the
treatment of cancer, such as
advanced malignant melanoma (skin cancer), advanced Hodgkin’s
disease (cancer of the lymph tissue)
or advanced adult soft tissue sarcoma (cancer of muscles, fat, fibrous
tissue, blood vessels or other
supporting tissue of the body). Dacarbazine Lipomed can be given in
combination with other
cytostatic agents.
2.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE DACARBAZINE LIPOMED
YOU MUST NOT RECEIVE DACARBAZINE LIPOMED:
•
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 breast-feeding,
•
in combination with yellow fever vaccine.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before you are given Dacarbazine
Lipomed.
Before each administration you will have blood tests to check that
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
09 August 2022
CRN00CZCV
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dacarbazine Lipomed 500 mg powder for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single-dose vial of Dacarbazine Lipomed 500 mg contains 500 mg
dacarbazine (as dacarbazine citrate, formed _in situ_).
After reconstitution of Dacarbazine Lipomed 500 mg with 50 ml of water
for injections, 1 ml of solution contains 10 mg
dacarbazine (see section 6.6).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for infusion.
White lyophilized powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Dacarbazine Lipomed 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
Treatment with Dacarbazine Lipomed should only be carried out by
physicians experienced in oncology or haematology
respectively.
During treatment with Dacarbazine Lipomed, frequent monitoring of
blood counts as well as monitoring of hepatic and renal
function are required. Since severe gastrointestinal reactions
frequently occur, anti-emetic and supportive measures are
advisable.
Because severe gastrointestinal and haematological disturbances can
occur, an extremely careful benefit-risk analysis has to be
made before every course of therapy with dacarbazine.
Food intake prior to administration of Dacarbazine Lipomed should be
avoided to reduce the severity of nausea and vomiting.
Excreta and vomit should be handled with care.
Posology
The following regimes can 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/m
2
body surface area/day intravenously for 5 days
every 3 weeks.
Dacarbazine can
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