DACARBAZINE MEDAC 200 MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION.

Active substance: DACARBAZINE CITRATE

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Dacarbazine medac 100 mg/200 mg · 80121-VPGB · DA · 05.14 · Pharma-Code: 132
Format: 444 x 150 mm · HKS 44 · Corrective action: KV01_osc_07.05.14

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.

Using DACARBAZINE MEDAC with food and drink
During chemotherapy you should not drink alcohol.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any
medicine.

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 or breast-feeding.
Take special care with DACARBAZINE MEDAC in the
following case:
During treatment with DACARBAZINE MEDAC men are
advised to take contraceptive measures, but also for
6 months after cessation of therapy.
You will have blood tests to check that you have enough
blood cells to receive DACARBAZINE MEDAC before each
administration. Your liver and kidney function will also be
monitored.

DACARBAZINE MEDAC must NOT be administered if you are
pregnant or if you are planning to become pregnant. You must
take adequate contraceptive precautions during therapy.
You must NOT breast-feed while you are treated with
DACARBAZINE MEDAC.
If you are thinking of becoming pregnant or of breast-feeding,
discuss it with your doctor first.
Driving and using machines
Your ability to drive or operate machines may be influenced
because of central nervous side effects (undesired effects on
the brain and nerves) or feeling sick and being sick; but there
is no reason why you cannot drive or use machines between
courses of therapy with DACARBAZINE MEDAC unless you
feel dizzy or unsure of yourself.

• Severe allergic reaction – you may experience a sudden itchy
rash (hives), swelling of the hands, feet, ankles, face, lips,
mouth or throat (which may cause difficulty in swallowing or
breathing), and you may feel you are going to faint
• Yellowing of the skin and eyes because of liver problems
• Signs of brain-related or nerve-related problems, such as
headaches, impaired vision, fits, confusion, lethargy (state of
being apathetic) or numbness and tingling of your face

The dose will depend on your blood counts and concurrent
chemotherapy. Your doctor will calculate your dose taking into
consideration your body surface area (m²), blood counts and
other anticancer medicines or therapies given.

These are all serious side effects. You may need urgent
medical attention.

Your doctor may change the dose and frequency of dosing
depending on your blood test, your general condition, further
therapies and your response to DACARBAZINE MEDAC. If you
have any questions about your treatment, ask your doctor,
nurse or pharmacist.
No special recommendations for the use of DACARBAZINE
MEDAC in children can be given to your doctor until further
data become available.
If you have any further questions on the use of this product,
ask your doctor or pharmacist.

3. HOW TO USE DACARBAZINE MEDAC

Taking other medicines
It is not advisable to use any medical treatment without
telling your doctor as there may be interactions between
DACARBAZINE MEDAC and other medicines.

This medicine will be given to you under the direction of a
physician specialised in oncology (cancer treatment), having
the facilities for regular monitoring of all clinical effects, during
and after your therapy.

Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines
obtained without a prescription.

Dacarbazine is a substance sensitive to light exposure.
The doctor or nurse giving you this medicine will make
sure that dacarbazine will be protected from exposure to
daylight during administration.

During chemotherapy you should avoid medicines that can
cause liver damage (e.g. diazepam, imipramin, ketoconazole
or carbamazepin).

Immediately before use, DACARBAZINE MEDAC 200 MG
powder will be dissolved in 20 ml of water for injection.
DACARBAZINE MEDAC will be given to you by intravenous
injection (injection into a vein).
Alternatively the resulting solution can be further diluted with
200 – 300 ml isotonic sodium chloride or glucose 5 % infusion
solution and will be given to you by intravenous infusion
(infusion into a vein) within 15 – 30 minutes.

Immediately before use, DACARBAZINE MEDAC 100 MG
powder will be dissolved in 10 ml of water for injection.

4. POSSIBLE SIDE EFFECTS
Like all medicines, DACARBAZINE MEDAC can cause side
effects, although not everybody gets them. Your doctor will
discuss these with you and will explain the risks and benefits
of your treatment.
Tell your doctor immediately, if you notice anything of the
following:
• Signs of infection, such as sore throat and high temperature
• Abnormal bruising or bleeding
• Extreme tiredness
• Persistent or severe vomiting or diarrhoea

In the following all undesirable effects are listed that have been
described:
Common side effects (more than 1 in 100 patients, but less
than 1 in 10 patients)
• Anaemia (decreased number of red blood cells)
• Leukopenia (decreased number of white blood cells)
• Thrombocytopenia (decreased number of platelets in the blood)
The changes in blood counts are dose-dependent and
delayed, with the lowest values often only occurring
after 3 to 4 weeks.
• Anorexia (loss of appetite), feeling sick and being sick (all of
which may be severe)
Uncommon side effects (more than 1 in 1,000 patients, but
less than 1 in 100 patients)
• Alopecia (hair loss)
• Hyperpigmentation (increased skin colouring)
• Photosensitivity (sensitivity to light) of the skin
• Flu-like symptoms with exhaustion, chills, fever and
muscular pain, occasionally during or often only days after
dacarbazine administration. These disturbances may recur
with the next infusion.
Rare side effects (more than 1 in 10,000 patients, but less
than 1 in 1,000 patients)
• Pancytopenia (decreased number of all cells in the blood)
• Agranulocytosis (severely decreased number of
granulocytes, a special type of white blood cells)

Dacarbazine medac 100 mg/200 mg · 80121-VPGB · DA · 05.14 · Pharma-Code: 132
Format: 444 x 150 mm · HKS 44 · Corrective action: KV01_osc_07.05.14

• Anaphylactic reactions (severe allergic reaction resulting
in e.g. drop in blood pressure, swelling of the hands, feet,
ankles, face, lips, mouth and throat which may cause
difficulty in swallowing or breathing, rapid pulse, hives and
generalised itching or skin redness)
• Headaches
• Impaired vision
• Confusion
• Lethargy (state of being apathetic)
• Convulsions (fits)
• Facial paraesthesia (abnormal sensations of the face),
numbness and flushing of the face shortly after injection
• Diarrhoea
• Veno-occlusive disease (VOD) (severe disease of the liver
due to obstruction of the liver blood vessels) with hepatic
necrosis (destruction of liver cells) which can be
life-threatening. If this complication is suspected, your
doctor will consider appropriate treatment.
• Elevation of liver enzymes
• Impaired kidney function
• Erythema (red skin)
• Maculopapular exanthema (skin eruptions)
• Urticaria (hives)
• Application site irritation
You may experience one or several of these symptoms,
be sure to inform your doctor if you do.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via www.mhra.gov.
uk/yellowcard. By reporting side effects you can help provide
more information on the safety of this medicine.
5. HOW TO STORE DACARBAZINE MEDAC
Do not store above 25 °C. Keep the vial in the outer carton in
order to protect from light.
The shelf-life under these conditions is 3 years.

Keep out of the reach and sight of children.
Do not use DACARBAZINE MEDAC after the expiry date which
is stated on the label and carton. The expiry date refers to the
last day of that month.
Freshly prepared (reconstituted) solutions of DACARBAZINE
MEDAC were demonstrated to be stable for 24 hours at 20 °C
protected from light. From a microbiological point of view, the
product should be used immediately. If not used immediately,
in-use storage times and conditions prior to use are the
responsibility of the user and would normally be no longer than
24 hours at 2 to 8 °C, unless reconstitution has taken place in
controlled and validated aseptic conditions.
The reconstituted and further diluted solution must be used
immediately.
DACARBAZINE MEDAC is for single use only.
Any portion of the contents remaining after use should be
discarded by your doctor as well as solutions where the visual
appearance of the product has changed. The diluted solution
for infusion should be visually inspected by your doctor and
only clear solutions practically free from particles should be
used.
6. FURTHER INFORMATION
What DACARBAZINE MEDAC contains
• The active substance is dacarbazine (as dacarbazine citrate).
• The other ingredients are citric acid, anhydrous, and
mannitol.
What DACARBAZINE MEDAC looks like and contents
of the pack
The pharmaceutical DACARBAZINE MEDAC is a white or
pale-yellow powder which is supplied in amber glass vials
(Type I, Ph.Eur.).
Each single-dose vial of DACARBAZINE MEDAC 100 MG
contains 100 mg dacarbazine, as dacarbazine citrate.

Each single-dose vial of DACARBAZINE MEDAC 200 MG
contains 200 mg dacarbazine, as dacarbazine citrate.
After reconstitution DACARBAZINE MEDAC contains
10 mg/ml dacarbazine.

Sweden

Vials of DACARBAZINE MEDAC are packed in boxes each
containing 10 vials.

This leaflet was last revised in 05/2014.

Marketing Authorisation Holder and Manufacturer
medac
Gesellschaft für klinische
Spezialpräparate mbH
Theaterstr. 6
22880 Wedel
Germany
Phone: +49 (0)4103 8006-0
Fax:
+49 (0)4103 8006-100
This medicinal product is authorised in the Member States
of the EEA under the following names:
Austria
Dacarbazine medac 100 mg/200 mg,
Pulver zur Herstellung einer Injektions- oder
Infusionslösung
Belgium
Dacarbazine medac 100 mg/200 mg,
Poeder voor oplossing voor injectie of infusie
Denmark
Dacarbazine medac 100 mg/200 mg,
pulver til injektions- og infusionsvæske,
opløsning
Germany
Detimedac 100 mg/200 mg,
Pulver zur Herstellung einer Injektions- oder
Infusionslösung
Ireland
Dacarbazine medac 200 mg,
Powder for solution for injection or infusion
Italy
Dacarbazina medac 100 mg/200 mg,
polvere per soluzione iniettabile o per infusione
Netherlands Dacarbazine medac 100 mg/200 mg,
Poeder voor oplossing voor injectie of infusie
Portugal
Dacarbazina medac 100 mg/200 mg,
Pó para solução injectável ou para perfusão

United
Kingdom

Dacarbazine medac 100 mg/200 mg, Pulver till
injektions- och infusionsvätska, lösning
Dacarbazine medac 100 mg/200 mg,
Powder for solution for injection or infusion

-----------------------------------------------------------------------The following information is intended for medical or healthcare
professionals only:
Dacarbazine is an antineoplastic agent. Before commencing,
local cytotoxic guidelines should be referred to.
Dacarbazine should only be opened by trained staff and
as with all cytotoxic agents precautions should be taken to
avoid exposing staff. Handling of cytotoxic drugs should be
generally avoided during pregnancy. Preparation of solution for
administration should be carried out in a designated handling
area and working over a washable tray or disposable plasticbacked absorbent paper.
Suitable eye protection, disposable gloves, face mask and
disposable apron should be worn. Syringes and infusion sets
should be assembled carefully to avoid leakage (use of Luer
lock fittings is recommended).
On completion, any exposed surface should be thoroughly
cleaned and hands and face washed.
In the event of spillage, operators should put on gloves, face
masks, eye-protection and disposable apron and mop up the
spilled material with an absorbent material tapped in the area
for that purpose. The area should then be cleaned and all
contaminated material transferred to a cytotoxic spillage bag or
bin or sealed for incineration.
All reconstituted solutions should be suitably protected from
light also during administration (light-resistant infusion set).
80121-VPGB
DA

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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