DACARBAZIN LIPOMED

Main information

  • Trade name:
  • DACARBAZIN LIPOMED
  • Dosage:
  • 500 Milligram
  • Pharmaceutical form:
  • Pdr for Soln for Infusion
  • Prescription type:
  • Product subject to prescription which may not be renewed (A)
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DACARBAZIN LIPOMED
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic area:
  • dacarbazine

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization status:
  • Authorised
  • Authorization number:
  • PA1760/001/002
  • Authorization date:
  • 18-08-2017
  • Last update:
  • 12-12-2018

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

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.

side

effects,

talk

your

doctor

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 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

Special care is required if Dacarbazine Lipomed is given in

the following cases:

During treatment with Dacarbazine Lipomed and also for 6

months after cessation of therapy, men are advised to take

safe contraceptive measures.

Your doctor will test your blood to check that you have

enough blood cells to receive Dacarbazine Lipomed before

each administration. Your liver and kidney function will also

be monitored.

Talk

your

doctor

pharmacist

before

receiving

Dacarbazine Lipomed.

Other medicines and Dacarbazine Lipomed

It is not advisable to use any medical treatment without

telling your doctor as there may be interactions between

Dacarbazine Lipomed and other medicines.

In particular, you must not receive this medicine and tell your

doctor, nurse or pharmacist if you are taking or receiving any

of the following:

Phenytoin – for treatment of fits (epilepsy),

Yellow fever vaccine,

Live

vaccines,

since

dacarbazine

weaken

your

immune system and make you more likely to catch a

serious infection.

You must not receive Dacarbazine Lipomed if any of the

above apply to you. If you are not sure, talk to your doctor,

nurse or pharmacist before receiving Dacarbazine Lipomed.

Tell your doctor, nurse or pharmacist if you are receiving any

of the following treatments:

Fotemustine - You should not receive dacarbazine and

fotemustine at the same time to avoid damage to your

lungs.

Cyclosporin or tacrolimus: These medicines may reduce

the function of your immune system.

If any of the above apply to you (or you are not sure),

please tell your doctor, nurse or pharmacist before receiving

Dacarbazine Lipomed.

Your doctor will decide whether medicines to improve the

blood flow should be given to you and will check your

clotting tendency of the blood.

Tell your doctor or pharmacist if you are taking or using,

have recently taken or used or might take or use any other

medicines.

During chemotherapy you should avoid medicines that

cause

liver

damage

(e.g.

diazepam,

imipramin,

ketoconazole or carbamazepin).

Dacarbazine Lipomed with food, drink and alcohol

Do not eat just before receiving Dacarbazine Lipomed.

This will help to avoid feeling sick or being sick. During

chemotherapy, you should not drink alcohol.

Pregnancy, breast-feeding and fertility

Ask your doctor or pharmacist for advice before taking or

receiving any medicine.

Dacarbazine Lipomed must not be administered to you if

you are pregnant or if you are planning to become pregnant.

You must take adequate contraceptive precautions during

therapy.

must

breast-feed

while

treated

with

Dacarbazine Lipomed.

If you are pregnant or breast-feeding or if you assume that

you are pregnant or if you think of becoming pregnant, ask

your doctor for advice before receiving this medicine.

During treatment with Dacarbazine Lipomed and also for 6

months after cessation of therapy, men are advised to take

safe contraceptive measures.

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.

However, there is no reason why you cannot drive or use

machines between courses of therapy with Dacarbazine

Lipomed unless you feel dizzy or unsure of yourself.

3. How to use Dacarbazine Lipomed

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.

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.

Immediately before you receive it, Dacarbazine Lipomed

powder will be dissolved in 50 ml of water for injections. The

resulting solution will be further diluted with 200 – 300 ml

isotonic sodium chloride or glucose 5% solution and will be

given to you by intravenous infusion (infusion into a vein)

within 20 – 30 minutes.

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.

Your doctor may change the dose and frequency of dosing.

This depends on your blood test, your general condition,

further

therapies

your

response

Dacarbazine

Lipomed. If you have any questions about your treatment,

ask your doctor, nurse or pharmacist.

Use in children and adolescents

No special recommendations for the use of Dacarbazine

Lipomed in children and adolescents 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, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects,

although not everybody gets them. Your doctor will discuss

this with you and will explain the risks and benefits of your

treatment.

Tell your doctor immediately if you notice any of the following

side effects:

Signs

infection,

such

sore

throat

high

temperature.

Abnormal bruising or bleeding.

Extreme tiredness.

Persistent or severe vomiting or diarrhoea.

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.

These are all serious side effects. You may need urgent

medical attention.

In the following all known undesirable effects are listed:

Common side effects (1 to 10 of 100 patients treated)

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. The lowest values often only occur after 3

to 4 weeks.

Anorexia (loss of appetite), feeling sick and being sick. All

of these side effects may be severe.

Bone marrow suppression (decreased formation of all

blood cells in the bone marrow).

Uncommon side effects (1 to 10 of 1000 patients treated)

Alopecia (hair loss).

Hyperpigmentation (increased skin colouring).

Photosensitivity (increased sensitivity of your skin to

sunlight).

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.

Infections.

Transient rash.

Blurred vision.

Hepatotoxicity (liver damage).

Rare side effects (1 to 10 of 10,000 patients treated)

Pancytopenia (decreased number of all cells in the

blood).

Agranulocytosis

(severely

decreased

number

granulocytes, a special type of white blood cells).

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).

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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.

If this medicine is accidentally administered into the tissue

around your vein, it will be painful and there will be tissue

damage.

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 the

national reporting system:

HPRA Pharmacovigilance

Earlsfort Terrace

IRL - Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.hpra.ie

E-mail: medsafety@hpra.ie

reporting

side

effects

help

provide

more

information on the safety of this medicine.

5. How to store Dacarbazine Lipomed

Do not store above 25 °C. Keep the vial in the outer carton in

order to protect from light.

Keep this medicine out of the sight and reach of children.

This medicine must not be used after the expiry date which

is stated on the label and carton after “EXP”. The expiry date

refers to the last day of that month.

Dacarbazine Lipomed is for single use only.

Any portion of the contents remaining after use should be

discarded by your doctor, nurse or pharmacist. The same

applies to solutions where the visual appearance of the

product has changed. The diluted solution for infusion

should

visually

inspected

your

doctor,

nurse

pharmacist and only clear solutions practically free from

particles should be used.

Shelf life of the reconstituted solution

Chemical

physical

in-use

stability

been

demonstrated for 8 hours at room temperature and protected

from light and for 5 days at 2 to 8 °C and protected from light.

From a microbiological point of view, the reconstituted

solution should be used immediately.

If the reconstituted solution is not used immediately, the

duration and conditions of storage are the responsibility

of the user. The reconstituted solution should not be stored

for longer than 24 hours in a refrigerator (2 to 8 °C) and

protected from light, unless the reconstitution has taken

place under controlled and validated aseptic conditions.

Shelf life of the diluted solution for infusion

Chemical

physical

in-use

stability

been

demonstrated for 8 hours at room temperature and protected

from light and for 5 days at 2 to 8 °C and protected from light.

From a microbiological point of view, the diluted solution for

infusion should be used immediately.

If the diluted solution for infusion is not used immediately,

the duration and conditions of storage are the responsibility

of the user. The diluted solution for infusion should not be

stored for longer than 24 hours in a refrigerator (2 to 8 °C)

and protected from light, unless the reconstitution and

dilution have taken place under controlled and validated

aseptic conditions.

From a microbiological point of view it is recommended not

to exceed a total storage time of 24 hours after opening of

the product.

6. Contents of the pack and other information

What Dacarbazine Lipomed contains

The active substance is dacarbazine (as dacarbazine

citrate).

The other ingredients are citric acid monohydrate and

mannitol.

What Dacarbazine Lipomed looks like and contents of the

pack

pharmaceutical

Dacarbazine

Lipomed

white

lyophilized powder which is supplied in brown injection

vials (hydrolytical class I) closed with grey bromobutyl

rubber lyophilisation stoppers. Vials containing Dacarbazine

Lipomed 500 mg are aluminium crimped with grey flip-off

caps.

Each single-dose vial of Dacarbazine Lipomed 500 mg

contains 500 mg dacarbazine, as dacarbazine citrate.

After reconstitution of Dacarbazine Lipomed 500 mg with

50 ml of water for injections, 1 ml of solution contains

10 mg dacarbazine.

Before

reconstitution,

Dacarbazine

Lipomed

white

lyophilized powder. Reconstituted solutions are clear and

pale yellow. Diluted solutions for infusion are clear and

almost colourless.

Dacarbazine Lipomed 500 mg is packed in boxes. Each box

contains 1 vial.

Marketing Authorisation Holder and Manufacturer

Lipomed GmbH

Hegenheimer Str. 2

D-79576 Weil am Rhein

Germany

Phone: +49 7621 1693 472

Fax: +49 7621 1693 474

E-mail: lipomed@lipomed.com

This medicinal product is authorised in the Member States

of the EEA under the following names:

Austria: Dacarbazin Lipomed 500 mg Pulver

zur Herstellung einer Infusionslösung

Germany: Dacarbazin Lipomed 500 mg Pulver

zur Herstellung einer Infusionslösung

France: Dacarbazine Lipomed 500 mg poudre

pour solution pour perfusion

Italy: Dacarbazina Lipomed 500 mg polvere

per soluzione per infusione

Cyprus: Dacarbazine Lipomed 500 mg κόνις

για διάλυμα

ρος έγχυση

Denmark: Dacarbazine Lipomed 500 mg pulver

til infusionsvæske, opløsning

Finland: Dacarbazine Lipomed 500 mg infuusiokuiva-aine

liuosta varten

Norway: Dacarbazine Lipomed 500 mg pulver

til infusjonsvæske, oppløsning

Ireland: Dacarbazine Lipomed 500 mg powder

for solution for infusion

Romania: Dacarbazină Lipomed 500 mg pulbere

pentru soluţie perfuzabilă

This leaflet was last revised in January 2018.

following

information

intended

healthcare

professionals only:

Dacarbazine

anti-neoplastic

agent.

Before

commencing, local cytotoxic guidelines should be referred

Dacarbazine solutions should only be prepared 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 plastic-backed 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 of the work, 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 working 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.

Reconstituted solutions should be suitably protected from

light also during administration (light-resistant infusion set).

Shelf life of the reconstituted solution

Chemical

physical

in-use

stability

been

demonstrated for 8 hours at room temperature and protected

from light and for 5 days at 2 to 8 °C and protected from

light. From a microbiological point of view, the reconstituted

solution should be used immediately.

If the reconstituted solution is not used immediately, the

duration and conditions of storage are the responsibility

of the user. The reconstituted solution should not be stored

for longer than 24 hours in a refrigerator (2 to 8 °C) and

protected from light, unless the reconstitution has taken

place under controlled and validated aseptic conditions.

Shelf life of the diluted solution for infusion

Chemical

physical

in-use

stability

been

demonstrated for 8 hours at room temperature and protected

from light and for 5 days at 2 to 8 °C and protected from light.

From a microbiological point of view, the diluted solution for

infusion should be used immediately.

If the diluted solution for infusion is not used immediately,

the duration and conditions of storage are the responsibility

of the user. The diluted solution for infusion should not be

stored for longer than 24 hours in a refrigerator (2 to 8 °C)

and protected from light, unless the reconstitution and

dilution have taken place under controlled and validated

aseptic conditions.

From a microbiological point of view it is recommended not

to exceed a total storage time of 24 hours after opening of

the product.

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