English
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

DepoCyte (cytarabine) – Package leaflet - L01BC01

Updated on site: 06-Oct-2017

Medication nameDepoCyte
ATC CodeL01BC01
Substancecytarabine
ManufacturerPacira Limited

Package leaflet: Information for the user

DepoCyte 50 mg suspension for injection

Cytarabine

Read all of this leaflet carefully before you receive this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.

If you have further questions, ask your doctor.

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4..

What is in this leaflet:

1.What DepoCyte is and what it is given for

2.What you need to know before you are given DepoCyte

3.How DepoCyte is given

4.Possible side effects

5.How to store DepoCyte

6.Contents of the pack and other information

1.What DepoCyte is and what it is given for

DepoCyte is used to treat lymphomatous meningitis.

Lymphomatous meningitis is a condition in which tumour cells have invaded the fluid or membranes that surround the brain and spinal cord.

DepoCyte is used in adults to kill lymphoma tumour cells.

2. What you need to know before you are given DepoCyte

DepoCyte should not be given

if you are allergic to cytarabine or any of the other ingredients of this medicine (listed in section 6).

if you have a meningeal infection.

Warnings and precautions

Severe neurological side effects have been reported with the use of DepoCyte. Symptoms have included effects on the nervous system (e.g. convulsions, pain, numbness or tingling, blindness or visual disturbances). Your doctor will check for these symptoms regularly.

Make sure you take as directed any dexamethasone tablets that you may have been prescribed, as they reduce the risk of unwanted effects caused by DepoCyte.

If your side effects get worse or you notice any new side effects, tell your doctor.

Other medicines and DepoCyte

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

Pregnancy, breast-feeding and fertility

DepoCyte should not be given to pregnant women as it may harm an unborn child. Women of childbearing potential should use a reliable contraceptive method to avoid pregnancy whilst being treated with DepoCyte.

Male patients undergoing DepoCyte treatment should use a reliable contraceptive method.

Women should not breast-feed during treatment as DepoCyte may enter breast milk.

Driving and using machines

Do not drive during treatment.

Do not operate any tools or machines during treatment.

3.How DepoCyte is given

A qualified and experienced doctor or physician in the treatment of cancer will inject DepoCyte in the spinal fluid or lumber sac. DepoCyte must not be administered by any other way. Injections are given slowly over 1-5 minutes and you may be asked to lie flat for one hour afterwards.

You will also be given dexamethasone, usually as tablets but possibly by intravenous injection for 5 days after you receive each DepoCyte dose to help reduce any side effects which might occur.

Before DepoCyte is used the vial should be warmed to room temperature (18°C – 22°C) for at least 30 minutes. Just before withdrawing DepoCyte, the vial should be gently inverted to mix the particles evenly. It should not be shaken vigorously.

Proper precautions should be taken for the handling and administration of a cytotoxic drug (proper handling technique, use of a suitable designated area, protective clothing, procedures to address risk of contamination). Staff who are pregnant or trying to conceive (male and female) should not work with DepoCyte. In the event of accidental contact with the mucous membranes, treat immediately by copious washing with water; medical attention should be sought.

DepoCyte should be withdrawn from the vial immediately before administration; the medicinal product should be used within 4 hours of withdrawal from the vial. Unused medicinal product must be discarded and not used subsequently. DepoCyte must not be mixed with any other medicinal products. In-line filters must not be used when administering DepoCyte.

DepoCyte must be used as supplied without further dilution. The dose for adults is 50 mg (one vial of DepoCyte).

For the treatment of lymphomatous meningitis, DepoCyte is given according to the following schedules:

Start-up treatment: one vial of DepoCyte (50 mg) administered every 14 days for 2 doses (weeks 1 and 3).

Follow-up treatment: one vial of DepoCyte (50 mg) administered every 14 days for 3 doses (weeks 5, 7 and 9) followed by an additional dose at week 13.

Maintenance treatment: one vial of DepoCyte (50 mg) administered every 28 days for 4 doses (weeks 17, 21, 25 and 29).

If you are given more DepoCyte than you should

The recommended dose will be given to you by the doctor or physician as necessary. There is no antidote for DepoCyte. Management of overdose should be directed at maintaining vital functions.

4.Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects may occur after each injection, usually within the first five days.

Your doctor will discuss these with you and will explain the potential risks and benefits of your treatment.

The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10); common (affects 1 to 10 users in 100); uncommon (affects 1 to 10 users in 1,000); rare (affects 1 to 10 users in 10,000); very rare (affects less than 1 user in 10,000); not known (frequency cannot be estimated from the available data).

The severity of adverse events of DepoCyte may be increased when DepoCyte is given in combination with other chemotherapeutic agents.

Tell the medical staff monitoring you during this time, if you suffer from:

Very common (experienced in more than 1 in 10 patients)

Nausea and/or vomiting

Weakness

Confusion

Fever

Headaches

Dizziness

Shaking

Common (experienced in less than 1 in 10 but more than 1 in 100 patients)

Back pain

Convulsion

Neck pain

A stiff or rigid neck

Infection of the meninges

Fatigue

Pain, numbness or tingling (feeling of sensation of pins and needles)

Blindness and other visual disturbances

Hearing loss

Persistent or extreme sleepiness

Partial paralysis

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please inform the medical staff looking after you.

Reporting of side effects

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5.How to store DepoCyte

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

Do not use this medicine after the expiry date which is stated on the carton and on the vial after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C – 8°C).

Do not freeze.

DepoCyte should be used as soon as possible after first opening, and should normally be used within 4 hours (stored at 18-22ºC).

DepoCyte is a sterile white to off-white-suspension. Do not use this medicine if you notice severe discolouration, a changed appearance or a defective container.

Do not throw away any medicines via wastewater. DepoCyte contains cytarabine, and should be disposed of in a manner consistent with local requirements.

6. Contents of the pack and other information

What DepoCyte contains

The active substance is cytarabine. One ml of suspension contains 10 mg cytarabine. Each 5 ml vial contains 50 mg cytarabine

The other ingredients are cholesterol, triolein, dioleoylphosphatidylcholine, dipalmitoylphosphatidylglycerol, sodium chloride, and water for injections.

What DepoCyte looks like and contents of the pack

DepoCyte is a white to off-white-suspension for injection supplied in a glass vial. Each vial contains 5 ml of suspension for a single injection.

Each pack contains a single vial.

Marketing Authorisation Holder

Pacira Limited, Wessex House, Marlow Road, Bourne End, Buckinghamshire, SL8 5SP, United Kingdom.

Manufacturer

Almac Pharma Services Limited, 20 Seagoe Industrial Estate, Craigavon, Co Armagh, BT63 5QD,

United Kingdom.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien

Lietuva

Mundipharma Comm VA.

KBM Pharma OÜ

Tél/Tel: +32 (0) 15 45 11 80

Tel. +372 733 8080

info@mundipharma.be

kbmpharma@kbmpharma.eu

България

Luxembourg/Luxemburg

ТП Мундифарма Медикъл ООД

Mundipharma Comm VA.

Тел. +359 2 962 13 56/54

Tél: +32 (0) 15 45 11 80

mundipharma@mundipharma.bg

info@mundipharma.be

Česká republika

Magyarország

Mundipharma Ges.m.b.H. Austria

Medis Hungary Kft

Organizační složka ČR

Információsvonal: +36 2 380 1028

Tel : +420 222 318 221

info@medis.hu

office@mundipharma.cz

 

Danmark

Malta

Mundipharma A/S

Pacira Limited

Tlf: +45 45 17 48 00

Wessex House, Marlow Road

mundipharma@mundipharma.dk

Bourne End, Buckinghamshire

 

SL8 5SP - Renju Unit

 

Τel: +44 (0) 1628 530554

Deutschland

Nederland

Mundipharma GmbH

Mundipharma Pharmaceuticals B.V.

Tel: +31 (0) 33 450 8270

mundipharma@mundipharma.de

info@mundipharma.nl

Eesti

Norge

KBM Pharma OÜ

Mundipharma AS

Tel: +372 733 8080

Tlf: +47 67 51 89 00

kbmpharma@kbmpharma.eu

post@mundipharma.no

Eλλάδα

Österreich

Pacira Limited

Mundipharma Gesellschaft.m.b.H.

Wessex House, Marlow Road

Tel: + 43 (0) 1 523 25 05

Bourne End, Buckinghamshire

office@mundipharma.at

SL8 5SP

 

Ηνωμένο Βασίλειο

 

Τηλ: +44 (0) 1628 530554

 

España

Polska

Mundipharma Pharmaceuticals, S.L.

Mundipharma Polska Sp.z o.o.

Tel: +34 91 3821870

Tel: +48(0) 22 866 87 12

infomed@mundipharma.es

office@mundipharma.pl

France

Portugal

Mundipharma

Companhia Portuguesa Higiene Pharma –

Tel: +33 (0) 1 40 65 29 29

Produtos Farmacêuticos, S.A.

infomed@mundipharma.fr

Tel: +351 214 449 600

 

geral@ferrergrupo.com.pt

Hrvatska

România

Medis Adria d.o.o.

Mundipharma Gesellschaft m.b.H., Austria

Kolarova 7,

Tel: +40 751 121 222

10000 Zagreb

office@mundipharma.ro

Tel.: +385 1 2303 446

 

Ireland

Slovenija

Mundipharma Pharmaceuticals Limited

Medis, d.o.o.

Tel: +353 1 2063800

Tel: +386 158969 00

oncologymedinfo@napp.co.uk

info@medis.si

Ísland

Slovenská republika

Mundipharma A/S

Mundipharma Ges.m.b.H. - o.z

Tel: +45 45 17 48 00

Tel: +421 2 63811611

mundipharma@ mundipharma.dk

mundipharma@mundipharma.sk

Italia

Suomi/Finland

Mundipharma Pharmaceuticals Srl

Mundipharma Oy

Tel: + 39.02.318288216

Puh/Tel: +358 (0)9 8520 2065

Italy.InfoMedica@mundipharma.it

info@mundipharma.fi

Κύπρος

Sverige

Mundipharma Pharmaceuticals Ltd

Mundipharma AB

Τηλ: +357 22 81 56 56

Tel: + 46 (0)31 773 75 30

info@mundipharma.com.cy

info@mundipharma.se

Latvija

United Kingdom

Institute of Innovative Biomedical Technology

Napp Pharmaceuticals Limited

Tel: +371 7 800810

Tel: +44 (0) 1223 424444

info@ibti.lvoffice

oncologymedinfo@napp.co.uk

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

Comments

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
  • Help
  • Get it on Google Play
  • About
  • Info on site by:

  • Presented by RXed.eu

  • 27558

    prescription drugs listed