DepoCyte 50 mg suspension for injection

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.

DepoCyte should not be given

• If you are allergic (hypersensitive) to cytarabine or any of the other ingredients.
• If you have a meningeal infection.

Taking other medicines
Please inform your doctor or physician if you are taking or using any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

DepoCyte should not be given to pregnant women as it may harm an unborn child. Women of childbearing potential should use a reliable contraceptive 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.

Before using DepoCyte, warm the vial to room temperature (18°C ? 22°C) for at least 30 minutes. Just before withdrawing DepoCyte, gently invert the vial to mix the particles evenly. Do not shake the vial vigorously.

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 a few 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.

DepoCyte must be usedas 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.

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

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

• Pain, numbness or tingling (feeling of sensation of pins and needles)
• Nausea and/or vomiting
• Weakness
• Confusion
• Fever
• Headaches
• Fatigue
• Convulsion
• Dizziness
• Neck pain
• A stiff or rigid neck
• Partial paralysis
• Blindness and other visual disturbances
• Shaking
• Back pain
• Persistent or extreme sleepiness
• Hearing loss
• Infection of the meninges

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.

Keep out of the reach and sight of children.

Do not use DepoCyte after the expiry date which is stated on the carton and on the vial.

Store in a refrigerator (2°C ? 8°C).
Do not freeze.

What DepoCyte contains

• The active substance is 50 mg cytarabine (10 mg/ml)
• 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 vial containing a white to off-white-suspension for injection.
Each vial contains 5 ml of suspension for a single injection.
Each pack contains a single vial.

Marketing Authorisation Holder

Pacira Limited, 3 Glory Park Avenue, Wooburn Green, High Wycombe, Buckinghamshire, HP10 0DF, 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.

BelgiëBelgiqueBelgien Mundipharma Comm VA. Schaliënhoevedreef 20H B-2800 Mechelen TélTel 32 0 15 45 11 80 LuxembourgLuxemburg Mundipharma Comm VA. Schaliënhoevedreef 20H 2800 Mechelen BelgiqueBelgien Tél 32 0 15 45 11 80

Magyarország Medis, d.o.o. Ljubljana, Szlovénia Információsvonal 1- 487-5350 . 55 1407 e 359 8985 99700

Malta 3 Glory Park Avenue, Wooburn Green High Wycombe, Buckinghamshire HP10 0DF - Renju Unit el 44 0 144 228 3649 eská republika Mundipharma Ges.m.b.H. Austria organizaní sloka R Lerchova 9 PS 602 00 Brno Tel 420 543 215 070

Danmark Norpharma AS Slotsmarken 15 DK-2970 Hørsholm Tlf 45 45 17 48 00 Nederland Mundipharma Pharmaceuticals B.V. De Wel 20 NL-3871 MV Hoevelaken Tel 31 0 33 450 8270

Norge Mundipharma AS N-1366 Lysaker Tlf 47 67 51 89 00 Deutschland Mundipharma GmbH Mundipharmastrasse 2 D-65549 LimburgLahn Tel 49 6431 701 0

Eesti OÜ K-Büroo Marketing Kalevi 1122 EE - 50104 Tartu Tel 372 733 8080 Österreich Mundipharma Ges.m.b.H. Apollogasse 16-18 A-1072 Wien Tel 43 1 523 25 05

E 3 Glory Park Avenue, Wooburn Green High Wycombe, Buckinghamshire HP10 0DF 44 0 144 228 3649 Polska Mundipharma Polska Sp.zoo UL. Kochanowskiego 49A 01-864 Warszawa Tel 480 22 866 87 12

España Mundipharma Pharmaceuticals, S.L. Edificio ALVENTO Torre D Vía de los Poblados 1 28033 Madrid Tel 34 91 3821870 Portugal Mundipharma Farmacêutica Lda Edifício Atrium Saldanha Praça Duque de Saldanha, 1 6 Lisboa 1050-094 Tel 351 219 258064

France Mundipharma SAS 2 Rue du Docteur Lombard F-92130 Issy Les Moulineaux Tel 33 0 155 389230 România Mundipharma Medical GmbH Representative Office Romania Str. Mihail Petrini nr 4 Et. 2, apt. 6, sector 5 050582 Bucuresti Tel 4021 410 10 49

Slovenija Medis, d.o.o. Brnieva 1 SI - 1000 Ljubljana Tel 386 158969 00 Ireland Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW United Kingdom Tel 44 0 1223 424444

Slovenská republika Mundipharma Ges.m.b.H. - o.z Jaroslavova 23 SK-851 01 Bratislava Tel 421 2 63811611 Ísland Norpharma AS Slotsmarken 15 2970 Hørsholm Danmark Tel 45 45 17 48 00

Italia Mundipharma Pharmaceuticals Srl Via G. Serbelloni no 4 I-20122 Milano Tel 39.02.76001616 SuomiFinland Mundipharma Oy Rajatorpantie 41B FIN-01640 Vantaa PuhTel 358 09 8520 2065

Sverige Mundipharma AB Mölndalsvägen 30B S-412 63 Göteborg Tel 46 031 773 75 30 Mundipharma Pharmaceuticals Ltd 13 Othellos Street Dhali Industrial Zone CY- 1685 Nicosia 357 22 81 56 56

Latvija KD, SIA A. Saharova iela 16-342 Rga LV-1021 Tel 371 7 800810 United Kingdom Napp Pharmaceuticals Limited Cambridge Science Park Milton Road Cambridge CB4 0GW - UK Tel 44 0 1223 424444

Lietuva

OÜ K-Büroo Marketing
Kalevi 112/2
EE - 50104 Tartu
Estija
Tel. +372 733 8080

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