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AstraZeneca

Cerezyme
imiglucerase

Package leaflet: Information for the user


Cerezyme 400 Units powder for concentrate for solution for infusion

Imiglucerase


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


What Cerezyme looks like and contents of the pack

Cerezyme, 400 Units, is presented as a powder for concentrate for solution for infusion (in a vial, pack size of 1, 5 or 25). Not all pack sizes may be marketed.


Cerezyme is supplied as a white to off-white powder. After reconstitution it is a clear, colourless liquid, free from foreign matter. The reconstituted solution must be further diluted.

Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder

Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP, Amsterdam, the Netherlands


Manufacturer

Genzyme Ireland Limited., IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland

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


België/Belgique/Belgien/ Luxembourg/Luxemburg Sanofi Belgium

Tél/Tel: + 32 2 710 54 00


България

Swixx Biopharma EOOD

Тел.: +359 (0)2 4942 480

Magyarország SANOFI-AVENTIS Zrt. Tel: +36 1 505 0050


Malta

Sanofi S.r.l.

+39 02 39394275


Česká republika sanofi-aventis, s.r.o. Tel: +420 233 086 111


Danmark

Sanofi A/S

Tlf: +45 45 16 70 00

Nederland

Genzyme Europe B.V. Tel: +31 20 245 4000


Norge

sanofi-aventis Norge AS Tlf: + 47 67 10 71 00


Deutschland

Sanofi-Aventis Deutschland GmbH Tel: 0800 04 36 996

Tel. aus dem Ausland: +49 69 305 70 13

Österreich

sanofi-aventis GmbH Tel: + 43 1 80 185 - 0


Eesti

Swixx Biopharma OÜ Tel: +372 640 10 30

Polska

sanofi-aventis Sp. z o.o. Tel.: +48 22 280 00 00


Ελλάδα

sanofi-aventis AEBE

Τηλ: +30 210 900 1600

Portugal

Sanofi – Produtos Farmacêuticos, Lda. Tel: +351 21 35 89 400


España

sanofi-aventis, S.A. Tel: +34 93 485 94 00

România

Sanofi Romania SRL Tel: +40 (0) 21 317 31 36


France

sanofi-aventis France Tél: 0 800 222 555

Appel depuis l’étranger : +33 1 57 63 23 23

Slovenija

Swixx Biopharma d.o.o. Tel: +386 1 235 51 00


Hrvatska

Swixx Biopharma d.o.o. Tel: +385 1 2078 500

Slovenská republika Swixx Biopharma s.r.o. Tel: +421 2 208 33 600


Ireland

sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +353 (0) 1 403 56 00


Ísland

Vistor hf.

Sími: +354 535 7000

Suomi/Finland

Sanofi Oy

Puh/Tel: + 358 201 200 300

Italia

Sanofi S.r.l.

Tel: 800 536 389


Κύπρος

C.A. Papaellinas Ltd.

Τηλ: +357 22 741741

Sverige

Sanofi AB

Tel: +46 (0)8 634 50 00


United Kingdom (Northern Ireland) sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +44 (0) 800 035 2525


Latvija

Swixx Biopharma SIA Tel: +371 6 616 47 50


Lietuva

Swixx Biopharma UAB Tel: +370 5 236 91 40


This leaflet was last revised in:


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The following information is intended for healthcare professionals only: Instructions for use – reconstitution, dilution and administration

Each vial of Cerezyme is for single use only. After reconstitution, each vial of Cerezyme contains 400

units of imiglucerase in 10.0 ml (40 units per ml).


Determine the number of vials to be reconstituted based on the individual patient's dosage regimen and remove the vials from the refrigerator.


Use Aseptic Technique


Reconstitution

Reconstitute each vial with 10.2 ml water for injections; avoid forceful impact of water for injections on the powder and, by mixing gently, avoid foaming of the solution. The reconstituted volume is

10.6 ml. The pH of the reconstituted solution is approximately 6.2.


After reconstitution it is a clear, colourless liquid, free from foreign matter. The reconstituted solution must be further diluted. Before further dilution, visually inspect the reconstituted solution in each vial for foreign particles and discoloration. Do not use vials exhibiting foreign particles or discoloration. After reconstitution, promptly dilute vials and do not store for subsequent use.


Dilution

The reconstituted solution contains 40 units imiglucerase per ml. The reconstituted volume allows accurate withdrawal of 10.0 ml (equal to 400 units) from each vial. Withdraw 10.0 ml reconstituted solution from each vial and combine the withdrawn volumes. Then dilute the combined volumes with 0.9% sodium chloride intravenous solution to a total volume of 100 to 200 ml. Mix the infusion solution gently.


Administration

It is recommended to administer the diluted solution through an in-line low protein-binding 0.2 µm filter to remove any protein particles. This will not lead to any loss of imiglucerase activity. It is

recommended that the diluted solution be administered within 3 hours. The product diluted in 0.9% sodium chloride intravenous solution will retain chemical stability if stored up to 24 hours at 2°C and 8°C under protection from light; but microbiological safety will depend on the reconstitution and dilution having been performed aseptically.


Cerezyme contains no preservatives. Any unused product or waste material should be disposed of in accordance with local requirements.