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AstraZeneca

Velcade
bortezomib

Package leaflet: Information for the user


VELCADE 1 mg powder for solution for injection

bortezomib


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


What VELCADE looks like and contents of the pack

VELCADE powder for solution for injection is a white to off-white cake or powder.


Each carton of VELCADE 1 mg powder for solution for injection contains a glass vial with a green cap, in a transparent blister pack.


Marketing Authorisation Holder

JANSSEN-CILAG INTERNATIONAL NV

Turnhoutseweg 30 B-2340 Beerse

Belgium

Manufacturer

Janssen Pharmaceutica NV Turnhoutseweg 30

B-2340 Beerse Belgium


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


België/Belgique/Belgien Janssen-Cilag NV Tel/Tél + 32 14 64 94 11

janssen@jacbe.jnj.com

Lietuva

UAB "JOHNSON & JOHNSON" Tel: +370 5 278 68 88

lt@its.jnj.com


България

„Джонсън & Джонсън България” ЕООД Тел.: +359 2 489 94 00

jjsafety@its.jnj.com

Luxembourg/Luxemburg

Janssen-Cilag NV Tél/Tel: + 32 14 64 94 11

janssen@jacbe.jnj.com


Česká republika Janssen-Cilag s.r.o. Tel: +420 227 012 227

Magyarország Janssen-Cilag Kft. Tel.: +36 1 884 2858

janssenhu@its.jnj.com


Danmark

Janssen-Cilag A/S Tlf: +45 4594 8282

jacdk@its.jnj.com

Malta

AM MANGION LTD. Tel: +356 2397 6000


Deutschland

Janssen-Cilag GmbH Tel: +49 2137 955 955

jancil@its.jnj.com

Nederland

Janssen-Cilag B.V. Tel: + 31 76 711 1111

janssen@jacnl.jnj.com


Eesti

UAB "JOHNSON & JOHNSON" Eesti filiaal Tel: +372 617 7410

ee@its.jnj.com

Norge

Janssen-Cilag AS Tlf: + 47 24 12 65 00

jacno@its.jnj.com


Ελλάδα

Janssen-Cilag Φαρμακευτική Α.Ε.Β.Ε. Tηλ: +30 210 80 90 000

Österreich

Janssen-Cilag Pharma GmbH Tel:+43 1 610 300


España

Janssen-Cilag, S.A. Tel: +34 91 722 81 00

contacto@its.jnj.com

Polska

Janssen-Cilag Polska Sp. z o.o. Tel.: + 48 22 237 60 00


France

Janssen-Cilag

Tél: 0 800 25 50 75 / + 33 1 55 00 40 03

medisource@its.jnj.com

Portugal

Janssen-Cilag Farmacêutica, Lda. Tel: +351 214 368 600

Hrvatska

Johnson & Johnson S.E. d.o.o. Tel: +385 1 6610 700

jjsafety@JNJCR.JNJ.com

România

Johnson & Johnson România SRL Tel: +40 21 207 1800


Ireland

Janssen Sciences Ireland UC Tel: +353 1 800 709 122

Slovenija

Johnson & Johnson d.o.o. Tel. +386 1 401 18 00

Janssen_safety_slo@its.jnj.com


Ísland

Janssen-Cilag AB c/o Vistor hf.

Sími: +354 535 7000

janssen@vistor.is

Slovenská republika Johnson & Johnson s.r.o. Tel: +421 232 408 400


Italia

Janssen-Cilag SpA

Tel: 800.688.777 / +39 02 2510 1

janssenita@its.jnj.com

Suomi/Finland

Janssen-Cilag Oy

Puh/Tel: +358 207 531 300

jacfi@its.jnj.com


Κύπρος

Βαρνάβας Χατζηπαναγής Λτδ Τηλ: +357 22 207 700

Sverige

Janssen-Cilag AB Tel: +46 8 626 50 00

jacse@its.jnj.com


Latvija

UAB "JOHNSON & JOHNSON" filiāle Latvijā Tel: +371 678 93561

lv@its.jnj.com

United Kingdom (Northern Ireland)

Janssen Sciences Ireland UC Tel: +44 1 494 567 444


This leaflet was last revised in


The following information is intended for healthcare professionals only:


  1. RECONSTITUTION FOR INTRAVENOUS INJECTION


    Note: VELCADE is a cytotoxic agent. Therefore, caution should be used during handling and preparation. Use of gloves and other protective clothing to prevent skin contact is recommended.


    ASEPTIC TECHNIQUE MUST BE STRICTLY OBSERVED THROUGHOUT HANDLING OF VELCADE SINCE NO PRESERVATIVE IS PRESENT.


    1. Preparation of the 1 mg vial: carefully add 1.0 ml of sterile, 9 mg/ml (0.9%) sodium chloride solution for injection to the vial containing the VELCADE powder by using a 1 ml syringe without removing the vial stopper. Dissolution of the lyophilised powder is completed in less than 2 minutes.


      The concentration of the resulting solution will be 1 mg/ml. The solution will be clear and colourless, with a final pH of 4 to 7. You do not need to check the pH of the solution.


    2. Before administration, visually inspect the solution for particulate matter and discolouration. If any discolouration or particulate matter is observed, the solution should be discarded. Confirm concentration on vial to ensure that the correct dose is being given for the intravenous route of administration (1 mg/ml).


    3. The reconstituted solution is preservative free and should be used immediately after preparation.

      However, the chemical and physical in-use stability has been demonstrated for 8 hours at 25°C stored in the original vial and/or a syringe. The total storage time for the reconstituted medicinal product should not exceed 8 hours prior to administration. If the reconstituted solution is not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.


      It is not necessary to protect the reconstituted medicinal product from light.


  2. ADMINISTRATION


    • Once dissolved, withdraw the appropriate amount of the reconstituted solution according to calculated dose based upon the patient´s Body Surface Area.

    • Confirm the dose and concentration in the syringe prior to use (check that the syringe is marked as intravenous administration).

    • Inject the solution as a 3-5 second bolus intravenous injection through a peripheral or central intravenous catheter into a vein.

    • Flush the peripheral or intravenous catheter with sterile, 9 mg/ml (0.9%) sodium chloride solution.


    VELCADE 1 mg powder for solution for injection IS FOR INTRAVENOUS USE ONLY. Do not give by other routes. Intrathecal administration has resulted in death.


  3. DISPOSAL


A vial is for single use only and the remaining solution must be discarded.

Any unused product or waste material should be disposed of in accordance with local requirements.