Home page Home page
AstraZeneca

Pixuvri
pixantrone dimaleate

Package leaflet: Information for the user


Pixuvri 29 mg powder for concentrate for solution for infusion

pixantrone


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


Reporting of side effects

If you get any side effects, talk to your doctor. 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.


  1. How to store Pixuvri


    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 vial label and carton after “EXP”. The expiry date refers to the last day of that month.


    Store in a refrigerator (2°C to 8°C).

    Keep the vial in the outer carton in order to protect from light.


    Pixuvri does not contain anything to prevent the growth of bacteria and it is, therefore, recommended that it be used immediately after reconstitution. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2°C to 8°C.


    Reconstituted pixantrone solution is stable for up to 24 hours at room temperature (15°C to 25°C) in standard infusion bags.


    Pixuvri is for single use only. Any unused medicinal product or waste material, including materials used for reconstitution, dilution, and administration should be disposed of in accordance with local requirements.


  2. Contents of the pack and other information What Pixuvri contains

The active substance is pixantrone. Each vial contains 50 mg pixantrone dimaleate (equivalent to 29 mg pixantrone). The other ingredients are lactose monohydrate, sodium hydroxide, hydrochloric acid, and sodium chloride.


What Pixuvri looks like and contents of the pack

Pixuvri is a powder for concentrate for solution for infusion. It appears as a dark blue powder which comes in vials containing 29 mg of pixantrone. Pack size: 1 vial.


Marketing Authorisation Holder

Les Laboratoires Servier 50, rue Carnot

92284 Suresnes cedex France


Manufacturer

Les Laboratoires Servier Industrie 905 Route de Saran

45520 Gidy France


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


België/Belgique/Belgien

S.A. Servier Benelux N.V. Tél/Tel: +32 (0)2 529 43 11

Lietuva

UAB “SERVIER PHARMA” Tel: +370 (5) 2 63 86 28


България

Сервие Медикал ЕООД Тел.: +359 2 921 57 00

Luxembourg/Luxemburg

S.A. Servier Benelux N.V. Tel: +32 (0)2 529 43 11


Česká republika

Servier s.r.o.

Tel: +420 222 118 111

Magyarország Servier Hungaria Kft. Tel: +36 1 238 7799


Danmark

Servier Danmark A/S Tlf: +45 36 44 22 60

Malta

V.J. Salomone Pharma Ltd Tel: + 356 21 22 01 74


Deutschland

Servier Deutschland GmbH Tel: +49 (0)89 57095 01

Nederland

Servier Nederland Farma B.V. Tel: + 31 (0)71 5246700


Eesti

Servier Laboratories OÜ Tel:+ 372 664 5040

Norge

Servier Danmark A/S Tlf: +45 36 44 22 60


Eλλάδα

ΣΕΡΒΙΕ ΕΛΛΑΣ ΦΑΡΜΑΚΕΥΤΙΚΗ ΕΠΕ Τηλ: + 30 210 939 1000

Österreich

Servier Austria GmbH Tel: +43 (1) 524 39 99


España

Laboratorios Servier S.L. Tel: + 34 91 748 96 30

Polska

Servier Polska Sp. z o.o. Tel: + 48 (0) 22 594 90 00


France

Les Laboratoires Servier Tél: + 33 (0)1 55 72 60 00

Portugal

Servier Portugal, Lda Tel: + 351 21 312 20 00


Hrvatska

Servier Pharma, d. o. o. Tel: + 385 (0)1 3016 222

România

Servier Pharma SRL Tel: + 4 021 528 52 80


Ireland

Servier Laboratories (Ireland) Ltd. Tel: + 353 (0)1 663 8110

Slovenija

Servier Pharma d. o. o. Tel: + 386 (0)1 563 48 11


Ísland

Servier Laboratories c/o Icepharma hf Sími: + 354 540 8000

Slovenská republika Servier Slovensko spol. s r.o. Tel: + 421 2 5920 41 11


Italia

Servier Italia S.p.A. Tel: + 39 (06) 669081

Suomi/Finland

Servier Finland Oy

P. /Tel: +358 (0)9 279 80 80


Κύπρος

CA Papaellinas Ltd.

Τηλ: + 357 22 741 741

Sverige

Servier Sverige AB

Tel : +46 (0)8 522 508 00


Latvija

SIA Servier Latvia Tel: + 371 67502039

United Kingdom (Northern Ireland)

Servier Laboratories (Ireland) Ltd Tel: +44 (0)1753 666409


This leaflet was last revised in




This leaflet is available in all EU/EEA languages on the European Medicines Agency website.

------------------------------------------------------------------------------------------------------------------------


The following information is intended for healthcare professionals only:


Detailed instructions for users


READ ENTIRE PREPARATION INSTRUCTIONS PRIOR TO RECONSTITUTION


Special precautions for use

Pixuvri is an anticancer medicinal product that is harmful to cells; caution should be exercised in handling. Avoid contact with eyes and skin. Use gloves, masks, and protective eyewear when

handling and during decontamination procedures. If Pixuvri (lyophilised powder or reconstituted

liquid solution) contacts the skin, wash the skin immediately and flush the membranes thoroughly with water.


Reconstitution/preparation for intravenous administration

Each single-use vial of Pixuvri contains pixantrone dimaleate equivalent to 29 mg pixantrone. After reconstitution with 5 ml sodium chloride 9 mg/ml (0.9%) solution for injection, each ml of

concentrate contains pixantrone dimaleate equivalent to 5.8 mg pixantrone.


Using sterile procedures, reconstitute each 29 mg vial with 5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection. The powder should completely dissolve in 60 seconds with agitation. This yields a dark blue solution with a pixantrone concentration of 5.8 mg/ml.


Using sterile procedures, withdraw the volume needed for the required dose (based on 5.8 mg/ml concentration) and further dilute with sodium chloride 9 mg/ml (0.9%) solution for injection to a final volume of 250 ml.


Compatibility with other diluents has not been determined. After transferring, thoroughly mix the contents of the infusion bag. The mixture should be a dark blue solution.

Polyethersulfone 0.2 µm pore size in-line filters should be used during administration of the diluted Pixuvri solution.


In-use storage conditions

Pixuvri does not contain anything to prevent the growth of bacteria and it is therefore recommended that it be used immediately after reconstitution. If not used immediately, in-use storage times and

conditions prior to use are the responsibility of the user and should not be longer than 24 hours at

2°C to 8°C.


The reconstituted and diluted solution is stable for up to 24 hours at room temperature (15°C to 25°C) and daylight exposure in standard polyethylene (PE) infusion bags.

Special precautions for disposal and handling

Pixuvri is a cytotoxic agent. Any unused product or waste material should be disposed of in accordance with local requirements.


Devices and surfaces accidentally contaminated with Pixuvri must be treated with a solution of sodium hypochlorite (100 µl of water and 20 µl of sodium hypochlorite [7 ± 2% of available chlorine] for 0.58 mg of Pixuvri).


Equipment such as vials, needles and syringes used for Pixuvri administration should be handled as toxic waste.