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AstraZeneca

Vectibix
panitumumab

Package Leaflet: Information for the user


Vectibix 20 mg/mL concentrate for solution for infusion

panitumumab


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



What Vectibix looks like and contents of the pack


Vectibix is a colourless liquid that may contain visible particles and is supplied in a glass vial. Each pack contains one vial.


Marketing Authorisation Holder and Manufacturer

Amgen Europe B.V. Minervum 7061

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4817 ZK Breda The Netherlands


Marketing Authorisation Holder

Amgen Europe B.V. Minervum 7061

4817 ZK Breda The Netherlands

Manufacturer

Amgen Technology (Ireland) Unlimited Company Pottery Road

Dun Laoghaire Co Dublin Ireland


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Manufacturer Amgen NV Telecomlaan 5-7

1831 Diegem Belgium


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


België/Belgique/Belgien

s.a. Amgen n.v.

Tel/Tél: +32 (0)2 7752711

Lietuva

Amgen Switzerland AG Vilniaus filialas Tel: +370 5 219 7474


България

Амджен България ЕООД Тел.: +359 (0)2 424 7440

Luxembourg/Luxemburg

s.a. Amgen Belgique/Belgien

Tel/Tél: +32 (0)2 7752711


Česká republika

Amgen s.r.o.

Tel: +420 221 773 500

Magyarország

Amgen Kft.

Tel.: +36 1 35 44 700


Danmark

Amgen, filial af Amgen AB, Sverige Tlf: +45 39617500

Malta Amgen S.r.l. Italy

Tel: +39 02 6241121


Deutschland

Amgen GmbH

Tel.: +49 89 1490960

Nederland

Amgen B.V.

Tel: +31 (0)76 5732500


Eesti

Amgen Switzerland AG Vilniaus filialas Tel: +372 586 09553

Norge

Amgen AB

Tel: +47 23308000


Ελλάδα

Amgen Ελλάς Φαρμακευτικά Ε.Π.Ε. Τηλ.: +30 210 3447000

Österreich

Amgen GmbH

Tel: +43 (0)1 50 217


España

Amgen S.A.

Tel: +34 93 600 18 60

Polska

Amgen Biotechnologia Sp. z o.o. Tel.: +48 22 581 3000


France

Amgen S.A.S.

Tél: +33 (0)9 69 363 363

Portugal

Amgen Biofarmacêutica, Lda. Tel: +351 21 4220606

Hrvatska

Amgen d.o.o.

Tel: +385 (0)1 562 57 20

România

Amgen România SRL Tel: +4021 527 3000


Ireland

Amgen Ireland Limited Tel: +353 1 8527400

Slovenija

AMGEN zdravila d.o.o. Tel: +386 (0)1 585 1767


Ísland

Vistor hf.

Sími: +354 535 7000

Slovenská republika Amgen Slovakia s.r.o. Tel: +421 2 321 114 49


Italia

Amgen S.r.l.

Tel: +39 02 6241121

Suomi/Finland

Amgen AB, sivuliike Suomessa/Amgen AB, filial i Finland

Puh/Tel: +358 (0)9 54900500


Kύπρος

C.A. Papaellinas Ltd Τηλ.: +357 22741 741

Sverige

Amgen AB

Tel: +46 (0)8 6951100


Latvija

Amgen Switzerland AG Rīgas filiāle Tel: +371 257 25888

United Kingdom (Northern Ireland)

Amgen Limited

Tel: +44 (0)1223 420305


This leaflet was last revised in


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The following information is intended for healthcare professionals only:


Vectibix is intended for single use only. Vectibix should be diluted in sodium chloride 9 mg/mL (0.9%) solution for injection by healthcare professional using aseptic technique. Do not shake or vigorously agitate the vial. Vectibix should be inspected visually prior to administration. The solution should be colourless and may contain visible translucent-to-white, amorphous, proteinaceous particulates (which will be removed by in-line filtration). Do not administer Vectibix if its appearance is not as described above. Using only a 21-gauge or smaller diameter hypodermic needle, withdraw the necessary amount of Vectibix for a dose of 6 mg/kg. Do not use needle-free devices (e.g. vial adapters) to withdraw vial contents. Dilute in a total volume of 100 mL. Doses higher than 1,000 mg should be diluted in 150 mL sodium chloride 9 mg/mL (0.9%) solution for injection. The final concentration should not exceed 10 mg/mL. The diluted solution should be mixed by gentle inversion, do not shake.


Vectibix does not contain any antimicrobial preservative or bacteriostatic agent. The product should be used immediately after dilution. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should be no longer than 24 hours at 2°C – 8°C. The diluted solution must not be frozen.


Discard the vial and any liquid remaining in the vial after the single-use.


The infusion line should be flushed with sodium chloride solution before and after Vectibix administration to avoid mixing with other medicinal products or intravenous solutions.

Vectibix must be administered as an intravenous infusion via an infusion pump, using a low protein binding 0.2 or 0.22 micrometre in-line filter, through a peripheral line or indwelling catheter. The recommended infusion time is approximately 60 minutes. Doses higher than 1,000 mg should be infused over approximately 90 minutes.


No incompatibilities have been observed between Vectibix and sodium chloride 9 mg/mL (0.9%) solution for injection in polyvinyl chloride bags or polyolefin bags.