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AstraZeneca

Faslodex
fulvestrant

Package leaflet: Information for the user


Faslodex 250 mg solution for injection

fulvestrant


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


What Faslodex looks like and contents of the pack

Faslodex is a clear, colourless to yellow, viscous solution in a pre-filled syringe fitted with a

tamper-evident closure, containing 5 ml solution for injection. Two syringes must be administered to receive the 500 mg recommended monthly dose.


Faslodex has 2 pack presentations, either a pack containing 1 glass pre-filled syringe or a pack containing 2 glass pre-filled syringes. Safety needles (BD SafetyGlide) for connection to each barrel are also provided.


Not all pack sizes may be marketed.


Marketing Authorisation Holder

AstraZeneca AB

SE-151 85 Södertälje Sweden


Manufacturer

AstraZeneca AB

Global External Sourcing (GES) Astraallén

Gärtunaporten

SE-151 85 Södertälje Sweden

AstraZeneca UK Limited Silk Road Business Park Macclesfield

Cheshire SK10 2NA

United Kingdom


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


België/Belgique/Belgien AstraZeneca S.A./N.V. Tel: +32 2 370 48 11

Lietuva

UAB AstraZeneca Lietuva Tel: +370 5 2660550


България

АстраЗенека България ЕООД

Тел.: +359 24455000

Luxembourg/Luxemburg AstraZeneca S.A./N.V. Tél/Tel: +32 2 370 48 11


Česká republika

AstraZeneca Czech Republic s.r.o. Tel: +420 222 807 111

Magyarország AstraZeneca Kft Tel: +36 1 883 6500


Danmark AstraZeneca A/S Tlf: +45 43 66 64 62

Malta

Associated Drug Co. Ltd

Tel: +356 2277 8000


Deutschland AstraZeneca GmbH Tel: +49 41 03 7080

Nederland

AstraZeneca BV

Tel: +31 79 363 2222


Eesti

AstraZeneca

Tel: +372 6549 600

Norge

AstraZeneca AS

Tlf: +47 21 00 64 00


Ελλάδα

AstraZeneca A.E.

Τηλ: + 30 210 6871500

Österreich

AstraZeneca Österreich GmbH Tel: +43 1 711 31 0


España

AstraZeneca Farmacéutica Spain, S.A. Tel: +34 91 301 91 00

Polska

AstraZeneca Pharma Poland Sp. z o.o. Tel.: +48 22 245 73 00


France

AstraZeneca

Tél: +33 1 41 29 40 00

Portugal

AstraZeneca Produtos Farmacêuticos, Lda. Tel: +351 21 434 61 00


Hrvatska AstraZeneca d.o.o. Tel: +385 1 4628 000

România

AstraZeneca Pharma SRL

Tel: +40 21 317 60 41


Ireland

AstraZeneca Pharmaceuticals (Ireland) DAC Tel: +353 1609 7100

Slovenija

AstraZeneca UK Limited Tel: +386 1 51 35 600


Ísland Slovenská republika

Vistor hf.

Sími: +354 535 7000

AstraZeneca AB, o.z. Tel: +421 2 5737 7777


Italia

AstraZeneca S.p.A. Tel: +39 02 9801 1

Suomi/Finland

AstraZeneca Oy

Puh/Tel: +358 10 23 010


Κύπρος

Αλέκτωρ Φαρµακευτική Λτδ Τηλ: +357 22490305

Sverige

AstraZeneca AB

Tel: +46 8 553 26 000


Latvija

SIA AstraZeneca Latvija Tel: +371 67377100

United Kingdom AstraZeneca UK Ltd Tel: +44 1582 836 836


This leaflet was last revised in


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The following information is intended for healthcare professionals only:


Faslodex 500 mg (2 x 250 mg/5 ml solution for injection) should be administered using two pre-filled syringes, see section 3.


Instructionsforadministration

Warning - Do not autoclave safety needle (BD SafetyGlide Shielding Hypodermic Needle) before use. Hands must remain behind the needle at all times during use and disposal.


For each of the two syringes:


NOTE: Activate away from self and others. Listen for click and visually confirm needle tip is fully covered.

Figure 2


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Figure 3


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Figure 4


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Figure 5


Disposal

Pre-filled syringes are for single use only.

This medicine may pose a risk to the aquatic environment. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.