What Faslodex contains
- The active substance is fulvestrant. Each pre-filled syringe (5 ml) contains 250 mg fulvestrant.
- The other ingredients are ethanol (96 per cent), benzyl alcohol, benzyl benzoate and castor oil.
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 UK Limited
AstraZeneca UK Limited
Silk Road Business Park
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder (see contacts list):
BelgiëBelgiqueBelgien NV AstraZeneca SA Tel 32 2 370 48 11 LuxembourgLuxemburg NV AstraZeneca SA TélTel 32 2 370 48 11
AstraZeneca UK Limited . 359 2 971 25 33 Magyarország AstraZeneca Kft Tel 36 1 883 6500
eská republika AstraZeneca Czech Republic s.r.o. Tel 420 222 807 111 Malta Associated Drug Co. Ltd Tel 356 2277 8000
Danmark AstraZeneca AS Tlf 45 43 66 64 62 Nederland AstraZeneca BV Tel 31 79 363 2222
Tlf: +47 21 00 64 00
Tel: +49 41 03 7080
Eesti AstraZeneca Tel 372 6549 600 Österreich AstraZeneca Österreich GmbH Tel 43 1 711 31 0
AstraZeneca A.E. 30 2 106871500 Polska AstraZeneca Pharma Poland Sp. z o.o. Tel. 48 22 874 35 00
España AstraZeneca Farmacéutica Spain, S.A. Tel 34 91 301 91 00 Portugal AstraZeneca Produtos Farmacêuticos, Lda. Tel 351 21 434 61 00
France AstraZeneca Tél 33 1 41 29 40 00 România AstraZeneca Pharma SRL Tel 40 21 317 60 41
Ireland AstraZeneca Pharmaceuticals Ireland Ltd Tel 353 1609 7100 Slovenija AstraZeneca UK Limited Tel 386 1 51 35 600
Ísland Vistor hf. Sími 354 535 7000 Slovenská republika AstraZeneca AB o.z. Tel. 421 2 5737 7777
Italia AstraZeneca S.p.A. Tel 39 02 9801 1 SuomiFinland AstraZeneca Oy PuhTel 358 10 23 010
357 22490305 Sverige AstraZeneca AB Tel 46 8 553 26 000
Latvija AstraZeneca AB prstvniecba Latvij Tel 371 67377100 United Kingdom AstraZeneca UK Ltd Tel 44 1582 836 836
UAB AstraZeneca Lietuva
Tel: +370 5 2660550
This leaflet was last approved in
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.
BD SafetyGlide is a trademark of Becton Dickinson and Company and is CE-marked: CE 0050.
Instructions for administration
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:
Remove glass syringe barrel from tray and check that it is Figure 1 not damaged. Break the seal of the white plastic cover on the syringe Luer connector Luer-Lok to remove the cover with the attached rubber tip cap see Figure 1.
Peel open the safety needle BD SafetyGlide outer Figure 2 packaging. Attach the safety needle to the Luer-Lok see Figure 2 Twist until firmly seated. Twist to lock the needle to the Luer connector. Pull shield straight off needle to avoid damaging needle point. Transport filled syringe to point of administration. Remove needle sheath. Parenteral solutions must be inspected visually for particulate matter and discolouration prior to administration. Expel excess gas from the syringe.
- Administer intramuscularly slowly (1-2 minutes/injection) Figure 3 into the buttock. For user convenience, the needle bevel- up position is oriented to the lever arm (see Figure 3).
- After injection, immediately apply a single-finger stroke to Figure 4 the activation assisted lever arm to activate the shielding mechanism (see Figure 4). NOTE: Activate away from self and others. Listen for click and visually confirm needle tip is fully covered.
Pre-filled syringes are for single use only.
Any unused product or waste material should be disposed of in accordance with local requirements.