FASLODEX 250 mg /5 Ml Roztwór Do Wstrzykiwań

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1. Faslodex 250 mg solution for injection
   1. What is Faslodex and what is it used for
   2. What you need to know before using Faslodex
   3. How to use Faslodex
   4. Possible side effects
   5. How to store Faslodex
   6. Contents of the pack and other information

Faslodex 250 mg solution for injection

fulvestrant

Read this leaflet carefully before you start to use this medicine because it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Faslodex is and what it is used for
• 2. What you need to know before you use Faslodex
• 3. How to use Faslodex
• 4. Possible side effects
• 5. How to store Faslodex
• 6. Contents of the pack and other information

1. What is Faslodex and what is it used for

Faslodex contains the active substance fulvestrant, which belongs to the group of estrogen blockers. Estrogens, a type of female sex hormones, can in some cases be involved in the growth of breast cancer.
Faslodex is used both:

• alone, for the treatment of postmenopausal women with a type of breast cancer called estrogen receptor-positive locally advanced or metastatic breast cancer, or
• in combination with palbociclib for the treatment of women with a type of breast cancer called hormone receptor-positive, human epidermal growth factor receptor 2 (HER2) negative, which is locally advanced or metastatic. Women who are not yet menopausal will be treated with a medicine called a luteinizing hormone-releasing hormone (LHRH) agonist.

When Faslodex is administered in combination with palbociclib, it is also important to read the package leaflet of palbociclib. If you have any doubts about the use of palbociclib, ask your doctor.

2. What you need to know before using Faslodex

Do not use Faslodex

• if you are allergic to fulvestrant or any of the other ingredients of this medicine (listed in section 6)
• if you are pregnant or breastfeeding
• if you suffer from serious liver diseases

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Faslodex if you are in any of the
following conditions:

• kidney or liver problems
• low number of platelets (which help blood clotting) or bleeding problems
• previous problems with blood clots
• osteoporosis (loss of bone density)
• alcoholism

Children and adolescents
Faslodex is not indicated in children and adolescents under 18 years of age.

Other medicines and Faslodex
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
In particular, you should tell your doctor if you are using anticoagulants (medicines that prevent
blood clots).

Pregnancy and breastfeeding
You must not use Faslodex if you are pregnant. If there is a possibility that you may become
pregnant, you must use effective contraceptive measures during treatment with Faslodex and for 2 years
after the last dose.
You must not breastfeed during treatment with Faslodex.

Driving and using machines
Faslodex is not expected to affect your ability to drive or use machines, however, if you feel
tired after treatment do not drive or use machines.

Faslodex contains 10% weight/volume of ethanol (alcohol), i.e. up to 500 mg per injection,
equivalent to 10 ml of beer or 4 ml of wine.
It is harmful to those suffering from alcoholism.
Exercise caution in high-risk groups such as patients with liver disorders or epilepsy.

Faslodex contains 500 mg of benzyl alcohol per injection, equivalent to 100 mg/ml.
Benzyl alcohol can cause allergic reactions.

Faslodex contains 750 mg of benzyl benzoate per injection, equivalent to 150 mg/ml.

3. How to use Faslodex

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts
consult your doctor or pharmacist.
The recommended dose is 500 mg of fulvestrant (two 250 mg/5 ml injections) administered once a
month with an additional 500 mg dose administered 2 weeks after the initial dose.
Your doctor or nurse will administer Faslodex with a slow intramuscular injection, one in
each buttock.
If you have any doubts, consult your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Immediate medical attention may be necessary if any of the following side effects occur:

• Allergic reactions (hypersensitivity), including swelling of the face, lips, tongue and/or throat, which may be signs of anaphylactic reactions
• Thromboembolism (increased risk of blood clots)*
• Inflammation of the liver (hepatitis)
• Liver failure

If any of the following side effects occur, tell your doctor, pharmacist or
nurse:
Very common side effects (may affect more than 1 in 10 people)

• Reactions at the injection site, such as pain and/or inflammation
• Abnormal levels of liver enzymes (in blood tests)*
• Nausea (feeling unwell)
• Weakness, fatigue*
• Musculoskeletal and joint pain
• Hot flushes
• Skin rash
• Allergic reactions (hypersensitivity), including swelling of the face, lips, tongue and/or throat

All other side effects:
Common side effects (may affect up to 1 in 10 people)

• Headache
• Vomiting, diarrhea or loss of appetite*
• Urinary tract infections
• Back pain*
• Increased levels of bilirubin (a pigment of bile produced by the liver)
• Thromboembolism (increased risk of blood clots)*
• Reduced levels of platelets (thrombocytopenia)
• Vaginal bleeding
• Pain in the lower back that radiates down the leg (sciatica)
• Sudden weakness, numbness, tingling, or loss of movement in the leg, especially on one side of the body, sudden problems with walking or balance (peripheral neuropathy)

Uncommon side effects (may affect up to 1 in 100 people)

• Thick, white vaginal discharge and candidiasis (infection)
• Bruising and bleeding at the injection site
• Increased levels of gamma-GT, a liver enzyme detected by blood tests
• Inflammation of the liver (hepatitis)
• Liver failure
• Numbness, tingling and pain
• Anaphylactic reactions

*Includes adverse drug reactions for which the exact contribution of Faslodex cannot be assessed
because of the underlying disease.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed
in this leaflet. You can also report side effects directly through the
national reporting system listed in Annex V. By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Faslodex

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 pack or on the label of the
syringe after the abbreviation Exp. The expiry date refers to the last day of that month.
Store and transport in a refrigerator (2°C - 8°C).
Temperature excursions outside of 2°C - 8°C should be limited. This includes avoiding
storage at temperatures above 30°C, and not exceeding a period of 28 days at a
mean storage temperature of the product below 25°C (but above 2 - 8°C). After
temperature excursions, the product must be immediately returned to the recommended storage
conditions (store and transport in a refrigerator 2°C - 8°C). Temperature excursions have a cumulative effect on product quality and the period of 28 days must not be exceeded during the
4-year shelf life of Faslodex. Exposure to temperatures below 2°C does not
damage the product provided it is not stored at temperatures below -20°C.
Store the pre-filled syringe in the original packaging to protect the medicine from light.
Healthcare professionals will be responsible for the correct storage, use and disposal of
Faslodex.
This medicine may pose a risk to the environment. Do not dispose of any medicine in
drain water and household waste. Ask your pharmacist how to dispose of medicines that you no longer use.
This will help protect the environment.

6. Contents of the pack and other information

What Faslodex contains

• The active substance is fulvestrant. Each pre-filled syringe (5 ml) contains fulvestrant 250 mg.
• The other ingredients (excipients) are ethanol (96 percent), benzyl alcohol, benzyl benzoate and refined castor oil.

Description of Faslodex and contents of the pack
Faslodex is a clear solution, from colourless to yellow viscous in a pre-filled syringe assembled with
a tamper-evident closure, containing 5 ml of solution for injection. To receive the recommended monthly
dose of 500 mg, two syringes must be administered.
Faslodex is available in two packs, either a pack containing one pre-filled glass syringe
or a pack containing two pre-filled glass syringes. Safety needles
with a device (BD SafetyGlide) are also provided for connection to each syringe body.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
AstraZeneca AB
SE-151 85 Södertälje
Sweden

Manufacturer
AstraZeneca AB
Karlebyhusentrén
Astraallén
SE-152 57 Södertälje
Sweden
For further information on this medicinal product, 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 40 809034100

Nederland
AstraZeneca BV
Tel: +31 85 808 9900

Eesti
AstraZeneca
Tel: +372 6549 600

Norge
AstraZeneca AS
Tlf: +47 21 00 64 00

Ελλάδα
AstraZeneca A.E.
Τηλ: + 30 2 106871500

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
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 00704500

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 (Northern Ireland)
AstraZeneca UK Ltd
Tel: +44 1582 836 836

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines
Agency: http://www.ema.europa.eu .
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The following information is intended exclusively for healthcare professionals:
Faslodex 500 mg (2x250 mg/5 ml solution for injection) must be administered using two pre-filled
syringes, see section 3.
Instructions for administration
Warnings - Do not autoclave the needle with the protection device (BD SafetyGlide Hypodermic Needle with
Protection) before use. Hands must remain behind the needle throughout use and disposal.
For each of the two syringes:

• Remove the glass syringe body from the tray and check that it is not damaged.
• Remove the safety needle (SafetyGlide) from the outer packaging.
• Before administration, parenteral solutions must be visually inspected for particulate contamination and discoloration.
• Hold the syringe in a vertical position on the knurled part
• (C). With the other hand, grasp the cap (A) and carefully tilt back and forth until the cap detaches and can be removed, do not rotate (see Figure 1) Figure 1

• Remove the cap (A) by pulling it straight up. To ensure sterility, do not touch the syringe tip (B) (see Figure 2). Figure 2

• Attach the safety needle to the Luer-Lok and rotate to lock securely (see Figure 3).
• Check that the needle is fixed to the Luer connector before removing it outside the vertical plane
• Quickly remove the needle protection to avoid damage to the needle tip.
• Bring the filled syringe to the injection site.
• Remove the needle sheath.
• Expel excess gas from the syringe. Figure 3

• Administer slowly (1 or 2 minutes/injection) intramuscularly into the gluteus (gluteal area). For user convenience, the “bevelled” needle tip is aligned with the lever arm (see Figure 4). Figure 4

• After the injection, immediately apply the force of a single finger on the lever arm with assisted activation to activate the protection mechanism (see Figure 5). NOTE: activate it away from yourself and others. Hear the click and visually confirm that the needle tip is completely covered. Figure 5

Disposal
The pre-filled syringes are for singleuse only.
This medicinal product may pose a risk to the environment. Unused medicinal product and waste derived
from this medicinal product must be disposed of in accordance with local regulations.