Faslodex 250 mg. 5 ml. 1 ampule

What Faslodex is and what it is used for
Faslodex contains the active substance fulvestrant, which belongs to the group of estrogen blockers. Estrogens, a type of female sex hormone, may in some cases be involved in the development of breast cancer.
Faslodex is used to treat advanced or metastatic breast cancer in postmenopausal women.

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 'What Faslodex ");
If you are pregnant or breast-feeding;
If you have severe liver problems.
Warnings and precautions
Tell your doctor if any of the following conditions apply to you:
Kidney or liver problems;
Decreased number of platelets (involved in blood clotting) or bleeding disorders;
Previous problems associated with blood clotting;
Osteoporosis (reduced bone density);
Alcoholism.
Children and adolescents
Faslodex is not indicated for use in children and adolescents under 18 years of age.

Other medicines and Faslodex
Please tell your doctor, nurse or pharmacist if you are taking or have recently taken any other medicines.
It is especially important to tell your doctor if you are using anticoagulants (medicines to prevent blood clots).

Pregnancy and breastfeeding
If you are pregnant, you should not use Faslodex. If you are able to become pregnant, you should use effective contraception during treatment with Faslodex.
You should not breast-feed while you are on Faslodex.

Driving and using machines
Faslodex is not expected to affect your ability to drive or use machines. However, if you feel unconscious after treatment, do not drive or operate machinery.

Faslodex contains 10% w / v. Ethanol (alcohol), i. E. To 1000 mg per dose equivalent to 20 ml of beer or 8 ml of wine per dose.
The preparation is harmful to people suffering from alcoholism.
This should be taken into consideration in pregnant or breast-feeding women, children and at risk patients such as those with liver disease or epilepsy.

3. How to use Faslodex
The recommended dose is 500 mg fulvestrant (two injections of 250 mg / 5 ml) once monthly plus one additional 500 mg dose two weeks after the first.
Your doctor or nurse will inject Faslodex as a slow intramuscular injection, one on each side of the seat.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.

You may need immediate treatment if you experience any of the following side effects:
Allergic reactions (hypersensitivity) including swelling of the face, lips, tongue and / or throat;
Thromboembolism (increased risk of thrombus formation) *;
Inflammation of the liver (hepatitis);
Hepatic failure.
Tell your doctor, pharmacist or nurse if you notice any of the following side effects:
Very common side effects (may affect more than 1 in 10 people):
Injection site reactions such as pain and / or inflammation;
Liver enzyme abnormalities (detected by blood test) *;
Nausea (lifting);
Weakness, fatigue *.
All other side effects:
Common side effects (may affect up to 1 in 10 people):
Headache;
Warm waves;
Vomiting, diarrhea, loss of appetite *;
Rash;
Urinary tract infections;
Back pains*;
Increase in bilirubin (bile pigment produced by the liver);
Thromboembolism (increased risk of blood clots) *;
Allergic reaction (hypersensitivity) including swelling of the face, lips, tongue and / or throat.
Uncommon side effects (may affect up to 1 in 100 people):
Vaginal bleeding, thick, whitish secretion and candidiasis (infection);
Bleeding and bleeding at the injection site;
Increase in GGT - a hepatic enzyme found in blood tests;
Inflammation of the liver (hepatitis);
Hepatic failure.
* Includes side effects for which the exact role of Faslodex can not be estimated with certainty due to the underlying disease.

If any of the side effects gets serious, tell your doctor, pharmacist or nurse. This includes all possible side effects not listed in this leaflet.

5. How to store Faslodex
Store and transport refrigerated (2 ° C - 8 ° C).
Temperature deviations outside the range of 2 ° C - 8 ° C should be limited. In addition, storage at temperatures above 30 ° C as well as storage for more than 28 days at an average temperature below 25 ° C (but above 2 ° C - 8 ° C) should be avoided. After any temperature deviations, the product should immediately return to the recommended storage conditions (stored and transported in the refrigerator at 2 ° C - 8 ° C). Temperature abnormalities have a cumulative effect on the quality of the product and the 28-day period should not be exceeded over the 4-year lifetime of Faslodex. Exposing the product to temperatures below 2 ° C will not harm it as long as it is not stored
Below -20 ° C.
The pre-filled syringe should be stored in the original package in order to protect from light.
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton or the label of the syringe after "EXP". The expiry date refers to the last day of that month.
Your healthcare professional is responsible for the proper storage, use and disposal of Faslodex.

6. Package Contents and Additional Information
What Faslodex contains
The active substance is fulvestrant. Each pre-filled syringe (5 ml) contains 250 mg of fulvestrant.
The other ingredients (excipients) are: ethanol (96%), benzyl alcohol, benzylbenzoate and castor oil.

What Faslodex looks like and contents of the pack
Faslodex is a clear, colorless to yellow viscous solution in a pre-filled syringe with an opaque cap containing 5 ml of solution for injection. To obtain the recommended monthly dose of 500 mg, two syringes should be injected.
Faslodex comes in two types of packs - either a pack containing 1 glass pre-filled syringe or a pack containing 2 glass pre-filled syringes. Also secured needles (BD SafetyGlide) are provided to connect with each syringe.
Not all pack sizes may be marketed.
The following information is intended for medical professionals only:
Faslodex 500 mg (2 x 250 mg / 5 ml solution for injection) should be administered by two pre-filled syringes, see section 3.
"BD SafetyGlide" is a trademark of "Becton Dickinson and Company" and bears CE marking: CE 0050.

Instructions for use
Caution - Do not sterilize the safety needle (subcutaneous needle with "BD SafetyGlide") in an autoclave before use. At all times during the use of the needle and the ejection, the hands should remain behind it.

For each of the two syringes:
Remove the glass body of the syringe from the box and make sure it is not damaged;
Break the seal of the Luer-Lock Luer Plug with the white plastic cap to remove the cap with the rubber cap attached;
Open the BD SafetyGlide needle outer packaging. Secure the secure needle to the Luer-Lock nozzle;
Turn it until it is firmly attached;
Turn to lock the needle in the Luer connector;
Pull the needle guard straight forward so as not to damage its tip;
Drag the syringe to the application site;
Remove the needle guard;
Prior to injection, solutions for parenteral administration should be examined for visible particulate matter and discoloration;
Eject excess air from the syringe;
Apply slowly intramuscularly (1-2 minutes / injection) in the seat. For the convenience of the injector, the tapered side of the needle is oriented toward the lever;
Immediately after one-finger injection, press the lever to activate the fuse.
NOTE: When activating, do not point the needle toward yourself or other people. Wait for a click and see if the tip of the needle is fully covered.

Disposal
Pre-filled syringes are for single use only. Any unused product or waste material should be disposed of in accordance with local requirements.

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