ERIBULIN 0.44 mg/ml Roztwór do wstrzykiwań

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1. Eribulin Baxter 0.44 mg/mL injectable solution
   1. What is Eribulin Baxter and what is it used for
   2. What you need to know before using Eribulin Baxter
   3. How to use Eribulin Baxter
   4. Possible side effects
   5. How to store Eribulin Baxter
   6. Package contents and other information

Eribulin Baxter 0.44 mg/mL injectable solution

eribulina

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If any side effects occur, including those not listed in this leaflet, ask your doctor or nurse. See section 4. Contents of this leaflet
• 1. What Eribulin Baxter is and what it is used for
• 2. What you need to know before using Eribulin Baxter
• 3. How to use Eribulin Baxter
• 4. Possible side effects
• 5. How to store Eribulin Baxter
• 6. Contents of the pack and other information

1. What is Eribulin Baxter and what is it used for

Eribulin Baxter contains the active substance eribuline and is an antineoplastic medicine that works
by stopping the growth and spread of cancer cells.
It is used in adults for locally advanced or metastatic breast cancer (breast cancer that has spread beyond the original tumor) when at least one other therapy has been attempted, but
has not been effective.
It is also used in adults for advanced or metastatic liposarcoma (a type of cancer that
originates from fatty tissue) when a previous therapy has been attempted, but has not been effective.

2. What you need to know before using Eribulin Baxter

Do not use Eribulin Baxter

• if you are allergic to eribulin mesylate or any of the other ingredients of this medicine (listed in section 6).
• if you are breastfeeding.

Warnings and precautions
Talk to your doctor or nurse before using Eribulin Baxter:

• if you have liver problems
• if you have a fever or an infection
• if you experience pain, tingling, prickling sensations, sensitivity to touch or muscle weakness
• if you have heart problems

If any of these apply to you, tell your doctor, who may decide to stop treatment or to
reduce the dose.

Children and adolescents
Do not give this medicine to children aged between 0 and 18 years because it is not effective.

Other medicines and Eribulin Baxter
Tell your doctor if you are taking, have recently taken or might take any other medicines.

Pregnancy, breastfeeding and fertility
Eribulin Baxter can cause serious birth defects and must not be used during
pregnancy unless absolutely necessary and after careful consideration of all the risks to you
and to the baby. It can also cause future permanent fertility problems in men undergoing
treatment; therefore, you need to discuss this with your doctor before starting
treatment. Women of childbearing potential must use effective contraception during and for up to 3 months
after treatment with Eribulin Baxter.
Eribulin Baxter must not be used during breastfeeding, due to the possible
risks to the baby.

Driving and using machines
Eribulin Baxter can cause side effects such as fatigue (very common) and dizziness
(common). Do not drive or use machines if you feel tired or dizzy.

Eribulin Baxter contains anhydrous ethanol
This medicine contains 78.9 mg (0.1 mL) of anhydrous ethanol in each vial. The amount in
2 mL of this medicine is equivalent to 2 mL of beer or less than 1 mL of wine. The small amount
of alcohol in this medicine will not have any significant effects.

Eribulin Baxter contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. essentially
'sodium-free'.

3. How to use Eribulin Baxter

Eribulin Baxter will be administered to you by a qualified healthcare professional, via injection into a
vein, over 2-5 minutes. The dose that will be administered to you is based on your body surface area
(expressed in square meters, or m²), calculated on the basis of your weight and height. The usual dose of Eribulin Baxter is 1.23 mg/m², but this dose may be adjusted by the doctor based on the
results of blood tests or other factors. To ensure that the entire dose of Eribulin Baxter
is administered, it is recommended that a physiological solution is injected through the same
infusion line into the vein after the administration of Eribulin Baxter.

How often will Eribulin Baxter be administered to you?
Eribulin Baxter is usually administered on day 1 and day 8 of each 21-day cycle. The
doctor will determine the number of treatment cycles. Depending on the results of blood tests, the
doctor may decide to postpone the administration of the medicine until the values return to
normal. The doctor may also decide to reduce the dose to be administered.
If you have any doubts about the use of this medicine, please consult your doctor.

4. Possible side effects

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

If you experience any of the following serious symptoms,stop taking Eribulin Baxter and consult your
doctor immediately:

• fever, with a rapid heartbeat, shallow rapid breathing, cold, pale, moist or mottled skin and/or confusion. These may be signs of a condition called sepsis: a serious and intense reaction to an infection. Sepsis has an uncommon frequency (may affect up to 1 in 100 people) and can be very dangerous and life-threatening.
• difficulty breathing or swelling of the face, mouth, tongue or throat. These may be signs of an uncommon allergic reaction (may affect up to 1 in 100 people).
• severe skin rash with blistering on skin, mouth, eyes and genitals, which may be signs of a condition called Stevens-Johnson syndrome/toxic epidermal necrolysis. This condition has an unknown frequency but can be life-threatening.

Other side effects:
Very common side effects (may affect more than 1 in 10 people) are:

• decreased number of white blood cells or red blood cells
• fatigue or weakness
• nausea, vomiting, constipation, diarrhea
• sensations of numbness, tingling or prickling
• fever
• loss of appetite, weight loss
• difficulty breathing, cough
• joint, muscle and back pain
• headache
• hair loss

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

• reduction in the number of platelets (which can cause bruising or an increased time it takes to stop bleeding)
• infection with fever, pneumonia, chills
• fast heartbeat, hot flushes
• dizziness, lightheadedness
• increased tear production, conjunctivitis (redness and pain on the surface of the eye), nosebleeds
• dehydration, dry mouth, cold sores, oral thrush, indigestion, heartburn, abdominal pain or swelling
• swelling of soft tissues, pain (especially in the chest, back and bones), muscle spasm or weakness
• infections of the mouth, respiratory tract and urinary tract, pain when urinating
• sore throat, irritated or runny nose, flu-like symptoms, sore throat
• abnormalities in liver function tests, altered levels of sugars, bilirubin, phosphates, potassium, magnesium or calcium in the blood
• difficulty sleeping, depression, taste alterations
• skin rash, itching, nail problems, dry or red skin
• excessive sweating (including night sweats)
• ringing in the ears
• blood clots in the lungs
• shingles
• swelling of the skin and numbness of the hands and feet

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

• blood clots
• abnormalities in liver function tests (hepatotoxicity)
• kidney failure, blood or protein in the urine
• widespread inflammation of the lungs, which can lead to scarring
• inflammation of the pancreas
• mouth ulcers

Rare side effects (may affect up to 1 in 1,000 people) are:

• serious blood clotting disorder, which causes widespread blood clots and internal bleeding. Reporting of side effectsIf you get any side effects, talk to your doctor or nurse. This includes any possible 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 Eribulin Baxter

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 package and vial after
Exp. The expiry date refers to the last day of that month.
Store at a temperature below 30 °C.

If Eribulin Baxter is diluted for infusion:
Chemical and physical stability during use of the diluted solution has been demonstrated for 24 hours at a
temperature of 15-25 °C and for 72 hours at a temperature of 2°C -8 °C.
From a microbiological point of view, the medicine must be used immediately. If not
used immediately, the storage times and conditions during use are the responsibility of the
user and should generally not exceed 24 hours at a temperature of 2°C -8 °C, unless
the dilution has taken place under controlled and validated aseptic conditions.

If Eribulin Baxter as an undiluted solution has been transferred into a syringe:
Chemical and physical stability during use of the undiluted solution in a syringe has been demonstrated
for 4 hours at a temperature of 15-25 °C and for 24 hours at a temperature of 2°C -8 °C.
The vials of Eribulin Baxter are for single use only. Discard any unused portions of
Eribulin Baxter.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Eribulin Baxter contains

• The active substance is eribuline. Each 2 mL vial contains eribuline mesylate equivalent to 0.88 mg of eribuline.
• The other ingredients are anhydrous ethanol and water for injections; concentrated hydrochloric acid (for pH adjustment) and sodium hydroxide (for pH adjustment) may be present in very small quantities.

Description of the appearance of Eribulin Baxter and contents of the pack
Eribulin Baxter is a clear and colourless aqueous solution for injection, essentially free from
visible particulate matter, supplied in glass vials containing 2 mL of solution. Each pack contains
1 vial.

Marketing Authorisation Holder
Baxter Holding B.V.
Kobaltweg 49
3542 CE, Utrecht
Netherlands

Manufacturer
Baxter Oncology GmbH
Kantstraße 2
33790 Halle/Westfalen
Germany
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Baxter Belgium SPRL/BVBA
Tél/Tel: +32 (0)2 386 80 00
[email protected]

Lietuva
UAB „Baxter Lithuania“
Tel: +37052527100

България
Baxter Holding B.V.
Тел.: +31 (0)30 2488 911

Luxembourg/Luxemburg
Baxter Belgium SPRL/BVBA
Tél/Tel: +32 (0)2 386 80 00
[email protected]

Česká republika
BAXTER CZECH spol. s r.o.
Tel: +420 225 774 111

Magyarország
Baxter Hungary Kft.
Tel: +36 1 202 1980

Danmark
Baxter A/S
Tlf: +45 4816 6400

Malta
Baxter Holding B.V.
Tel: +44 (0)1635 206345

Deutschland
Baxter Deutschland GmbH
Tel: +49 (0)89 31701-0
[email protected]

Nederland
Baxter B.V.
Tel: +31 (0)30 2488 911
[email protected]

Eesti
OÜ Baxter Estonia
Tel: +372 651 5120

Norge
Baxter AS
Tlf: +47 22 58 48 00

Ελλάδα
Baxter (Hellas) Ε.Π.Ε.,
Τηλ: +30 210 28 80 000

Österreich
Baxter Healthcare GmbH
Tel: +43 1 71120 0
[email protected]

España
Baxter S.L.
Tel: +34 91 678 93 00

Polska
Baxter Polska Sp. z o.o.
Tel: +48 22 488 37 77

France
Baxter SAS
Tél: +33 1 34 61 50 50

Portugal
Baxter Médico Farmacêutica, Lda.
Tel: +351 21 925 25 00

Hrvatska
Baxter Healthcare d.o.o.
Tel: +385 1 6610314

România
BAXTER HEALTHCARE SRL
Tel: +40 372 302 053

Ireland
Baxter Holding B.V.
Tel: +44 (0)1635 206345

Slovenija
Baxter d.o.o.
Tel: +386 1 420 16 80

Ísland
Baxter Medical AB
Sími: +46 8 632 64 00

Slovenská republika
Baxter Slovakia s.r.o.
Tel: +421 2 32 10 11 50

Italia
Baxter S.p.A.
Tel: +390632491233

Suomi/Finland
Baxter Oy
Puh/Tel: +358 (09) 862 111

Κύπρος
Baxter Holding B.V.
Τηλ: +31 (0)30 2488 911

Sverige
Baxter Medical AB
Tel: +46 (0)8 632 64 00

United Kingdom (Northern Ireland)
Baxter Holding B.V.
Tel: +44 (0)1635 206345
Baxter is a registered trademark of Baxter International Inc.
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, https://www.ema.europa.eu/ .

Latvija
Baxter Latvia SIA
Tel: +371 677 84784