ERIBULINA 0.44 MG/ML Инъекционный раствор

Содержание инструкции

1. Eribulina Advanz Pharma 0.44 mg/mL injectable solution
   1. What is Eribulina Advanz Pharma and what is it used for
   2. What you need to know before you use Eribulina Advanz Pharma
   3. How to use Eribulina Advanz Pharma
   4. Possible side effects
   5. How to store Eribulina Advanz Pharma
   6. Contents of the pack and other information

Eribulina Advanz Pharma 0.44 mg/mL injectable solution

eribulina

Generic medicine

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 you experience any side effects, including those not listed in this leaflet, ask your doctor or nurse. See section 4.

Contents of this leaflet:

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

1. What is Eribulina Advanz Pharma and what is it used for

Eribulina Advanz Pharma contains the active substance eribulina and is an antineoplastic medicine that
works by stopping the growth and spread of cancer cells.
It is used in adults for metastatic or locally advanced 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 tumor that
originates from fatty tissue) when a previous therapy has been attempted, but has not been effective.

2. What you need to know before you use Eribulina Advanz Pharma

Do not use Eribulina Advanz Pharma

• if you are allergic to eribulin mesylate or to 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 you use Eribulina Advanz Pharma:

• 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 Eribulina Advanz Pharma
Tell your doctor if you are taking, have recently taken or might take any other medicines.

Pregnancy, breastfeeding and fertility
This medicine 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 and therefore you need to discuss this with your doctor before starting the
treatment. Women of childbearing potential must use effective contraception during and for up to 3 months
after treatment with Eribulina Advanz Pharma.
This medicine must not be used during breastfeeding, due to the possible
risks to the baby.

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

Eribulina Advanz Pharma contains ethanol (alcohol)
This medicine contains small amounts of ethanol (alcohol) less than 100 mg per vial.

3. How to use Eribulina Advanz Pharma

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

How often will Eribulina Advanz Pharma be administered to you?
This medicine 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 blood test results, the
doctor may decide to postpone 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 Eribulina Advanz Pharma and
consult your doctor immediately:

• fever, with a rapid heartbeat, shallow rapid breathing, cold, pale, clammy 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 rashes 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):

• 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):

• reduction in the number of platelets (which can cause bruising or an increase in the time it takes to stop bleeding)
• infection with fever, pneumonia, chills
• rapid heartbeat, hot flushes
• dizziness, lightheadedness
• increased production of tears, conjunctivitis (redness and pain on the surface of the eye), nosebleeds
• dehydration, dry mouth, cold sores, thrush, indigestion, heartburn, pain or swelling in the abdomen
• 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, altered sense of taste
• rash, itching, nail problems, dry or red skin
• excessive sweating (including night sweats)
• ringing in the ears
• blood clots in the lungs
• shingles (herpes zoster)
• swelling of the skin and numbness in the hands and feet

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

• 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 1000 people):

• severe blood clotting disorder, which causes widespread blood clots and internal bleeding.

Reporting of side effects
If you get any side effects, talk to your doctor or nurse. You can also report side effects directly through the national reporting system:
Website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Eribulina Advanz Pharma

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 after “Exp.” and on the
vial after “Exp”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
If Eribulina Advanz Pharma is diluted for infusion, the diluted solution must be used
immediately. If not used immediately, the diluted solution should not be stored
for more than 48 hours at 25°C and ambient lighting or 72 hours at 2°C-8°C.
If Eribulina Advanz Pharma as an undiluted solution has been transferred into a syringe, it must be
stored at 25°C and in ambient light conditions for no more than 48 hours, or 72 hours at 2°C-8°C.
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. Contents of the pack and other information

What Eribulina Advanz Pharma contains

• The active substance is eribuline. One mL of solution contains eribuline mesylate equivalent to 0.44 mg of eribuline. Each vial of 2 mL contains eribuline mesylate equivalent to 0.88 mg of eribuline.
• The other ingredients are anhydrous ethanol and water for injections, with hydrochloric acid and sodium hydroxide, possibly present in very small amounts.

Description of the appearance of Eribulina Advanz Pharma and contents of the pack
Eribulina Advanz Pharma is a clear and colorless solution, free from visible particles and is supplied in
glass vials containing 2 mL of solution. Each cardboard pack contains 1 vial.

Marketing authorization holder
ADVANZ PHARMA Limited
Suite 17, Northwood House,
Northwood Avenue, Santry,
Dublin 9,
Ireland

Manufacturer
KeVaRo Group Ltd
9 Tzaritza Elenora str., office 23
Sofia 1618
Bulgaria
or
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park
Paola PLA 3000
Malta

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Iceland Eribulin Advanz Pharma 0.44 mg/ml stungulyf, lausn
Austria Eribulin Advanz Pharma 0.44 mg/ml Injektionslösung
Belgium Eribulin Advanz Pharma 0.44 mg/ml Injektionslösung/ solution injectable/ oplossing voor
injectie
Spain Eribulin Advanz Pharma 0.44 mg/ml solución inyectable EFG
Finland Eribulin Advanz Pharma 0.44 mg/ml injektioneste, liuos
France Eribulin Advanz Pharma 0.44 mg/mL solution injectable
Ireland Eribulin Advanz Pharma 0.44 mg/ml solution for injection
Italy Eribulina Advanz Pharma
Norway Eribulin Advanz Pharma
Portugal Eribulin Advanz Pharma
Sweden Eribulin Advanz Pharma 0.44 mg/ml injektionsvätska, lösning