Eribulina glenmark 0,44 mg/ml soluciÓn inyectable efg
Introduction
Leaflet: information for the user
Eribulina Glenmark 0.44 mg/ml injectable solution EFG
Read this leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor or nurse.
- If you experience any side effects, consult your doctor or nurse, even if they are not listed in this leaflet. See section 4.
Contents of the leaflet
- What Eribulina Glenmark is and what it is used for
- What you need to know before starting to use Eribulina Glenmark
- How to use Eribulina Glenmark
- Possible side effects
- Storage of Eribulina Glenmark
- Contents of the container and additional information
1. What is Eribulina Glenmark and what is it used for
Eribulina Glenmark contains the active ingredient eribulina and is a cancer medication that works by slowing down the growth and spread of cancer cells.
It is used for the treatment of adult patients with locally advanced or metastatic breast cancer (breast cancer that has spread beyond the original tumor) when at least one other treatment has stopped working.
It is also used for the treatment of adult patients with advanced or metastatic liposarcoma (a type of cancer that appears in fatty tissue) when a previous treatment has stopped working.
2. What you need to know before starting to use Eribulin Glenmark
No use Eribulina Glenmark
- If you are allergic to eribulina mesylate or any of the other components of this medication (listed in section 6).
- If you are breastfeeding.
Advertencias y precauciones
Consult your doctor or nurse before starting to use eribulina.
- if you have liver problems
- if you have a fever or an infection
- if you experience numbness, tingling, pins and needles, sensitivity to touch, or muscle weakness
- if you have heart problems
If you are affected by any of the above points, inform your doctor as they may want to suspend your treatment or reduce your dose.
Niños y adolescentes
Do not administer this medication to children aged 0 to 18 years as it has no effect on them.
Otros medicamentos y Eribulina Glenmark
Inform your doctor if you are using, have used recently, or may need to use any other medication.
Embarazo, lactancia y fertilidad
Eribulina may cause severe congenital malformations and should not be used during pregnancy, unless it is clearly necessary after carefully considering all the risks for you and the baby. It may also cause permanent fertility problems in the future for men who take it, and you should consult your doctor before starting treatment.
Women of childbearing age should use highly effective contraceptive methods during eribulina treatment and for up to 7 months after treatment is completed.
Eribulina should not be used during breastfeeding due to the possible risk to the child.
Males with partners of childbearing age should not leave them pregnant while receiving eribulina. They should use effective contraceptive methods during eribulina treatment and for up to 4 months after treatment is completed.
Conducción y uso de máquinas
Eribulina may cause adverse effects such as fatigue (very frequent) and dizziness (frequent). Do not drive or use machines if you are fatigued or dizzy.
Eribulina Glenmark contains etanol (alcohol)
This medication contains 79 mg of alcohol (ethanol) in each vial equivalent to 40 mg/ml. The amount in each vial of this medication is equivalent to less than 2 ml of beer or 1 ml of wine.
The small amount of alcohol in this medication does not produce any perceptible effect.
Eribulina Glenmark contains sodium
This medication contains less than 1 mmol of sodium (23 mg) per ml; it is essentially "sodium-free".
3. How to Use Eribulina Glenmark
A qualified healthcare professional will administer eribulina as an injection into a vein over a period of 2 to 5 minutes. The dose you receive is based on your body surface area (expressed in square meters, or m2) calculated from your weight and height. The usual dose of eribulina is 1.23 mg/m2, although your doctor may adjust it based on blood test results or other factors. After eribulina administration, it is recommended to irrigate the vein with a saline solution to ensure the complete administration of eribulina.
Frequency of Eribulina Glenmark Administration
Eribulina is usually administered on days 1 and 8 of each 21-day cycle. Your doctor will determine how many treatment cycles you should receive. Depending on blood test results, your doctor may need to delay administering the medication until blood test results return to normal values. At that time, your doctor may also decide to reduce the dose you receive.
If you have any other questions about the use of this medication, ask your doctor.
4. Possible Adverse Effects
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you experience any of the following severe symptoms, stop taking eribulina and see your doctor immediately:
- Fever, with very rapid heart rate, rapid and shallow breathing, cold, pale, moist, or mottled skin, and/or confusion. These may be signs of a condition called septicemia, a severe and life-threatening reaction to an infection. Septicemia is rare (may affect up to 1 in 100 people) and can be life-threatening and fatal.
- Difficulty breathing or swelling of the face, mouth, tongue, or throat. These may be signs of a rare allergic reaction (may affect up to 1 in 100 people).
- Severe skin eruptions with blisters on the skin, mouth, eyes, and genitals. These may be signs of a condition called Stevens-Johnson syndrome/toxic epidermal necrolysis. The frequency of this condition is unknown, but it can be potentially fatal.
Other side effects:
Very common side effects(may affect more than 1 in 10 people):
- Decreased white blood cell or red blood cell count
- Fatigue or weakness
- Nausea, vomiting, constipation, diarrhea
- Numbness, tingling, or pins and needles
- Fever
- Loss of appetite, weight loss
- Difficulty breathing, cough
- Pain in the joints, muscles, and back
- Headache
- Hair loss
Common side effects(may affect up to 1 in 10 people):
- Decreased platelet count (which may lead to bruising or delayed bleeding)
- Infection with fever, pneumonia, chills
- Rapid heart rate, palpitations
- Dizziness, vertigo
- Increased tear production, conjunctivitis (redness and irritation of the eye surface), nasal bleeding
- Dehydration, dry mouth, herpes labialis, oral thrush, indigestion, stomach pain or swelling
- Swelling of soft tissues, pain (particularly chest, back, and bone pain), muscle spasms or weakness
- Infections in the mouth, respiratory tract, and urinary tract, painful urination
- Sore throat, nasal congestion, increased nasal secretion, flu-like symptoms, pharyngitis
- Abnormal liver function test results, altered blood sugar, bilirubin, phosphate, potassium, magnesium, or calcium levels
- Inability to sleep, depression, altered sense of taste
- Rash, itching, nail problems, dry or red skin
- Excessive sweating (including nocturnal sweating)
- Tinnitus in the ears
- Pulmonary embolism
- Herpes zoster
- Swelling of the skin and numbness in hands and feet
Rare side effects(may affect up to 1 in 100 people):
- Clotting in the blood
- Abnormal liver function test results (hepatotoxicity)
- Renal failure, blood or protein in the urine
- Extensive pulmonary inflammation that may lead to scarring
- Pancreatitis
- Mouth ulcers
Rare side effects(may affect up to 1 in 1,000 people):
- A severe blood clotting disorder that may lead to extensive blood clots and internal bleeding
Reporting of side effects
If you experience any type of side effect, consult your doctor or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.
5. Conservation of Eribulina Glenmark
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date that appears on the box and vial after CAD. The expiration date is the last day of the month indicated.
This medication does not require special storage conditions.
If Eribulina Glenmark is diluted for infusion, the diluted solution must be used immediately. If not used immediately, the diluted solution must be stored between 2 °C and 8 °C for no more than 48 hours.
If Eribulina Glenmark as undiluted solution has been transferred to a syringe, it must be stored at 25°C for no more than 24 hours, or between 2 °C and 8 °C for no more than 96 hours.
From a microbiological point of view, the product must be used immediately. If not used immediately, the times and storage conditions during use are the responsibility of the user and should normally not be stored for more than 24 hours between 2 °C and 8 °C
Medications should not be disposed of through drains or trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.
6. Contents of the packaging and additional information
Composition of Eribulina Glenmark
- The active ingredient is eribulina. Each ml contains eribulina mesylate equivalent to 0.44 mg of eribulina. Each vial of 2 ml contains eribulina mesylate equivalent to 0.88 mg of eribulina.
- The other components are ethanol and water for injectable preparations, with hydrochloric acid and sodium hydroxide.
Appearance of the product and contents of the package
Eribulina Glenmark is a transparent and colorless injectable aqueous solution that comes in glass vials containing 2 ml of solution. Each box contains 1 or 6 vials.
Only some package sizes may be marketed.
Marketing authorization holder and manufacturer
Marketing authorization holder:
Glenmark Arzneimittel GmbH
Industriestr. 31
82194 Gröbenzell
Germany
Manufacturer:
AqVida GmbH
Kaiser-Wilhelm-Str. 89
20355 Hamburg
Germany
For more information about this medication, please contact the local representative of the marketing authorization holder:
Viso Farmacéutica S.L.U.
c/ Retama 7, 7th floor
28045 Madrid
Spain
This medication is authorized in the member states of the European Economic Area with the following names:
Country | Medication name |
Denmark | Eribulin Glenmark |
Spain | Eribulina Glenmark 0.44 mg/ml injectable solution EFG |
Finland | Eribulin Glenmark 0.44 mg/ml injection solution |
Italy | Eribulina Glenmark |
Norway | Eribulin Glenmark 0.44 mg/ml injection solution |
Sweden | Eribulin Glenmark 0.44 mg/ml injection solution |
Last review date of this leaflet:April 2025.
Other sources of information
More detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).
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