VINORELBINA 10 мг/мл Концентрат для приготовления раствора для инфузий

Содержание инструкции

1. Vinorelbina Aurobindo 10 mg/ml concentrate for solution for infusion
   1. What is Vinorelbina Aurobindo and what it is used for
   2. What you need to know before you use Vinorelbina Aurobindo
   3. How to use Vinorelbina Aurobindo
   4. Possible side effects
   5. How to store Vinorelbina Aurobindo
   6. Package Contents and Other Information

Vinorelbina Aurobindo 10 mg/ml concentrate for solution for infusion

Generic medicine

Read this leaflet carefully before you use 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.
• 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 or nurse. See section 4.

Contents of this leaflet:

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

1. What is Vinorelbina Aurobindo and what it is used for

Vinorelbina Aurobindo is indicated for use in adults.
Vinorelbina Aurobindo is used in the treatment of cancer and belongs to the group of medicines known
as Vinca alkaloids.
Vinorelbina Aurobindo is used to treat certain types of lung and breast cancer.

2. What you need to know before you use Vinorelbina Aurobindo

Do not use Vinorelbina Aurobindo

• If you are allergic to vinorelbine or other Vinca alkaloids or to any of the other ingredients of this medicine (listed in section 6).
• If you have or have recently had severe infections or a severe decrease in white blood cells (neutropenia).
• If you have a severe decrease in platelets.
• If you are breastfeeding.
• If you are a potentially fertile woman who is not using effective contraception.
• In combination with the yellow fever vaccine.

The medicine is strictly for intravenous use only and must not be injected into the spine.

Warnings and precautions
Talk to your doctor or nurse before using Vinorelbina Aurobindo:

• If you have had heart problems involving a lack of blood supply to the heart (ischemic heart disease, angina).
• If you are undergoing radiotherapy and the treatment area includes the liver.
• If you show signs or symptoms indicative of infection (such as fever, chills, sore throat), immediately inform your doctor so that they can perform all necessary tests.
• If you have impaired liver function.
• If you need to be vaccinated. You must inform your doctor about the treatment before any vaccination.
• If you are receiving a cancer medicine called mitomycin C.
• If you are of Japanese origin, as you may be more vulnerable to lung problems during treatment with Vinorelbina Aurobindo.
• If the pelvis, spine or long bones are irradiated simultaneously with the administration of vinorelbine, greater bone marrow damage (myelotoxicity) is predictable. The same applies to previous radiation treatment (< 3 weeks) of the regions mentioned.
• If treatment with vinorelbine is continued or if you are at higher risk, neurological assessments are necessary.

Vinorelbina Aurobindo must not come into contact with the eyes because there is a risk of severe
irritation and even corneal ulceration. If this happens, immediately rinse your eyes with a physiological
solution and contact an ophthalmologist.
Men and women who are treated with Vinorelbina Aurobindo must use effective contraception
during treatment. Men and women must BOTH read the information described in the
pregnancy and breastfeeding section.
Before each administration of Vinorelbina Aurobindo, a blood sample must be taken
for analysis of the components. If the results of these analyses are not satisfactory, treatment may be
delayed and further tests must be performed until the values return to normal.

Other medicines and Vinorelbina Aurobindo
Tell your doctor if you are taking, have recently taken or might take any other medicines.
This is especially important if you are taking any of the following medicines:

• Other medicines that can affect the bone marrow, e.g. cancer medicines.
• Carbamazepine, phenytoin or fosphenytoin and phenobarbital (medicines for the treatment of epilepsy).
• Antibiotics such as rifampicin, erythromycin, clarithromycin, telithromycin.
• St. John's Wort (Hypericum perforatum).
• Ketoconazole or posaconazole and itraconazole (medicines for the treatment of fungal infections).
• Antiviral medicines for the treatment of HIV infections, for example ritonavir (HIV protease inhibitors).
• Nefazodone (medicines for the treatment of depression).
• Cyclosporine and tacrolimus (medicines that decrease the activity of the immune system).
• Other medicines for the treatment of cancer, for example mitomycin C, cisplatin.
• Anticoagulant medicines, for example warfarin.
• Yellow fever vaccine and other live vaccines. You must inform your doctor if you need to be vaccinated, as this may cause serious side effects when performed during treatment with Vinorelbina Aurobindo.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Vinorelbina Aurobindo must not be administered to pregnant women, as it causes serious birth defects.
If you are a woman of childbearing potential, you must use an effective method of contraception during treatment and for 3
months after stopping treatment. If you become pregnant during treatment, you should immediately
inform your doctor. If you are or become pregnant during treatment with vinorelbine, genetic
counseling is recommended.
If you are a man, you must avoid fathering a child during treatment with vinorelbine and for 6 months
after stopping treatment. There is also a risk that treatment with Vinorelbina Aurobindo
may lead to male infertility and you may ask for advice on sperm preservation before
treatment.
Although it is not known whether vinorelbine passes into breast milk and therefore affects the baby, you must
stop breastfeeding beforestarting treatment with Vinorelbina Aurobindo.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and operating machinery
Caution is advised due to possible side effects

3. How to use Vinorelbina Aurobindo

Vinorelbina Aurobindo will be administered to you under the supervision of a doctor specializing in this type
of treatment.

The recommended dose is
The dose depends on the conditions for which you are being treated, your response to therapy and other treatments you have
received. Your general condition and your response to treatment will be closely monitored before,
during and after treatment with vinorelbina.
The usual dose with vinorelbina is 25-30 mg/m of body surface area administered once a week.

Elderly patients
Clinical experience has not highlighted any significant differences regarding how elderly patients
respond to Vinorelbina Aurobindo; however, some elderly patients may be more
sensitive to this medicine.

Patients with hepatic impairment
The dose will be reduced if you have severe liver problems.

Patients with renal impairment
It is not necessary to reduce the dosage in patients with renal impairment.

Use in children
The safety and efficacy in children under the age of 18 have not been determined and therefore
administration is not recommended.

Method of administration
The medicine must be diluted before use with a solution of sodium chloride or glucose and
administered into the veins as an injection of 6-10 minutes or by infusion (intravenous drip) of 20-30 minutes. After
treatment, a sodium chloride solution should be used to flush the vein.

If you use more Vinorelbina Aurobindo than you should
Although the medicine is administered to you in hospital and it is unlikely that you will be given too little
or too much, still inform your doctor or pharmacist if you have any doubts. Paralytic ileus (intestinal obstruction) is also possible.

Information for the doctor:
Since there is no specific antidote for vinorelbine overdose, symptomatic measures are necessary in case of overdose.
These measures include:

• Continuous monitoring of vital signs and particularly careful monitoring of the patient.
• Daily blood count to be able to promptly recognize the need for transfusions, administration of growth factors or intensive care and to be able to assess the risk of infection.
• Measures to prevent paralytic ileus.
• Monitoring of the circulatory system and liver function.

Complications related to infection can be treated with broad-spectrum antibiotics, paralytic ileus
with decompression via tube.

4. Possible side effects

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

Serious side effects – if any of the following side effects occur, contact your doctor immediately:
Uncommon (may affect up to 1 in 100 people):
Severe infections with severe organ failure or sepsis. Shortness of breath and narrowing of the airways (bronchospasm).
Rare (may affect up to 1 in 1,000 people):
Chest pain that may spread behind your neck and to your arms, caused by reduced blood flow to the heart (angina pectoris). Heart attack (myocardial infarction).
Not known (frequency cannot be estimated from available data):
Widespread and very serious allergic reactions. Symptoms may include sudden wheezing, swelling of the lips, tongue and throat or body, difficulty swallowing, rash, confusion, fainting (anaphylaxis / anaphylactic shock / anaphylactoid reaction), chest pain, shortness of breath and fainting, which may be symptoms of a blood clot in the lungs (pulmonary embolism), headache, altered mental status that may cause confusion and coma, seizures, blurred vision and high blood pressure, which may be a sign of a neurological condition such as reversible posterior encephalopathy syndrome.
These are very serious side effects. You may need immediate medical attention.

Other side effects – if any of the following side effects occur, contact your doctor as soon as possible:
Very common (may affect more than 1 in 10 people):
Low red blood cell count (anemia), which may make you tired. Loss of tendon reflexes. Weakness of the lower extremities. Inflammation of the mouth or throat. Nausea and vomiting. Constipation. Abnormal liver function test results. Hair loss. Redness (erythema), burning pain, discoloration of the veins and/or inflammation of the veins (local phlebitis) at the injection site.
Common (may affect up to 1 in 10 people):
Infections (bacterial, viral or fungal infections) in the body (respiratory system, urinary gastrointestinal and others) with symptoms such as pain. Low platelet count in the blood (risk of bleeding).
Diarrhea. Joint and muscle pain, including jaw pain. Change in kidney function (increased creatinine levels). Weakness, fatigue, fever, pain in various sites.
Uncommon (may affect up to 1 in 100 people):
Severe numbness (paresthesia). Low blood pressure, high blood pressure, hot flashes and cold extremities.
Rare (may affect up to 1 in 1,000 people):
Low sodium levels in the blood (this may cause symptoms such as fatigue, confusion, muscle contraction and coma). Change in heart activity (ECG changes). Serious drop in blood pressure or collapse. Lung disease (interstitial pneumopathy). Inflammation of the pancreas.
Paralytic intestinal blockage (ileus). Skin reactions such as rash, itching and hives. Necrosis at the injection site. Swelling of the tissues (angioedema).
Very rare (may affect up to 1 in 10,000 people):
Sepsis which may be life-threatening. Strong heartbeat, rapid heartbeat, heart rhythm disturbances.
Not known (frequency cannot be estimated from available data):
Abnormal liver function. Chills with fever. Loss of muscle coordination which may be associated with abnormal gait, speech abnormalities and abnormal eye movements (ataxia). Headache.
Cough. Abdominal pain and gastrointestinal bleeding. Weight loss. A widespread infection in combination with a drop in white blood cell count (sepsis neutropenia). A drop in white blood cell count with fever (febrile neutropenia). Reduction in the number of red blood cells and white blood cells, and also platelets in the blood. Low sodium levels due to overproduction of a hormone that causes fluid retention, resulting in weakness, fatigue or disorientation (SIADH syndrome). Loss of appetite (anorexia). Redness (erythema) of the hands and feet, darker color of the skin along the path of the veins. Acute lung dysfunction (respiratory failure) resulting in death after previous radiotherapy.
As with other vinca alkaloids, vinorelbine is a moderate vesicant agent.
Since changes in the blood may occur, the doctor may prescribe blood tests to monitor them (low white blood cell count, anemia and/or low platelet count in the blood, influence on liver and kidney function and electrolyte balance in the body).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at 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 Vinorelbina Aurobindo

Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2°C - 8°C). DO NOT FREEZE.
Keep the vial in the package to protect from light.
Do not use this medicine after the expiry date which is stated on the vial label and
on the package, after Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater. 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 Vinorelbina Aurobindo Contains

• The active ingredient is vinorelbine. 1 ml of concentrate for solution for infusion contains 10 mg of vinorelbine (as tartrate). Each vial of 1 ml contains 10 mg of vinorelbine (as tartrate). Each vial of 5 ml contains 50 mg of vinorelbine (as tartrate).
• The other component is water for injections.

Description of the Appearance of Vinorelbina Aurobindo and Package Contents
Vinorelbina Aurobindo 10 mg/ml concentrate for solution for infusion is a clear solution, from
colorless to yellowish.

Pack sizes:
1 vial x 1 ml
10 vials x 1 ml
1 vial x 5 ml
10 vials x 5 ml
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Eugia Pharma (Malta) Limited
Vault 14, Level 2,
Valletta Waterfront,
Floriana FRN 1914, Malta

Manufacturer Responsible for Batch Release
APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000,
Malta

This medicinal product is authorised in the Member States of the European Economic Area with the following
denominations:
Belgium Vinorelbin Eugia 10 mg/ml concentrate for solution for infusion / solution à diluer pour
perfusion / Konzentrat zur Herstellung einer Infusionslösung
Germany Vinorelbin Aurobindo 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
Spain Vinorelbina Aurovitas 10 mg/ml concentrated for solution for perfusion EFG
France Vinorelbine Arrow 10mg/ml solution à diluer pour perfusion
Italy Vinorelbina Aurobindo
Portugal Vinorrelbina Aurovitas
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The following information is intended exclusively for healthcare professionals or healthcare operators:
Vinorelbina Aurobindo 10 mg/ml concentrate for solution for infusion
Instructions for Use
ANTINEOPLASTIC AGENT
For detailed information regarding this product, please refer to the summary of product characteristics.

Handling and Disposal
The preparation and administration of injectable solutions of cytotoxic agents must be carried out by
specialized personnel who are familiar with the medicines used, in order to ensure the protection of the environment and
in particular the protection of personnel handling the medicine. This requires the establishment of a dedicated area
for this purpose.
Smoking, eating or drinking is prohibited in this area.
Personnel must be provided with suitable materials for handling, long-sleeved gowns, protective masks, headgear, protective glasses, sterile disposable gloves, protective mats for the work area, containers and collection bags for waste.
Syringes and infusion sets must be carefully assembled to avoid leaks (the use of Luer connectors is recommended).
Spills and leaks must be cleaned up.
Precautions must be taken to avoid exposure of personnel during pregnancy.
All contact with the eyes must be strictly avoided. If this occurs, immediately flush the eye with plenty of physiological solution. If irritation occurs, contact an ophthalmologist.
If contact with the skin occurs, wash the affected area thoroughly with water.
Upon completion, all exposed surfaces must be thoroughly cleaned and hands and face washed.
Any unused product or waste material must be disposed of in accordance with current regulations.

Incompatibilities
Vinorelbina Aurobindo must not be diluted in alkaline solutions (risk of precipitation)
In the absence of compatibility studies, these medicines must not be mixed with other medicines
except those specified in the “Dilution and Administration” section.
There is no incompatibility between Vinorelbina Aurobindo and glass vials, PVC bags, polyethylene vial or polypropylene syringe.

Dilution and Administration
Vinorelbina Aurobindo must be administered only intravenously and after dilution.
Vinorelbina Aurobindo must be administered via a slow bolus (6-10 minutes) after dilution in
20-50 ml of sodium chloride 9 mg/ml (0.9%) solution for injection or in a 50mg/ml (5%) glucose solution for
injection or via a short infusion (20-30 minutes) after dilution in 125ml of sodium chloride
9mg/ml (0.9%) solution for injection or in a 50mg/ml (5%) glucose solution for injection. The
administration must always be followed by at least 250ml of sodium chloride 9 mg/ml (0.9%) solution
for injection to flush the vein.
It is very important to ensure that the cannula is correctly positioned in the vein before
the injection begins. If Vinorelbina Aurobindo infiltrates into the surrounding tissue during intravenous administration
severe irritation may occur. In this case, the injection must be stopped, the vein
flushed with physiological solution and the remainder of the dose administered into another vein. In
cases of extravasation, intravenous glucocorticoids may be administered to reduce the risk of phlebitis.
Excretions and vomit must be handled with care.

Storage

Packaged product
Store in a refrigerator (2°C – 8°C). Keep the vial in the carton to protect from light. DO NOT
FREEZE. Do not use Vinorelbina Aurobindo after the expiry date which is indicated on the
vial label and the carton.

After opening
The contents of the vial must be used immediately after the first opening of the vial.

After dilution
The chemical and microbiological stability of the drug has been demonstrated after dilution in the recommended
infusion solutions for 24 hours at 2-8°C and 25°C.
From a microbiological point of view, the medicine must be used immediately.
If not used immediately, the times and conditions of storage of the solution ready for use
are the responsibility of the user and should not normally exceed 24 hours at 2-8°C, unless
the preparation has been carried out under controlled and validated sterility conditions.