Vinorelbine Aurovitas 10 mg/ml concentrate for infusion solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Vinorelbine Aurovitas 10 mg/ml concentrate for solution for infusion EFG

Read all of this leaflet carefully before you start using this medicine, because 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 and must not be given to other people, even if they have the same symptoms as you. It could harm them.
• If you experience any adverse reactions, consult your doctor or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Vinorelbina Aurovitas is indicated for use in adults.

Vinorelbine is used in the treatment of cancer and belongs to a group of medicines known as vinca alkaloids.

Vinorelbine is used to treat certain types of lung and breast cancer.

2. What you need to know before using Vinorelbine Aurovitas

Do not use Vinorelbine Aurovitas

• if you are allergic to vinorelbine or to other vinca alkaloids, or to any of the other ingredients of this medicine (listed in section 6).
• if you have or have recently had a serious infection or a significant decrease in the number of white blood cells (neutropenia).
• if you have a marked decrease in the number of platelets.
• if you are breastfeeding.
• if you are a woman of childbearing age and are not using an effective method of contraception.
• in combination with the yellow fever vaccine.

This medicine is administered exclusively by intravenous route and must not be injected into the spinal column.

Warnings and precautions

Talk to your doctor before starting to use Vinorelbine Aurovitas:

• if you have had heart disease involving reduced blood supply to the heart (ischaemic heart disease, angina).
• if you are receiving radiotherapy and the treated area includes the liver.
• if you experience signs or symptoms suggesting infection (such as fever, chills, sore throat), inform your doctor immediately so that appropriate tests can be carried out.
• if liver function is reduced.
• if you need to be vaccinated. You must inform your doctor about your treatment before any vaccination.
• if you are taking a cancer treatment medicine called mitomycin C.
• if you are of Japanese origin, as you may be more prone to lung problems during treatment with vinorelbine.
• if pelvic, spinal, or long bone irradiation is administered simultaneously with vinorelbine, an increased risk of bone marrow damage (myelotoxicity) is expected. The same applies to prior radiotherapy (<3 weeks) of the aforementioned areas.
• neurological assessments should be performed if you continue treatment with vinorelbine or if you are at higher risk.

Vinorelbine must not come into contact with the eyes, as there is a risk of severe irritation and even corneal ulceration. If this occurs, immediately rinse the eye with normal saline solution and contact an ophthalmologist.

Men and women treated with vinorelbine must use an effective method of contraception during treatment. BOTH MEN AND WOMEN MUST read the information on pregnancy and breastfeeding provided below.

Before each administration of vinorelbine, a blood sample will be taken to analyse blood components. If results are unsatisfactory, your treatment may be delayed, and further tests may be performed until results return to normal.

Other medicines and Vinorelbine Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. It is especially important if you are taking any of the following:

• other medicines that may affect the bone marrow, e.g. cancer treatment medicines.
• carbamazepine, phenytoin or fosphenytoin, and phenobarbital (medicines used to treat epilepsy).
• antibiotics such as rifampicin, erythromycin, clarithromycin, telithromycin.
• St John’s wort (Hypericum perforatum).
• ketoconazole, posaconazole, and itraconazole (medicines used to treat fungal infections).
• antiviral medicines for treating HIV infection, e.g. ritonavir (HIV protease inhibitors).
• nefazodone (medicines used to treat depression).
• ciclosporin and tacrolimus (medicines that suppress the immune system).
• other cancer treatment medicines, e.g. mitomycin C, cisplatin, lapatinib.
• medicines that thin the blood, e.g. warfarin.
• yellow fever vaccine and other live vaccines. Inform your doctor if you need any vaccination, as serious adverse effects may occur if they are administered during treatment with vinorelbine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Vinorelbine must not be given to pregnant women, as it may cause severe birth defects.

If you are a woman of childbearing age, you must use an effective method of contraception during treatment and for up to 3 months after treatment ends. If you become pregnant during treatment, inform your doctor immediately. If you are pregnant or may become pregnant during vinorelbine treatment, genetic counselling is recommended.

If you are a man, you must avoid fathering a child during vinorelbine treatment and for up to 6 months after treatment ends. Treatment with vinorelbine may also cause infertility in men, so you may wish to seek advice on sperm preservation before starting treatment.

You must stop breastfeeding before starting treatment with vinorelbine, as it is unknown whether the medicine passes into breast milk and could therefore affect the baby.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Caution is advised due to possible adverse effects.

3. How to use Vinorelbine Aurovitas

Vinorelbine Aurovitas will be administered under the supervision of a physician experienced in this type of treatment.

Recommended dose:

The dose depends on the disease being treated, the response to treatment, and other medications being administered. Your general condition and response to treatment will be closely monitored before, during, and after vinorelbine therapy.

The usual dose of vinorelbine is 25–30 mg/m² of body surface area, administered once weekly.

Patients over 65 years of age

Clinical experience has not identified significant differences in how elderly patients respond to vinorelbine. However, some of these patients may be more sensitive to this medicine.

Patients with liver problems

Your dose will be reduced if you have severe liver problems.

Patients with kidney problems

Dose reduction is not required in patients with renal impairment.

Use in children

The safety and efficacy have not been established in children, and therefore administration of this medicine is not recommended in this population.

Method of administration

The medicine must be diluted prior to use with either a sodium chloride or glucose solution and administered intravenously either as an injection over 6–10 minutes or as an infusion (drip) over 20–30 minutes. After treatment, the vein will be flushed with a sodium chloride solution.

If you use more Vinorelbine Aurovitas than you should

Since this medicine will be administered in a hospital setting, it is unlikely that you will receive too little or too much. However, if you have any concerns, consult your doctor or pharmacist. Paralytic ileus (intestinal obstruction) may also occur.

Information for the physician:

As there is no specific antidote for vinorelbine overdose, symptomatic measures must be applied in case of overdose. These measures include:

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

Infection-related complications can be treated with broad-spectrum antibiotics; paralytic ileus can be managed with tube decompression.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount administered.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Serious adverse effects – if any of the following serious adverse effects occur, contact a doctor immediately:

Uncommon (may affect up to 1 in 100 people)

Severe infections with failure of multiple organs or blood poisoning (sepsis). Difficulty breathing and narrowing of the airways (bronchospasm).

Rare (may affect up to 1 in 1,000 people)

Chest pain that may spread to the back of the neck and arm, due to reduced blood supply to the heart (angina pectoris). Heart attack (myocardial infarction).

Frequency not known (cannot be estimated from available data)

Widespread and very severe allergic reactions. Symptoms may include sudden difficulty breathing, swelling of the lips, tongue and throat or body, difficulty swallowing, rash, dizziness, fainting (anaphylaxis, anaphylactic shock, anaphylactoid reaction), chest pain, difficulty breathing and collapse, which may indicate a blood clot in a vessel in the lungs (pulmonary embolism), headaches, changes in mental status that may lead to confusion and coma, seizures, blurred vision and high blood pressure, which could indicate a neurological disorder such as reversible posterior encephalopathy syndrome.

These are very serious adverse effects. Immediate medical attention may be required.

Other adverse effects – if any of the following adverse effects occur, contact your doctor as soon as possible:

Very common (may affect more than 1 in 10 people)

Low white blood cell count, which may increase the risk of infection. Low red blood cell count (anemia), which may make you feel tired. Loss of deep tendon reflexes. Weakness in the legs. Inflammation of the mouth or throat. Nausea and vomiting. Constipation. Abnormal liver function test results. Hair loss. Redness (erythema), stinging, discoloration of the vein and/or inflammation of veins (local phlebitis) at the injection site.

Common (may affect up to 1 in 10 people)

Infections (caused by bacteria, viruses or fungi) in your body (in the respiratory, urinary, gastrointestinal systems and possibly others), with symptoms such as pain. Low platelet count (risk of bleeding). Diarrhea. Muscle and joint pain, including jaw pain. Impaired kidney function (increased creatinine levels). Weakness, fatigue, fever, pain in various sites.

Uncommon (may affect up to 1 in 100 people)

Severe tingling (paresthesia). Low blood pressure, high blood pressure, flushing, and peripheral coldness.

Rare (may affect up to 1 in 1,000 people)

Low sodium levels in the blood (which may cause symptoms such as tiredness, confusion, muscle cramps, and coma). Changes in heart function (changes in electrocardiogram). Severely low blood pressure or collapse. Lung disease (interstitial lung disease). Inflammation of the pancreas. Bowel obstruction (paralytic ileus). Skin reactions such as rash, itching, and hives. Necrosis at the injection site. Swelling of tissues (angioedema).

Very rare (may affect up to 1 in 10,000 people)

Blood poisoning (sepsis) which may be life-threatening. Strong heartbeat, rapid heartbeat, irregular heart rhythms.

Frequency not known (cannot be estimated from available data)

Abnormal liver function. Chills with fever. Loss of muscle coordination that may be associated with abnormal gait, changes in speech, and abnormal eye movements (ataxia). Headache. Cough. Abdominal pain and gastrointestinal bleeding. Weight loss. Systemic infection combined with decreased white blood cell count (neutropenic sepsis). Decreased white blood cell count with fever (febrile neutropenia). Reduction in red blood cells, white blood cells, and platelets. Low sodium levels caused by overproduction of a hormone that leads to fluid retention, resulting in weakness, fatigue, and confusion (Syndrome of Inappropriate Antidiuretic Hormone Secretion, SIADH). Loss of appetite (anorexia). Redness (erythema) of hands and feet. Acute lung dysfunction (respiratory failure) leading to death after previous radiotherapy. Darker skin color following the path of the veins.

Like other vinca-derived alkaloids, vinorelbine has moderate potential to cause blistering.

Since blood abnormalities may occur, your doctor may request blood tests to monitor them (low white blood cell count, anemia and/or low platelet count, changes in liver or kidney function, and disturbances in your body's electrolyte balance).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Vinorelbine Aurovitas

Keep this medicine out of sight and reach of children.

Store in a refrigerator (between 2°C and 8°C). DO NOT FREEZE.

Keep the vial in the outer packaging to protect it from light.

Do not use this medicine after the expiry date stated on the vial label and on the carton after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Package contents and other information

Composition of Vinorelbina Aurovitas

• The active substance is vinorelbine. One ml of concentrate for solution for infusion contains 10 mg of vinorelbine (as tartrate).

Each 1 ml vial contains 10 mg of vinorelbine (as tartrate).

Each 5 ml vial contains 50 mg of vinorelbine (as tartrate).

• The other component is: water for injections.

Appearance of the product and contents of the pack

Vinorelbina Aurovitas 10 mg/ml concentrate for solution for infusion is a clear, colourless to pale yellow solution.

Pack sizes:

1 vial of 1 ml

10 vials of 1 ml

1 vial of 5 ml

10 vials of 5 ml

Only some pack sizes may be marketed.

Marketing Authorization Holder

Eugia Pharma (Malta) Limited

Vault 14, Level 2, Valletta Waterfront

Floriana, FRN 1914

Malta

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

For further information on this medicine, please contact the local representative of the Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany	Vinorelbin-Aurobindo 10 mg/ml concentrate for solution for infusion
Belgium	Vinorelbin Eugia 10 mg/ml concentrate for solution for intravenous infusion / solution to dilute for perfusion / concentrate for solution for infusion
Spain	Vinorelbina Aurovitas 10 mg/ml concentrate for solution for perfusion EFG
France	Vinorelbine Arrow 10 mg/ml solution to dilute for perfusion
Italy	Vinorelbina Aurobindo
Portugal	Vinorelbina Aurovitas

Date of the most recent review of this leaflet: July 2025

Detailed information about this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).

This information is intended for healthcare professionals only:

Vinorelbine Aurovitas 10 mg/ml concentrate for solution for infusion EFG

Instructions for use

CYTOSTATIC MEDICINAL PRODUCT

Refer to the Summary of Product Characteristics for more detailed information about this medicinal product.

Handling and disposal precautions

Preparation and administration of injectable cytotoxic drug solutions must be carried out by trained, specialized personnel with knowledge of the drugs used, under conditions ensuring environmental protection and, in particular, protection of personnel handling the drugs. A dedicated preparation area must be available. Smoking, eating, or drinking is prohibited in this area.

Personnel must have appropriate protective equipment, including long-sleeved gowns, protective masks, caps, protective glasses, single-use sterile gloves, protective covers for the work area, and waste disposal bags.

Syringes and infusion sets must be assembled carefully to prevent spills (use of Luer-lock connectors is recommended).

Instructions for extracting the appropriate volume from the vial

To ensure complete withdrawal of the drug from a vial, a 21-gauge or smaller diameter needle is recommended, which facilitates efficient transfer of the solution.

Spills and leaks must be cleaned up promptly.

Caution must be taken to avoid exposure of pregnant personnel to the drug.

Any contact with the eyes must be strictly avoided. If contact occurs, immediately rinse the eye with normal saline solution. In case of irritation, consult an ophthalmologist.

In case of skin contact, wash the affected area thoroughly with abundant water.

After handling, any exposed surfaces must be carefully cleaned, and hands and face must be washed.

Disposal of unused medicinal product and all materials that have come into contact with it must be carried out in accordance with local regulations.

Incompatibilities

Vinorelbine Aurovitas must not be diluted in alkaline solutions (risk of precipitation).

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in the section “Dilution and administration”.

There is no incompatibility between Vinorelbine Aurovitas and glass vials, PVC bags, polyethylene vials, or polypropylene syringes.

Dilution and administration

Vinorelbine Aurovitas must be administered exclusively by intravenous route and only after dilution.

Vinorelbine Aurovitas may be administered as a slow bolus (6–10 minutes) after dilution in 20–50 ml of 9 mg/ml (0.9%) sodium chloride solution for injection or 50 mg/ml (5%) glucose solution for injection, or by short infusion (20–30 minutes) after dilution in 125 ml of 9 mg/ml (0.9%) sodium chloride solution for injection or 50 mg/ml (5%) glucose solution for injection. Administration must always be followed by at least 250 ml of 9 mg/ml (0.9%) sodium chloride solution for injection to flush the vein.

Before starting the injection, it is essential to ensure that the cannula is correctly placed within the vein. If Vinorelbine Aurovitas infiltrates into surrounding tissue during intravenous administration, significant irritation may occur. In such cases, the infusion must be stopped immediately, the vein flushed with saline solution, and the remaining dose administered through another vein. In case of extravasation, intravenous glucocorticoids may be administered to reduce the risk of phlebitis.

Faeces and vomit must be handled with care.

Storage

Marketing container

Store in a refrigerator (between 2°C and 8°C). Keep the vial in the outer packaging to protect it from light. DO NOT FREEZE. Do not use Vinorelbine Aurovitas after the expiry date stated on the vial label and carton.

After opening

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

After dilution

It has been demonstrated that the physico-chemical and microbiological stability of the medicinal product after dilution with the recommended infusion solutions is 24 hours at 2°C–8°C and at 25°C.

From a microbiological standpoint, the product should be used immediately.

If not used immediately, the conditions and duration of storage in use are the responsibility of the user and normally should not exceed 24 hours at 2°C–8°C, unless reconstitution was performed under controlled and validated aseptic conditions.