VINORELBINE Aurovitas 10 mg/ml concentrate for infusion solution

Introduction

Package Leaflet: Information for the User

Vinorelbine Aurovitas10 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Vinorelbine 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 you use Vinorelbine Aurovitas

Do not use Vinorelbine Aurovitas

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

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

Warnings and precautions

Consult your doctor before starting treatment with Vinorelbine Aurovitas:

• if you have had heart disease where there has been a lack of blood flow to the heart (ischemic heart disease, angina).
• if you are receiving radiotherapy and the treated area includes the liver.
• if you have signs or symptoms suggesting the presence of an infection (such as fever, chills, sore throat), inform your doctor immediately so that any necessary tests can be performed.
• if your liver function is impaired.
• if you need to be vaccinated. You should inform your doctor of the treatment before any vaccination.
• if you are taking a cancer medicine called mitomycin C.
• if you are of Japanese origin, as you may be more prone to lung problems during treatment with vinorelbine.
• if you are irradiating the pelvis, spine, or long bones at the same time as administering vinorelbine, an increase in bone marrow damage (myelotoxicity) is expected. The same applies to previous radiation treatment (<3 weeks) of the mentioned areas.< li>
• neurological evaluations should be performed if you continue treatment with vinorelbine or if you are at higher risk.

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

Men and women treated with vinorelbine should use an effective contraceptive method during treatment. BOTH MEN AND WOMEN SHOULD READ THE INFORMATION ON PREGNANCY AND BREAST-FEEDING INCLUDED BELOW.

Before each administration of vinorelbine, a blood sample will be taken to perform an analysis of its components. If the results are not satisfactory, your treatment may be delayed and other analyses may be performed again until the results return to normal.

Other medicines and Vinorelbine Aurovitas

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. It is especially important if you are using any of the following medicines:

• other medicines that may 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, posaconazole, and itraconazole (medicines for the treatment of fungal infections).
• antiviral medicines for the treatment of HIV infection, e.g., ritonavir (HIV protease inhibitors).
• nefazodone (medicines for the treatment of depression).
• cyclosporine and tacrolimus (medicines that decrease the activity of the immune system).
• other cancer medicines, e.g., mitomycin C, cisplatin, lapatinib.
• medicines that make the blood less dense, e.g., warfarin.
• yellow fever vaccine and other live vaccines. Inform your doctor if you need any vaccine, as they may produce severe side effects if administered during treatment with vinorelbine.

Pregnancy, breast-feeding, and fertility

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

Vinorelbine should not be administered to pregnant women, as it may cause severe birth defects.

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

If you are a man, you should avoid conceiving a child during treatment with vinorelbine and up to 6 months after treatment ends. There is also a risk that treatment with vinorelbine may cause infertility in men, so you may want to be advised on sperm preservation before starting treatment.

You should stop breast-feeding beforestarting treatment with vinorelbine, as it is unknown whether it can pass into breast milk and affect the baby.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Caution is recommended due to possible side effects.

3. How to use Vinorelbine Aurovitas

Vinorelbine Aurovitas will be administered under the supervision of a specialist doctor in this type of treatment.

The recommended dose is:

The dose depends on the disease for which you are being treated, your response to treatment, and other medicines you are being given. Your general condition and response to treatment will be closely monitored before, during, and after treatment with vinorelbine.

The usual dose of vinorelbine is 25-30 mg/m2 of body surface area, once a week.

Patients over 65 years of age

Clinical experience has not identified significant differences in how older 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

In patients with renal insufficiency, dose reduction is not necessary.

Use in children

Safety and efficacy have not been established in children, and therefore, this medicine should not be administered to this population.

Method of administration

The medicine should be diluted before use with a sodium chloride or glucose solution and administered into a vein in the form of an injection over 6-10 minutes or by 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 while you are in the hospital, it is unlikely that you will be given too little or too much; however, if you have any doubts, consult your doctor or pharmacist. It is also possible to have paralytic ileus (intestinal obstruction).

Information for the doctor:

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

• Continuous monitoring of vital signs and close monitoring of the patient.
• Daily monitoring of the blood count to recognize the need for blood transfusions, administration of growth factors, or intensive care and 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 by probe.

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

4. Possible side effects

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

Serious side effects - if you get any of the following side effects, contact a doctor immediately:

Uncommon (may affect up to 1 in 100 people)

Severe infections with organ failure or blood poisoning. 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 your neck and arm, due to lack of blood supply to the heart (angina pectoris). Heart attack (myocardial infarction).

Frequency not known (cannot be estimated from the available data)

Extensive and 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 fainting, which may be a symptom of a blood clot in a blood vessel in the lungs (pulmonary embolism), headaches, changes in mental status that can lead to confusion and coma, seizures, blurred vision, and high blood pressure, which may indicate a neurological disorder such as posterior reversible encephalopathy syndrome.

These are very serious side effects. You may need immediate medical attention.

Other side effects - if you get any of the following side effects, contact your doctor as soon as possible:

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

Low white blood cell count, which can increase the risk of infection. Low red blood cell count (anemia), which can 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), itching, color change of the vein, and/or inflammation of the 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, and possibly other systems), with symptoms such as pain. Low platelet count (risk of bleeding). Diarrhea. Pain in the muscles and joints, including pain in the jaw. Impaired kidney function (increased creatinine values). Weakness, fatigue, fever, pain in different areas.

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 can produce symptoms of fatigue, confusion, muscle cramps, and coma). Changes in heart activity (changes in the electrocardiogram). Severely low blood pressure or collapse. Lung disease (interstitial pneumopathy). Pancreatitis. Intestinal obstruction (paralytic ileus). Skin reactions, such as rash, itching, and urticaria. Necrosis at the injection site. Swelling of the tissues (angioedema).

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

Life-threatening blood poisoning. Strong heartbeat, rapid heartbeat, changes in heart rhythm.

Frequency not known (cannot be estimated from the available data)

Abnormal liver function. Chills with fever. Loss of muscle coordination that can be associated with an abnormal gait, changes in speech, and abnormal eye movements (ataxia). Headache. Cough. Abdominal pain and gastrointestinal bleeding. Weight loss. Generalized infection combined with a decrease in the number of white blood cells (septic neutropenia). Decrease in the number of white blood cells with fever (febrile neutropenia). Reduction in the number of red blood cells, white blood cells, and platelets. Low sodium levels caused by excessive production of a hormone that produces fluid retention and leads to weakness, fatigue, and confusion (Syndrome of Inappropriate Antidiuretic Hormone Secretion, SIADH). Decreased appetite (anorexia). Redness (erythema) of hands and feet. Acute lung dysfunction (respiratory failure) that causes death after previous radiotherapy. Darker skin color that follows the path of the veins.

Like other vinca alkaloids, vinorelbine has a moderate ability to produce blisters.

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

Reporting of side effects

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

5. Storage of Vinorelbine Aurovitas

Keep this medicine out of the 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 which is stated on the vial label and carton after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Content and Additional Information

Vinorelbine Aurovitas Composition

• The active ingredient 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 components are: water for injectable preparations.

Product Appearance and Container Content

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

Container Sizes:

1 vial of 1 ml

10 vials of 1 ml

1 vial of 5 ml

10 vials of 5 ml

Only some container 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 about this medicinal product, 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:

Date of the last revision of this leaflet: July 2025

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

This information is intended exclusively for healthcare professionals:

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

Instructions for Use

ANTINEOPLASTIC MEDICAMENT

Consult the Summary of Product Characteristics for more detailed information on this medicinal product.

Handling and Disposal Precautions

The preparation and administration of injectable solutions of cytotoxic medicinal products should be carried out by specialized personnel, trained and knowledgeable about the medicinal products used, and under conditions that ensure environmental protection and, in particular, the protection of personnel handling the medicinal products. A dedicated preparation area is required. Smoking, eating, or drinking is prohibited in this area.

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

Syringes and infusion equipment should be assembled carefully to avoid spills (Luer-lock closure is recommended).

Instructions for extracting the appropriate volume from the vial

To ensure the extraction of all the medicinal product from a vial, a 21-gauge or smaller diameter needle is recommended, which facilitates efficient transfer of the solution.

Spills and leaks should be cleaned up.

Pregnant women who are part of the personnel should avoid exposure to the medicinal product.

Any contact with the eyes should be strictly avoided. If it occurs, the eye should be rinsed immediately with a normal saline solution. In case of irritation, an ophthalmologist should be consulted.

In case of skin contact, the affected area should be washed with a large amount of water.

After completion, any exposed surface should be thoroughly cleaned, and hands and face should be washed.

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

Incompatibilities

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

In the absence of compatibility studies, this medicinal product should not be mixed with other medicinal products, except those mentioned in the "Dilution and Administration" section.

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

Dilution and Administration

Vinorelbine Aurovitas should be administered exclusively by the intravenous route and after dilution.

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

Before starting the injection, it is essential to ensure that the cannula is placed exactly in the vein. If Vinorelbine Aurovitas infiltrates the surrounding tissue during intravenous administration, significant irritation may occur. In this case, the injection should be interrupted, the vein should be flushed with a saline solution, and the remaining dose should be administered in another vein. If extravasation occurs, glucocorticoids may be administered intravenously to reduce the risk of phlebitis.

Excrements and vomits should be handled with care.

Storage

Marketing Authorization Holder

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 the first opening of the vial.

After Dilution

The physical-chemical and microbiological stability of the medicinal product after dilution with the recommended infusion solutions has been demonstrated for 24 hours at 2°C-8°C and 25°C.

From a microbiological point of view, the medicinal product should be used immediately.

If not used immediately, the in-use storage conditions and times are the responsibility of the user and normally should not exceed 24 hours at 2°C-8°C, unless the reconstitution has been carried out in controlled and validated aseptic conditions.