Prospecto: information for the user

Vinorelbina Aurovitas10 mg/ml concentrate for infusion solution EFG

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any questions, consult your doctor or nurse.

-This medicine has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or nurse, even if they are not listed in this prospect. See section 4.

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

2.What you need to know before starting to use Vinorelbina Aurovitas

3.How to use Vinorelbina Aurovitas

4.Possible adverse effects

5.Storage of Vinorelbina Aurovitas

6.Contents of the package and additional information

Vinorelbina Aurovitas is indicated for use in adults.

Vinorelbina is used in the treatment of cancer and belongs to a group of medications known as Vinca alkaloids.

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

No use Vinorelbina Aurovitas

-if you are allergic to vinorelbina or to other vinca alkaloids or to any of the other ingredients of this medicine (listed in section 6).

-if you have or have 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 breastfeeding.

-if you are a fertile woman and are not using an effective contraceptive method.

-when used 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

Consult your doctor before starting to useVinorelbinaAurovitas:

-if you have had a heart disease in which there has been a lack of blood supply to the heart (ischemic heart disease, angina).

-if you are receiving radiation therapy, and the treated area includes the liver.

-if you have signs or symptoms that suggest the presence of an infection (such as fever, chills, sore throat), inform your doctor immediately, so that they can perform any necessary tests.

-if liver function is decreased.

-if you need to be vaccinated. You must inform your doctor of the 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 having lung problems during treatment withvinorelbina.

-if you are irradiating the pelvis, spinal column, or long bones at the same time as administering vinorelbina, it is expected that there will be an increase in bone marrow damage (myelotoxicity). The same applies to previous radiation therapy (<3>

-neurolgical evaluations should be performed if you continue treatment with vinorelbina or if you are at higher risk.

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

Men and women treated with vinorelbina should use an effective contraceptive method during treatment. Both MEN and WOMEN SHOULD read the information on pregnancy and breastfeeding that is included below.

Before each administration of vinorelbina, a blood sample will be taken to perform a blood component analysis. If the results are not satisfactory, your treatment may be delayed and further tests may be performed until the results return to normal.

Other Medicines and Vinorelbina Aurovitas

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine. It is especially important if you are using any of the following medicines:

-other medicines that can affect the bone marrow, e.g. cancer treatment medicines.

-carbamazepine, phenytoin, or fosphenytoin and phenobarbital (epilepsy treatment medicines).

-antibiotics such as rifampicin, erythromycin, clarithromycin, telithromycin.

-St. John's Wort (Hypericum perforatum).

-ketoconazole, posaconazole, and itraconazole (fungal infection treatment medicines).

-antiviral medicines for treating HIV infection, e.g. ritonavir (HIV protease inhibitors).

-nefazodone (depression treatment medicines).

-ciclosporin and tacrolimus (medicines that decrease the activity of the immune system).

-other cancer treatment 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 vaccination, as they may cause severe side effects if administered during treatment with vinorelbina.

Pregnancy, Breastfeeding, and Fertility

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

Vinorelbina must not be administered to pregnant women, as it may cause severe birth defects.

If you are a fertile woman, you must use an effective contraceptive method during treatment and for 3 months after it ends. If you become pregnant during treatment, inform your doctor immediately. If you are pregnant or may become pregnant during treatment with vinorelbina, it is recommended that you receive genetic counseling.

If you are a man, you must avoid fathering a child during treatment with vinorelbina and for 6 months after it ends. There is also a risk that treatment with vinorelbina may cause infertility in men, so you may want to be advised on sperm conservation before starting treatment.

You must stop breastfeedingbeforestarting treatment with vinorelbina, 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 Operating Machinery

Caution is recommended due to the possible side effects.

Vinorelbina Aurovitas will be administered under the supervision of a specialist doctor for this type of treatment.

The recommended dose is:

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

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

Patients over 65 years old

Clinical experience has not identified significant differences in how patients of advanced age respond to vinorelbina. However, some of these patients may be more sensitive to this medication.

Patients with liver problems

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

Patients with kidney problems

No dose reduction is necessary in patients with renal insufficiency.

Use in children

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

Administration form

The medication must be diluted before use with a sodium chloride solution or glucose, and administered through a vein as an injection over 6-10 minutes or by infusion (drip) over 20-30 minutes. After treatment, the vein will be irrigated with a sodium chloride solution.

If you use more Vinorelbina Aurovitas than you should

Since this medication will be administered while you are in the hospital, it is unlikely that you will receive an insufficient or excessive amount; however, if you have any doubts, consult your doctor or pharmacist. It is also possible to experience paralytic ileus (intestinal obstruction).

Information for the doctor:

Since there is no specific antidote for a vinorelbina overdose, in case of an overdose, symptomatic measures must be applied. These measures include:

-Continuous monitoring of vital signs and careful monitoring of the patient.

-Daily hemogram control to recognize the need for blood transfusions, administration of growth factors, or intensive care, and to evaluate the risk of infection.

-Measures to prevent paralytic ileus.

-Circulatory system control and liver function.

Complications related to infection can be treated with broad-spectrum antibiotics, paralytic ileus with decompression using a catheter.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Severe side effects - if any of the following severe side effects occur, contact a doctor immediately:

Rare (may affect up to 1 in 100 people)

Severe infections with failure of different organs 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 extend to the back of your neck and arm, due to a lack of blood supply to the heart (angina pectoris). Heart attack (myocardial infarction).

Unknown frequency (cannot be estimated from available data)

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 dizziness, which may be a symptom of a blood clot in a lung blood vessel (pulmonary embolism), headaches, changes in mental state that may 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 severe side effects. You may need immediate medical assistance.

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 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 results from liver function tests. Hair loss. Redness (erythema), itching, change in color 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. Muscle and joint pain, including jaw pain. Kidney function alteration (increased creatinine values). Weakness, fatigue, fever, pain in different locations.

Rare (may affect up to 1 in 100 people)

Severe numbness (paresthesia). Low blood pressure, high blood pressure, redness, and peripheral coldness.

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

Low sodium levels in the blood (which may cause 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 pneumonitis). 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)

Blood poisoning that may be life-threatening. Strong heartbeat, rapid heartbeat, heart rhythm alterations.

Unknown frequency (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. General infection combined with a decrease in white blood cell count (neutropenic sepsis). Fever with decreased white blood cell count (febrile neutropenia). Reduction in red blood cell, white blood cell, and platelet counts.Low sodium levels caused by excessive production of a hormone that leads to fluid retention and results 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 insufficiency) that leads to death after previous radiation therapy. Darker skin color that follows the path of the veins.

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

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish 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.

Keep this medication out of the sight and reach of children.

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

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

Do not use this medication after the expiration date that appears on the vial label and on the box after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medicines that you no longer need. In this way, you will help protect the environment.

Composition of Vinorelbina Aurovitas

-The active ingredient is vinorelbine. One ml of concentrate for infusion solution 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 components are: water for injection.

Appearance of the product and contents of the package

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

Package sizes:

1 vial of 1 ml

10 vials of 1 ml

1 vial of 5 ml

10 vials of 5 ml

Only some package sizes may be marketed.

Marketing Authorization Holder

Eugia Pharma (Malta) Limited

Vault 14, Level 2, Valletta Waterfront

Floriana, FRN 1914

Malta

Responsible for manufacturing

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

For more information about 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 medicine is authorized in the Member States of the European Economic Area with the following names:

Last review date of this leaflet: November 2023

For detailed information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).

This information is intended solely for healthcare professionals:

Vinorelbina Aurovitas 10 mg/ml concentrate for infusion solution EFG

Instructions for use

ONCOLOGIC MEDICINE

See the Technical Data Sheet for more detailed information about this medicine.

Precautions for handling and disposal

The preparation and administration of cytotoxic drug solutions must be carried out by specialized personnel, trained, with knowledge of the drugs used, and in conditions that ensure the protection of the environment and, in particular, the protection of the personnel handling the drugs. A reserved preparation area is required. Smoking, eating, or drinking are prohibited in this area.

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

Needles and infusion equipment must be assembled carefully to avoid spills (the use of Luer-lock closure is recommended).

Spills and leaks must be cleaned up.

Care must be taken to avoid exposure of pregnant women who are part of the staff to the drug.

Strictly avoid any contact with the eyes. If this occurs, immediately wash the eye with normal saline solution. In case of irritation, contact an ophthalmologist.

In case of skin contact, wash the affected area with a large amount of water.

After finishing, thoroughly clean any exposed surface, and wash hands and face.

The disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.

Incompatibilities

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

In the absence of compatibility studies, this medicine should not be mixed with other medications, except those mentioned in the "Dilution and administration" section.

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

Dilution and administration

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

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

Before starting the injection, it is very important to ensure that the cannula is exactly in the vein. If Vinorelbina Aurovitas infiltrates into the surrounding tissue during intravenous administration, it may cause significant irritation. In this case, the injection should be interrupted, the vein should be irrigated 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.

Stools and vomit should be handled with care.

Storage

Package for commercialization

Store in refrigerator (between 2°C and 8°C). Store the vial in the outer packaging to protect it from light. DO NOT FREEZE. Do not use Vinorelbina Aurovitas after the expiration date appearing on the vial label and in the box.

After opening

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

After dilution

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

From a microbiological point of view, the medicine must be used immediately.

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