Prospect: information for the user

Vinorelbina Accord 10 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 doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you, and you must 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 pharmacist, even if they are not listed in this prospect. See section 4.

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

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

3. How to use Vinorelbina Accord

4. Possible adverse effects

5. Storage of Vinorelbina Accord

6. Contents of the package and additional information

Vinorelbina Accord contains vinorelbina as the active ingredient which belongs to the group of anticancer drugs. These drugs interfere with the growth of malignant cells.

Vinorelbina Accord is indicated in adults for the treatment of cancer, specifically non-small cell lung cancer and breast cancer.

No use Vinorelbina Accord:

-if you are allergic to vinorelbina or to any medicine in the family of medicines called vinca alkaloids;

-if you are allergic to any of the other components of this medicine (listed in section 6);

-if you are pregnant or think you might be;

-if you are breastfeeding;

-if you have a decrease in white blood cell count (neutrophils) or a severe infection currently or recently (in the last two weeks);

-if you have a decrease in platelet count;

-if you are planning to receive (or have recently received) the yellow fever vaccine

-This medicine is for exclusive intravenous use and should not be injected into the spinal column.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Vinorelbina Accord.

Inform your doctor if:

-you have a history of heart attack or intense chest pain;

-you have received radiation therapy and the treated area included the liver;

-you have symptoms of infection (such as fever, chills, or cough);

-you are planning to get vaccinated;

-you have liver problems.

-Vinorelbina Accord should not come into contact with the eyes because there is a risk of severe irritation and even corneal ulcers. If this occurs, wash your eyes immediately with isotonic saline solution and call an ophthalmologist.

-Men and women being treated with Vinorelbina Accord should use an effective contraceptive method during treatment and after it; see the section on pregnancy and breastfeeding. Both men and women should read the information in this section.

Before administering Vinorelbina Accord, a blood sample will be taken to analyze its components. If the results of this analysis are not satisfactory, treatment may be delayed and further analysis may be performed until the values return to normal.

Use of Vinorelbina Accord with other medicines

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine.

Your doctor should exercise special caution if you are taking any of the following medicines:

- medicines that make the blood thinner (anticoagulants);

- an antiepileptic medicine called phenytoin;

- an antifungal medicine called itraconazole;

- an antineoplastic medicine called mitomycin C;

- medicines that affect the immune system, such as cyclosporine and tacrolimus;

- simultaneous use with lapatinib (medicine used to treat cancer);

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

- antibiotics such as rifampicin, erythromycin, clarithromycin, or telithromycin;

- antivirals used to treat HIV (AIDS) such as ritonavir (HIV protease inhibitors);

- verapamil, quinidine (used to treat heart problems).

It is not recommended to get vaccinated; e.g., chickenpox, mumps, measles, etc.; or the yellow fever vaccine during treatment with Vinorelbina Accord, as it may increase the risk of developing a life-threatening systemic disease.

The simultaneous use of Vinorelbina Accord with other medicines known to have myelotoxicity (affecting white blood cells, red blood cells, and platelets) may worsen some adverse reactions.

Administration of Vinorelbina Accord with food and drinks

No interactions of Vinorelbina Accord with food or drinks have been identified.

Use in children and adolescents

The safety and efficacy have not been established in children and adolescents.

Pregnancy, breastfeeding, and fertility

Pregnancy

• Do nottake Vinorelbina Accord if you are pregnant or think you might be.
• If you are pregnant and must start treatment with Vinorelbina Accord or if you become pregnant during treatment with Vinorelbina Accord, contact your doctor immediately.

Breastfeeding

• Do nottake Vinorelbina Accord if you are breastfeeding.
• Discontinue breastfeeding if treatment with Vinorelbina Accord is considered necessary.

Fertility

Men treated with Vinorelbina Accord are advised not to father children during treatment and for three months after the end of treatment and to seek advice on sperm conservation before starting treatment, as Vinorelbina Accord may affect male fertility.

Fertile women

Fertile women should use effective contraceptive methods during treatment and for three months after its completion, and should contact their doctor if they become pregnant.

Driving and operating machinery

No studies have been conducted on the effects of Vinorelbina Accord on the ability to drive and operate machinery. Therefore, do not drive if your doctor has advised you to do so or if you do not feel well.

Follow exactly the administration instructions provided by your doctor for this medication. In case of doubt, consult your doctor againorpharmacist.

Dosage

Only qualified healthcare professionals specializing in oncology can prepare and administer Vinorelbina Accord.

Before each administration, a new blood sample will be obtained to check its composition, in order to confirm that the patient has sufficient blood cells to receive Vinorelbina Accord. If the results of these tests are not satisfactory, it may be necessary to postpone treatment and perform new tests until the values return to normal.

The usual dose for adults is 25mg/m2to 30 mg/m².

Administration Frequency

Vinorelbina Accord is programmed once a week. Your doctor will determine the frequency.

Always follow your doctor's instructions.

Dose adjustment:

- In case of significant liver insufficiency, your doctor may adjust the dose. You must follow

your doctor's instructions.

• No dose adjustment is necessary in case of renal insufficiency. You must follow

your doctor's instructions.

Form and Route of Administration

Vinorelbina Accord must be diluted before administration.

Vinorelbina Accord can only be administered intravenously. It will be administered through a vein infusion lasting between 6 and 10 minutes.

After administration, the vein will be abundantly irrigated with a sterile solution.

If you take more Vinorelbina Accord than you should

Your doctor must ensure that you receive the correct dose in your situation. However, you must contact your doctor, the emergency service, or your pharmacist if you suspect or experience symptoms of a possible overdose, such as fever, signs of infection, or constipation.

If you have any doubts, consult your doctor or pharmacist.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

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

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

- Nausea, vomiting, constipation;

- Decrease in red blood cells that may cause pale skin and cause weakness or difficulty breathing;

- Decrease in white blood cells that makes you more vulnerable to infections;

- Weakness of the lower limbs;

- Loss of some reflexes, occasional alterations in tactile perception;

- Hair loss, usually not severe in long-term treatments;

- Inflammation or ulceration in the mouth or throat;

- Reactions at the injection site of Vinorelbina Accord such as redness, burning, discoloration of veins, inflammation of veins;

- Liver changes (altered liver tests).

Common side effects(may affect up to 1 in 10 people):

- Decrease in platelet count that may increase the risk of bleeding or petechiae;

- Joint pain;

- Jaw pain;

- Muscle pain;

- Fatigue (asthenia, fatigue);

- Fever;

- Pain in different parts of the body, such as chest pain or pain where the tumor is located;

- Diarrhea;

- Infections in different locations.

Uncommon side effects(may affect up to 1 in 100 people):

- Severe difficulties in movement and abnormal sensation to the touch;

- Dizziness;

- Sudden sensation of heat and redness of the face and neck skin;

- Sensation of cold in hands and feet;

- Difficulty breathing or wheezing (dyspnea and bronchospasm);

- Blood infections (sepsis) with symptoms such as high fever and general deterioration of health;

- High blood pressure.

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

- Heart attack (myocardial ischemia, angina pectoris, myocardial infarction, sometimes fatal);

- Pulmonary toxicity (inflammation and fibrosis, sometimes fatal);

- Severe abdominal and back pain (pancreatitis);

- Low sodium levels in your blood (which may cause symptoms such as fatigue, confusion, muscle twitching, and loss of consciousness);

- Ulcers at the injection site where Vinorelbina Accord was administered (local necrosis);

- Skin rashes on your body such as urticaria and rashes (generalized skin reactions).

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

- Irregular heart rate (tachycardia), palpitations, alterations in heart rhythm.

Unknown frequency(cannot be estimated from available data):

- Abdominal pain, gastrointestinal bleeding;

- Heart failure that may cause difficulty breathing and swelling of the ankles;

- Redness of hands and feet (erythema);

- Low sodium levels due to excessive production of a hormone that causes fluid retention and causes weakness, fatigue, or confusion (SIADH syndrome);

- Lack of muscle control that may be associated with abnormal gait, changes in speech, and abnormal eye movements (ataxia);

- Headache;

- Chills with fever;

- Cough;

- Loss of appetite;

- Weight loss.

- Color more dark of the skin that follows the path of the veins.

Reporting of side effects

If you experience side effects, consult your doctor or nurse. Even if they are possible side effects that do not appear in this leaflet. You can also report them directly through the Spanish System for the 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.

Do not use this medication after the expiration date that appears on the vial and the outer packaging, after «CAD». The expiration date is the last day of the month indicated.

Store in refrigerator (2 ºC- 8 ºC). Do not freeze.

Store in the original packaging to protect it from light.

Period of validity after dilution

Chemical and physical stability has been demonstrated in use for 24 hours at 25°C.

From a microbiological standpoint,unless the method of opening and dilution excludes the risk of microbial contamination, the product should be used immediately after dilution. If not used immediately, the storage times and conditions during use are the responsibility of the user.

Do not freeze.

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

Medications should not be thrown down the drain or in the trash. In case of doubt, ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Vinorelbina Accord

The active ingredient is vinorelbina (in the form of tartrate). Each 1 ml of solution contains 10mg of vinorelbina (in the form of vinorelbina tartrate).

The other components are: water for injection.

Each vial of 1 ml contains a total of 10 mg of vinorelbina (as tartrate).

Each vial of 5 ml contains a total of 50 mg of vinorelbina (as tartrate).

Appearance of Vinorelbina Accord and packaging contents

Vinorelbina Accord is a concentrate for solution for infusion. The solution is transparent, colorless to pale yellow. It is marketed in transparent type I glass vials with bromobutyl rubber stoppers sealed with an aluminum cap protected by a blue plastic overcap.

Vinorelbina Accord is available in:

1 vial of 1 ml

1 vial of 5 ml

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Accord Healthcare S.L.U.

World Trade Center

Moll de Barcelona, s/n

Edifici Est, 6th floor

08039 Barcelona

Spain

Manufacturer responsible

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50,

95-200 Pabianice,

Poland

Last review date of this leaflet: June 2023

This medicinal product is authorized in the EEA Member States under the following names:

The detailed information of this medicinal product is available on 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 Accord 10 mg/ml concentrate for solution for infusion EFG

Instructions for use

ANTINEOPLASTIC AGENT

Consult the detailed information of this medicinal product in the technical data sheet.

Handling and use

The preparation and administration of injectable solutions of cytotoxic drugs should be carried out by specialized personnel with training, who are familiar with the drugs used, in conditions that guarantee the protection of the environment and, especially, the protection of the personnel who handle the drugs. It requires a reserved preparation area for this purpose. Smoking, eating, and drinking are prohibited in this area.

The personnel should have the appropriate handling materials, especially long-sleeved gowns, masks, caps, protective glasses, disposable sterile gloves, protective aprons for the work area, and waste collection bags.

The syringes and infusion sets should be assembled with caution to avoid leaks (the use of Luer connections is recommended).

The spills and leaks should be cleaned up using protective gloves.

Precautions should be taken to avoid exposure of personnel during pregnancy.

It should be strictly avoided any contact with the eyes. In case of contact with the eyes, it is essential to wash them immediately with isotonic saline solution. In case of irritation, a contact with an ophthalmologist should be made.

In case of contact with the skin, the affected area should be washed abundantly with water.

After finishing, the area exposed should be thoroughly cleaned, and the hands and face should be washed.

Preparation of the infusion solution.

There is no incompatibility between Vinorelbina Accord and glass vials, PVC bags, vinyl acetate bags, or polipropylene syringes.

If polychemotherapy is administered, Vinorelbina Accord should not be mixed with other drugs.

The intrathecal administration is contraindicated.

Vinorelbina Accord should only be administered intravenously by infusion.

Vinorelbina Accord can be administered in slow bolus (6-10 minutes) after dilution in 20-50 ml of isotonic saline solution or 50 mg/ml glucose solution (5%), or in short infusion (20-30 minutes) after dilution in 125 ml of isotonic saline solution or 50 mg/ml glucose solution (5%). The administration should always be followed by the infusion of at least 250 ml of isotonic solution to irrigate the vein.

Vinorelbina should only be administered intravenously. Before proceeding with the injection, it is very important to ensure that the cannula is correctly placed in the vein. If vinorelbina infiltrates the surrounding tissue during intravenous administration, it may cause considerable irritation. In this case, the injection should be interrupted, the vein should be irrigated with saline solution, and the remaining dose should be administered in another vein. In case of extravasation, intravenous glucocorticoids may be administered to reduce the risk of phlebitis.

The excreta and vomit should be handled with care.

Storage

Store in refrigerator (2 °C- 8 °C). Do not freeze.

Store in the original packaging to protect it from light.

Validity period after dilution

Its chemical and physical stability has been demonstrated in use for 24 hours at 25°C.

From a microbiological point of view,unless the opening and dilution method excludes the risk of microbial contamination, the product should be used immediately after dilution. If not used immediately, the times and conditions of storage during use are the responsibility of the user.

Do not freeze.

Elimination

The elimination of the unused medicinal product and all materials that have been in contact with it should be carried out in accordance with local regulations for cytotoxics.