VINORELBINE ACCORD 10 mg/ml CONCENTRATE FOR INFUSION SOLUTION

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

Do not use Vinorelbina Accord:

• if you are allergic to vinorelbina or to any other medicine of the group of medicines called vinca alkaloids;
• if you are allergic to any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or think you may be pregnant;
• if you are breast-feeding;
• if you have a low white blood cell count (neutrophils) or a severe infection, current or recent (in the last two weeks);
• if you have a low platelet count;
• if you are scheduled to receive (or have recently received) the yellow fever vaccine
• This medicine is for intravenous use only and must not be injected into the spinal column.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Vinorelbina Accord.

Tell your doctor if:

• you have a history of heart attack or severe 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 scheduled to be vaccinated;
• you have liver problems.
• Vinorelbina Accord must not come into contact with the eyes because there is a risk of severe irritation and even corneal ulcers. If this happens, you should immediately rinse your eyes with isotonic saline solution and call an ophthalmologist.
• Men and women undergoing treatment with Vinorelbina Accord must use an effective contraceptive method during treatment and after treatment; see the section on pregnancy and breastfeeding. Both men and women should read the information in this section.

Before administration of Vinorelbina Accord, a blood sample will be taken to analyze its components. If the results of this analysis are not satisfactory, it is possible that treatment will be delayed and other tests will be performed until the values return to normal.

Using Vinorelbina Accord with other medicines

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Your doctor should be particularly cautious if you are taking any of the following medicines:

• medicines that make the blood more fluid (anticoagulants);
• an antiepileptic medicine called phenytoin;
• an antifungal medicine called itraconazole;
• an anticancer medicine called mitomycin C;
• medicines that affect the immune system, such as cyclosporin and tacrolimus;
• concomitant use with lapatinib (a medicine used to treat cancer);
• St. John's Wort (Hypericum perforatum);
• antibiotics such as rifampicin, erythromycin, clarithromycin or telithromycin;
• antivirals used to treat AIDS (HIV) such as ritonavir (HIV protease inhibitors);
• verapamil, quinidine (used to treat heart problems).

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

Concomitant use of Vinorelbina Accord with other medicines with known medullary toxicity (affecting white blood cells, red blood cells and platelets) may worsen some of the adverse reactions.

Taking Vinorelbina Accord with food and drinks

No interaction of Vinorelbina Accord with food or drinks is known.

Use in children and adolescents

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

Pregnancy, breastfeeding and fertility

Pregnancy

• Do not take Vinorelbina Accord if you are pregnant or think you may be pregnant.
• If you are pregnant and need to start treatment with Vinorelbina Accord or if you become pregnant during treatment with Vinorelbina Accord, you should contact your doctor immediately.

Breastfeeding

• Do not take Vinorelbina Accord if you are breast-feeding.
• Breastfeeding should be discontinued if treatment with Vinorelbina Accord is necessary.

Fertility

Men treated with Vinorelbina Accord are advised not to father a child during treatment and up to 3 months after the end of treatment and to seek advice on the conservation of their sperm before starting treatment, as Vinorelbina Accord may affect male fertility.

Fertile women

Women of childbearing age must use effective contraceptive measures during treatment and for three months after the end of treatment, and should contact their doctor if they become pregnant.

Driving and using machines

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

3. How to use Vinorelbina Accord

Follow exactly the administration instructions indicated by your doctor for this medicine. In case of doubt, consult your doctor or pharmacist again.

Dosage

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

Before each administration, a new blood sample will be taken to check its composition, in order to confirm that the patient has enough blood cells to receive Vinorelbina Accord. If the results of these tests are not satisfactory, it is possible that treatment will be delayed and new tests will be performed until the values return to normal.

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

Frequency of administration

Vinorelbina Accord is scheduled once a week. The doctor will determine the frequency.

Always follow the instructions of your doctor.

Dose adjustment:

• In case of significant liver insufficiency, the doctor may adjust the dose. You should follow

the instructions of your doctor.

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

the instructions of your doctor.

Form and route of administration

Vinorelbina Accord must be diluted before administration.

Vinorelbina Accord can only be administered intravenously. It will be administered by infusion in one of your veins, which will last between 6 and 10 minutes.

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

If you take more Vinorelbina Accord than you should

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

If you have any further questions, ask your doctor or pharmacist.

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

4. Possible side effects

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

Tell your doctor immediately if you develop any of the following symptoms while using Vinorelbina Accord:

- Signs of infection such as cough, fever and chills.

- Severe constipation with abdominal pain after several days without bowel movement.

- Severe dizziness, fainting when standing up, which can be signs of a severe drop in blood pressure.

- Severe chest pain unusual for you, the symptoms may be due to an alteration in cardiac function, followed by insufficient blood flow such as ischemic heart disease, such as angina pectoris and myocardial infarction (sometimes fatal).

- Difficulty breathing, which can be a symptom of a condition known as acute respiratory distress syndrome and can be severe and potentially fatal.

- Dizziness, skin rash that affects the whole body or swelling of the eyelids, lips, face or throat, which can be signs of an allergic reaction.

- Chest pain, difficulty breathing and fainting that can be symptoms 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 could indicate a neurological disorder such as posterior reversible encephalopathy syndrome

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

• Nausea, vomiting, constipation;
• Decrease in red blood cells that can cause paleness of the 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, occasionally alterations in tactile perception;
• Hair loss, usually not severe in long treatments;
• Inflammation or ulceration in the mouth or throat;
• Reactions at the injection site of Vinorelbina Accord such as redness, burning, discoloration of the veins, inflammation of the veins;
• Liver alterations (altered liver tests).

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

• Decrease in the number of platelets that can increase the risk of bleeding or bruising;
• 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 performing movements and abnormal sensation to touch;
• Dizziness;
• Sudden feeling of heat and redness of the skin of the face and neck;
• Feeling of cold in hands and feet;
• Difficulty breathing or wheezing (dyspnea and bronchospasm);
• Blood infections (sepsis) with symptoms such as high fever and deterioration of general 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);
• Lung toxicity (inflammation and fibrosis, sometimes fatal);
• Severe abdominal and back pain (inflammation of the pancreas);
• Low sodium levels in the blood (which can 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 the body such as rash 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.

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

• Abdominal pain, gastrointestinal bleeding;
• Heart failure that can cause difficulty breathing and swelling of the ankles;
• Redness of hands and feet (erythema);
• Low sodium level due to an overproduction of a hormone that causes fluid retention and produces weakness, fatigue or confusion (Syndrome of Inappropriate Antidiuretic Hormone Secretion SIADH);
• Lack of muscle control that can be associated with an abnormal gait, changes in speech and abnormal eye movements (ataxia);
• Headache;
• Chills with fever;
• Cough;
• Lack of appetite;
• Weight loss.
• Darker skin color that follows the path of the veins.

Reporting of side effects

If you experience side effects, consult your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Vinorelbina Accord

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

Do not use this medicine after the expiry date which is stated on the vial and the outer packaging after ‘EXP’. The expiry date is the last day of the month shown.

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

Store in the original packaging to protect from light.

Shelf-life after dilution

Chemical and physical stability has been demonstrated 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 in-use storage times and conditions are the responsibility of the user.

Do not freeze.

Disposal of unused medicine and all materials that have been in contact with it will be carried out in accordance with local regulations for cytotoxics.

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. Contents of the pack and other information

Composition of Vinorelbina Accord

The active substance is vinorelbina (as tartrate). Each 1 ml of solution contains 10 mg of vinorelbina (as vinorelbina tartrate).

The other ingredients are: water for injections.

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

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

Appearance of Vinorelbina Accord and contents of the pack

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

Vinorelbina Accord is available in:

1 vial of 1 ml

1 vial of 5 ml

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Accord Healthcare S.L.U.

World Trade Center

Moll de Barcelona, s/n

Edifici Est, 6ª planta

08039 Barcelona

Spain

Manufacturer

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50,

95-200 Pabianice,

Poland

Date of last revision of this leaflet: June 2023

This medicine is authorized in the Member States of the EEA under the following names:

Vinorelbine Accord Healthcare 10 mg/ml, concentrate for solution for intravenous infusion

CY

Vinorelbine Accord 10 mg/ml, concentrate for solution for infusion

CZ

Vinorelbine Accord 10 mg/ml concentrate for infusion solution

DK

Vinorelbin Accord

DE

Vinorelbine Accord 10 mg/ml concentrate for preparation of an infusion solution

EE

Vinorelbine Accord

ES

Vinorelbine Accord 10 mg/ml concentrate for solution for perfusion EFG

FI

Vinorelbine Accord 10 mg/ml infusion concentrate for solution

FR

Vinorelbine Accord 10 mg/ml solution to be diluted for perfusion

IT

Vinorelbina Accord

LV

Vinorelbine Accord 10 mg/ml concentrate for infusion solution preparation

LT

Vinorelbine Accord 10 mg/ml concentrate for infusion solution

ML

Vinorelbine 10 mg/ml concentrate for infusion solution

NO

Vinorelbine Accord 10 mg/ml, concentrate for infusion fluid

PL

Vinorelbine Accord

RO

Vinorelbina Accord 10 mg/ml concentrate for perfusion solution

NL

Vinorelbine Accord 10 mg/ml concentrate for solution for infusion

SK

Vinorelbine Accord 10 mg/ml infusion concentrate

SE

Vinorelbine Accord 10 mg/ml concentrate for infusion fluid, solution

SI

Vinorelbin Accord 10 mg/ml concentrate for infusion solution

UK

Vinorelbine 10 mg/ml concentrate for solution for infusion

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

This information is intended only for healthcare professionals:

Vinorelbine Accord 10 mg/ml concentrate for solution for perfusion EFG

Instructions for use

ANTINEOPLASTIC AGENT

Consult the detailed information on this medication in the technical data sheet.

Handling and use

The preparation and administration of injectable solutions of cytotoxic drugs must be carried out by specialized personnel with training, who know the medications used, under conditions that guarantee environmental protection and, especially, the protection of personnel handling the medications. A reserved preparation area is required. Smoking, eating, and drinking are prohibited in this area.

Personnel must have appropriate handling materials, especially long-sleeved gowns, masks, caps, protective glasses, sterile disposable gloves, protective covers for the work area, and waste collection bags.

Syringes and perfusion sets must be assembled with caution to avoid leaks (Luer connections are recommended).

Spills and leaks must be cleaned up using protective gloves.

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

Any contact with the eyes must be strictly avoided. In case of eye contact, it is essential to rinse immediately with isotonic saline solution. In case of irritation, an ophthalmologist should be consulted.

In case of skin contact, the affected area must be washed thoroughly with water.

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

Preparation of the perfusion solution.

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

If polychemotherapy is administered, Vinorelbine Accord must not be mixed with other medications.

Intrathecal administration is contraindicated.

Vinorelbine Accord should only be administered intravenously in perfusion.

Vinorelbine 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 perfusion (20-30 minutes) after dilution in 125 ml of isotonic saline solution or 50 mg/ml glucose solution (5%). Administration must always be followed by perfusion of at least 250 ml of isotonic solution to irrigate the vein.

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

Excretions and vomit must be handled with care.

Storage

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

Keep in the original packaging to protect from light.

Validity period after dilution

Chemical and physical stability has been demonstrated 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 must 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.

Disposal

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.