VINORELBINA 10 mg /Ml Koncentrat Do Sporządzania Roztworu Infuzyjnego

Treść ulotki

1. Vinorelbina Accord 10 mg/ml concentrate for solution for infusion
   1. What is Vinorelbina Accord and what is it used for
   2. What you need to know before you use Vinorelbina Accord
   3. How to use Vinorelbina Accord
   4. Possible side effects
   5. How to store Vinorelbina Accord
   6. Package Contents and Other Information

Vinorelbina Accord 10 mg/ml concentrate for solution for infusion

Generic medicine

Read this leaflet carefully before you use this medicine, as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Vinorelbina Accord is a concentrate for solution for infusion. The active ingredient vinorelbine
belongs to a group of cytostatic agents. These agents interfere with the growth of malignant cells.
Vinorelbina Accord is indicated in the treatment of tumors in adults, particularly in
non-small cell lung cancer and breast cancer in patients over the age of
18 years.

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

Do not use Vinorelbina Accord
if you are allergic to vinorelbine or to any of the excipients of Vinorelbina Accord (listed in section
6);
if you are allergic to any of the other components of Vinorelbina Accord (listed in paragraph
6);
if you are breastfeeding;
if you have a low number of white blood cells (neutrophils) or if you have had or recently had (within the
past 2 weeks) a serious infection;
if you have a low number of platelets;

if you are about to receive (or have just received) the yellow fever vaccine.
This medicine is strictly for intravenous use only and must not be injected into the
spinal column.

Warnings and precautions
Talk to your doctor or pharmacist before using Vinorelbina Accord.
Tell your doctor:

• if you have a history of heart attacks or severe chest pain;
• if you have been treated with radiotherapy to an area including the liver;
• if you have symptoms of infection (such as fever, chills, cough);
• if you are about to receive a vaccine;
• if your liver is not functioning normally;
• if you are pregnant. Vinorelbina Accord must not come into contact with the eyes as there is a risk of severe irritation and even corneal ulcers. If this occurs, immediately wash the eye with a normal saline solution and contact an ophthalmologist. Before each administration of Vinorelbina Accord, a blood sample will be taken for analysis of its components. If the results of these analyses are not satisfactory, treatment may be delayed and further checks will be carried out until these values return to normal.

Other medicines and Vinorelbina Accord
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Your doctor will need to be particularly careful if you are taking any of the following medicines:

• medicines to make the blood more fluid (anticoagulants)
• an antiepileptic medicine called phenytoin
• an antifungal medicine called itraconazole
• an anticancer medicine called mitomycin C
• medicines that interfere with the immune system, such as cyclosporine and tacrolimus
• concurrent use with lapatinib (medicine used to treat cancer)
• St John's wort (Hypericum perforatum)
• antibiotics such as rifampicin, erythromycin, clarithromycin, telithromycin
• antiviral medicines used for AIDS (HIV) such as ritonavir (HIV protease inhibitors)
• verapamil, quinidine (used for heart problems)

Vaccines (e.g. varicella, mumps, measles, etc.) and yellow fever vaccines are not recommended
during treatment with Vinorelbina Accord, as they may increase the risk of a fatal systemic illness.
The use of Vinorelbina Accord simultaneously with other medicines with known bone marrow toxicity
(affecting white blood cells and red blood cells and platelets) may worsen some side effects.

Vinorelbina Accord with food and drink
There are no interactions with food and drink during treatment with Vinorelbina Accord.

Use in children and adolescents
Safety and efficacy in children and adolescents have not been established.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, ask your doctor for advice before
taking this medicine because there are potential risks to the baby.

Pregnancy
Before starting treatment, you must inform your doctor and ask their opinion if you are pregnant, if you think you are pregnant or if you intend to become pregnant as there may be
potential risks to the baby.
If you are a woman of childbearing potential, you must use an effective contraceptive method (birth control)
during treatment and for 7 months after the end of treatment.

Breastfeeding
You must not breastfeed while being treated with Vinorelbina Accord (see section 2
Do not use Vinorelbina Accord).

Fertility
Men treated with Vinorelbina Accord are advised not to father children during treatment and
for 4 months after the end of treatment and to inquire about the possibility of sperm preservation
before starting treatment, as Vinorelbina Accord may alter male fertility.
You must use an effective contraceptive method during treatment and for 4 months after the end of
treatment.

Driving and using machines
Studies have not been conducted on the effects of Vinorelbina Accord on the ability to drive vehicles or
operate machinery. Therefore, do not drive if your doctor has recommended you not to drive or if you feel unwell.

3. How to use Vinorelbina Accord

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.

Dosage
Vinorelbina Accord can only be prepared and administered by qualified healthcare professionals
specialized in oncology.
Before each administration, a new blood sample must be taken to check its components, in order to
verify that the patient has enough blood cells to receive Vinorelbina Accord. If the results of these tests
are not satisfactory, treatment may be postponed and new tests will be carried out until these values
return to normal.
The usual dose for adults is 25-30 mg/m².

Frequency of administration
The administration of Vinorelbina Accord is scheduled once a week. The frequency will be
determined by the doctor.
Always follow the doctor's instructions.
Dosage adjustment:

• In case of significant hepatic insufficiency, the dose may be adjusted by the doctor. It is necessary to follow the doctor's instructions.
• In case of renal insufficiency, no dose adjustment is necessary. It is necessary to follow the doctor's instructions.

Method and route of administration
Vinorelbina Accord must be diluted before administration.
Vinorelbina Accord must be administered only intravenously. It will be administered to you by
intravenous infusion. This will take 6 to 10 minutes.
After administration, the vein must be flushed with a sterile solution.

If you take more Vinorelbina Accord than you should
The doctor must always ensure that you receive the dose appropriate for your condition. However, contact
your doctor, emergency room or pharmacist if you have any suspicion or if you have symptoms of a
potential overdose, such as fever, signs of infection or constipation.
If you have any doubts, ask your doctor or pharmacist.

4. Possible side effects

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

Contact your doctor immediately while receiving Vinorelbina Accord if you experience any of the following symptoms:

• Signs of infection, such as cough, fever and chills,
• Severe constipation with abdominal pain, when your bowel does not move for several days,
• Severe dizziness, feeling lightheaded when standing up, a sign of a serious drop in blood pressure,
• Severe chest pain that is unusual for you, the symptoms may be due toimpaired cardiac function due to insufficient blood flow,called ischemic heart disease such as angina pectoris and myocardial infarction (sometimeswith fatal outcome),
• Difficulty breathing, which may be symptoms of a condition known as acute respiratory distress syndrome and can be severe and life-threatening,
• Dizziness, low blood pressure, skin rashes affecting the whole body or swelling of the eyelids, face, lips or throat, which may be signs of an allergic reaction,
• Chest pain, shortness of breath and fainting, which may be symptoms of a blood clot in a blood vessel in the lungs (pulmonary embolism),
• Headache, altered mental status that can cause confusion and coma, seizures, blurred vision and high blood pressure, which may be a sign of a neurological condition such as reversible posterior encephalopathy syndrome.

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

• Nausea, vomiting, constipation;
• A decrease in red blood cells, which can make the skin pale and cause weakness or shortness of breath;
• A decrease in white blood cells, which makes you more vulnerable to infections;
• Weakness of the lower limbs;
• Loss of some reflexes, occasionally alterations in the perception of touch;
• Hair loss (alopecia), normally not severe for prolonged treatment;
• Inflammation or sores in the mouth or throat;
• Reactions at the site where Vinorelbina Accord was administered such as redness, burning pain (which causes a burning sensation), abnormal color of the veins, inflammation of the veins;
• Liver problems (abnormal liver tests).

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

• A decrease in platelets, which can increase the risk of bleeding or bruising;
• Joint pain;
• Jaw pain;
• Muscle pain;
• Fatigue (asthenia, tiredness);
• Fever;
• Pain in different parts of the body, for example chest pain and at the site of the tumor;
• Diarrhea;
• Infections in different areas.

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

• Severe difficulty with body movements and sense of touch;
• Dizziness;
• Sudden feeling of warmth and redness of the skin of the face and neck;
• Coldness in the hands and feet;
• Difficulty breathing or wheezing (dyspnea and bronchospasm);
• Blood infection (sepsis) with symptoms such as high fever and deterioration of general physical health;
• High blood pressure.

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

• Heart attack (ischemic heart disease, angina pectoris, myocardial infarction, sometimes fatal);
• Lung toxicity (inflammation and fibrosis, sometimes fatal);
• Severe abdominal and back pain (inflammation of the pancreas);
• Low levels of sodium in the blood (which can cause symptoms of fatigue, confusion, muscle cramps and loss of consciousness),
• Ulcers at the injection site where Vinorelbina Accord was administered (local necrosis);
• Skin rashes on the body, such as irritation and eruptions (generalized skin reactions).

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

• Irregular heartbeat (tachycardia), palpitations, heart rhythm disturbances. Side effects with unknown frequency (cannot be estimated on the basis of the availabledata)
• Abdominal pain, gastrointestinal bleeding;
• Heart failure that can cause shortness of breath and swelling of the ankles,
• Redness of hands and feet (erythema);
• Low level of sodium due to overproduction of a hormone that causes fluid retention and causes weakness, fatigue or confusion (Syndrome of inappropriate antidiuretic hormone secretion SIADH),
• Lack of muscle control may be associated with abnormal gait, speech alterations and abnormalities in eye movement (ataxia);
• Headache;
• Chills with fever;
• Cough;
• Loss of appetite;
• Weight loss;
• Darker color of the skin along the path of the veins.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the
national reporting system at https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse. By reporting side effects you can help provide more information
about the safety of this medicine.

5. How to store 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 on the packaging
after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C). Do not freeze.
Store in the original package to protect the medicine from light.

Validity after dilution
Chemical and physical stability during use has been demonstrated for 24 hours at 25° C.
From a microbiological point of view, unless the opening/dilution method precludes the risk
of microbial contamination, the product must be used immediately after dilution. If
not used immediately, the storage times and conditions are the responsibility
of the user.
Do not freeze.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Vinorelbina Accord Contains
The active ingredient is vinorelbine (as tartrate). 1 ml of solution contains 10 mg of vinorelbine
(as vinorelbine tartrate).
The other component is water for injections.
Each 1 ml vial contains a total of 10 mg of vinorelbine (as tartrate).
Each 5 ml vial contains a total of 50 mg of vinorelbine (as tartrate).

Description of Vinorelbina Accord and Package Contents
Clear solution, from colourless to pale yellow. Vinorelbina Accord is packaged in
transparent type I glass vials, with a bromobutyl rubber stopper and a blue aluminium flip-off seal.
Vinorelbina Accord is available in:
1 vial of 1 ml
1 vial of 5 ml
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturers
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50,95-200 Pabianice,
Poland

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:

The following information is intended exclusively for physicians and healthcare professionals:
Vinorelbina Accord 10 mg/ml concentrate for solution for infusion
Instructions for Use
ANTINEOPLASTIC AGENT
Refer to the Summary of Product Characteristics for detailed information regarding
this product.

Handling and Use
The preparation and administration of injectable solutions of cytotoxic agents must be carried out
by qualified and experienced personnel in conditions that
ensure the protection of the environment and, in particular, the protection of personnel involved in
handling the drugs. A dedicated preparation area is required. Smoking, eating or drinking is
prohibited in this area.
Personnel must be provided with appropriate materials for handling, in particular long-sleeved clothing,
protective masks, caps, safety glasses, sterile disposable gloves,
protective covers for the work area and waste collection bags.
Syringes and infusion sets must be assembled carefully to avoid leaks (use of Luer lock fittings is
recommended).
Spills and leaks must be cleaned up while wearing protective gloves.
Precautions must be taken to avoid exposure of personnel during pregnancy.
Contact with eyes must be absolutely avoided. If this occurs, immediately wash the eyes with normal saline.
If irritation occurs, contact an ophthalmologist.
If contact with skin occurs, wash the affected area thoroughly with water.
Finally, any exposed surface should be cleaned carefully, and hands and face washed.
Preparation of the infusion solution.
There is no incompatibility of Vinorelbina Accord with glass vials, PVC bags, vinyl acetate bags or polypropylene syringes.
In the case of polychemotherapy, Vinorelbina Accord should not be mixed with other agents.
Intrathecal administration is contraindicated.
Vinorelbina Accord must be administered as an infusion only by the intravenous route.
Vinorelbina Accord can be administered as a slow bolus (6-10 minutes) after dilution in 20-50
ml of normal saline or 50 mg/ml (5%) glucose solution or for a short infusion (20-30 minutes) after dilution in 125 ml of normal saline or
50 mg/ml (5%) glucose solution. Administration must always be followed by an infusion of at least
250 ml of isotonic solution to flush the vein.
Vinorelbine must be administered only by the intravenous route. It is very important to ensure,
before starting the injection, that the cannula is correctly positioned in the vein. If vinorelbine leaks into the surrounding tissues during
intravenous administration, significant irritation may occur. In this case, the injection should be stopped, the vein flushed with saline and the
remainder of the dose administered in another vein. In case of extravasation, corticosteroids may be administered intravenously to reduce the risk of phlebitis.
Faeces and vomit must be handled with care.

Storage
Store in a refrigerator (2 °C – 8 °C). Do not freeze.
Keep in the original package to protect from light.

Stability after dilution
Chemical and physical stability during use has been demonstrated for 24 hours at 25°C.
From a microbiological point of view, unless the opening/dilution method precludes microbial contamination, the product must be used immediately after dilution. If not
used immediately, storage times and conditions are the responsibility of the user.
Do not freeze.
Disposal
Unused medicinal product and waste materials derived from such medicinal product should be disposed of in accordance with
local regulations.