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VINORELBINE 50MG/5 ML CONCENTRATE FOR SOLUTION FOR INFUSION

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Vinorelbine Polpharma, 10 mg/ml, concentrate for solution for infusion
Vinorelbine Polpharma 50 mg/5 ml, concentrate for solution for infusion
Vinorelbine
Read all of this leaflet carefully before you start taking this medicine.
• 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. Do not pass it on to others. It may harm them, even if
their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor.

In this leaflet:
1.
What Vinorelbine Polpharma is and what it is used for
2.
Before you take Vinorelbine Polpharma
3.
How to take Vinorelbine Polpharma
4.
Possible side effects
5.
How to store Vinorelbine Polpharma
6.
Further information

1.

WHAT VINORELBINE POLPHARMA IS AND WHAT IT IS USED FOR

Vinorelbine belongs to a group of medicines known as vinca alkaloids, which are used in the treatment
of cancer.
Vinorelbine Polpharma has been prescribed by your doctor for the treatment of advanced breast cancer
or special forms of lung cancer (non-small cell lung cancer).

2.

BEFORE YOU TAKE VINORELBINE POLPHARMA

You will not be given vinorelbine:


if you are allergic (hypersensitive) to vinorelbine or other Vinca alkaloids or any of the



if you have or recently had serious infection or severe decrease in white blood cells
(neutropenia)
if you have severe decrease in blood platelets
if you are pregnant
if you are breast-feeding
if you are women of childbearing potential not using effective contraception
if you have a severe liver disease not caused by cancer
in combination with yellow fever vaccine.

other ingredients of Vinorelbine Polpharma







This medicine is strictly for intravenous use only and should not be injected into the spine.
Take special care with vinorelbine:

• if you have had a heart disease involving lack of blood supply to the heart (ischaemic heart

disease, angina)
• if you are having radiotherapy and the treatment field includes the liver
• if you present signs or symptoms suggestive of infection (such as fever, chills, sore throat), let

your doctor know immediately, so that he/she can carry out any tests which may be needed
• if you have impaired liver function
• if you need a vaccination. You should inform your doctor of the treatment before any
vaccinations.
• if you receive a cancer medicine named mitomycin C.
Vinorelbine must not get into contact with the eye as there is a risk of severe irritation and even
corneal ulceration. If this occurs, immediately rinse the eye with normal saline solution and contact an
ophthalmologist.
Men and women who are treated with vinorelbine should use an effective contraception during
treatment. Men and women should both read the information under pregnancy and breast-feeding
below.
Before each administration of vinorelbine a blood sample will be taken for analysis of its components.
If the results of this analysis are not satisfactory, your treatment may be delayed and further checks
made until these values return to normal.
Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription. This is especially important if you are using any of the
following medicines:














other medicines which can affect the bone marrow e.g. cancer medicines
carbamazepine, phenytoin and phenobarbital (medicines for the treatment of epilepsy)
antibiotics such as rifampicin, erythromycin, clarithromycin, telithromycin
St. John’s Wort (Hypericum perforatum)
ketoconazole and itraconazole (medicines for the treatment of fungal infections)
antiviral medicines to treat HIV-infection eg. ritonavir (HIV protease inhibitors)
nefazodon (medicine for the treatment of depression)
ciclosporin and tacrolimus (medicine which decrease the activity of the immune system)
verapamil, quinidine (medicines for the treatment of heart diseases)
other medicines for the treatment of cancer e.g. mitomycin C, cisplatin
blood thinning medicines e.g. warfarin
yellow fever vaccine and other live vaccines.

Pregnancy and breast-feeding
Vinorelbine should not be given to pregnant women, because it can cause serious birth defects.
If you are a women of childbearing age you must use an effective method of contraception during
treatment. If pregnancy occurs during your treatment you must immediately inform your doctor. If you
are or become pregnant during treatment with vinorelbine, genetic counselling is recommended.
If you are man, you should avoid fathering a child during treatment with vinorelbine and minimally
for 3 months after treatment has stopped. There is also a risk that treatment with vinorelbine will lead
to male infertility and you may wish to seek advice about sperm storage before the treatment starts.

You must discontinue breast-feeding before treatment with vinorelbine starts as it is not known
whether it might pass into breast milk thereby affecting the baby.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
No studies of the effects on the ability to drive and use machines have been performed.

3.

HOW TO TAKE VINORELBINE POLPHARMA

Vinorelbine Polpharma will be given to you under the supervision of a doctor specialized in this type
of treatment.
The dosage of vinorelbine depends on the condition you are being treated for, your response to the
therapy and other medication you are being given. Your general condition and your response to the
treatment will be closely observed before, during and after the vinorelbine treatment.
The usual dosage of vinorelbine is 25-30 mg/m2 of body surface area given once a week.
The medicine should be diluted before use with a solution of sodium chloride or glucose and given
into a vein as an injection over 6-10 minutes or by infusion (drip) over 20-30 minutes. Following your
treatment a solution of sodium chloride will be used to flush the vein.
Dosage will be reduced if you have severe liver problems.
The safety and efficacy in children have not been determined.
If you use Vinorelbine Polpharma more than you should
As this medicine will be given to you whilst you are in hospital it is unlikely that you will be given to
little or to much, however, tell your doctor or pharmacist if you have any concerns.

4.

POSSIBLE SIDE EFFECTS

Like all medicines, Vinorelbine Polpharma can cause side effects, although not everybody gets them.
Your doctor will discuss these with you and will explain the potential risks and benefits of your
treatment.
You should contact your doctor immediately if you develop any allergic (hypersensitive) reactions
to vinorelbine, including skin rashes, breathing difficulties. They are serious and need immediate
medical attention.
The hospital staff will monitor your condition closely during treatment. Tell them immediately if you
notice any of these effects.
Between infusions of Vinorelbine Polpharma the following may occur, and the frequency may vary
with the combinations of drugs that are received:
Very common (experienced in more than 1 in 10 patients)
• decrease in the number of red (anaemia), or white blood cells (which are important in
fighting infection)
• loss of some reflex reactions, occasionally difference in the perception of touch
• weakness of the lower extremities
• inflammation of oral mucosa (the lining of the inside of the mouth) or oesophagus (throat)
• stomach upsets including nausea, vomiting, constipation
• raised liver enzymes (hence the need for regular blood tests)

• hair loss
• at the injection site: pain, phlebitis (inflammation of the vein), skin colour disorder, redness

of the skin.
Common (experienced in less than 1 in 10 but more than 1 in 100 patients)
• infections
• decrease in the number of platelets (may cause unusual bleeding or bruising)
• diarrhoea
• tiredness
• fever: if this happens you must tell your doctor immediately
• pain at different sites in your body such as chest pain and pain where the tumour is
• joint pain, jaw pain, muscle pain.
Uncommon (experienced in less than 1 in 100 but more than 1 in 1000 patients)
• severe signs of a major infection such as cough, fever, chills and blood infection
• severe difficulties with your body movements and sense of touch (severe paresthesias)
• reduced blood pressure (hypotension with symptoms such as dizziness or feeling faint)
• raised blood pressure (hypertension) with symptom such as a headache.
• a sudden feeling of heat and skin redness of the face and neck (flushing)
• feeling cold in the hands and feet (peripheral coldness)
• difficulty in breathing or wheezing (dyspnoea and bronchospasm).
Rare (experienced in less than 1 in 1000 but more than 1 in 10,000)
• breathing difficulties (interstitial pneumopathies) - if you are receiving another cancer drug
called mitomycin C
• paralysis of the gut
• inflammation of pancreas
• skin rashes on your body such as rashes and eruptions (generalised cutaneous reactions)
• any extravasation may induce local reactions which rarely progress to necrosis (death of
cells and/or tissues).
• low blood sodium
• angina pectoris (chest pain), heart attack
• severe drop in blood pressure causing dizziness, fainting (severe hypotension, collapse).
Very rare (experienced in less than 1 in 10,000 patients)
• irregular heartbeats (tachycardia, palpitation, and heart rhythm disorders)
• life threatening infections in your body such as severe fever, chest infections and infections
at other sites in your body (septicaemia).
Not known (cannot be estimated from the available data)
• generalised allergic reactions. These are serious reactions which can cause severe difficulty in
breathing, dizziness, rash affecting your whole body, swelling of the eyelids, face lips, throat
(anaphylactic shock, anaphylaxis, anaphylactoid type reactions)
• loss of appetite (anorexia)
• SIADH-syndrome, which may include symptoms of increased weight, nausea (feeling sick),
vomiting, muscle cramps, confusion and seizures (fits).
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor.

5.

HOW TO STORE VINORELBINE POLPHARMA

Keep out of the reach and sight of children.

Store in the refrigerator (2–8°C).
Store in the original package, in order to protect from light.
Do not use after the expiry date which is stated on the carton. The expiry date refers to the last day of
that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.

6.

FURTHER INFORMATION

What Vinorelbine Polpharma contains
- The active substance is vinorelbine (as tartrate).
Each 1 ml vial contains a total content of vinorelbine of 10 mg.
Each 5 ml vial contains a total content of vinorelbine of 50 mg.
- The other ingredients are sodium hydroxide, water for injections.
What Vinorelbine Polpharma looks like and contents of the pack
Vinorelbine Polpharma concentrate for solution for infusion is clear, colourless solution with a pH of
3.3 to 3.8 and an osmolarity 47 mOsm/kg.
Contents of the pack
1 ml or 5 ml concentrate in glass vials with butyl rubber stopper laminated with fluororesin and
aluminium closure.
Pack size: 1 or 10 vials. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Pharmaceutical Works POLPHARMA SA
19 Pelplińska Street, 83-200 Starogard Gdański, Poland

This leaflet was last approved in November 2011

--------------------------------------------------------------------------------------------------------------------------THE FOLLOWING INFORMATION IS INTENDED FOR MEDICAL OR HEALTHCARE
PROFESSIONALS ONLY:
Please refer to the summary of product characteristics for detailed information regarding this product.
Handling and disposal
The preparation of injectable solutions of cytotoxic agents must be carried out by trained specialist
personnel with knowledge of the medicines used, in conditions that guarantee the protection of the
environment and, in particular, the protection of the personnel handling the medicines. It requires a
preparation area reserved for this purpose. It is forbidden to smoke, eat or drink in this area.

Personnel must be provided with appropriate handling materials, notably sleeved gowns, protection
masks, caps, protective goggles, sterile single-use gloves, protective covers for the work area and
collection bags for waste.
Syringes and infusion sets should be assembled carefully to avoid leakage (use of Luer lock fittings is
recommended).
Spills and leakages must be wiped up.
Precautions should be taken to avoid exposing staff during pregnancy.
All contact with eyes must be strictly avoided.
Immediate washing of the eye with normal saline solution should be undertaken if any contact occurs.
In case of irritation contact an ophthalmologist.
In case of skin contact , thoroughly wash the affected area with water.
On completion, any exposed surface should be thoroughly cleaned and hands and face washed.
Any unused product or waste material should be disposed of in accordance with local requirements.
Incompatibilities
Vinorelbine should not be diluted in alkaline solutions (risk of precipitation).
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal
products except those mentioned in section “Dilution and administration”.
There is no incompatibility between vinorelbine and glass vials, PVC bag, polyethylene vial or
propylene syringe.
Dilution and administration
Vinorelbine should only be given intravenously and after dilution.
Vinorelbine may be administered by slow bolus (6-10 minutes) after dilution in 20-50 ml of sodium
chloride 9 mg/ml (0.9%) solution for injection or in glucose solution for injection 5% or by a short
infusion (20-30 minutes) after dilution in 125 ml of normal saline or glucose 50 mg/ml (5%) solution.
After administration the vein should be thoroughly flushed with at least 250 ml of isotonic solution.
It is very important to make sure that the cannula is accurately placed in the vein before the injection is
commenced. If vinorelbine infiltrates the surrounding tissue during intravenous administration, a
substantial irritation may occur. In this case, the injection should be stopped, the vein flushed with
saline solution and the rest of the dose should be administered in another vein.
In the event of extravasation, glucocorticoids could be given intravenously to reduce the risk of
phlebitis.
Excreta and vomit must be handled with care.
Storage
As package for sale: Store in a refrigerator (2°C - 8°C). Keep the vial in the outer carton in order to
protect from light. Do not freeze. Do not use after the expiry date which is stated on the carton.
After opening: The content of the vial should be used immediately after the first breakage of vial.
After dilution: The physicochemical and microbiological stability of the drug product after dilution in
the recommended solutions for infusion has been demonstrated for 24 hours at 2-8°C and 25°C.
From a microbiological point of view the product should be used immediately.
If not used immediately, in-use storage times and conditions are the responsibility of the user and
would normally not be longer than 24 hours at 2-8°C, unless reconstitution has taken place in
controlled and validated aseptic conditions.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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