PACKAGE LEAFLET: INFORMATION FOR THE USER    SZ00000LT000

Vinorelbine 10 mg/ml Concentrate for Solution for Infusion

Vinorelbine    ASANDOZ

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

•    Keep this leaflet. You may need to read it again.

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

•    If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet.

What is in this leaflet

1.    What Vinorelbine is and what it is used for

2.    What you need to know before you use Vinorelbine

3.    How to use Vinorelbine

4.    Possible side effects

5.    How to store Vinorelbine

6.    Contents of the pack and other information

What Vinorelbine is and what it is used for

Vinorelbine is an anti-cancer medicine. It belongs to a group of drugs called vinca alkaloids.

•    carbamazepine, phenytoin and phenobarbital (used to treat epilepsy)

•    antibiotics such as rifampicine, erythromycin, clarithromycin, telithromycin

•    St. John’s Wort (Hypericum perforatum)

•    ketoconazole and itraconazole (medicines for fungal infections)

•    antiviral medicines used for AIDS (HIV) such as ritonavir (HIV protease inhibitors)

•    nefazodone (antidepressant)

•    cyclosporine, tacrolimus (medicines that reduce the activity of the immune system)

•    verapamil, quinidine (used for heart problems)

•    anti-cancer medicines such as mitomycine C and cisplatine; there is an increased risk of difficulty breathing if Vinorelbine is used with mitomycin C (see section 4)

•    medicines to prevent blood clots, such as warfarin

•    vaccines (see “Take special care with Vinorelbine”).

Pregnancy, breast-feeding and

fertility

Ask your doctor or pharmacist for

advice before taking any medicine.

Vinorelbine is used for certain types of advanced lung and breast cancer.

What you need to know before you use Vinorelbine

Do not use Vinorelbine:

•    if you are allergic (hypersensitive) to vinorelbine, other vinca alkaloids, or any of the other ingredients of this medicine (see section 6)

•    if you have or have recently had a serious infection, or if you have a significant reduction of your white blood cells (neutropenia)

•    if you have a significant reduction of your blood platelets

•    if you are a woman of childbearing age not using effective contraception

• if you are pregnant

• if you are breast feeding

•    if you have recently had or you are going to have a vaccine against yellow fever.

If any of the above applies to you, do

not use this medicine and talk to

your doctor.

Pregnancy

Do not use this medicine during pregnancy. Inform your doctor if you are pregnant or you think you might be pregnant.

Women of child-bearing potential Women of child-bearing potential must use effective contraception (birth control) during treatment and for up to 3 months after the end of the treatment.

Breast-feeding

It is not known if this medicine passes into breast milk. Therefore, you must stop breast-feeding before starting the treatment.

Male fertility

Men being treated with this medicine are advised not to father a child during treatment and for up to 6 months (minimum 3 months) after the end of the treatment.

You should seek advice on conservation of sperm prior to treatment because of the possibility of irreversible infertility due to therapy with vinorelbine.

Warnings and precautions:

•    Tell your doctor if you have had a heart disease called “ischemic heart disease”

•    Tell your doctor if you have liver problems

•    Tell your doctor if you develop shortness of breath

•    You should not have radiotherapy in the area of your liver while you are having this medicine

•    Tell your doctor immediately if you have symptoms of an infection (such as fever, chills, or sore throat), so that he can carry out any tests which may be needed

•    Tell your doctor if you have had a vaccination recently. Special care must be taken with live attenuated vaccines such as measles, mumps, rubella, polio, varicella, and tuberculosis (BCG)

•    Any contact with the eye must be strictly avoided, since there is a risk of serious irritation or even ulceration of the surface of the eye (corneal ulcers). In case of contact, immediately rinse the eye with normal saline solution and contact the doctor.

•    You should use effective contraception (birth control) during treatment and for up to 3 months after the end of the treatment.

•    Men should not father a child during and for up to 6 months (minimum 3 months) after stopping this treatment.

•    Take special care if you use mitomycin C, phenytoin, itraconazole, or any other medicine mentioned in the section “Using other medicines”.

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.

Children and adolescents

Vinorelbine is used in patients over 18 years old. It is not recommended for use by children under 18 years old.

Other medicines and Vinorelbine

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained without a prescription. In particular if you take one of the following medicines:

•    any medicine that may affect the bone marrow, such as anti-cancer medicines

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed.

However, do not drive or use machines if you feel drowsy, or if you experience any other effect which may impair your ability to drive or use machines.

3 How to use Vinorelbine

Your doctor will decide how much Vinorelbine you will have.

The dosage you are given will depend on your general medical condition. It will also depend on any other treatment you may have received for your cancer.

Vinorelbine is used in patients over 18 years old. It is not recommended for use by children under 18 years old.

Vinorelbine should not be given as an injection to the spine.

The usual dose is 25 to 30 milligrams weekly for every square metre of your body’s surface area.

Before and during treatment with Vinorelbine your doctor will check your blood cell count. The results of your blood test will decide when you receive your treatment. Your nurse will measure your height and weight and work out the surface area of your body from these measurements. Your doctor will use this body surface area to work out the right dose for you.

The medicine will be diluted with a solution such as physiologic saline or glucose 5% before it is given to you.

Vinorelbine is always administered intravenously. This may be by injection over a 6 to 10 minute period or by infusion over 20 to 30 minutes. At the end of the injection or infusion, the vein will be flushed with physiologic saline.

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The following information is intended for medical or healthcare

professionals only:

Special precautions

•    Only trained staff should carry out the preparation and administration of Vinorelbine

•    As with all cytotoxic agents, precautions should be taken to avoid exposing staff during pregnancy

•    Suitable safety equipment, such as eye protection, disposable gloves, facemask and disposable apron, should be worn. Spills and leakages must be wiped up

•    All contact with the eye must be strictly avoided. Immediate washing of the eye with sodium chloride 9 mg/ml (0.9 %) solution for injection should be undertaken if any contact occurs

•    On completion, any exposed surface should be thoroughly cleaned and hands and face washed.

Only for intravenous administration. Must be diluted before use immediately after opening the vial.

Incompatibility

Vinorelbine should not be diluted in alkaline solutions (risk of precipitation). Vinorelbine must not be mixed with other medicinal products except normal saline or glucose (5%) solution.

There is no incompatibility between Vinorelbine and clear glass vials, PVC or vinyl acetate bags, or infusion sets with PVC tubing.

As this medicine will be given to you whilst you are in hospital it is unlikely that you will be given too little or too much, however tell your doctor or nurse if you think you were given too much of this medicine. Some of the symptoms of being given too much may develop (such as fever, chills, joint pain). You may also become severely constipated.

If you have any further questions on the use of this medicine, ask your doctor or nurse.

4 Possible side effects

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

Serious side effects:

The following are all serious side effects. You may need urgent medical attention if you have any of them.

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

•    chest pain, heart attack

•    severe pain in the abdomen and back, caused by inflammation of the pancreas

•    shortness of breath, caused by pulmonary diseases (interstitial pneumopathy).

Very rare (may affect up to 1 in

10.000    people):

•    life threatening infections in your body with severe fever, such as chest infections and infections at other sites in your body (septicaemia).

Not known (frequency 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).

If any of the above happens to you, stop using this medicine and tell your doctor immediately or go to the

casualty department at your nearest hospital.

Other possible side effects:

Tell your doctor if any of the following side effects become troublesome.

Very common (may affect more than 1 in 10 patients):

•    shortage of white blood cells, which makes infections more likely

•    shortage of red blood cells which can make the skin pale and cause weakness or breathlessness

•    inflammation of mouth or throat, nausea and vomiting, constipation

•    hair loss, pain and/or redness at the site of injection

•    loss of deep tendon reflexes, weakness in the legs

•    blood tests which show changes in the way the liver is working.

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

•    shortage of white blood cells that may cause the occurrence of fever and sepsis

•    shortage of blood platelets which increases risk of bruising and bleeding

•    infections

•    diarrhoea

•    joint pain, muscle pain, pain in the jaw

•    weakness, tiredness, fever and pain.

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

•    severe signs of a major infection such as cough, fever, chills and blood infection

•    severe difficulties with your body movements and abnormal sensation of touch

•    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.

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

•    severe drop in blood pressure causing dizziness, fainting (severe hypotension, collapse)

•    bowel obstruction

•    skin rashes on your body such as rashes and eruptions (generalised cutaneous reactions)

•    skin reactions at site of injection (ulcer, necrosis)

•    decrease of the level of sodium in the blood (hyponatraemia).

Very rare (may affect up to 1 in

10.000    people):

•    irregular heartbeats (tachycardia, palpitation, and heart rhythm disorders).

Not known (frequency cannot be estimated from the available data):

•    a fall in white blood cell count with fever (febrile neutropenia), a general infection in combination with a fall in white blood cell count (neutropenic sepsis)

•    low sodium level due to an overproduction of a hormone causing fluid retention and resulting in weakness, tiredness or confusion (Syndrome of Inappropriate Antidiuretic Hormone secretion, SIADH)

•    loss of appetite (anorexia)

•    skin redness (erythema) on the hands and feet.

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet.

5 How to store Vinorelbine

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

Do not use Vinorelbine after the expiry date which is stated on the on the outer carton 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 the vial in the outer carton in order to protect from light.

In-use: After opening, the contents should be reconstituted and used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user. If prepared aseptically, the stability of the diluted solution in normal saline or glucose has been demonstrated for 48 hours when stored in a refrigerator (2°C - 8°C).

Do not freeze. Protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6 Contents of the pack and other information

What Vinorelbine contains

•    The active substance is vinorelbine Each 1 ml vial contains vinorelbine tartrate equivalent to 10 mg vinorelbine.

Each 5 ml vial contains vinorelbine tartrate equivalent to 50 mg vinorelbine.

•    The other ingredient is water for injections

What Vinorelbine looks like and contents of the pack

Vinorelbine is a clear, colourless or pale yellow solution.

Vinorelbine is packed in clear, colourless glass vials (type I) with fluoropolymer coated bromobutyl rubber stoppers and aluminium crimp caps.

Pack sizes: 1x1 ml vial, 10x1 ml vials, 1x5 ml vials, 5x5 ml vials and 10x5 ml vials.

Not all pack sizes may be marketed

Marketing Authorisation Holder

Sandoz Ltd,

Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK.

Manufacturer

Lek Pharmaceuticals d.d.,

Verovskova 57, 1526 Ljubljana, Slovenia

or

Salutas Pharma GmbH,

Otto von Guericke Allee 1,

39179 Barleben,

Germany

or

Ebewe Pharma Ges.m.b.H. Nfg. KG, MondseestraGe 11,4866 Unterach, Austria.

This leaflet was last revised in 09/2013.

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Administration

Vinorelbine may be administered by slow bolus (6-10 minutes) after dilution in 20-50 ml of normal saline or glucose 50 mg/ml (5%) solution or by a short infusion (20-30 minutes) after dilution in 125 ml of normal saline or glucose 50 mg/ml (5%) solution. Administration should always be followed with at least 250 ml of a normal saline infusion to flush the vein.

Vinorelbine should only be given intravenously. 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.

Storage

Store in a refrigerator (2°C - 8°C). Do not freeze. Store the vial in the outer carton in order to protect from light.

In-use: After opening, the contents should be reconstituted and used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user. If prepared aseptically, the diluted solution can be stored for maximum 48 hours in a refrigerator (2°C - 8°C). Do not freeze. Protect from light.

For more information read the SmPC.

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