PACKAGE LEAFLET: INFORMATION FOR THE USER

NAVELBINE® 10 mg/ml

concentrate for solution for infusion

Vinorelbine as tartrate

In this leaflet:

1.    What Navelbine is and what it is used for

2.    Before you use Navelbine

3.    How to use Navelbine

4.    Possible side effects

5.    How to store Navelbine

6.    Further information

1.    What Navelbine is and what it is used for

Navelbine belongs to a family of medicines used to treat cancer called the vinca-alkaloid family.

Navelbine is used to treat some types of lung and breast cancer in patients over 18 years of age.

•    Non-small cell lung cancer

•    Advanced breast cancer that has not responded to other medicines. It is not recommended for use by children under 18 years old.

2.    Before you use Navelbine

Do not use Navelbine

•    If you are allergic (hypersensitive) to the active substance (vinorelbine), or to any of the related family of cancer drugs called the vinca alkaloids,

•    If you are allergic to any of the other ingredients of Navelbine (refer to section 6 in this leaflet),

•    If you are pregnant or think that you might be pregnant,

•    If you are breast feeding,

•    If you have a low white blood cell (neutrophils, leucocyte) count or a severe infection current or recent (within 2 weeks),

•    If you have a low platelet count (thrombocytopenia),

•    If you plan to receive a yellow fever vaccination or have just received one. Take special care with Navelbine

Please inform your doctor if:

•    you have a history of heart attack or severe chest pain,

•    you have problems with your liver or you have received radiotherapy where the treatment field included the liver,

•    you have signs or symptoms of infection (such as fever, chills, joint pain, cough),

•    you take or have recently taken any other medicines including medicines obtained without prescription,

•    you plan to have a vaccination or have just had one.

Before and during your treatment with Navelbine, blood cell counts are performed to check that it is safe for you to receive treatment. If the results of this analysis are not satisfactory, your treatment may be delayed and further checks made until these values return to normal. Using with other medicines

Please inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines including medicines obtained without prescription.

Your doctor should take special attention if you are taking the following medicines:

•    medicines used to thin your blood (anticoagulants),

•    an anti-epileptic medicine called phenytoin,

•    antifungal medicines such as itraconazole and ketaconazole,

•    an anti-cancer medicine called mitomycin C,

•    medicines that impair your immune system such as ciclosporin and tacrolimus.

Many vaccines (live attenuated vaccines) are not recommended during treatment with Navelbine. Please inform your doctor if you require any vaccinations. If you are given Navelbine as well as medicines that affect your bone marrow it may make some of the side effects worse. Using Navelbine with food and drink

There are no known interactions with food and drink when using Navelbine. However, you should check with your doctor if taking alcohol is advisable for you.

Male fertility

Men being treated with Navelbine are advised not to father a child during treatment and for up to 3 months after the end of the treatment and to seek advice on conservation of sperm prior to treatment because Navelbine may alter male fertility.

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.

Pregnancy

•    Do not take Navelbine if you are pregnant or think that you might be pregnant.

•    If you have to start treatment with Navelbine and are pregnant or if pregnancy occurs during your treatment with Navelbine, you must immediately contact your doctor for advice.

Breast-feeding

•    Do not take Navelbine if you are breast feeding.

•    Breast-feeding must be discontinued if treatment with Navelbine is necessary.

Driving and using machines

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

However, some of the possible side effects of Navelbine could affect your ability to drive or perform skilled tasks: see section 4; Possible side effects below for details. Therefore, it is recommended that you should not drive if you feel unwell or if your doctor has advised you not to drive.

3.    How to use Navelbine

Navelbine should be prescribed by a qualified doctor who is experienced in the use of cancer treatments.

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

Dosage

Before and during your treatment with Navelbine your doctor will check your blood cell count. The results of your blood test will decide when you receive your treatment. The dose will depend on your height and weight and your general condition. Your doctor will calculate your body surface area and will determine the dose you should receive. Frequency of administration

Normally Navelbine is scheduled once a week. The frequency will be determined by your doctor.

Duration of treatment

The duration of your treatment is decided by your doctor.

Method and route of administration

•    Navelbine must be diluted before administration.

•    Navelbine must only be administered into a vein. It will be given by an infusion into one of your veins. It will take between 6 to 10 minutes.

•After administration the vein will be rinsed thoroughly with a sterile solution.

If you use more Navelbine than you should

Your dose of Navelbine is carefully monitored and checked by your doctor and pharmacist. However, although you will have received the correct amount of chemotherapy your body may sometimes react giving severe symptoms. Some of these symptoms may develop as signs of an infection (such as fever, chills, cough, joint pain). You may also become severely constipated. You must immediately contact your doctor if any of these severe symptoms occur.

If you stop using Navelbine

Your doctor will decide when you should stop your treatment. However, if you want to stop your treatment earlier, you should discuss other options with your doctor.

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

4.    Possible side effects

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

While taking Navelbine, if you develop any of the following symptoms you should contact your doctor immediately:

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

•    severe constipation with abdominal pain when your bowels have not been open for several days,

•    severe dizziness, light-headedness when you stand up,

•    severe chest pain which is not normal for you,

•    signs of allergy such as itching, shortness of breath.

The following information is intended for medical or healthcare professionals only:

Below is a summary of information to assist in the preparation and administration of Navelbine 10mg/ml concentrate for solution for infusion.

The preparation and administration of Navelbine should be carried out by trained staff and as with all cytotoxic agents, precautions should be taken to avoid exposing staff during pregnancy.

PREPARATION GUIDE

NAVELBINE® 10 mg/mI

concentrate for solution for infusion

Vinorelbine as tartrate

Read this guide prior to the preparation and administration of Navelbine.

1.    PRESENTATION

Navelbine is a concentrate for solution for infusion. It is a clear colourless to pale yellow solution with a pH of 3.3 - 3.8 in clear glass vials containing 10 mg per 1 ml, 40 mg per 4 ml and 50 mg per 5 ml of vinorelbine (as tartrate). These are supplied in boxes containing 10 vials.

2.    RECOMMENDATION FOR SAFE HANDLING

Procedures for proper handling and disposal of anticancer drugs should be considered.

As with other cytotoxic compounds, caution should be exercised in handling and preparing the Navelbine solution:

•    Suitable eye protection, disposable gloves, face mask and disposable apron should be worn.

•    Eventual spillage or leakage should be mopped up.

•    All contact with the eye should be strictly avoided. Immediate liberal 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.

Preparation of the solution for infusion

For single use only, discard any unused contents

Navelbine must be diluted prior to administration in a 50 ml infusion

bag with sodium chloride 9 mg/ml (0.9%) solution for injection or in

5% glucose solution for injection.

Navelbine should not be diluted in alkaline solutions as there is a risk of precipitation.

After diluting Navelbine in sodium chloride 9 mg/ml (0.9 %) solution for injection or in glucose solution for injection 5%,chemical and physical in-use stability has been demonstrated for 8 days at room temperature (20°C ± 5°C) or in the refrigerator (2°C - 8°C) protected from light, in neutral glass bottle, PVC and vinyl xxxxxx acetate bags. There is no content / container incompatibility between Navelbine and infusion sets with PVC tubing.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions priorto use are underthe responsibility of the user and would normally not be longer than 24 hours at 2°C - 8°C, unless preparation has taken place in controlled and validated aseptic conditions.

Dosage and instructions for use

STRICTLY INTRAVENOUS ADMINISTRATION AFTER APPROPRIATE DILUTION

Intra-thecal administration of Navelbine may be fatal The use of intrathecal route is contra-indicated.

•It is recommended to infuse Navelbine over 6-10 minutes after dilution in a 50 ml infusion bag with sodium chloride 9 mg/ml (0.9%) solution for injection or in 5% glucose solution for injection.

•    After administration the vein should be thoroughly flushed with at least 250 ml of saline solution.

•    Navelbine must be given strictly intravenously. It is very important to make sure that the cannula is accurately placed in the vein before starting to infuse Navelbine.

•    If the drug extravasates into the surrounding tissue during the administration considerable local irritation may occur. In this case, the administration should be stopped, the vein flushed with normal saline solution and the remaining dose administered in another vein. The management of any extravasation should be according to local hospital guidelines and policies.

•    Do not infuse concomitantly with another cytotoxic agent. It should be given as the first drug where the patient is treated with combination chemotherapy due to the risk of venous irritation.

Storage

Unopened vials should be stored in a refrigerator at a temperature of 2°C - 8°C in the original package in order to protect from light.

•    The product should not be frozen as this could adversely affect the product.

•    An expiry date is stated on both the vial and outer box and refers to the last day of that month.

•    Do not use the product after this date.

Navelbine will be diluted and stored by hospital staff.

3.    PROCEDURE FOR PROPER DISPOSAL

Any unused product or waste should be disposed of in accordance with local requirements for cytotoxic drugs.

4.    FURTHER INFORMATION

Please refer to SPC.

Below is a list of side effects that have occurred in some people following treatment with Navelbine. This list is classified according to the decreasing frequency of side effects occurrence.

Very common side effects (can occur in more than 1 in 10 patients treated)	What should you do?
•    Feeling sick (nausea). •    Vomiting.	Immediately contact your doctor if this becomes uncontrollable. These side effects may be controlled with standard anti-sickness therapy.
A fall in white blood cells which makes you more vulnerable to infection. This can commonly cause bacterial, viral or fungal infections in your body (respiratory, urinary, gastro-intestinal systems and possibly others).	Immediately contact your doctor, especially if your temperature reaches 38°C or higher.
•    A fall in red blood cells (anaemia) which can make the skin pale and cause weakness or breathlessness. •    Weakness of the lower extremeties. •    Loss of some reflex reactions, occasionally difference in the perception of touch. •    Constipation. If you have abdominal pain or if you do not have a bowel movement for several days.	Immediately contact your doctor for treatment, should these symptoms become severe.
•    Hair loss (alopecia). Reactions at the site where Navelbine was administered such as: •    Redness (erythema), •    Burning pain, •    Vein discolouration, Inflammation of the veins (local phlebitis).	Immediately contact your doctor for treatment, should these symptoms become severe. These are possible symptoms when receiving chemotherapy.
• Inflammation or sores in the mouth or throat (stomatitis).	Immediately contact your doctor.
Abnormal liver test.	Your doctor should check your liver function when you are receiving chemotherapy.
Common side effects (can occur in less than 1 in 10 patients treated)	What should you do?
•    A fall in platelets which can increase the risk of bleeding or bruising (thrombocytopenia). •    Joint pain (arthralgia). •    Jaw pain. •    Muscle pain (myalgia).	Immediately contact your doctor for treatment, should these symptoms become severe.
•    Tiredness (asthenia, fatigue). •    Fever. •    Pain at different sites in your body such as chest pain and pain where the tumour is.	If the symptoms persist or if your temperature reaches 38°C or higher, ask your doctor for advice. These symptoms are expected when receiving chemotherapy.
• Diarrhoea.	Immediately contact your doctor.