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NAVELBINE 10MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): VINORELBINE TARTRATE

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NAVELBINE 10 mg/ml
®

concentrate for solution for infusion
Vinorelbine as tartrate
Read all of this leaflet carefully before you start using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or your pharmacist.
• If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
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
•D
 o not take Navelbine if you are breast feeding.
•B
 reast-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.

#

PACKAGE LEAFLET: INFORMATION FOR THE USER

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,
• s evere 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,
• s igns 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/ml

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
XXXXXX
from light, in neutral glass bottle, PVC and vinyl
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 prior to use are under the 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.

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)

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.

• 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.

Abnormal liver test.

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.

If the symptoms persist or
if your temperature reaches
• Tiredness (asthenia, fatigue).
38°C or higher, ask your
• Fever.
doctor for advice.
• Pain at different sites in your body such as
These symptoms are
chest pain and pain where the tumour is.
expected when receiving
chemotherapy.
• Diarrhoea.

#

4. FURTHER INFORMATION
Please refer to SPC.

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?

Immediately contact your
Effects on your blood:
• Severe signs of a major infection such as doctor if you experience
any of these side effects.
cough, fever, chills and blood infection.
Effects on your nervous system:
• Severe difficulties with your body movements
and sense of touch (severe paresthesias).
Effects on your heart and blood vessels:
• Reduced blood pressure (hypotension with
symptoms such as dizziness or feeling faint).
• Raised blood pressure (hypertension) with Immediately contact your
symptom such as a headache.
doctor if you experience
• A sudden feeling of heat and skin redness of any of these side effects.
the face and neck (flushing).
• Feeling cold in the hands and feet (peripheral
coldness).
Effects on your respiratory system:
• Difficulty in breathing or wheezing (dyspnoea
and bronchospasm).
Rare side effects

(can occur in less than 1 in 1,000 patients treated)

What should you do?

Effects on your heart and blood vessels
• Severe chest pain, heart attack (ischaemic

• Inflammation or sores in the mouth or throat Immediately contact your
doctor.
(stomatitis).

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.

What should you do?

Uncommon side effects

(can occur in less than 1 in 100 patients treated)

Immediately contact your
doctor.

heart disease, angina pectoris, myocardial
infarction).

• Severe drop in blood pressure causing dizziness,
fainting (severe hypotension, collapse).
Effects on your respiratory system:
• If you are receiving another cancer drug called
mitomycin C, you may experience breathing
difficulties (interstitial pneumonopathy).
Effects on your blood:
• Severe hyponatraemia which is when there
Immediately contact your
are low blood levels of sodium in your blood
doctor if you experience
(which can cause symptoms of tiredness,
any of these side effects.
confusion, muscle twitching and coma).
Effects on your gastrointestinal system:
• Severe constipation with abdominal pain
when your bowels have not been open for
several days (paralytic ileus).
• Severe abdominal and back pain
(pancreatitis).
Allergic reaction effects
• Skin rashes on your body such as rashes and
eruptions (generalised cutaneous reactions).
• Ulcer at the injection site where the
Navelbine was given (local necrosis).
Very rare side effects

(can occur in less than 1 in 10,000 patients treated)

What should you do?

• Life threatening infection in your body
such as severe fever, chest infection and
Immediately contact your
infections at other sites in your body
doctor if you experience
(septicaemia).
any of these side effects.
• Irregular heartbeat (tachycardia, palpitation,
and heart rhythm disorders).

Other side effects have been reported with a “not known” frequency:
• 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).
• 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.
Do not be alarmed by this list. If you suffer from any of these side
effects or if you have any other unusual symptom or feelings,
you should contact your doctor as soon as possible.
If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store Navelbine
Keep out of the reach and sight of children.
Do not use Navelbine after the expiry date which is stated on the vial and
box (after Exp). The expiry date refers to the last day of that month.
Navelbine will be diluted and stored by hospital staff.
6. Further Information
What Navelbine contains
• The active substance is Vinorelbine (as tartrate). Each 1 ml of solution
contains 10 mg of vinorelbine as vinorelbine tartrate.
• The other ingredient is water for injection.
What Navelbine looks like and contents of the pack
Navelbine is a clear colourless to pale yellow solution.
This medicinal product is a concentrate for solution for infusion,
in clear glass vials of 1, 4 or 5 ml. Navelbine is available as:
Box of 10 vials of 1ml, Box of 10 vials of 4 ml, Box of 10 vials of 5 ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder: PIERRE FABRE Ltd
Hyde Abbey House - 23 Hyde Street - Winchester
Hampshire SO23 7DR - UNITED KINGDOM
Manufacturer: Pierre Fabre Médicament Production
Avenue du Bearn - BP 9097 - F-64320 - Pau Idron - Bizanos - FRANCE
For any information on this product please contact:
Pierre Fabre Ltd; Phone: 01962 874400
Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio
please call, free of charge: 0800 198 5000 (UK Only):
Please be ready to give the following information:
Product Name

Reference Number

Navelbine 10 mg/ml concentrate for solution for infusion 00603/0028
This is a service provided by the Royal National Institute of the Blind.
This leaflet was last approved in Feburary 2011

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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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