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VINORELBINE 10 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): VINORELBINE / VINORELBINE TARTRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Vinorelbine 10 mg/ml Concentrate for
Solution for Infusion

SZ00000LT000

Vinorelbine

• carbamazepine, phenytoin and
phenobarbital (used to treat
epilepsy)
• antibiotics such as rifampicine,
erythromycin, clarithromycin,
telithromycin
• St. Johnʼs 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”).

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

1

What Vinorelbine is and
what it is used for

Pregnancy, breast-feeding and
fertility
Ask your doctor or pharmacist for
advice before taking any medicine.

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

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

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

2

What you need to know
before you use Vinorelbine

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.

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.

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.

If any of the above applies to you, do
not use this medicine and talk to
your doctor.

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”.

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 bodyʼs
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.

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.

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

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

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.

Continued on the next page >>

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.

Artwork Proof Box
Ref: N002 - BROMI to submit PIL in Ebewe keylines
Proof no.
005.0

Date prepared:
19/09/2013

Colours:
Black
Dimensions: 120 x 594 mm

Font size:
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Fonts:
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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.

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

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

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

5

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

How to store Vinorelbine

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

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).

Do not use Vinorelbine after the expiry
date which is stated on the on the
outer carton after ʻEXPʼ. 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.

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).

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.

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).

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.

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.

6

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

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.

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.

• 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.

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.

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.,
Verovškova 57, 1526 Ljubljana,
Slovenia

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.

or

Salutas Pharma GmbH,
Otto von Guericke Allee 1,
39179 Barleben,
Germany
or

Ebewe Pharma Ges.m.b.H. Nfg. KG,
Mondseestraße 11, 4866 Unterach,
Austria.
This leaflet was last revised in
09/2013.

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).

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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.

SZ00000LT000

Artwork Proof Box
Ref: N002 - BROMI to submit PIL in Ebewe keylines
Proof no.
005.0

Date prepared:
19/09/2013

Colours:
Black
Dimensions: 120 x 594 mm

Font size:
8pt
Fonts:
Helvetica

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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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