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FLUOROURACIL INJECTION 50MG/ML SOLUTION FOR INJECTION

Active substance(s): FLUOROURACIL

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Fluorouracil medac 50 mg/ml · 81260-VP1GB · CA · 03.14 · Pharma-Code: 94
Format: 444 x 150 mm · HKS 44 · Corrective action: KV01_jem_25.02.14

medac GmbH

PACKAGE LEAFLET: INFORMATION FOR THE USER

Fluorouracil Injection 50 mg/ml,
solution for injection
Fluorouracil
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 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 or pharmacist.
In this leaflet:
1. What Fluorouracil Injection 50 mg/ml is and what it is used for
2. Before you use Fluorouracil Injection 50 mg/ml
3. How to use Fluorouracil Injection 50 mg/ml
4. Possible side effects
5. How to store Fluorouracil Injection 50 mg/ml
6. Further information

1.3.2.1.9

2. BEFORE YOU USE FLUOROURACIL INJECTION
50 MG/ML
Do not use Fluorouracil Injection 50 mg/ml
• if you are allergic (hypersensitive) to fluorouracil,
• if you are pregnant or breast-feeding,
• if you have been seriously weakened by long illness or other
treatments (including radiotherapy) for your cancer,
• if you are receiving treatment for chickenpox or shingles (Herpes
zoster) with brivudine, sorivudine or similar substances, or have
received such treatment in the last four weeks.
Take special care with Fluorouracil Injection 50 mg/ml
Before you receive fluorouracil tell your doctor if you
• have suffered from angina (heart condition marked by sudden
attacks of chest pain),
• have a history of heart disease,
• have ever experienced chest pain,
• have had problems with your kidneys or liver,
• take phenytoin for epileptic fits.
Your treatment will be first given to you in hospital. Before you are
given fluorouracil you will have to have a blood test, and possibly other
tests, so that your doctor can be sure that you can undergo fluorouracil
treatment.
Tell your doctor if you experience any chest pain during treatment.

1. WHAT FLUOROURACIL INJECTION 50 MG/ML IS AND WHAT IT
IS USED FOR
Fluorouracil is an anti-cancer drug.
Fluorouracil Injection 50 mg/ml, solution for injection, is used to treat
the symptoms of many common cancers, particularly cancers of the
large bowel and breast. It may be used in combination with other
anti-cancer drugs.

Taking other medicines
Fluorouracil is known to interact with the following medicines:
• allopurinol (used to treat high levels of uric acid),
• leucovorin (also called folinic acid – used in cancer therapy and
treatment of folic acid deficiency),
• cimetidine (used to treat heartburn and gastrointestinal ulcers),
• clozapine (used to treat schizophrenia),
• methotrexate (used to treat cancer or autoimmune diseases),
• metronidazole (used to treat infections),
• phenytoin (used to treat epilepsy),

• sorivudine (used to treat viral infections) or chemically related
analogues (e.g. brivudine),
• warfarin (used to prevent blood from clotting).

document page: 1

Tell your doctor if you are taking or have recently taken any of these
medicines. Your doctor may decide that you can be given fluorouracil
at the same time as these medicines.

The dosage will depend on the condition being treated and whether
or not other drugs are being administered. It will also depend on the
results of your blood tests and the state of your health.
The usual fluorouracil dose is around 1 g (1000 mg) per day. Your
treatment may be given daily or at weekly intervals initially. Further
courses may be prescribed by your doctor according to your response
to treatment.

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

If you take more Fluorouracil Injection 50 mg/ml
If you are given more fluorouracil than intended, consult your doctor
immediately.

Pregnancy and breast-feeding
Do not use Fluorouracil Injection 50 mg/ml if you are pregnant or
breast-feeding.

If you forget to take Fluorouracil Injection 50 mg/ml
If you miss a dose or if you are at home and have any trouble with your
pump, contact your nurse or pharmacist as soon as possible.

Ask your doctor or pharmacist for advice before taking any medicine.

If you stop using Fluorouracil Injection 50 mg/ml
When your course of fluorouracil is finished you may feel tired and
experience some of the undesirable effects (see below) associated
with fluorouracil treatment.

Driving and using machines
Fluorouracil may induce side effects such as nausea and vomiting.
This may influence your ability to drive or use machines.

4. POSSIBLE SIDE EFFECTS
3. HOW TO USE FLUOROURACIL INJECTION 50 MG/ML
If you are using Fluorouracil Injection 50 mg/ml, solution for injection,
at home, it is important to follow the instructions given to you by
your doctor, nurse and pharmacist. If the container is damaged, and
fluorouracil is spilt, you should contact your nurse or pharmacist. If
fluorouracil comes into contact with your skin, wash the area with soap
and water and contact your doctor, nurse or pharmacist. Do not clean
up spilt fluorouracil without first contacting your nurse or pharmacist.
Fluorouracil is given by intravenous injection or infusion (drip or pump).
If you are in hospital it may be given by intra-arterial infusion.

Like all medicines, Fluorouracil Injection 50 mg/ml can cause side
effects, although not everybody gets them.
Prior to commencement of treatment, your doctor will inform you of
the expected benefits and potential risks of the use of Fluorouracil
Injection 50 mg/ml, solution for injection.
If your bowel motions are bloodstained or if your mouth becomes
very sore, tell your doctor immediately.
Common side effects are:
• an increased risk of infections,
• changes in the components of the blood,
• inflammation of the eyes,
• unsteady on feet,

Fluorouracil medac 50 mg/ml · 81260-VP1GB · CA · 03.14 · Pharma-Code: 94
Format: 444 x 150 mm · HKS 44 · Corrective action: KV01_jem_25.02.14

medac GmbH













increase in heart rate,
chest pain,
breathlessness,
diarrhoea,
nausea,
vomiting,
sore mouth,
hair loss,
reddening of palms of hands and soles of feet,
tiredness,
fever.

Diarrhoea and sickness are quite common, but your doctor may be
able to give you medicine(s) to reduce this.
Hair loss is particularly common in women. The hair usually grows
again when fluorouracil is stopped. Talk to your nurse if you are
unhappy about this.
You may become unsteady on your feet or experience a quickening
of your heart rate and breathlessness. Tell your doctor or nurse if this
occurs.
If you experience chest pain tell your doctor or nurse.
Fluorouracil affects the components of blood and you will need to have
blood tests during and after treatment with fluorouracil.
Less common side effects are:
• severe infection,
• increase in the level of uric acid in the blood,
• allergic reaction,
• headache,
• seizure,
• painful and/or watering eyes,
• vision changes,
• nose-bleeds,
• wheezing,

1.3.2.1.9






stomach ulceration and bleeding,
liver problems,
skin and nail changes,
pain or discoloration of the vein where Fluorouracil
Injection 50 mg/ml is administered,
• confusion,
• abnormal movements,
• blood circulation disorders.
Fluorouracil treatment may cause you to become confused; however
this is reversible when treatment is stopped. Tell your doctor
immediately if this occurs.
Blood circulation disorders can lead to e.g. numbness or paleness
(extremities), pain (digestive tract), paralysis or speech difficulties
(brain).
You may experience one or several of these symptoms during therapy
or after your fluorouracil treatment: be sure to inform your doctor if you
do.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the
safety of this medicine.
5. HOW TO STORE FLUOROURACIL INJECTION 50 MG/ML
Do not store above 25 °C.
Do not refrigerate or freeze.
Keep the container in the outer carton.
Do not use Fluorouracil Injection 50 mg/ml after the expiry date
which is stated on the carton.
Keep out of the reach and sight of children!

6. FURTHER INFORMATION
What Fluorouracil Injection 50 mg/ml contains
The active substance is fluorouracil. Each septum vial contains
10 ml (20 ml, 50 ml, 100 ml) of solution containing 500 mg
(1000 mg, 2500 mg, 5000 mg) fluorouracil.
The other ingredients are: sodium hydroxide and water for injections.
What Fluorouracil Injection 50 mg/ml looks like and contents
of the pack
Fluorouracil Injection 50 mg/ml, solution for injection, is a clear,
colourless or almost colourless solution.
Fluorouracil Injection 50 mg/ml, solution for injection, is an aqueous
solution for injection which is supplied in colourless glass vials.
Fluorouracil Injection 50 mg/ml, solution for injection vials are supplied
in packs containing one vial or ten vials.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
medac
Gesellschaft für klinische
Spezialpräparate mbH
Theaterstr. 6
22880 Wedel
Germany
Manufacturer
medac
Gesellschaft für klinische
Spezialpräparate mbH
Theaterstr. 6
22880 Wedel
Germany
This leaflet was last revised in 03/2014.
----------------------------------------------------------------------

document page: 2

The following information is intended for medical or healthcare
professionals only:
Instructions on how to store, handle, and dispose Fluorouracil Injection
50 mg/ml
Shelf life after preparing the solution for infusion ready for use
Chemical and physical in-use stability of the solution diluted
with glucose 5 % or sodium chloride 0.9 % injection has been
demonstrated for 24 hours at a temperature not exceeding 25 °C.
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 the responsibility of the user and would
normally not be longer than 24 hours at 2 to 8 °C, unless dilution has
taken place in controlled and validated aseptic conditions.
If a precipitate has formed as a result of exposure to low temperatures,
redissolve by heating to 40 °C accompanied by vigorous shaking.
Allow to cool to body temperature prior to use.
Handling and disposal
Preparation of solution for administration should be carried out in
a designated handling area and working over a washable tray or
disposable plastic-backed absorbent paper.
Suitable eye protection, disposable gloves, face mask and disposable
apron should be worn. Syringes and infusion sets should be
assembled carefully to avoid leakage (use of Luer lock fittings is
recommended).
All materials that have been utilised for dilution and administration
should be disposed of according to standard procedures (incineration).
Any solution remaining after first use should be discarded. Waste
disposal procedures should take into account the cytotoxic nature of
this substance.
81260-VP1GB
CA

Fluorouracil medac 50 mg/ml · 81250-VP1GB · CA · 03.14 · Pharma-Code: 1737
Format: 444 x 132 mm · HKS 44 · Corrective action: KV01_jem_09.12.14

medac GmbH

PACKAGE LEAFLET: INFORMATION FOR THE USER

Fluorouracil Injection 50 mg/ml,
solution for injection
Fluorouracil
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 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 or pharmacist.
In this leaflet:
1. What Fluorouracil Injection 50 mg/ml is and what it is used for
2. Before you use Fluorouracil Injection 50 mg/ml
3. How to use Fluorouracil Injection 50 mg/ml
4. Possible side effects
5. How to store Fluorouracil Injection 50 mg/ml
6. Further information

1.3.2.1.9

2. BEFORE YOU USE FLUOROURACIL INJECTION 50 MG/ML
Do not use Fluorouracil Injection 50 mg/ml
• if you are allergic (hypersensitive) to fluorouracil,
• if you are pregnant or breast-feeding,
• if you have been seriously weakened by long illness or other
treatments (including radiotherapy) for your cancer,
• if you are receiving treatment for chickenpox or shingles (Herpes
zoster) with brivudine, sorivudine or similar substances, or have
received such treatment in the last four weeks.
Take special care with Fluorouracil Injection 50 mg/ml
Before you receive fluorouracil tell your doctor if you
• have suffered from angina (heart condition marked by sudden
attacks of chest pain),
• have a history of heart disease,
• have ever experienced chest pain,
• have had problems with your kidneys or liver,
• take phenytoin for epileptic fits.
Your treatment will be first given to you in hospital. Before you are given
fluorouracil you will have to have a blood test, and possibly other tests, so that
your doctor can be sure that you can undergo fluorouracil treatment.

• sorivudine (used to treat viral infections) or chemically related
analogues (e.g. brivudine),
• warfarin (used to prevent blood from clotting).
Tell your doctor if you are taking or have recently taken any of these
medicines. Your doctor may decide that you can be given fluorouracil
at the same time as these medicines.
Please also tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.
Pregnancy and breast-feeding
Do not use Fluorouracil Injection 50 mg/ml if you are pregnant or
breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Fluorouracil may induce side effects such as nausea and vomiting.
This may influence your ability to drive or use machines.
3. HOW TO USE FLUOROURACIL INJECTION 50 MG/ML

Tell your doctor if you experience any chest pain during treatment.
1. WHAT FLUOROURACIL INJECTION 50 MG/ML IS AND WHAT IT
IS USED FOR
Fluorouracil is an anti-cancer drug.
Fluorouracil Injection 50 mg/ml, solution for injection, is used to treat
the symptoms of many common cancers, particularly cancers of the
large bowel and breast. It may be used in combination with other
anti-cancer drugs.

Taking other medicines
Fluorouracil is known to interact with the following medicines:
• allopurinol (used to treat high levels of uric acid),
• leucovorin (also called folinic acid – used in cancer therapy and
treatment of folic acid deficiency),
• cimetidine (used to treat heartburn and gastrointestinal ulcers),
• clozapine (used to treat schizophrenia),
• methotrexate (used to treat cancer or autoimmune diseases),
• metronidazole (used to treat infections),
• phenytoin (used to treat epilepsy),

If you are using Fluorouracil Injection 50 mg/ml, solution for injection,
at home, it is important to follow the instructions given to you by
your doctor, nurse and pharmacist. If the container is damaged, and
fluorouracil is spilt, you should contact your nurse or pharmacist. If
fluorouracil comes into contact with your skin, wash the area with soap
and water and contact your doctor, nurse or pharmacist. Do not clean
up spilt fluorouracil without first contacting your nurse or pharmacist.
Fluorouracil is given by intravenous injection or infusion (drip or pump).
If you are in hospital it may be given by intra-arterial infusion.

document page: 3

The dosage will depend on the condition being treated and whether or not
other drugs are being administered. It will also depend on the results of your
blood tests and the state of your health.
The usual fluorouracil dose is around 1 g (1000 mg) per day. Your treatment
may be given daily or at weekly intervals initially. Further courses may be
prescribed by your doctor according to your response to treatment.
If you take more Fluorouracil Injection 50 mg/ml
If you are given more fluorouracil than intended, consult your doctor immediately.
If you forget to take Fluorouracil Injection 50 mg/ml
If you miss a dose or if you are at home and have any trouble with your pump,
contact your nurse or pharmacist as soon as possible.
If you stop using Fluorouracil Injection 50 mg/ml
When your course of fluorouracil is finished you may feel tired and
experience some of the undesirable effects (see below) associated with
fluorouracil treatment.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Fluorouracil Injection 50 mg/ml can cause side effects,
although not everybody gets them.
Prior to commencement of treatment, your doctor will inform you of
the expected benefits and potential risks of the use of Fluorouracil
Injection 50 mg/ml, solution for injection.
If your bowel motions are bloodstained or if your mouth becomes
very sore, tell your doctor immediately.
Common side effects are:
• an increased risk of infections,
• changes in the components of the blood,
• inflammation of the eyes,
• unsteady on feet,

Fluorouracil medac 50 mg/ml · 81250-VP1GB · CA · 03.14 · Pharma-Code: 1737
Format: 444 x 132 mm · HKS 44 · Corrective action: KV01_jem_09.12.14

medac GmbH













increase in heart rate,
chest pain,
breathlessness,
diarrhoea,
nausea,
vomiting,
sore mouth,
hair loss,
reddening of palms of hands and soles of feet,
tiredness,
fever.

Diarrhoea and sickness are quite common, but your doctor may be able to
give you medicine(s) to reduce this.
Hair loss is particularly common in women. The hair usually grows again when
fluorouracil is stopped. Talk to your nurse if you are unhappy about this.
You may become unsteady on your feet or experience a quickening of your
heart rate and breathlessness. Tell your doctor or nurse if this occurs.
If you experience chest pain tell your doctor or nurse.
Fluorouracil affects the components of blood and you will need to have blood
tests during and after treatment with fluorouracil.
Less common side effects are:
• severe infection,
• increase in the level of uric acid in the blood,
• allergic reaction,
• headache,
• seizure,
• painful and/or watering eyes,
• vision changes,
• nose-bleeds,
• wheezing,

1.3.2.1.9






stomach ulceration and bleeding,
liver problems,
skin and nail changes,
pain or discoloration of the vein where Fluorouracil Injection 50 mg/ml
is administered,
• confusion,
• abnormal movements,
• blood circulation disorders.
Fluorouracil treatment may cause you to become confused; however
this is reversible when treatment is stopped. Tell your doctor immediately
if this occurs.
Blood circulation disorders can lead to e.g. numbness or paleness
(extremities), pain (digestive tract), paralysis or speech difficulties (brain).
You may experience one or several of these symptoms during therapy
or after your fluorouracil treatment: be sure to inform your doctor if you do.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety
of this medicine.
5. HOW TO STORE FLUOROURACIL INJECTION 50 MG/ML
Do not store above 25 °C.
Do not refrigerate or freeze.
Keep the container in the outer carton.
Do not use Fluorouracil Injection 50 mg/ml after the expiry date
which is stated on the carton.
Keep out of the reach and sight of children!

6. FURTHER INFORMATION
What Fluorouracil Injection 50 mg/ml contains
The active substance is fluorouracil. Each septum vial contains
10 ml (20 ml, 50 ml, 100 ml) of solution containing 500 mg
(1000 mg, 2500 mg, 5000 mg) fluorouracil.
The other ingredients are: sodium hydroxide and water for injections.
What Fluorouracil Injection 50 mg/ml looks like and contents of the pack
Fluorouracil Injection 50 mg/ml, solution for injection, is a clear,
colourless or almost colourless solution.
Fluorouracil Injection 50 mg/ml, solution for injection, is an aqueous solution
for injection which is supplied in colourless glass vials.
Fluorouracil Injection 50 mg/ml, solution for injection vials are supplied in
packs containing one vial or ten vials.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
medac
Gesellschaft für klinische
Spezialpräparate mbH
Theaterstr. 6
22880 Wedel
Germany
Manufacturer
medac
Gesellschaft für klinische
Spezialpräparate mbH
Theaterstr. 6
22880 Wedel
Germany
This leaflet was last revised in 03/2014.
----------------------------------------------------------------------

document page: 4

The following information is intended for medical or healthcare
professionals only:
Instructions on how to store, handle, and dispose Fluorouracil
Injection 50 mg/ml
Shelf life after preparing the solution for infusion ready for use
Chemical and physical in-use stability of the solution diluted with glucose 5 %
or sodium chloride 0.9 % injection has been demonstrated for 24 hours at a
temperature not exceeding 25 °C.
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
the responsibility of the user and would normally not be longer than 24 hours
at 2 to 8 °C, unless dilution has taken place in controlled and validated aseptic
conditions.
If a precipitate has formed as a result of exposure to low temperatures,
redissolve by heating to 40 °C accompanied by vigorous shaking. Allow to
cool to body temperature prior to use.
Handling and disposal
Preparation of solution for administration should be carried out in a designated
handling area and working over a washable tray or disposable plastic-backed
absorbent paper.
Suitable eye protection, disposable gloves, face mask and disposable apron
should be worn. Syringes and infusion sets should be assembled carefully to
avoid leakage (use of Luer lock fittings is recommended).
All materials that have been utilised for dilution and administration should be
disposed of according to standard procedures (incineration).
Any solution remaining after first use should be discarded. Waste disposal
procedures should take into account the cytotoxic nature of this substance.
81250-VP1GB
CA

Expand view ⇕

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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