Fluorouracil 250mg/10ml solution for injection vials

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)

Wirkstoff:

Fluorouracil sodium

Verfügbar ab:

Pfizer Ltd

ATC-Code:

L01BC02

INN (Internationale Bezeichnung):

Fluorouracil sodium

Dosierung:

25mg/1ml

Darreichungsform:

Solution for injection

Verabreichungsweg:

Intraarterial; Intravenous

Klasse:

No Controlled Drug Status

Verschreibungstyp:

Valid as a prescribable product

Produktbesonderheiten:

BNF: 08010300; GTIN: 5015997266952

Gebrauchsinformation

Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
FLUOROURACIL 25 MG/ML INJECTION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 is and what it is used for
2.
Before you use Fluorouracil Injection
3.
How to use Fluorouracil Injection
4.
Possible side effects
5.
How to store Fluorouracil Injection
6.
Further information
1. WHAT FLUOROURACIL INJECTION IS AND WHAT IT IS USED FOR
Fluorouracil Injection is an anti-cancer medicine. Treatment with an
anti-cancer
medicine is sometimes called cancer chemotherapy.
Fluorouracil Injection is used to treat many common cancers,
particularly cancers of
the large bowel and breast. It may be used in combination with other
anti-cancer
medicines or radiotherapy.
2. BEFORE YOU USE FLUOROURACIL INJECTION
DO NOT USE FLUOROURACIL INJECTION

if you have shown signs of hypersensitivity (severe allergy) to
fluorouracil in
the past

if you are in a seriously weakened state due to long illness

if your bone marrow has been damaged by other cancer treatments
(including
radiotherapy)

if you have a potentially serious infection

if your cancer is non-malignant

if you are pregnant or you are breast-feeding

if you are taking or have taken in the past 4 weeks brivudine,
sorivudine and
similar drugs (antivirals)
Tell your doctor if any of the above applies to you before this
medicine is used.
TAKE SPECIAL CARE WITH FLUOROURACIL INJECTION

if your bone marrow is not producing blood cells normally (your doctor
will
do a blood test to check this)
Page 2 of 8

if you have any problems with yo

Fachinformation

OBJECT 1
FLUOROURACIL 25 MG/ML INJECTION
Summary of Product Characteristics Updated 08-Feb-2017 | Hospira UK
Ltd
1. Name of the medicinal product
Fluorouracil 25mg/ml Injection.
2. Qualitative and quantitative composition
Each 1 ml contains 25mg of fluorouracil.
Presentations
250mg / 10ml
500mg / 20ml
2.5g / 100ml
Amount fluorouracil
present (as sodium
salt) per vial
250mg
500mg
2.5g
For excipients see 6.1
3. Pharmaceutical form
Solution for injection.
Clear, colourless or slightly yellow solution.
4. Clinical particulars
4.1 Therapeutic indications
Fluorouracil may be used alone, or in combination, for the management
of common malignancies
particularly cancer of the colon and breast.
4.2 Posology and method of administration
_Adults:_
Selection of an appropriate dose and treatment regime depends upon the
condition of the patient, the type
of carcinoma being treated and whether fluorouracil is to be
administered alone or in combination with
other therapy. Initial treatment should be given in hospital and the
_total daily dose should not exceed 0.8 -_
_1 gram. _It is customary to calculate the dose in accordance with the
patient's actual bodyweight unless
there is obesity, oedema or some form of abnormal fluid retention such
as ascites. Ideal weight is used as
the basis for calculation in such cases. The initial dose should be
reduced by one-third to one half in
patients with any of the following:
1. Cachexia.
2. Major surgery within preceding 30 days.
3. Reduced bone marrow function.
4. Impaired hepatic or renal function.
Fluorouracil injection should not be mixed directly, in the same
container, with other chemotherapeutic
agents or intravenous additives.
The following regimens have been recommended for use as a single
agent:
_Initial Treatment:_
This may be in the form of an infusion or an injection, the former
usually being preferred because of
lesser toxicity.
_Intravenous infusion:_
15mg/kg bodyweight, but not more than 1g per infusion, diluted in 300
- 500ml of 5% glucose or 0.9%
NaCl injection and given ov