Fluorouracil 5g/100ml solution for infusion vials

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Fluorouracil sodium

Dostupné z:

Pfizer Ltd

ATC kód:

L01BC02

INN (Medzinárodný Name):

Fluorouracil sodium

Dávkovanie:

50mg/1ml

Forma lieku:

Solution for infusion

Spôsob podávania:

Intravenous; Intraarterial

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 08010300; GTIN: 5015997269816

Príbalový leták

Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
FLUOROURACIL 50 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

Súhrn charakteristických

OBJECT 1
FLUOROURACIL 50 MG/ML INJECTION
Summary of Product Characteristics Updated 24-Feb-2017 | Hospira UK
Ltd
1. Name of the medicinal product
Fluorouracil 50mg/ml Injection.
2. Qualitative and quantitative composition
Each 1 ml contains 50 mg of fluorouracil.
Presentations:
250 mg_/_5 ml
500 mg/10 ml
1 g_1_20 ml
2.5 g/50 ml
5g/100ml
Amount
fluorouracil
present (as
sodium salt) per
vial
250 mg
500 mg
1 g
2.5 g
5 g
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 its palliative
action in the management of common
malignancies particularly cancer of the colon and breast, either as a
single agent or in combination with
other cytotoxic agents.
4.2 Posology and method of administration
Selection of an appropriate dose and treatment regime will depend 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
1 gram. It is customary to calculate the dose in accordance with
patient's actual weight unless there is
obesity, oedema or some other form of abnormal fluid retention such as
ascites. In this case, ideal weight
should be used as the basis for the calculation. Reduction of the dose
is advisable 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 can be given by intravenous injection or,
intravenous or intra-arterial infusion.
Fluorouracil injection should not be mixed directly, in the same
container, with other chemotherapeutic
agents or intravenous additives.
_Adult Dose_
The following regimen have been recommended for use as a single agent:
_Initial Treatment: _This may be in the form of an infusion or an
injection, the