Fluorouracil 50mg/ml Solution for Injection or Infusion (50ml vial)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

FLUOROURACIL

Available from:

Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland

ATC code:

L01BC02

INN (International Name):

FLUOROURACIL 50 mg/ml

Pharmaceutical form:

SOLUTION FOR INFUSION OR INJECTION

Composition:

FLUOROURACIL 50 mg/ml

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Authorization status:

Withdrawn

Authorization date:

2013-05-10

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FLUOROURACIL 50 MG/ML SOLUTION FOR INJECTION OR INFUSION
Fluorouracil
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 pharmacist or
nurse
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their
signs of illness
are the same as yours.
•
If you get any side effects
, talk to your doctor or pharmacist or nurse. This includes any
possible side effects
not listed in this leaflet. See Section 4.
WHAT IS IN THIS LEAFLET:
1. What Fluorouracil Injection is and what it is used for
2. What you need to know before you use Fluorouracil Injection
3. How to use Fluorouracil Injection
4. Possible side effects
5. How to store Fluorouracil Injection
6.
Contents of the pack and other information
1. WHAT FLUOROURACIL INJECTION IS AND WHAT IT IS USED FOR
The name of your medicine is ‘
Fluorouracil 50 mg/ml Solution for Injection or Infusion’ but in the
rest of
the leaflet it will be called ‘Fluorouracil Injection’.
WHAT FLUOROURACIL INJECTION IS
Fluorouracil Injection contains the active ingredient Fluorouracil. It
is an anti-cancer medication.
WHAT FLUOROURACIL INJECTION IS USED FOR
Fluorouracil Injection is used to treat many common cancers,
particularly cancers of the large bowel
,
oesophagus, pancreas, stomach, head and neck
and breast. It may be used in combination with other anti-cancer
medicines and radiotherapy.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE FLUOROURACIL INJECTION
DO NOT USE FLUOROURACIL INJECTION
•
if you are allergic (hypersensitive) to Fluorouracil or any of the
other ingredients of Fluorouracil Injection
(listed in section 6)
.
•
if you have serious infections (e.g. Herpes zoster, chickenpox)
•
if your tumour is non-malignant.
•
if you have been very much weakened by long illness.
•
if your bone

Summary of Product characteristics

Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS (SPC)
1. NAME OF THE MEDICINAL PRODUCT
Fluorouracil 50 mg/ml Solution for Injection or Infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution contains 50 mg of fluorouracil (as sodium salt formed
_in situ_
).
Each 5 ml vial contains 250 mg of fluorouracil.
Each 10 ml vial contains 500 mg of fluorouracil.
Each 20 ml vial contains 1000 mg of fluorouracil.
Each 50 ml vial contains 2500 mg of fluorouracil.
Each 100 ml vial contains 5000 mg of fluorouracil.
Excipients with known effect:
8.25 mg/ml (0.360 mmol/ml) sodium
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for Injection or Infusion.
A clear colourless solution with a pH in the range of 8.6 to 9.4. 4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fluorouracil is indicated in adults.
Fluorouracil is indicated in the treatment of the following
malignancies and disease settings:
-
in the treatment of metastatic colorectal cancer
-
as adjuvant treatment in colon and rectal cancer
-
in the treatment of advanced gastric cancer,
-
in the treatment of advanced pancreatic cancer,
-
in the treatment of advanced oesophageal cancer,
-
in the treatment of advanced or metastatic breast cancer,
-
as adjuvant treatment in patients with operable primary invasive
breast cancer,
-
in the treatment of inoperable locally advanced squamous cell
carcinoma of the head and
neck in previously untreated patients
in the treatment of locally recurrent or metastatic squamous cell
carcinoma of the head and neck
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
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5-fluorouracil should be administered only under the supervision of a
qualified physician with
extensive experience in cytotoxic treatment.
Patients must be carefully and frequently monitored during the
treatment. The risks and benefits to
individual patients should be carefully considered before each
treatment.
Method of administration
5-fluorouracil can be administered by intravenous injection as bolus,
infusion or con