Fluorouracil 25 mg/ml Solution for Injection or Infusion

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Fluorouracil sodium

Saadav alates:

Pfizer Healthcare Ireland

ATC kood:

L01BC; L01BC02

INN (Rahvusvaheline Nimetus):

Fluorouracil sodium

Annus:

25 milligram(s)/millilitre

Ravimvorm:

Solution for injection/infusion

Retsepti tüüp:

Product subject to prescription which may not be renewed (A)

Terapeutiline ala:

Pyrimidine analogues; fluorouracil

Volitamisolek:

Marketed

Loa andmise kuupäev:

1986-05-22

Infovoldik

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PACKAGE LEAFLET: INFORMATION FOR THE USER
FLUOROURACIL 25 MG/ML SOLUTION FOR INJECTION OR INFUSION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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.
•
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 you get any side effects, talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Fluorouracil Solution for Injection or Infusion is and what it is
used for
2.
What you need to know before you use Fluorouracil Solution for
Injection or Infusion
3.
How to use Fluorouracil Solution for Injection or Infusion
4.
Possible side effects
5.
How to store Fluorouracil Solution for Injection or Infusion
6.
Contents of the pack and other information
1. WHAT FLUOROURACIL SOLUTION FOR INJECTION OR INFUSION IS AND WHAT IT
IS USED FOR
Fluorouracil Solution for Injection or Infusion is an anti-cancer
medicine. Treatment with an
anti-cancer medicine is sometimes called cancer chemotherapy.
Fluorouracil Solution for Injection or Infusion 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.
You must talk to a doctor if you do not feel better or if you feel
worse.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE FLUOROURACIL SOLUTION FOR
INJECTION OR INFUSION
DO NOT USE FLUOROURACIL SOLUTION FOR INJECTION OR INFUSION
•
if you have shown signs of hypersensitivity (severe allergy) to
fluorouracil or any of
its ingredients in the past
•
if you are in a seriously weakened state (including nutritional) due
to long illness
•
if you have a serious infection (e.g. chickenpox or shingles)
•
if your bone marrow has been damag

Toote omadused

Health Products Regulatory Authority
21 March 2024
CRN00DPR2
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fluorouracil 25 mg/ml Solution for Injection or Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml of the solution contains 25 mg of fluorouracil (present as
sodium salt).
Excipient with known effect
The 10ml vial contains 40.1 mg of sodium in each vial.
The 20ml vial contains 80.2 mg of sodium in each vial.
The 100ml vial contains 401 mg of sodium in each vial.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection or infusion.
Clear, colourless or slightly yellow solution without visible
particles.
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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration
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
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.
Fluorouracil may be used in combination with other cytotoxic
chemotherapeutic agents; however, fluorouracil injection should
not be mixed directly in the same container with other
chemotherapeutic agents or intravenous additives.
Fluorouracil Injection BP can be given by intravenous injection or
infusion or intra-arterial regional perfusion.
Fluorouracil is often administered concomitantly with calcium folinate
(folinic acid) which may potentiate the therapeutic
effects of fluorouracil. Therefore, the