FLUOROURACIL 50 Mg/Ml Solution for Inj/Inf

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

FLUOROURACIL

Saadav alates:

Generics (UK) Limited

ATC kood:

L01BC02

INN (Rahvusvaheline Nimetus):

FLUOROURACIL

Annus:

50 Mg/Ml

Ravimvorm:

Solution for Inj/Inf

Manustamisviis:

Intravenous injection as bolus, infusion or continuous infusion

Ühikuid pakis:

500 mg/ 10 ml:1, 5 or 10 x 10 ml vials. 1 g/20 ml: 1, 5 or 10 x 20 ml vials. 2.5 g/50 ml: 1, 5 or 10 x 50 ml vials.

Retsepti tüüp:

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

Terapeutiline rühm:

Pyrimidine analogues

Terapeutiline ala:

Pyrimidine analogues

Näidustused:

It 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

Toote kokkuvõte:

Also avalaible in 5 g/100 ml: 1, 5 or 10 x 100 ml vials

Volitamisolek:

Authorised

Loa andmise kuupäev:

2015-06-19

Infovoldik

 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

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, 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 is and what it is used for 
2.  What you need to know before you  use Fluorouracil  
3.  How to use Fluorouracil   
4.  Possible side effects 
5.  How to store Fluorouracil  
6.  Contents of the pack and other information 

1. WHAT FLUOROURACIL IS AND WHAT IT IS USED FOR  

Fluorouracil  contains the active
ingredient fluorouracil. It is an anti-cancer medicine.  

This medicine  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  

DO NOT USE FLUOROURACIL  
•  if you are allergic
to fluorouracil or any of the other ingredients of this medicine (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 marrow has been damage

Toote omadused

SUMMARY OF PRODUCT CHARACTERISTICS
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.
Each 10 ml vial contains 500 mg of fluorouracil.
Each 20 ml vial contains 1 g of fluorouracil.
Each 50 ml vial contains 2.5g of fluorouracil.
Each 100 ml vial contains 5 g of fluorouracil.
Each ml of solution for injection/infusion contains approximately 0.34 to 0.39mmol / ml (or 7.9–9.0 mg/ml) of sodium
in the form of Sodium Hydroxide.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection/infusion.
Clear colourless to yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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
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 treatme