Fluorouracil Mylan 50mg per ml 100ml vial

Negara: Malta

Bahasa: Inggris

Sumber: Medicines Authority

Bahan aktif:

FLUOROURACIL

Tersedia dari:

Mylan S.A.S. 117 Allee des Parcs, 69800 Saint Priest, France

Kode ATC:

L01BC02

INN (Nama Internasional):

FLUOROURACIL 50 mg/ml

Bentuk farmasi:

SOLUTION FOR INFUSION OR INJECTION

Komposisi:

FLUOROURACIL 50 mg/ml

Jenis Resep:

POM

Area terapi:

ANTINEOPLASTIC AGENTS

Status otorisasi:

Withdrawn

Tanggal Otorisasi:

2014-07-02

Selebaran informasi

Page 1 of 12
PACKAGE LEAFLET: INFORMATION FOR THE USER
FLUOROURACIL MYLAN 50 MG/ML SOLUTION FOR INJECTION/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 thisleaflet. See Section 4.
WHAT IS IN THIS LEAFLET
1.
What Fluorouracil Mylan is and what it is used for
2.
What you need to know before you use Fluorouracil Mylan
3.
How to use Fluorouracil Mylan
4.
Possible side effects
5.
How to store Fluorouracil Mylan
6.
Contents of the pack and other information
1. WHAT FLUOROURACIL MYLAN IS AND WHAT IT IS USED FOR
Fluorouracil Mylan 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 MYLAN
DO NOT USE FLUOROURACIL MYLAN

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 damaged by other treatments (including
radiotherapy).

if you are taking brivudin, sorivudin and analogues (an antiviral
medicine)

if you are pregnant or breast feeding women

if you have serious impaired liver function

if you are homozygotic for dihydropyrimidine dehydrogenase (DPD)
enzy

Karakteristik produk

Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Fluorouracil Mylan 50 mg/ml solution for injection/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 Mylan 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
Page 2 of 15
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Fluorouracil Mylan 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.
Fluorouracil
Mylan
can
be
administered
by
intravenous
injection
as
bolus,
infusion
or
continuous infusion for up to several days.
“These are general advices. Please refer to a local or