Fluorouracil 50mg/ml solution for injection or infusion solution for injection or infusion

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

fluorouracil

Available from:

Accord Healthcare Limited

ATC code:

L01BC02

INN (International Name):

fluorouracil

Dosage:

50mg/ml

Pharmaceutical form:

solution for injection or infusion

Units in package:

20ml glass vial

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2018-02-27

Patient Information leaflet

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 marrow has been dam

Summary of Product characteristics

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 (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
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 continuous infusion
for up to seve