Fluorouracil 500mg/10ml solution for injection vials

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiivinen ainesosa:

Fluorouracil sodium

Saatavilla:

Accord-UK Ltd

ATC-koodi:

L01BC02

INN (Kansainvälinen yleisnimi):

Fluorouracil sodium

Annos:

50mg/1ml

Lääkemuoto:

Solution for injection

Antoreitti:

Intraarterial; Intravenous

luokka:

No Controlled Drug Status

Prescription tyyppi:

Valid as a prescribable product

Tuoteyhteenveto:

BNF: 08010300; GTIN: 5060149312148

Pakkausseloste

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 d

Valmisteyhteenveto

OBJECT 1
FLUOROURACIL 50 MG/ML SOLUTION FOR INJECTION OR
INFUSION
Summary of Product Characteristics Updated 27-Apr-2016 | Accord
Healthcare Limited
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-