FLUOROURACIL ACCORD fluorouracil 2500 mg/50 mL injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

fluorouracil, Quantity: 50 mg/mL

Available from:

Accord Healthcare Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sodium hydroxide; hydrochloric acid; water for injections

Administration route:

Intravenous Infusion, Intravenous

Units in package:

1 vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Alone or in combination, for the palliative treatment of malignant tumours, particularly of the breast, colon or rectum; and in the treatment of gastric, primary hepatic, pancreatic, uterine (cervical particularly), ovarian and bladder carcinomas.,Fluorouracil should only be used when other proven measures have failed or are considered impractical.

Product summary:

Visual Identification: A clear, colourless to slightly pale yellow solution in a glass vial.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2018-06-08

Patient Information leaflet

Version 2.0
Page 1 of 4
FLUOROURACIL ACCORD
_Fluorouracil Injection Solution 250 mg/5 mL, 500 mg/10 mL, 1 g/20 mL,
2.5 g/50 mL _
_and 5 g/100 mL _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Fluorouracil Accord.
It does not contain all the available
information. It does not take the place
of talking to your doctor, nurse or
pharmacist.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you being given this medicine against
the benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT BEING
GIVEN THIS MEDICINE, ASK YOUR DOCTOR,
NURSE OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT FLUOROURACIL
ACCORD IS USED FOR
Fluorouracil Accord belongs to a group
of medicines known as antineoplastic
or cytotoxic agents. You may also hear
of these being called chemotherapy
medicines.
It is used to treat some types of cancer.
Fluorouracil Accord is classified as an
'antimetabolite' type of cytotoxic agent.
It works by interfering with the growth
of cancer cells which are eventually
destroyed.
Your doctor, however, may prescribe
Fluorouracil Accord for another
purpose.
ASK YOUR DOCTOR, NURSE OR
PHARMACIST IF YOU HAVE ANY QUESTIONS
ABOUT WHY FLUOROURACIL ACCORD HAS
BEEN PRESCRIBED FOR YOU.
This medicine is only available with a
doctor's prescription.
Fluorouracil Accord is not addictive.
BEFORE YOU ARE GIVEN IT
_WHEN YOU MUST NOT BE _
_GIVEN IT _
DO NOT RECEIVE FLUOROURACIL ACCORD IF
YOU HAVE AN ALLERGY TO FLUOROURACIL
OR ANY OF THE INGREDIENTS LISTED AT THE
END OF THIS LEAFLET.
Symptoms of an allergic reaction
include:
•
shortness of breath, wheezing,
difficulty breathing or a tight
feeling in your chest;
•
swelling of the face, lips, tongue or
other parts of the body;
•
rash, itching, hives or flushed, red
skin;
•
dizziness or light-headedness.
DO NOT RECEIVE FLUOROURACIL ACCORD IF
YOU HAVE, OR HAVE HAD, ANY OF THE
FOLLOWING MEDICAL CONDITIONS:
•
problems with blood clotting
•
an

Summary of Product characteristics

Page 1 of 11
AUSTRALIAN PRODUCT INFORMATION
FLUOROURACIL ACCORD (FLUOROURACIL) INJECTION
1
NAME OF THE MEDICINE
Fluorouracil
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fluorouracil Accord injection solution contains fluorouracil as the
active ingredient. Five strengths are
available as follows: 250 mg/5 mL, 500 mg/10 mL, 1 g/20 mL, 2.5 g/50
mL and 5 g/100 mL. The 2.5
g/50 mL and 5 g/100 mL vials are Pharmacy Bulk Packs.
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
Fluorouracil Accord Solution for Injection is a clear, colourless to
slightly pale yellow solution
containing fluorouracil. The pH of the fluorouracil injection solution
is approximately 8.9.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Alone or in combination, for the palliative treatment of malignant
tumours, particularly of the breast,
colon
or
rectum;
and
in
the
treatment
of
gastric,
primary
hepatic,
pancreatic,
uterine
(cervical
particularly), ovarian and bladder carcinomas.
Fluorouracil should only be used when other proven measures have
failed or are considered impractical.
4.2
D
OSE AND METHOD OF ADMINISTRATION
GENERAL DIRECTIONS
Fluorouracil Accord contains no antimicrobial agent. The product is
for single use in one patient only.
Discard any residue.
The use of the Pharmacy Bulk Pack should be restricted to suitably
qualified pharmacists operating in
suitably equipped hospital pharmacies or compounding centres. The
Pharmacy Bulk Pack is intended for
multiple dispensing but should be spiked only once.
To reduce microbiological hazard, use as soon as practicable after
preparation. If storage is necessary,
hold at 2°C to 8°C for not more than 24 hours after preparation.
Administration should be completed
within 24 hours of preparation of the infusion and any residue
discarded according to the guidelines for
the disposal of cytotoxic drugs (see
HANDLING PRECAUTIONS AND SPILLS AND DISPOSAL
).
Fluorouracil Injection may be administered by intravenous infusion or
intravenous injection, the dosag