DBL FLUOROURACIL INJECTION BP Fluorouracil 2.5g/50mL injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

fluorouracil, Quantity: 50 mg/mL

Available from:

Pfizer Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: water for injections; sodium hydroxide

Administration route:

Intravenous

Units in package:

1 x 2.5g/50mL vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Fluorouracil is indicated 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: Clear, colourless to slightly yellow solution, free from visible particulates.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store between 8-25 degrees celsius

Authorization status:

Licence status A

Authorization date:

2000-08-30

Patient Information leaflet

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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor, nurse or
pharmacist.
1.
WHY AM I BEING TREATED DBL FLUOROURACIL INJECTION BP?
DBL Fluorouracil Injection BP contains the active ingredient
fluorouracil. DBL Fluorouracil Injection BP is used to treat some
types of
cancer.
For more information, see Section 1. Why am I using DBL Fluorouracil
Injection BP? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE TREATMENT WITH DBL FLUOROURACIL INJECTION
BP?
Do not use if you have ever had an allergic reaction to fluorouracil
or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, have an
infection or high temperature, take any other medicines, or if
you are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use
DBL Fluorouracil Injection BP? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with DBL Fluorouracil Injection BP and
affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW IS DBL FLUOROURACIL INJECTION BP GIVEN?
Your doctor will decide what dose you will receive. This depends on
your medical condition and other factors. Fluorouracil must only
be given by a doctor or nurse.
More instructions can be found in Section 4. How do I use DBL
Fluorouracil Injection BP? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE BEING TREATED WITH DBL FLUOROURACIL INJECTION
BP?
There are many important things to consider while you are taking this
medicine. The most common and serious considerations are
summarised below (see the full CMI for more details).
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
DBL Fluorouracil Injection BP.
•
Tell your doctor immediately

Summary of Product characteristics

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Page 1 of 14
AUSTRALIAN
PRODUCT
INFORMATION
–
DBL
™ FLUOROURACIL INJECTION BP (FLUOROURACIL)
1.
NAME OF THE MEDICINE
Fluorouracil
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of DBL Fluorouracil Injection BP contains fluorouracil 25 mg
or 50 mg.
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Solution for injection.
DBL Fluorouracil Injection BP is a sterile, colourless,
preservative-free solution containing 5-
Fluorouracil in Water for Injections, prepared with the aid of sodium
hydroxide. The pH of the
solution is approximately 8.9. DBL Fluorouracil Injection BP is a
clear, colourless to slightly
yellow solution.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fluorouracil is indicated 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 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
The dosage being based on the patient's actual weight. Ideal weight is
used only if the patient
is obese or if there has been a spurious weight gain due to oedema,
ascites or other forms of
abnormal fluid retention. Prior to treatment each patient is to be
carefully evaluated in order to
estimate the optimum initial dosage of fluorouracil.
THE TOTAL DAILY DOSE OF FLUOROURACIL SHOULD NOT EXCEED 1 GRAM.
The following regimens have been recommended for use of fluorouracil
as a single agent in
adults:
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Supersedes: Version pfpfluoi10821
Page 2 of 14
_INTRAVENOUS INFUSION _
15 milligrams/kg bodyweight (to a maximum of 1 g) daily diluted in 300
to 500 mL of 5%
glucose given over a period of 4 hours. Infusion may be continued
daily until the first
gastrointestinal side effects occur, ie. stomatitis, diarrhoea,
leuc