FLUOROURACIL EBEWE fluorouracil 1000mg/ 20mL solution for injection vial

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

fluorouracil, Quantity: 1000 mg

Disponibil de la:

Sandoz Pty Ltd

Forma farmaceutică:

Injection, solution

Compoziție:

Excipient Ingredients: sodium hydroxide; water for injections

Calea de administrare:

Intravenous

Unități în pachet:

1 vial

Tip de prescriptie medicala:

(S4) Prescription Only Medicine

Indicații terapeutice:

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

Rezumat produs:

Visual Identification: Clear and colourless solution, free of particles.; Container Type: Vial; Container Material: Glass Type I Coloured; Container Life Time: 2 Years; Container Temperature: Store between 8-25 degrees celsius

Statutul autorizaţiei:

Registered

Data de autorizare:

2006-03-15

Prospect

Fluorouracil Ebewe®
1
FLUOROURACIL EBEWE®
INJECTION
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 WITH FLUOROURACIL EBEWE INJECTION?
Fluorouracil Ebewe Injection contains the active ingredient
fluorouracil. Fluorouracil Ebewe Injection is used to treat some
types of cancer.
For more information, see Section 1. Why am I using Fluorouracil Ebewe
Injection?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE FLUOROURACIL EBEWE INJECTION?
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, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Fluorouracil Ebewe Injection?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Fluorouracil Ebewe Injection 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 FLUOROURACIL EBEWE INJECTION 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 Fluorouracil Ebewe
Injection? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING FLUOROURACIL EBEWE INJECTION?
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).
For more information, see Section 5. What should I know while using
Fluorouracil Ebewe Injection? in the full CMI.
6.
ARE THERE ANY SIDE EFFECTS?
Side effects of this medicine may include nausea; vomiting; diarrhoea;
loss of appetite; hair or nail loss; changes in sk

Caracteristicilor produsului

210802-fluorouracil-ebewe-pi
Page 1 of 14
AUSTRALIAN PRODUCT INFORMATION
FLUOROURACIL EBEWE
® (FLUOROURACIL)
1
NAME OF THE MEDICINE
Fluorouracil
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fluorouracil Ebewe
®
contains 50 mg/mL of fluorouracil.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Solution for injection.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Fluorouracil Ebewe 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
D
OSE 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 G
.
The following regimens have been recommended for use of fluorouracil
as a single agent in
adults:
_INTRAVENOUS INFUSION _
15 mg/kg bodyweight (to a maximum of 1 g) daily diluted in 300 to 500
mL of glucose 5%
given
over
a
period
of
four
hours.
Infusions
may
be
continued
daily
until
the
first
gastrointestinal side effects occur, i.e. stomatitis, diarrhoea,
leucopenia, thrombocytopenia;
treatment should then be discontinued. After the side effects have
subsided and the WBC count
has risen to 3,000 to 4,000/mm
3
or the platelet count to 80,000 to 100,000/mm
3
, the patient
may then be placed on a maintenance therapy program.
_INTRAVENOUS INJECTION _
12 mg/kg bodyweight daily for three consecutive days.
If toxic effects do not appear, the patient may then be given 6 mg/kg
may be given
intravenou