FLUOROURACIL EBEWE 50 MGML

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

FLUOROURACIL

Available from:

NOVARTIS ISRAEL LTD

ATC code:

L01BC02

Pharmaceutical form:

CONCENTRATE FOR SOLUTION FOR INJECTION / INFUSION

Composition:

FLUOROURACIL 50 MG/ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

EBEWE PHARMA GES.M.B.H NFG.KG, AUSTRIA

Therapeutic group:

FLUOROURACIL

Therapeutic area:

FLUOROURACIL

Therapeutic indications:

Palliative management of carcinoma of the colon, rectum, breast, stomach and pancreas, in selected patients considered incurable by surgery or other means.As leucovorin-fluorouracil chemotherapy combination for cancer treatment.

Authorization date:

2014-01-31

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
FLUOROURACIL “EBEWE” 50MG/ML
Concentrate for Solution for Injection / Infusion
1.
NAME OF THE MEDICINAL PRODUCT
Fluorouracil “EBEWE” 50mg/ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial containing 20 mL contains 1,000 mg of fluorouracil.
One vial containing 50 mL contains 2,500 mg of fluorouracil.
One vial containing 100 mL contains 5,000 mg of fluorouracil.
Excipient with known effect:
Each ml contains 7.58-9.31mg sodium.
For the full list of excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for injection/infusion.
Clear and colourless to slightly yellowish solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Palliative management of carcinoma of the colon, rectum, breast,
stomach and pancreas, in selected
patients considered incurable by surgery or other means.
As leucovorin-fluorouracil chemotherapy combination for cancer
treatment.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Note: when using leucovorin (calcium folinate) - fluorouracil
chemotherapy combination, strict caution
should be exercised not to mix the 2 drugs in the same administration
set because of incompatibility (see
section 6.2).
Selection of an appropriate dose and treatment regime will depend upon
the condition of the patient, the
type of carcinoma being treated and whether fluorouracil is to be
administered alone or in combination
with other therapy. Initial treatment should be given in hospital and
the total daily dose should not exceed
1 gram. It is customary to calculate the dose in accordance with
patient's actual weight unless there is
obesity, oedema or some other form of abnormal fluid retention such as
ascites. In this case, ideal weight
should be used as the basis for the calculation. Reduction of the dose
is advisable in patients with any
of the following:
1)
Cachexia
2)
Major surgery within preceding 30 days
3)
Reduced bone marrow function
4)
Impaired hepatic or renal function
2
Fluorouracil injection can be given by intravenous injection or
intr