FLUOROURACIL TEVA

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

FLUOROURACIL

Available from:

ABIC MARKETING LTD, ISRAEL

ATC code:

L01BC02

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

FLUOROURACIL 50 MG/ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

PHARMACHEMIE BV, HOLLAND (TEVA GROUP)

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:

2014-11-30

Patient Information leaflet

העדוה
העדוה
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אפור
ןכדועמ(
ןכדועמ(
05.2013
05.2013
)
)
ךיראת
רושיא
תורמחהה :
12.04.2016
םש
רישכת
תילגנאב
רפסמו
םושירה
FLUOROURACIL INJECTION 50 MG/ML
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תורמחהה
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ןולעב
טסקט
יחכונ
טסקט
שדח
INDICATION
CONTRAINDICATIONS
POSOLOGY, DOSAGE & 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
Fluorouracil injection can be given by intravenous
injection or, intravenous or intra-arterial infusion.
Fluorouracil injection should not be mixed directly, in
the same container, with other chemotherapeutic agents
or intravenous additives.
_Children_
No recommendations are made regarding the use of
Fluorouracil in children.
_Elderly_
Fluorouracil should be used in the elderly with simi

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
FLUOROURACIL TEVA
Solution for Injection
1.
NAME OF THE MEDICINAL PRODUCT
Fluorouracil Teva
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial containing 5 mL of solution for injection contains 250 mg of
fluorouracil.
Each vial containing 10 mL of solution for injection contains 500 mg
of fluorouracil.
Each vial containing 20 mL of solution for injection contains 1,000 mg
of fluorouracil.
Each vial containing 100 mL of solution for injection contains 5,000
mg of fluorouracil.
Excipient with known effect:
8.21 mg/mL (0.36 mmol/mL) sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless or almost colourless 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 functi