Fluracedyl

Negara: Armenia

Bahasa: Inggris

Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Bahan aktif:

fluorouracil

Tersedia dari:

Pharmachemie B.V.

INN (Nama Internasional):

fluorouracil

Dosis:

50mg/ml

Bentuk farmasi:

solution for injection

Jenis Resep:

Prescription

Selebaran informasi

FLURACEDYL
SOLUTION FOR INJECTION 50 MG/ML
‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐
1. NAME OF THE MEDICINAL PRODUCT
Fluracedyl
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
A sterile, isotonic solution of 50 mg fluorouracil per ml solution for
injection.Fluracedyl® solution for
injection has not been preserved and is therefore meant for single
use.
3. PHARMACEUTICAL FORM
Solution for injection.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
FLURACEDYL® may be used alone or in combination, for its palliative
action in the management of
common malignancies, particularly cancer of the colon and breast.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
5-Fluorouracil is applied alone and in combination with other
cytostatic drugs. The 5-fluorouracil dosage
depends on the schedule opted for, the use of other cytostatic drugs,
the application of radiotherapy and the
method of administration. The total daily dosage will usually not
exceed 1 gram.
Colorectal tumours:
The initial therapy may be given as intravenous injections or
intravenous infusion. The toxicity of 5-
fluorouracil is usually higher after injection than after infusion.
As intravenous infusion, 600 mg/m
2
daily (with a maximum of 1 g each time) in 300-500ml 5% glucose
solution may be given during 4 hours. This dosage is repeated daily
untilthe first side effects occur. Therapy
should then be interrupted. After disappearance of thehaematological
and gastrointestinal side effects, a
maintenance therapy is given.
5-Fluorouracil is also given as a continuous infusion. The dosage and
duration of the infusiondepends on the
schedule chosen, the use of other cytostatic drugs and the
applicationof radiotherapy.

Karakteristik produk

_ _
FLURACEDYL
®
SOLUTION FOR INJECTION
PART I
: GENERAL PARTICULARS
DATE: 10
TH OFSEPTEMBER 2012
1.3.1
: PRODUCT INFORMATION
PAGE: 1
rvg 11900 1.3.1 SPC 0912.3v.HW
1. NAME OF THE MEDICINAL PRODUCT
FLURACEDYL®, solution for injection.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
FLURACEDYL®contains50 mg of 5-fluorouracil per mlsolution for
injection.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless to practicallycolourless solution free from
particles.
4.CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
FLURACEDYL®may be used alone or in combination, for its palliative
action in the management of
common malignancies, particularly cancer of the colon and breast.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Selection of an appropriate dose and treatment regime depends upon the
condition of the patient, the
type of carcinoma being treated and whether fluorouracil is to be
administered alone or in combination
with another therapy. Initial treatment should be given in hospital
and the total daily dose should not
exceed 1 gram. In general the dose is calculated 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 is used as the basis for calculation.
Reduction of the dose is advisable in patients with any of the
following complications:
1. Cachexia
2. Major surgery within preceding 30 days
3. Reduced bone marrow function
4. Impaired hepatic or renal function
FLURACEDYL®can be given by intravenous injection or, intravenous or
intra-arterial infusion.
_ADULTS _
_ _
FLURACEDYL
®
SOLUTION FOR INJECTION
PART I
: GENERAL PARTICULARS
DATE: 10
TH OFSEPTEMBER 2012
1.3.1
: PRODUCT INFORMATION
PAGE: 2
rvg 11900 1.3.1 SPC 0912.3v.HW
The following regimens have been recommended for use as a single
agent.
INITIAL TREATMENT
This may be in the form of an infusion or an injection, the former
usually being preferred because of
lesser toxicity.
INTRAVENOUS INFUSI