FLUOROURACIL INJECTION SOLUTION

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

FLUOROURACIL

Prieinama:

BIOLYSE PHARMA CORPORATION

ATC kodas:

L01BC02

INN (Tarptautinis Pavadinimas):

FLUOROURACIL

Dozė:

5G

Vaisto forma:

SOLUTION

Sudėtis:

FLUOROURACIL 5G

Vartojimo būdas:

INTRAVENOUS

Vienetai pakuotėje:

100ML

Recepto tipas:

Prescription

Gydymo sritis:

ANTINEOPLASTIC AGENTS

Produkto santrauka:

Active ingredient group (AIG) number: 0107505004; AHFS:

Autorizacija statusas:

APPROVED

Leidimo data:

2018-03-12

Prekės savybės

PRODUCT MONOGRAPH
PR
FLUOROURACIL INJECTION
FLUOROURACIL INJECTION
USP
50 MG/ML
(0.5 g/10 mL and 5g/100 mL)
THERAPEUTIC CLASSIFICATION
Antineoplastic Agent
Biolyse Pharma Corp
Date of Preparation: March 7, 2018
St. Catharines, Ontario
59 Welland Vale Rd.
L2S 3Y2
Control #191317
_PRODUCT MONOGRAPH; Fluorouracil Injection _
_Page 2 of 20 _
PR
FLUOROURACIL INJECTION
USP
50 MG/ML
(0.5 g/10 mL and 5 g/100 mL)
THERAPEUTIC CLASSIFICATION
Antineoplastic agent
CAUTION
FLUOROURACIL IS A POTENT DRUG AND SHOULD BE ADMINISTERED BY, OR
UNDER SUPERVISION OF, A PHYSICIAN, WHO IS EXPERIENCED IN CANCER
CHEMOTHERAPY.
ACTIONS AND CLINICAL PHARMACOLOGY
There appears to be two mechanisms of action of fluorouracil which
result in cytotoxic effects.
One is the competitive inhibition of thymidylate synthetase, the
enzyme catalyzing the
methylation of deoxyuridylic acid to thymidylic acid. The consequent
thymidine deficiency
results in inhibition of deoxyribonucleic acid (DNA) synthesis, thus
inducing cell death. A
second mechanism of action is evidenced by the moderate inhibition of
ribonucleic acid (RNA)
and incorporation of fluorouracil into RNA. The predominant mechanism
of antitumour action
appears to be dependent, at least in part, on individual tumour
intracellular metabolism.
The effects of DNA and RNA deprivation are most significant on those
cells which are most
rapidly proliferating.
Following intravenous injection, fluorouracil is cleared rapidly from
the plasma (half-life about
10 to 20 minutes), and distributed throughout body tissues including
the cerebrospinal fluid and
malignant effusions, exhibiting a volume of distribution equivalent to
the total body water.
Plasma concentrations fall below measurable levels within 3 hours.
Oral administration of
fluorouracil has shown marked variability
in its bioavailability, from 28% to 100%. Constant
intravenous infusion for 96 hours showed constant plasma drug levels
and significantly less drug
(50 to 1000 fold) in the bone marrow.
Fluorouracil is converted to active nucleotide met