FLUOROURACIL EBEWE fluorouracil 2500 mg/50 mL solution for injection vial

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

fluorouracil, Quantity: 2500 mg

Saatavilla:

Sandoz Pty Ltd

INN (Kansainvälinen yleisnimi):

Fluorouracil

Lääkemuoto:

Injection, solution

Koostumus:

Excipient Ingredients: water for injections; sodium hydroxide

Antoreitti:

Intravenous

Kpl paketissa:

1 vial pack

Prescription tyyppi:

(S4) Prescription Only Medicine

Käyttöaiheet:

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.

Tuoteyhteenveto:

Visual Identification: Clear and colourless; Container Type: Vial; Container Material: Glass Type I Coloured; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Valtuutuksen tilan:

Licence status A

Valtuutus päivämäärä:

2011-03-24

Valmisteyhteenveto

_Product Information _
_ _
_Page 1_
_ _
_Fluorouracil Ebewe 500mg/10mL; 1000mg/20mL; 2500mg/50mL; 5000mg/100mL
injection _
_JULY 2017_
_Sandoz Pty Ltd _
_ _
_Version 09 _
PRODUCT INFORMATION
FLUOROURACIL EBEWE
®
500MG/10ML, 1000MG/20ML, 2500MG/50ML,
5000MG/100ML INJECTION SOLUTION
NAME OF THE MEDICINE
Fluorouracil
COMPOSITION
_ACTIVE_
. Fluorouracil.
_INACTIVE_
. Water for injections, sodium hydroxide.
FLUOROURACIL
DESCRIPTION
Chemical name: 5-fluoro-1H, 3H-pyrimidine-2, 4-dione. C
4
H
3
FN
2
O
2
. MW: 130.1. CAS: 51-
21-8. Fluorouracil is a white to almost white, practically odourless,
crystalline powder. It is
sparingly soluble in water, slightly soluble in alcohol and
practically insoluble in chloroform
and ether. The pH of the fluorouracil injection solution is
approximately 8.9.
PHARMACOLOGY
Fluorouracil is an analogue of uracil, a component of ribonucleic
acid. The drug is believed
to function as an antimetabolite. Fluorouracil itself is inactive and
is converted intracellularly
to active metabolites. After conversion to the active deoxynucleotide,
it interferes with the
synthesis of DNA by blocking the conversion of deoxyuridylic acid to
thymidylic acid by the
cellular enzyme thymidylate synthetase. Fluorouracil may also
interfere with RNA synthesis.
Pharmacokinetics
After intravenous administration, fluorouracil is distributed
throughout body tissues and
fluids. The plasma half-life is 8 to 22 minutes and is dose dependent.
Fluorouracil disappears
from the blood within four hours. It is preferentially taken up by
actively dividing tissues and
_Product Information _
_ _
_Page 2_
_ _
_Fluorouracil Ebewe 500mg/10mL; 1000mg/20mL; 2500mg/50mL; 5000mg/100mL
injection _
_JULY 2017_
_Sandoz Pty Ltd _
_ _
_Version 09 _
tumours after conversion to its nucleotide. Fluorouracil readily
enters the cerebrospinal fluid
(CSF).
About 20% is excreted unchanged in the urine and the remainder is
mostly metabolised in the
liver by the usual body mechanisms for uracil.
INDICATIONS
Alone or in combination, for the palliative t