מדינה: אוסטרליה
שפה: אנגלית
מקור: Department of Health (Therapeutic Goods Administration)
fluorouracil, Quantity: 2500 mg
Sandoz Pty Ltd
Fluorouracil
Injection, solution
Excipient Ingredients: water for injections; sodium hydroxide
Intravenous
1 vial pack
(S4) Prescription Only Medicine
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.
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
Licence status A
2011-03-24
_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 קרא את המסמך השלם