Fondaparinux nonclinical toxicology: Difference between revisions
Jump to navigation
Jump to search
No edit summary |
No edit summary |
||
| Line 3: | Line 3: | ||
{{CMG}}; {{AE}} {{AZ}} | {{CMG}}; {{AE}} {{AZ}} | ||
== | ==NONCLINICAL TOXICOLOGY== | ||
=== Carcinogenesis, Mutagenesis, Impairment of Fertility=== | |||
No long-term studies in animals have been performed to evaluate the carcinogenic potential of fondaparinux sodium. | No long-term studies in animals have been performed to evaluate the carcinogenic potential of fondaparinux sodium. | ||
| Line 13: | Line 12: | ||
At subcutaneous doses up to 10 mg/kg/day (about 32 times the recommended human dose based on body surface area), fondaparinux sodium was found to have no effect on fertility and reproductive performance of male and female rats.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = ARIXTRA (FONDAPARINUX SODIUM) INJECTION, SOLUTION [GLAXOSMITHKLINE LLC] | url =http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=05bb2dd4-5fb5-4ec9-29a8-d200e62d1a8f | publisher = | date = | accessdate = }}</ref> | At subcutaneous doses up to 10 mg/kg/day (about 32 times the recommended human dose based on body surface area), fondaparinux sodium was found to have no effect on fertility and reproductive performance of male and female rats.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = ARIXTRA (FONDAPARINUX SODIUM) INJECTION, SOLUTION [GLAXOSMITHKLINE LLC] | url =http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=05bb2dd4-5fb5-4ec9-29a8-d200e62d1a8f | publisher = | date = | accessdate = }}</ref> | ||
==References== | ==References== | ||
Revision as of 22:40, 3 March 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ahmed Zaghw, M.D. [2]
NONCLINICAL TOXICOLOGY
Carcinogenesis, Mutagenesis, Impairment of Fertility
No long-term studies in animals have been performed to evaluate the carcinogenic potential of fondaparinux sodium.
Fondaparinux sodium was not genotoxic in the Ames test, the mouse lymphoma cell (L5178Y/TK+/-) forward mutation test, the human lymphocyte chromosome aberration test, the rat hepatocyte unscheduled DNA synthesis (UDS) test, or the rat micronucleus test.
At subcutaneous doses up to 10 mg/kg/day (about 32 times the recommended human dose based on body surface area), fondaparinux sodium was found to have no effect on fertility and reproductive performance of male and female rats.[1]