Fondaparinux nonclinical toxicology: Difference between revisions

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__NOTOC__
#REDIRECT [[Fondaparinux#Nonclinical Toxicology]]
{{Fondaparinux}}
{{CMG}}; {{AE}} {{AZ}}


==NONCLINICAL TOXICOLOGY==
[[Category: Cardiovascular Drugs]]
 
[[Category: Drug]]
=== Carcinogenesis, Mutagenesis, Impairment of Fertility===
[[Category: Anticoagulants]]
 
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.<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==
 
{{Reflist|2}}
[[Category:Cardiovascular Drugs]]
[[Category:Drugs]]

Revision as of 16:17, 21 July 2014