Reteplase nonclinical toxicology: Difference between revisions
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{{CMG}}; {{AE}} {{AZ}} | {{CMG}}; {{AE}} {{AZ}} | ||
==Nonclinical Toxicology== | |||
<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = RETAVASE (RETEPLASE) KIT [EKR THERAPEUTICS, INC.] | url =http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=e9ae6656-977c-4105-8528-bee664aab27a | publisher = | date = | accessdate = }}</ref> | :*'''Carcinogenesis''' | ||
:*'''Mutagenesis''' | |||
:*'''Impairment of Fertility''' | |||
Long-term studies in animals have not been performed to evaluate the carcinogenic potential of Retavase.® Studies to determine mutagenicity, chromosomal aberrations, gene mutations, and micronuclei induction were negative at all concentrations tested. Reproductive toxicity studies in rats revealed no effects on fertility at doses up to 15 times the human dose (4.31 units/kg)<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = RETAVASE (RETEPLASE) KIT [EKR THERAPEUTICS, INC.] | url =http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=e9ae6656-977c-4105-8528-bee664aab27a | publisher = | date = | accessdate = }}</ref> | |||
==References== | ==References== | ||
Revision as of 19:11, 6 February 2014
| Reteplase |
|---|
| Retavase® FDA Package Insert |
| Indications and Usage |
| Dosage and Administration |
| Contraindications |
| Warnings and Precautions |
| Adverse Reactions |
| Drug Interactions |
| Use in Specific Populations |
| Description |
| Clinical Pharmacology |
| Nonclinical Toxicology |
| How Supplied/Storage and Handling |
| Labels and Packages |
| Clinical Trials on Reteplase |
| ClinicalTrials.gov |
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
Long-term studies in animals have not been performed to evaluate the carcinogenic potential of Retavase.® Studies to determine mutagenicity, chromosomal aberrations, gene mutations, and micronuclei induction were negative at all concentrations tested. Reproductive toxicity studies in rats revealed no effects on fertility at doses up to 15 times the human dose (4.31 units/kg)[1]
References
Adapted from the FDA Package Insert.