"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
DOTAREM administered to healthy volunteers and to patients at cumulative doses up to 0.3 mmol/kg was tolerated in a manner similar to lower doses. Adverse reactions to overdosage with DOTAREM have not been reported. Gadoterate meglumine can be removed from the body by hemodialysis [See CLINICAL PHARMACOLOGY].
History of clinically important hypersensitivity reactions to DOTAREM [see WARNINGS AND PRECAUTIONS].This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/5/2013
Additional Dotarem Information
Report Problems to the Food and Drug Administration
Find out what women really need.