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Risk Evaluation and Mitigation Strategies (REMS) is a program of the US Food and Drug Administration for the monitoring of medications with a high potential for serious adverse effects. REMS applies only to specific prescription drugs, but can apply to brand name or generic drugs. [1] The REMS program was formalized in 2007.
Clozapine, sold under the brand name Clozaril among others, is a psychiatric medication and was the first atypical antipsychotic to be discovered. [6] It is primarily used to treat people with schizophrenia and schizoaffective disorder who have had an inadequate response to two other antipsychotics, or who have been unable to tolerate other drugs due to extrapyramidal side effects.
Antipsychotics by class Generic name Brand names Chemical class ATC code Typical antipsychotics; Acepromazine: Atravet, Acezine: phenothiazine: N05AA04
Many different professionals (physicians, clinical pharmacists, nurses, medical laboratory scientists, etc.) are involved with the various elements of drug concentration monitoring, which is a truly multidisciplinary process. Because failure to properly carry out any one of the components can severely affect the usefulness of using drug ...
Clozaril – atypical antipsychotic used to treat resistant schizophrenia Concerta ( methylphenidate ) – an extended release form of methylphenidate Contrave ( naltrexone/bupropion ) – a combination drug used in the treatment of mood and psychotic disorders.
The FDA can require a pharmaceutical company to place a boxed warning. It is the strongest warning that the FDA requires, and signifies that medical studies indicate that the drug carries a significant risk of preventable, serious or even life-threatening adverse effects. [2] [3]
Software that is intended to be used to view images, or other real time data, as an adjunct to the monitoring device itself, for the purpose of aiding in treatment or diagnosis of a patient, would be Class I medical devices. Medical device software that is an adjunct to another medical device and is involved in data manipulation, data analysis ...
Lab orders in the LIMS module of the GNU Health project. A laboratory information management system (LIMS), sometimes referred to as a laboratory information system (LIS) or laboratory management system (LMS), is a software-based solution with features that support a modern laboratory's operations.