indicated use
[ˈɪndɪkeɪtɪd juːs]
nounpl: indicated uses
uso indicado
1. The specific purpose or application for which a drug, device, or treatment is recommended or approved by regulatory authorities
The indicated use for this medication is the treatment of hypertension in adults.
O uso indicado deste medicamento é o tratamento da hipertensão em adultos.
2. The intended or recommended function of a product or service as specified by manufacturers or healthcare professionals
The indicated use of the medical device must be clearly stated in the packaging.
O uso indicado do dispositivo médico deve estar claramente indicado na embalagem.
3. Off-label use refers to applications outside the indicated use approved by regulatory agencies
Doctors sometimes prescribe medications for uses beyond their indicated use.
Os médicos às vezes prescrevem medicamentos para usos além do uso indicado.
This term is fundamental in pharmaceutical and medical device regulation in both the United States (FDA) and Brazil (ANVISA). It carries legal significance as prescriptions and medical recommendations must align with indicated uses. In Brazil, 'uso indicado' or 'indicação terapêutica' appears on all medication inserts (bulas) and is crucial for patient safety and legal compliance. The distinction between indicated use and off-label use has important implications for liability and treatment protocols in both countries.
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