Pediatric Use Sample Clauses

Pediatric Use. Safety and effectiveness in pediatric patients below the age of 18 years have not been established.
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Pediatric Use. Safety and effectiveness of eszopiclone in children below the age of 18 have not been established. A total of 287 subjects in double-blind, parallel-group, placebo-controlled clinical trials who received eszopiclone were 65 to 86 years of age. The overall pattern of adverse events for elderly subjects (median age = 71 years) in 2-week studies with nighttime dosing of 2 mg eszopiclone was not different from that seen in younger adults (see ADVERSE REACTIONS, Table 2). LUNESTA 2 mg exhibited significant reduction in sleep latency and improvement in sleep maintenance in the elderly population. The premarketing development program for LUNESTA included eszopiclone exposures in patients and/or normal subjects from two different groups of studies: approximately 400 normal subjects in clinical pharmacology/pharmacokinetic studies, and approximately 1550 patients in placebo-controlled clinical effectiveness studies, corresponding to approximately 263 patient-exposure years. The conditions and duration of treatment with LUNESTA varied greatly and included (in overlapping categories) open-label and double-blind phases of studies, inpatients and outpatients, and short-term and longer-term exposure. Adverse reactions were assessed by collecting adverse events, results of physical examinations, ▇▇▇▇▇ ▇▇▇▇▇, weights, laboratory analyses, and ECGs. Adverse events during exposure were obtained primarily by general inquiry and recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of events into a smaller number of standardized event categories. In the tables and tabulations that follow, COSTART terminology has been used to classify reported adverse events. The stated frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. An event was considered treatment-emergent if it occurred for the first time or worsened while the patient was receiving therapy following baseline evaluation.
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Pediatric Use. Safety and effectiveness in pediatric patients have not been established.
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Related to Pediatric Use

  • Diagnostic procedures to aid the Provider in determining required dental treatment.

  • Speech Therapy This plan covers speech therapy services when provided by a qualified licensed • loss of speech or communication function; or • impairment as a result of an acute illness or injury, or an acute exacerbation of a chronic disease. Speech therapy services must relate to: • performing basic functional communication; or • assessing or treating swallowing dysfunction. See Autism Services when speech therapy services are rendered as part of the treatment of autism spectrum disorder. The amount you pay and any benefit limit will be the same whether the services are provided for habilitative or rehabilitative purposes.

  • Diagnostic Services Procedures ordered by a recognized Provider because of specific symptoms to diagnose a specific condition or disease. Some examples include, but are not limited to:

  • Behavioral Health Services – Mental Health and Substance Use Disorder Inpatient - Unlimited days at a general hospital or a specialty hospital including detoxification or residential/rehabilitation per plan year. Preauthorization may be required for services received from a non-network provider. 0% - After deductible 40% - After deductible Outpatient or intermediate careservices* - See Covered Healthcare Services: Behavioral Health Section for details about partial hospital program, intensive outpatient program, adult intensive services, and child and family intensive treatment. Preauthorization may be required for services received from a non-network provider. 0% - After deductible 40% - After deductible Office visits - See Office Visits section below for Behavioral Health services provided by a PCP or specialist. Psychological Testing 0% - After deductible 40% - After deductible Medication-assisted treatment - whenrenderedby a mental health or substance use disorder provider. 0% - After deductible 40% - After deductible Methadone maintenance treatment - one copayment per seven-day period of treatment. 0% - After deductible 40% - After deductible Outpatient - Benefit is limited to 18 weeks or 36 visits (whichever occurs first) per coveredepisode. 0% - After deductible 40% - After deductible In a physician's office - limited to 12 visits per plan year. 0% - After deductible 40% - After deductible Emergency room - When services are due to accidental injury to sound natural teeth. 0% - After deductible The level of coverage is the same as network provider. In a physician’s/dentist’s office - When services are due to accidental injury to sound natural teeth. 0% - After deductible 40% - After deductible Services connected to dental care when performed in an outpatient facility * 0% - After deductible 40% - After deductible Inpatient/outpatient/in your home 0% - After deductible 40% - After deductible (*) Preauthorization may be required for this service. Please see Preauthorization in Section 5 for more information. You Pay You Pay Outpatient durable medical equipment* - Must be provided by a licensed medical supply provider. 20% - After deductible 40% - After deductible Outpatient medical supplies* - Must be provided by a licensed medical supply provider. 20% - After deductible 40% - After deductible Outpatient diabetic supplies/equipment purchasedat licensed medical supply provider (other than a pharmacy). See the Summary of Pharmacy Benefits for supplies purchased at a pharmacy. 20% - After deductible 40% - After deductible Outpatient prosthesis* - Must be provided by a licensed medical supply provider. 20% - After deductible 40% - After deductible Enteral formula delivered through a feeding tube. Must be sole source of nutrition. 20% - After deductible 40% - After deductible Enteral formula or food taken orally * 20% - After deductible The level of coverage is the same as network provider. Hair prosthesis (wigs) - The benefit limit is $350 per hair prosthesis (wig) when worn for hair loss suffered as a result of cancer treatment. 20% - After deductible The level of coverage is the same as network provider. Coverage provided for members from birth to 36 months. The provider must be certified as an EIS provider by the Rhode Island Department of Human Services. 0% - After deductible The level of coverage is the same as network provider. Asthma management 0% - After deductible 40% - After deductible Hospital emergency room 0% - After deductible The level of coverage is the same as network provider.

  • Health Services At the time of employment and subject to (b) above, full credit for registered professional nursing experience in a school program shall be given. Full credit for registered professional nursing experience may be given, subject to approval by the Human Resources Division. Non-degree nurses shall be placed on the BA Track of the Teachers Salary Schedule and shall be ineligible for movement to any other track.