Prior and Concomitant Therapy or Medication Sample Clauses

Prior and Concomitant Therapy or Medication. Any prior or concomitant therapy or medication given to a patient from the start of screening or during study drug administration will be indicated on the CRF. Other medications used for SLE or other disorders will also be captured on the CRF, as detailed below. Dosage and generic name or trade name will be indicated. The sponsor will encode all therapy and medication according to the WHO drug dictionary (WHO Drug). As described in section 4.1, if the patient is using oral corticosteroids, the weekly cumulative dose must not exceed 80 mg of prednisone equivalent; the weekly dose must be stable over the 4 weeks preceding the 1st dose of study drug. If a patient is taking oral corticosteroids at study entry, the dose may be decreased during the study at the investigator’s discretion. The dose of background corticosteroid medication may be increased to treat the patient for minor fluctuations in lupus disease activity (ie, a mild or moderate flare). However, the dose of oral corticosteroid may not exceed 30 mg of prednisone or equivalent per day for more than 2 weeks. If a patient not previously treated with corticosteroids requires initiation of treatment with corticosteroids during the study to treat minor fluctuations in lupus disease activity (ie, a mild or moderate flare), the dose of oral corticosteroid may not exceed 30 mg of prednisone or equivalent per day for more than 2 weeks. If a patient requires a temporary increase in corticosteroid dose or a short course of corticosteroid treatment (ie, 2 weeks) and the medication is unable to be tapered to the baseline dose or be withdrawn, respectively, the patient is to be withdrawn from the study. If a patient requires treatment with corticosteroids for a condition other than SLE, these same restrictions on corticosteroid use, and those detailed in section 4.2, will apply. The use of intra- articular steroids may be allowed after consultation with the medical expert. Also, if the patient is using antimalarials, methotrexate, leflunomide, MMF, or azathioprine, the start date must be at least 3 months prior to the 1st dose of study drug, and the daily dose must be stable over the 4 weeks preceding the 1st dose of study drug. Dosages of these medications should remain stable during the study. In addition, if the patient is not currently using corticosteroids, antimalarials, methotrexate, MMF, or azathioprine, the last dose (in case of previous use) must be at least 4 weeks prior to the 1st dose of study drug....
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Related to Prior and Concomitant Therapy or Medication

  • Radiation Therapy/Chemotherapy Services This plan covers chemotherapy and radiation services. Respiratory Therapy This plan covers respiratory therapy services. When respiratory services are provided in your home, as part of a home care program, durable medical equipment, supplies, and oxygen are covered as a durable medical equipment service.

  • Infusion Therapy the administration of antibiotic, nutrients, or other therapeutic agents by direct infusion. Note: The limitations on Therapy Services contained in this Therapy Services provision do not apply to any Therapy Services that are received under the Home Health Care provision or to therapy services received under the Diagnosis and Treatment of Autism or Other Developmental Disabilities provision. .

  • Speech Therapy This plan covers speech therapy services when provided by a qualified licensed provider and part of a formal treatment plan for: • 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.

  • THERAPY SERVICES The following Services are covered when rendered by a Network Provider [upon prior written Referral by a [Member]'s Primary Care Provider [or the Care Manager]]. Subject to the stated limits, We cover the Therapy Services listed below. We cover other types of Therapy Services provided they are performed by a licensed Provider, are Medically Necessary and Appropriate and are not Experimental or Investigational.

  • Human and Financial Resources to Implement Safeguards Requirements 6. The Borrower shall make available necessary budgetary and human resources to fully implement the EMP and the RP.

  • Medication 1. Xxxxxxx’s physician shall prescribe and monitor adequate dosage levels for each Client.

  • Mastectomy Services Inpatient This plan provides coverage for a minimum of forty-eight (48) hours in a hospital following a mastectomy and a minimum of twenty-four (24) hours in a hospital following an axillary node dissection. Any decision to shorten these minimum coverages shall be made by the attending physician in consultation with and upon agreement with you. If you participate in an early discharge, defined as inpatient care following a mastectomy that is less than forty-eight (48) hours and inpatient care following an axillary node dissection that is less than twenty-four (24) hours, coverage shall include a minimum of one (1) home visit conducted by a physician or registered nurse.

  • Technical Standards Applicable to a Wind Generating Plant i. Low Voltage Ride-Through (LVRT) Capability A wind generating plant shall be able to remain online during voltage disturbances up to the time periods and associated voltage levels set forth in the standard below. The LVRT standard provides for a transition period standard and a post-transition period standard.

  • Therapies Acupuncture and acupuncturist services, including x-ray and laboratory services. • Biofeedback, biofeedback training, and biofeedback by any other modality for any condition. • Recreational therapy services and programs, including wilderness programs. • Services provided in any covered program that are recreational therapy services, including wilderness programs, educational services, complimentary services, non- medical self-care, self-help programs, or non-clinical services. Examples include, but are not limited to, Tai Chi, yoga, personal training, meditation. • Computer/internet/social media based services and/or programs. • Recreational therapy. • Aqua therapy unless provided by a physical therapist. • Maintenance therapy services unless it is a habilitative service that helps a person keep, learn or improve skills and functioning for daily living. • Aromatherapy. • Hippotherapy. • Massage therapy rendered by a massage therapist. • Therapies, procedures, and services for the purpose of relieving stress. • Physical, occupational, speech, or respiratory therapy provided in your home, unless through a home care program. • Pelvic floor electrical and magnetic stimulation, and pelvic floor exercises. • Educational classes and services for speech impairments that are self-correcting. • Speech therapy services related to food aversion or texture disorders. • Exercise therapy. • Naturopathic, homeopathic, and Christian Science services, regardless of who orders or provides the services. Vision Care Services • Eye exercises and visual training services. • Lenses and/or frames and contact lenses for members aged nineteen (19) and older. • Vision hardware purchased from a non-network provider. • Non-collection vision hardware. • Lenses and/or frames and contact lenses unless specifically listed as a covered healthcare service.

  • Required Procurement Procedures for Obtaining Goods and Services The Grantee shall provide maximum open competition when procuring goods and services related to the grant-assisted project in accordance with Section 287.057, Florida Statutes.

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