Clinical Indication definition

Clinical Indication. For Children (aged 6 years and over) and Adolescents with Attention Deficit Hyperactivity Disorder (ADHD) Version: 2 Approval date: November 2021 Review date: November 2023 The Shared Care Agreement (SCA) is intended to facilitate the accessibility and safe prescribing of complex treatments across the secondary/primary care interface. It does not contain all of the relevant product information, which should be sought using the current British National Formulary and Manufacturer’s Summary of Product Characteristics. Shared Care should usually take place once the patient’s condition is stable; the patient is demonstrably benefiting from the treatment and is free from any significant side effects. GPs should only take on the prescribing when they are confident in the agreed care plan advised by the specialist team. Contingency plans must be in place to enable the patient to receive the recommended treatment, should the GP decline to prescribe.
Sample 1
Clinical Indication. Renal Anaemia Version: 2 Date Approved: September 2013 Review Date: September 2016 Erythropoietin Stimulating Agents (ESAs) for Renal Anaemia AREAS OF RESPONSIBILITY FOR THE SHARING OF CARE This shared care agreement outlines suggested ways in which the responsibilities for managing the prescribing of ESAs can be shared between the specialist and general practitioner or non-medical prescriber in primary care (GP). GPs are invited to participate. If the GP is not confident to undertake these roles, then he or she is under no obligation to do so. In that case, the total clinical responsibility for the patient for the diagnosed condition remains with the specialist. If a specialist asks the GP to prescribe drugs for this treatment, the GP should reply to this request as soon as practicable. Sharing of care assumes communication between the specialist, GP and patient. The intention to share care should be explained to the patient by the doctor/non medical prescriber initiating treatment. It is important that patients are consulted about treatment and are in agreement with it. Patients with renal anaemia are under regular specialist follow-up. This provides an opportunity to discuss and to monitor drug therapy. The doctor/non medical prescriber who prescribes the medication legally assumes clinical responsibility for the drug and the consequences of its use. Responsibilities and Roles 1 Initiate treatment with ESAs or advise GP on initiating treatment. 2 Discuss the benefits and side effects of treatment with the patient.
Sample 1
Clinical Indication means an area of treatment of a condition in the Disease Area. Examples of Clinical Indications are, without limitation: [***].
Sample 1

Examples of Clinical Indication in a sentence

  • Duration Comments Precautions/ Contraindications Kidney / Bladder Ural Sachets or Cranberry tablets Oral Mouth Ulcers Kenalog and Ora-base Oral Apply a small dab onto the sore area in the mouth until a thin film develops 2-3 doses per day Apply after meals Oral hygiene Chlorhexidine gluconate mouthwash Oral – DO NOT SWALLOW As needed Clinical Indication Medication Route Recommended Adult Dose Max.

  • Scabies Lyclear (Permerthrin) 30g cream Topical Cover entire skin with cream and leave for 8-24 hours (use entire tube if needed) Repeat in 7 days Contact medical officer after first application if no improvement Clinical Indication Medication Route Recommended Adult Dose Max.

Related to Clinical Indication

  • Initial Indication means the treatment of Netherton Syndrome in humans in the Territory.

  • geographical indication , in relation to goods, means an indication which identifies such goods as agricultural goods, natural goods or manufactured goods as originating, or manufactured in the territory of a country, or a region or locality in that territory, where a given quality, reputation or other characteristic of such goods is essentially attributable to its geographical origin and in case where such goods are manufactured goods one of the activities of either the production or of processing or preparation of the goods concerned takes place in such territory, region or locality, as the case may be.

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

  • Diagnostic Product means In Vitro Diagnostics, In Vivo Diagnostic Agents and any product used for Diagnosis.

  • Licensed Compound means (a) 3,4-Diaminopyridine, the chemical structure of which is set forth on Exhibit B-2; and (b) any derivatives, isomers, metabolites, prodrugs, acid forms, base forms, salt forms, or modified versions of such compound in (a).

  • Licensed Product means any method, process, composition, product, service, or component part thereof that would, but for the granting of the rights set forth in this Agreement, infringe a Valid Claim contained in the Licensed Patents.

  • Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).

  • Licensed Compounds means any EZH2 Compound(s) that is:

  • Product Candidate means each of MYO-101, MYO-102, MYO-103, MYO-201 and MYO-301, as defined on Exhibit B, in each case in any form or formulation.

  • Additional Indication means any indication other than the Initial Indication.

  • New Product means the Synology-branded hardware product and Synology-branded accessories contained in the original packaging Customer bought from an authorized Synology distributor or reseller. You may see our “New Product” at Product Support Status.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • Lead Compound means any compound of lead other than galena which, when treated in the manner described below, yields to an aqueous solution of hydrochloric acid a quantity soluble lead compound exceeding, when calculated as lead monoxide, five percent of the dry weight of the portion taken analysis.

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Hemp product means the same as that term is defined in § 3.2-4112.

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • Collaboration Target means the Initial Collaboration Targets set forth on Exhibit F and any Additional Target or Substitute Target that is selected in accordance with Section 3.3 of this Agreement.

  • U.S. Territory means American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, the Commonwealth of Puerto Rico, or the U.S. Virgin Islands.

  • Development Candidate means a Compound that meets the Development Candidate Criteria for the initiation of a Development Program for the treatment of CF, and which is the subject of a notice from Vertex to CFFT that Vertex intends to commence formal pre-clinical development of the Compound in the Field pursuant to the provisions of Section 3.1 hereof.

  • Clinical Trial means a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, or any post-approval human clinical trial, as applicable.

  • Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • Phase 4 Clinical Trial means a Clinical Study in any country which is conducted after Regulatory Approval of a product has been obtained from an appropriate Regulatory Authority, consisting of trials conducted voluntarily for enhancing marketing or scientific knowledge of an approved indication and trials conducted due to request or requirement of a Regulatory Authority.