Indications. (a) The Parties acknowledge and agree that the initial Development Plan existing on the Execution Date covers four primary indications for Licensed Product, namely Triple-Negative Breast Cancer (“TNBC”), Non-Small-Cell Lung Cancer (“NSCLC”), Small-Cell Lung Cancer (“SCLC”), and Urothelial Cancer (“UC”) (the “First Indications”). The initial Development Plan includes the Phase I/II Study of IMMU-132 in Patients With *** (ClinicalTrials.gov Identifier: NCT01631552) (the “Existing Study”).
Indications. At the time of the JSC decision regarding nomination of a potential Development Candidate targeting a given Collaboration Target, the Parties, through the JSC, shall mutually determine which potential Indication(s) to pursue for such proposed Development Candidate and the related set of Progressed Collaboration Compounds. Notwithstanding the foregoing, the Parties agree that ChemoCentryx shall have the right to pursue CCX282 and its Back-up Compounds for CCR9, in Crohn’s Disease and in the Asthma CCR9 PoC Trial as provided for in this Agreement. In the event the JSC cannot agree on such Indications, it shall proceed as provided in Section 2.3.5.
Indications. Within [***] after the Effective Date the Parties shall mutually determine the prevalence of the indications related to the Potential Targets. The designation of each Potential Target as related to a Rare Indication, a Very Rare Indication or neither a Rare Indication nor a Very Rare Indication shall be set forth on the Potential Target List and such designation shall be binding upon both Parties for all purposes hereunder. If the Parties fail to agree on such designation(s) initially, or if at a future date a Party believes that a designation should change and the other Party does not agree with such change, the Parties shall refer the matter to a mutually-agreeable technical expert to make such determination. In the event that the designation with respect to an Additional Target changes after relevant payments with respect to such Additional Target have been made, such change shall only affect payments that first become payable after the Parties first initiate discussions regarding the change in designation for such Additional Target.
Indications. The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy. FDA-Approved IndicationEpidiolex is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome, or tuberous sclerosis complex (TSC) in patients 1 year of age and older. All other indications are considered experimental/investigational and not medically necessary.
Indications. APO-LOXAPINE (loxapine succinate tablets) is indicated in the management of the manifestations of schizophrenia. 1.1 PediatricsPediatrics (under 18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 1.2 GeriatricsGeriatrics (over 65 years of age): Elderly patients with dementia treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. APO-LOXAPINE is not indicated for the treatment of elderly patients with dementia. (See 3 SERIOUS WARNINGS AND PRECAUTIONS BOX and 7 WARNINGS AND PRECAUTIONS, 7.1 Special Populations, 7.1.4Geriatrics.)
Indications. KANUMA® (sebelipase alfa for injection) is indicated for:• the treatment of infants, children and adults diagnosed with lysosomal acid lipase (LAL) deficiency. KANUMA treatment should be supervised by a healthcare professional experienced in the management of patients with LAL deficiency, other metabolic disorders, or chronic liver diseases. KANUMA should be administered by a trained healthcare professional who can manage medical emergencies. 1.1 Pediatrics Pediatrics (0-18 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of KANUMA in pediatric patients has been established; therefore, Health Canada has authorized an indication for pediatric use. (See Section 14: Clinical Trials) Administration of KANUMA to infants with confirmed multiple-organ failure should be at the discretion of the treating physician. 1.2 Geriatrics Geriatrics (> 65 years of age): The safety and efficacy of KANUMA in patients older than 65 years have not been evaluated and no alternative dosage regimens can be recommended for these patients.
Indications. Please state whether licensed or unlicensed) Disease-modifying drugs (DMARDs) are used in rheumatic disease to suppress inflammation and the disease process. They may be used as monotherapy or more commonly in combination. DMARDs are also used for the treatment of other rheumatology conditions (e.g. connective tissue disease and vasculitis) and in other specialties, including dermatology, respiratory medicine, neurology, ophthalmology and gastroenterology.All recommendations are based on the practice of a responsible body of peers of similar professional standing (e.g. British Society for Rheumatology (BSR). Prescribers are advised to discuss with the patient if the medicine is used out of license and document patient’s agreement to treatment in their medical record.
Indications. Indications have been granted on the basis of similarity between Idacio® and the reference biologic drug Humira®.Idacio® (adalimumab injection) treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), adult and pediatric (13 to 17 years of age weighing ≥ 40 kg) Crohn’s disease (CD), ulcerative colitis (UC), adult and adolescent (12 to 17 years of age weighing ≥ 30 kg) hidradenitis suppurativa (HS), psoriasis (Ps) or adult and pediatric uveitis, and familiar with the Idacio® efficacy and safety profile.Idacio® is indicated for:Rheumatoid Arthritis• reducing the signs and symptoms, inducing major clinical response and clinical remission, inhibiting the progression of structural damage and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. Idacio® can be used alone or in combination with MTX (methotrexate) or other disease-modifying anti-rheumatic drugs (DMARDs).When used as first-line treatment in recently diagnosed patients who have not been previously treated with methotrexate, Idacio® should be given in combination with methotrexate. Idacio® can be given as monotherapy in case of intolerance to methotrexate or when treatment with methotrexate is contraindicated.Polyarticular Juvenile Idiopathic Arthritis• in combination with methotrexate, reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients, 2 years of age and older who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs). Idacio® can be used as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is not appropriate (see CLINICAL TRIALS - REFERENCE BIOLOGIC DRUG, Pediatric, Polyarticular Juvenile Idiopathic Arthritis,Study Results). Adalimumab Injection has not been studied in pediatric patients with polyarticular juvenile idiopathic arthritis aged less than 2 years.Psoriatic Arthritis• reducing the signs and symptoms of active arthritis and inhibiting the progression of structural damage and improving the physical function in adult psoriatic arthritis patients. Idacio® can be used in combination with MTX (methotrexate) in patients who do not respond adequately to methotrexate alone.Ankylosing Spondylitis• reducing sig...
Indications. Patients receive an endoscopy of the lower digestive tract under sedation.(1) Test area - lower digestive tract (large intestine). There are two types of endoscopic exams:⚫ Sigmoidscopy: the range of inspection is from the rectum to the sigmoid colon.⚫ Colonoscopy: covers all large intestines (from rectum to the cecum).(2) Test Purpose - to detect suspected lesions or source of bleeding in the large intestines for further management or treatment.※ Special instructions:⚫ For outpatients, please arrive on time for the scheduled appointment. Inpatients and ER patients should wait for the call.⚫ Please bring the appointment notice sheet, exam consent form (filled out and signed), and your Taiwan National Health Insurance card. Please sign your name on the Sedative Consent Form and the Self-Pay Agreement.⚫ The patient must be accompanied by an adult family member. Otherwise, the procedure will be rescheduled.If you choose to have the colonoscopy⚫ For inquiries or rescheduling, please call the exam room 3 days before the exam (23562590). You may reschedule your appointment only once.without sedation on the day of your exam, your examination will be delayed.⚫ Two days before the exam: stop eating meat, eggs, and milk. You may eat fish.⚫ One day before the exam: follow a low fiber diet, such as rice porridge, noodles, soybean juice, and tofu. Stop eating fruit and vegetables. Drink 300-500 c.c. of water after each meal.(Continued on page 2)文件編號01400-4-601642版次02Approved by the Medical Records Committee on Apr. 27, 2015 MR19-325 ➅ Approved by the Medical Records Committee on Apr. 27, 2015 MR19-325 ➅(Continued from page 1)⚫ For a morning exam: eat only low fiber food (breakfast, lunch, and dinner), and fast after midnight on the day before the exam. On the day of the exam: do not have any fluids after 5:00 AM, take your blood pressure medications before 5:00 AM, but do not take diabetic medications (nor use insulin injection).⚫ For an afternoon exam: eat low fiber food for lunch and dinner on the day before the exam. On the day of your exam, please fast from 5:00 AM; do not have any fluids after 9:00 AM. Take your blood pressure medications before 9:00 AM; do not take diabetic medications (nor use insulin injection).※ How to use laxatives:⚫ For Magvac◎ Colonoscopy in the morning: Two days before the colonoscopyPlease take low fiber food. Take 2 tablets of Dulcolax before sleep.One day before the colonoscopyAt 6:00PM only clear liquids may be taken as dinner (water, ...