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Teduglutide, sold under the brand names Revestive (EU) and Gattex (US), is a 33-membered polypeptide and glucagon-like peptide-2 (GLP-2) analog that is used for the treatment of short bowel syndrome. It works by promoting mucosal growth and possibly restoring gastric emptying and secretion. It was approved in both the European Union and the United States in 2012.
Read the full article on WikipediaType III Short bowel syndrome with intestinal failure Clinical criteria: Treatment Phase: Initial treatment Treatment criteria: Must be treated by a gastroenterologist; OR Must be treated by a specialist within a multidisciplinary intestinal rehabilitation unit. Patient must have short bowel syndrome with intestinal failure following major surgery, AND Patient must have a history of dependence on parenteral support for at least 12 months, AND Patient must have received a stable parenteral support regimen for at least 3 days per week in the previous 4 weeks, AND Patient must not have active gastrointestinal malignancy or history of gastrointestinal malignancy within the last 5 years, AND The treatment must not exceed 12 months under this restriction, AND Patient must not have previously received PBS-subsidised treatment with this drug for this condition. Provide a baseline value in this authority application of the amount of parenteral support per week, expressed as either: (i) for a patient of any age, the mean number of days of parenteral support per week (ii) for a patient yet to turn 18 years of age, the mean volume of parenteral support per week in mL per kg. Determine the mean over any given 4 week period prior to this authority application. For a patient yet to turn 18 years of age, both (i) and (ii) may be supplied, but provide at least (i). Assessment of treatment response/non-response in the 'Continuing treatment' authority application will be compared against the baseline value(s) submitted in this application. A stable parenteral support regimen is defined as a minimum of 3 days of parenteral support (parenteral nutrition with or without IV fluids) per week for 4 consecutive weeks to meet caloric, fluid or electrolyte needs. The authority application must be made in writing and must include: (a) details of the proposed prescription(s); and (b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
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