ChiRhoClin announced that the Food and Drug Administration (FDA) has approved several updates to the labeling for ChiRhoStim (human secretin for injection).
First, the need for injecting a test dose prior to ChiRhoStim administration has been removed from the labeling. Second, the contraindication against use in patients suffering from acute pancreatitis until resolution has been removed. The FDA has also approved an extended 5-year shelf life of ChiRhoStim.
“These improvements to our product shelf life and updated labeling will assist the medical community in shortening Gastroenterology and Radiology procedure times. As well as not delaying diagnostic testing such as secretin stimulated MRCP (SMRCP) or function testing while a patient is suffering from acute pancreatitis,” stated Skip Purich, COO.
ChiRhoStim, a secretin class hormone, is indicated for the stimulation of: pancreatic secretions, including bicarbonate, to aid in the diagnosis of exocrine pancreas dysfunction; gastrin secretion to aid in the diagnosis of gastrinoma; and pancreatic secretions to facilitate the identification of the ampulla of Vater and the accessory papilla during endoscopic retrograde cholangiopancreatography (ERCP).
ChiRhoStim is available as 16mcg and 40mcg strength lyophilized powder in single-dose vials for reconstitution.
For more information call (877) 272-4888 or visit ChiRhoStim.com.