Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
GLUCAGON HYDROCHLORIDE (UNII: 1H87NVF4DB) (GLUCAGON - UNII:76LA80IG2G)
Fresenius Kabi USA, LLC
GLUCAGON HYDROCHLORIDE
GLUCAGON 1 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
Glucagon for Injection is indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes. Glucagon for Injection is indicated as a diagnostic aid for use during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients. Glucagon for Injection is contraindicated in patients with: - Pheochromocytoma [see Warnings and Precautions (5.1)] - Insulinoma [see Warnings and Precautions (5.2)] because of the risk of hypoglycemia - Known hypersensitivity to glucagon or any of the excipients in Glucagon for Injection. Allergic reactions have been reported with glucagon and include anaphylactic shock with breathing difficulties and hypotension [see Warnings and Precautions (5.3)] - Glucagonoma [see Warnings and Precautions (5.8)] because of risk of hypoglycemia when used as a diagnostic aid Risk Summary Available data from case reports and a small number of observational studies with glucagon use in pregnant women over decades of use have not
Glucagon for Injection is supplied as a sterile, lyophilized white powder available as follows: Before Reconstitution The package containing Glucagon for Injection vials may be stored up to 24 months at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature] prior to reconstitution. Do not freeze. Keep in the original package to protect from light. After Reconstitution Use reconstituted glucagon solution immediately. Discard any unused portion [see Dosage and Administration (2.3)] .
New Drug Application
GLUCAGON - GLUCAGON INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION GLUCAGON- GLUCAGON FRESENIUS KABI USA, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE GLUCAGON FOR INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GLUCAGON FOR INJECTION. GLUCAGON FOR INJECTION, FOR SUBCUTANEOUS, INTRAMUSCULAR OR INTRAVENOUS USE INITIAL U.S. APPROVAL: 1960 RECENT MAJOR CHANGES Indications and Usage (1) 09/2019 Dosage and Administration (2) 09/2019 Contraindications (4) 09/2019 Warnings and Precautions (5) 09/2019 INDICATIONS AND USAGE Glucagon for Injection is an antihypoglycemic agent and a gastrointestinal motility inhibitor indicated: for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes (1.1) as a diagnostic aid for use during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients (1.2) DOSAGE AND ADMINISTRATION Dosage in adults and pediatric patients using the glucagon emergency kit for low blood sugar to treat severe hypoglycemia (2.2) Adults and Pediatric Patients Weighing More Than 25 kg or for Pediatric Patients with Unknown Weight 6 Years and Olde r: - - Pediatric Patients Weighing Less Than 25 kg or for Pediatric Patients with Unknown Weight Less Than 6 Years of Age: - - Important Administration Instructions for Using the Glucagon Emergency Kit for Low Blood Sugar to Treat Severe Hypoglycemia (2.1) Glucagon for Injection is for subcutaneous, intramuscular, or intravenous injection. Administer intravenously ONLY under medical supervision. See the Full Prescribing Information for administration instructions Dosage in Adults for Using Glucagon for Injection Diagnostic Kit and Glucagon for Injection Single-Dose Vial as a Diagnostic Aid (2.4) The recommended diagnostic dose for relaxation of the stomach, duodenal bulb, duodenum, and small bowel is 0.2 mg to 0.5 mg administered intravenously or 1 mg administered intramuscularly; the recommended dose to r Olvassa el a teljes dokumentumot