Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
GLUCAGON HYDROCHLORIDE (UNII: 1H87NVF4DB) (glucagon - UNII:76LA80IG2G)
Boehringer Ingelheim Pharmaceuticals, Inc.
GLUCAGON HYDROCHLORIDE
glucagon 1 mg in 1 mL
PRESCRIPTION DRUG
GlucaGen is indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes. GlucaGen is indicated as a diagnostic aid for use during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients. GlucaGen is contraindicated in patients with: 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 identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Multiple small studies have demonstrated a lack of transfer of pancreatic glucagon across the human placental barrier during early gestation. In rat and rabbit reproduction studies, no embryofetal toxicity was observed with glucagon administered by injection during the period of organogenesis at doses representing up to 100 and 200 times the human dose, respectively, based on body surface area (mg/m2 ) (see Data). The estimated background
GlucaGen for injection is supplied as a lyophilized white powder available as follows: Presentation NDC Strength Description Treatment of Severe Hypoglycemia GlucaGen HypoKit 0169-7065-15 1 mg per vial 1 mL single-dose vial of GlucaGen with 1 mL single-dose syringe of Sterile Water for Injection, USP for reconstitution Use as a Diagnostic Aid GlucaGen 10-pack: 10 Single-dose vials 0597-0053-45 1 mg per vial 1 mL single-dose vial of GlucaGen GlucaGen Diagnostic Kit 0597-0260-10 1 mg per vial 1 mL single-dose vial of GlucaGen with 1 mL single-dose vial of Sterile Water for Injection, USP for reconstitution Before Reconstitution: The GlucaGen package may be stored up to 24 months at controlled room temperature 20o to 25o C (68o to 77o F) prior to reconstitution. Do not freeze. Keep in the original package to protect from light. After Reconstitution: Use the reconstituted GlucaGen solution immediately. Discard any unused portion [see Dosage and Administration (2)].
New Drug Application
GLUCAGEN- GLUCAGON HYDROCHLORIDE GLUCAGEN- GLUCAGON HYDROCHLORIDE INJECTION, POWDER, FOR SOLUTION BOEHRINGER INGELHEIM PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE GLUCAGEN SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GLUCAGEN. GLUCAGEN (GLUCAGON) FOR INJECTION, FOR SUBCUTANEOUS, INTRAMUSCULAR OR INTRAVENOUS USE INITIAL U.S. APPROVAL: 1960 RECENT MAJOR CHANGES Dosage and Administration (2)--------------------------------------------03/2021 Contraindications (4)--------------------------------------------------------03/2021 Warnings and Precautions (5.1, 5.2, 5.3, 5.4, 5.6, 5.7, 5.8)------------03/2021 INDICATIONS AND USAGE GlucaGen is an antihypoglycemic agent and a gastrointestinal motility inhibitor indicated: • • DOSAGE AND ADMINISTRATION Dosage in adults and pediatric patients using the GlucaGen HypoKit to treat severe hypoglycemia (2.2) • • Important Administration Instructions for Using the GlucaGen HypoKit to Treat Severe Hypoglycemia (2.1) • • Dosage in Adults for Using GlucaGen Diagnostic Kit and GlucaGen 10-pack as a Diagnostic Aid (2.4) • • DOSAGE FORMS AND STRENGTHS ® 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) Adults and Pediatric Patients Weighing 25 kg or More or for Pediatric Patients with Unknown Weight 6 Years and Older: -The recommended dosage is 1 mg (1 mL) injected subcutaneously or intramuscularly into the upper arm, thigh, or buttocks, or intravenously. -If there has been no response after 15 minutes, an additional 1 mg dose (1 mL) of GlucaGen may be administered using a new kit while waiting for emergency assistance. Pediatric Patients Weighing Less Than 25 kg or for Pediatric Patients with Unknown Weight Less Than 6 Years of Age: -The recommended dosage is 0.5 mg (0.5 mL) inj Lees het volledige document