United States - English - NLM (National Library of Medicine)

fresenius kabi usa, llc - glucagon hydrochloride (unii: 1h87nvf4db) (glucagon - unii:76la80ig2g) - glucagon 1 mg in 1 ml - 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

United States - English - NLM (National Library of Medicine)

eli lilly and company - glucagon (unii: 76la80ig2g) (glucagon - unii:76la80ig2g) - glucagon 1 mg in 1 ml - glucagon for injection is indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes mellitus. 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 because of the risk of substantial increase in blood pressure [see warning and precautions (5.1)] - insulinoma because of the risk of hypoglycemia [see warning and precautions (5.2)] - 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 warning and precautions (5.3)] - glucagonoma when used as a diagnostic aid because of the risk of hypoglycemia [see warnings and precautions (5.8)] risk summary available data from case reports and a small number of observational st

United States - English - NLM (National Library of Medicine)

physicians total care, inc. - glucagon (unii: 76la80ig2g) (glucagon - unii:76la80ig2g) - glucagon 1 mg in 1 ml - glucagon is indicated as a treatment for severe hypoglycemia. because patients with type 1 diabetes may have less of an increase in blood glucose levels compared with a stable type 2 patient, supplementary carbohydrate should be given as soon as possible, especially to a pediatric patient. glucagon is indicated as a diagnostic aid in the radiologic examination of the stomach, duodenum, small bowel, and colon when diminished intestinal motility would be advantageous. glucagon is as effective for this examination as are the anticholinergic drugs. however, the addition of the anticholinergic agent may result in increased side effects. glucagon is contraindicated in patients with known hypersensitivity to it or in patients with known pheochromocytoma. glucagon for injection (rdna origin) become familiar with the following instructions before an emergency arises. do not use this kit after date stamped on the bottle label. if you have questions concerning the use of this product, consult a doctor, nurse or ph

United States - English - NLM (National Library of Medicine)

tya pharmaceuticals - glucagon (unii: 76la80ig2g) (glucagon - unii:76la80ig2g) - glucagon 1 mg in 1 ml - for the treatment of hypoglycemia: glucagon is indicated as a treatment for severe hypoglycemia. because patients with type 1 diabetes may have less of an increase in blood glucose levels compared with a stable type 2 patient, supplementary carbohydrate should be given as soon as possible, especially to a pediatric patient. for use as a diagnostic aid: glucagon is indicated as a diagnostic aid in the radiologic examination of the stomach, duodenum, small bowel, and colon when diminished intestinal motility would be advantageous. glucagon is as effective for this examination as are the anticholinergic drugs. however, the addition of the anticholinergic agent may result in increased side effects. glucagon is contraindicated in patients with known hypersensitivity to it or in patients with known pheochromocytoma. glucagon for injection (rdna origin) become familiar with the following instructions before an emergency arises. do not use this kit after date stamped on the bottle label. if you have questions concern

United States - English - NLM (National Library of Medicine)

fresenius kabi usa, llc - glucagon hydrochloride (unii: 1h87nvf4db) (glucagon - unii:76la80ig2g) - glucagon for injection is indicated for use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract.        limitations of use :  glucagon for injection is not indicated for the emergency treatment of hypoglycemia because it is not packaged with a syringe and diluent necessary for rapid preparation and administration during an emergency outside of a healthcare facility. glucagon for injection is contraindicated in patients with: - pheochromocytoma [see warnings and precautions (5.1)] because of the risk of increased blood pressure - insulinoma [see warnings and precautions (5.2)] because of the risk of hypoglycemia - glucagonoma [see warnings and precautions (5.2)] because of the risk of hypoglycemia pregnancy category b.  reproduction studies were performed in rats and rabbits with another glucagon product at doses of 0.4, 2, and 10 mg per kg.  these doses represent exposures of up to 100 and 200 times the human dose based on mg/m2 for rats and rab

United States - English - NLM (National Library of Medicine)

fresenius kabi usa, llc - glucagon hydrochloride (unii: 1h87nvf4db) (glucagon - unii:76la80ig2g) - 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

United States - English - NLM (National Library of Medicine)

deseret biologicals, inc. - glucagon (unii: 76la80ig2g) (glucagon - unii:76la80ig2g) - glucagon 8 [hp_x] in 1 ml - for temporary relief of symptoms related to lethargy, impaired mental function and irritability.** **these statements are based upon traditional homeopathic principles. they have not been reviewed by the food and drug administration. for temporary relief of symptoms related to lethargy, impaired mental function and irritability.** **these statements are based upon traditional homeopathic principles. they have not been reviewed by the food and drug administration.

United States - English - NLM (National Library of Medicine)

hf acquisition co llc, dba healthfirst - glucagon hydrochloride (unii: 1h87nvf4db) (glucagon - unii:76la80ig2g) - 1.1 severe hypoglycemia glucagon for injection is indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes. 1.2 diagnostic aid 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 ( 5-5.1)] insulinoma [see warnings and precautions ( 5-5.2)] 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 ( 5-5.3)] glucagonoma [see warnings and precautions ( 5-5.8)] because of risk of hypoglycemia when used as a diagnostic aid 8.1 pregnancy 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 risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively. data animal data in rats and rabbits given glucagon by injection at doses of 0.4, 2.0, and 10 mg/kg (up to 100 and 200 times the human dose based on mg/m2 for rats and rabbits, respectively) there was no evidence of increased malformations or embryofetal lethality. 8.2 lactation risk summary there is no information available on the presence of glucagon in human or animal milk, the effects of glucagon on the breastfed child or the effects of glucagon on milk production. however, glucagon is a peptide and would be expected to be broken down to its constituent amino acids in the infant's digestive tract and is therefore, unlikely to cause harm to an exposed infant. 8.4 pediatric use the safety and effectiveness of glucagon for injection for the treatment of severe hypoglycemia in pediatric patients with diabetes have been established. safety and effectiveness for use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in pediatric patients have not been established. instructions for use glucagon (gloo-ka-gon) for injection, for subcutaneous, intramuscular or intravenous use read this instructions for use before you start using glucagon and each time you get a refill. there may be new information. this information does not take the place of talking with your doctor about your medical condition or treatment. talk to your doctor or pharmacist if you have any questions about how to use glucagon. important: read and become familiar with this instructions for use before an emergency happens. show your family members and others where you keep your glucagon emergency kit for low blood sugar and how to use it the right way. call for emergency medical help right after you use glucagon. do not share your glucagon syringes or needles with another person. you may give other people a serious infection or other people may get a serious infection from you. the prefilled syringe that comes with your glucagon emergency kit for low blood sugar is meant for use with glucagon only. do not use glucagon syringes to inject other medicines. how should i store glucagon? before you mix the glucagon powder and liquid: store glucagon at room temperature between 68° to 77°f (20° to 25°c). check the expiration date on your vial of glucagon. do not use glucagon if the expiration date has passed. do not freeze glucagon. keep glucagon in its original package and glucagon out of light. after you mix the glucagon powder and liquid: use glucagon right away. throw away any unused glucagon. glucagon should be clear and colorless. do not use glucagon if it is cloudy or if you see particles in the solution. supplies you will need for your glucagon injection (see figure a): 1 glucagon emergency kit for low blood sugar that contains: 1 vial that contains 1 mg of glucagon for injection and 1 prefilled glass syringe with attached needle that contains 1 ml of sterile water for injection. 1 puncture resistant container for throwing away used needles and syringes. see “how should i dispose of (throw away) used glucagon prefilled syringes” at the end of these instructions. cotton ball or gauze pad (not included in kit) preparing the glucagon dose: the glucagon medicine comes as a dry powder. before you use glucagon, you must mix the dry powder with the syringe of sterile water that comes in the glucagon emergency kit for low blood sugar. do not use any other liquid to mix the medicine. check that the orange plastic cap on your vial of glucagon is firmly attached. do not use the vial of glucagon if the orange plastic cap is loose or missing. throw away your used syringe with the needle attached and any glucagon you did not use. see “how should i dispose of (throw away) used glucagon prefilled syringes” at the end of these instructions. step 12. turn the person on their side. when an unconscious person awakens, they may vomit. turning the person on their side will lessen the chance of choking. step 13. call for emergency medical help right away. if the person does not respond after 15 minutes, another dose may be given, if available. step 14. feed the person as soon as they are awake and able to swallow. give the person a fast acting source of sugar (such as a regular soft drink or fruit juice) and a long acting source of sugar (such as crackers and cheese or a meat sandwich). step 15. even if the glucagon for injection treatment wakes the person, tell their doctor right away. the doctor should be told whenever a severe drop in blood sugar (hypoglycemia reaction) happens. the person's dose of diabetes medicine may need to be changed. hypoglycemia may happen again after receiving glucagon for injection treatment. early symptoms of hypoglycemia may include: how should i dispose of (throw away) glucagon pre-filled syringes? put used syringes in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) loose needles and syringes in your household trash. if you do not have a fda-cleared sharps disposal container, you may use a household container that is: made of a heavy-duty plastic, can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, upright and stable during use, leak-resistant, and properly labeled to warn of hazardous waste inside the container. when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal. do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. keep glucagon and all medicines out of the reach of children. this instructions for use has been approved by the u.s. food and drug administration. approved: 09/2019 the brand names mentioned in this document are the trademarks of their respective owners. manufactured by: fresenius kabi lake zurich, il 60047 www.fresenius-kabi.com/us 451541

Canada - English - Health Canada

eli lilly canada inc - glucagon (recombinant dna origin) - kit - 1mg - glucagon (recombinant dna origin) 1mg - glycogenolytic agents

Israel - English - Ministry of Health

novo nordisk ltd., israel - glucagon as hydrochloride - powder and solvent for solution for injection - glucagon as hydrochloride 1 mg - glucagon - glucagon - treatment of severe hypoglycaemia reactions which may occur in the management of insulin treated persons with diabetes.