Uniunea Europeană - engleză - EMA (European Medicines Agency)

eli lilly nederland b.v. - glucagon - diabetes mellitus - pancreatic hormones, glycogenolytic hormones - baqsimi is indicated for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 4 years and over with diabetes mellitus.

Uniunea Europeană - engleză - EMA (European Medicines Agency)

tetris pharma b.v - glucagon - diabetes mellitus - pancreatic hormones, glycogenolytic hormones - ogluo is indicated for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 2 years and over with diabetes mellitus.

India - engleză - Central Drugs Standard Control Organization

abbott - glucagon - inj - 1mg/ml - vial

India - engleză - Central Drugs Standard Control Organization

torrent - glucagon - inj - 1mg/ml(hcl) - vial

Belgia - engleză - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

novo nordisk pharma sa-nv - glucagon hydrochloride, recombinant - eq. glucagon 1 mg/ml - powder and solvent for solution for injection - 1 mg - glucagon hydrochloride, recombinant - glucagon

Belgia - engleză - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

novo nordisk pharma sa-nv - glucagon hydrochloride - eq. glucagon 1 mg/ml - powder and solvent for solution for injection - 1 mg - glucagon hydrochloride - glucagon

Canada - engleză - Health Canada

novo nordisk canada inc - glucagon (recombinant dna origin) (glucagon hydrochloride) - kit - 1mg - glucagon (recombinant dna origin) (glucagon hydrochloride) 1mg - glycogenolytic agents

Canada - engleză - Health Canada

novo nordisk canada inc - glucagon (recombinant dna origin) (glucagon hydrochloride) - kit - 1mg - glucagon (recombinant dna origin) (glucagon hydrochloride) 1mg - glycogenolytic agents

Australia - engleză - Department of Health (Therapeutic Goods Administration)

novo nordisk pharmaceuticals pty ltd - glucagon, quantity: 1 mg (equivalent: glucagon, qty 1 iu) - diluent, not applicable - excipient ingredients: water for injections - therapeutic: treatment of severe hypoglycaemic reactions which may occur in the management of diabetic patients receiving insulin or oral hypoglycaemic agents. to prevent the occurrence of secondary hypoglycaemia, oral carbohydrate should be given to restore the hepatic glycogen when the patient has responded to the treatment. the mechanism and hence treatment of sulfonylurea-induced hypoglycaemia differs from that of severe insulin-induced hypoglycaemia in some important ways. consciousness should preferably be restored by the administration of intravenous glucose. if glucagon is used due to the unavailability of intravenous glucose (e.g. before reaching a hospital) care should be taken to protect against secondary hypoglycaemia with constant monitoring of the patient's blood sugar level by medical personnel. subsequent administration of intravenous glucose may be required.,diagnostic: motility inhibitor in examinations of the gastrointestinal tract in adults, e.g. double contrast radiography and endoscop

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

xeris pharmaceuticals, inc. - glucagon (unii: 76la80ig2g) (glucagon - unii:76la80ig2g) - gvoke is indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes ages 2 years and above. gvoke 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 a rat reproduction study, no embryofetal toxicity was observed with glucagon administered by injection during the period of organogenesis at doses representing up to 40 times the human dose, 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 pregnant rats given animal sourced glucagon twice-daily by injection at doses up to 2 mg/kg (up to 40 times the human dose based on body surface area extrapolation, mg/m2 ) during the period of organogenesis, there was no evidence of increased malformations or embryofetal lethality. risk summary there is no information available on the presence of glucagon in human or animal milk, the effects of the drug on the breastfed infant, or the effects of the drug 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. the safety and effectiveness of gvoke for the treatment of severe hypoglycemia in patients with diabetes have been established in pediatric patients ages 2 years and above. use of gvoke for this indication is supported by evidence from a study in 31 pediatric patients ages 2 and older with type 1 diabetes mellitus [see clinical studies (14.2)] . the safety and effectiveness of gvoke have not been established in pediatric patients younger than 2 years of age. clinical studies of gvoke did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. limited clinical trial experience has not identified differences in responses between the elderly and younger patients. gvoke hypopen® [gee-voke hypo-pen] (glucagon injection) auto-injector for subcutaneous use this “instructions for use” contains information on how to inject gvoke hypopen® section headings and other template-related items found in this ifu are for organization of the document only and are not intended for use in corresponding artwork/patient-facing ifu files. figure numbers in this content document may not correspond to figure numbers in corresponding artwork/patient-facing ifu files. appropriate trademark symbol (™ or ®) should be used upon first use of a trademarked name on each page; usage may differ from this content file and final artwork based on page layout. 1. gvoke hypopen® visual understanding gvoke hypopen adult gvoke hypopen contains a 1 mg dose of glucagon and is in a foil pouch. below is a picture of the pouch. see the gvoke hypopen package for a full view of the quick-use guide. adult gvoke hypopen (1 mg dose) pediatric gvoke hypopen contains a 0.5 mg dose of glucagon and is in a foil pouch. below is a picture of the pouch. see the gvoke hypopen package for a full view of the quick-use guide. pediatric gvoke hypopen (0.5 mg dose) hypopen device note: gvoke hypopen should be used one time and then thrown away (discarded) 2. important information you need to know before injecting gvoke hypopen® make sure that relatives, close friends, or caregivers know that if you become unconscious, they should call for emergency medical help right away. gvoke hypopen may have been prescribed so that relatives, close friends, and caregivers can give the injection if you become hypoglycemic (severe low blood sugar) and are unable to take sugar by mouth. if you are unconscious, gvoke hypopen can be given while awaiting medical assistance. show your relatives, close friends, or caregivers where you store gvoke hypopen and how to use it. they need to know how to use gvoke hypopen before an emergency situation happens. indications for use gvoke hypopen is for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes ages 2 years and above. symptoms of severe hypoglycemia include, unconsciousness, and seizures or convulsions. give gvoke hypopen if: milder cases of hypoglycemia should be treated promptly by eating sugar or a sugar sweetened product. (see information on hypoglycemia for more information on the symptoms of low blood sugar.) gvoke hypopen will not work when taken by mouth (orally). information on hypoglycemia early symptoms of hypoglycemia (low blood sugar) include: if not treated, the patient may progress to severe hypoglycemia which can include: the occurrence of early symptoms calls for quick and, if necessary, repeated administration of some form of carbohydrate. patients should always carry a quick source of sugar, such as candy mints or glucose tablets. the prompt treatment of mild hypoglycemic symptoms can prevent severe hypoglycemic reactions. if the patient does not improve or if administration of carbohydrate is impossible, gvoke hypopen® should be given or the patient should be treated with intravenous glucose by a medical professional. possible problems with gvoke hypopen treatment common side effects in adults and pediatric patients are nausea and vomiting. the product may cause serious side effects including serious allergic reactions, fast heart beat and high blood pressure. people may be allergic to glucagon or to one of the inactive ingredients in gvoke hypopen or may experience fast heart-beat for a short while. if you experience any other reactions that may have been caused by gvoke hypopen, please contact your healthcare provider. important: important warnings read and become familiar with the following instructions before an emergency happens. if you have questions about using gvoke hypopen, talk with your healthcare provider or pharmacist. 3. preparing to inject gvoke hypopen step 1. remove gvoke hypopen from foil pouch figure 1 step 2. check the expiration date figure 2 step 3. inspect the solution figure 3 4. injecting gvoke hypopen step 4. pull off red cap figure 4 step 5. choose injection site and expose bare skin figure 5 figure 6 step 6. push and hold to start injection figure 7 figure 8 step 7. lift away from skin lift the device straight up from the injection site (see figure 9). figure 9 step 8. turn patient onto side figure 10 step 9. make sure patient receives immediate medical attention after use 5. storing gvoke hypopen storage information 6. disposing of gvoke hypopen® re-cap and dispose of gvoke hypopen in an fda cleared sharps disposal container if a puncture-resistant sharps container is not available, carefully re-cap and store gvoke hypopen in a safe place until it can be disposed of into a fda cleared sharps container (see figure 11). 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. always keep the sharps container out of the reach of children. if needed, make sure to get a refill of gvoke hypopen. figure 11 7. additional information this instructions for use has been approved by the u.s. food and drug administration. distributed by: xeris pharmaceuticals, inc. chicago, il 60607 revised 04/2023 ©2023 by xeris pharmaceuticals, inc. gvoke® pfs [gee-voke p-f-s ] (glucagon injection) pre-filled syringe for subcutaneous use this “instructions for use” contains information on how to inject gvoke® pfs section headings and other template-related items found in this ifu are for organization of the document only and are not intended for use in corresponding artwork/patient-facing ifu files. figure numbers in this content document may not correspond to figure numbers in corresponding artwork/patient-facing ifu files. appropriate trademark symbol (™ or ®) should be used upon first use of a trademarked name on each page; usage may differ from this content file and final artwork based on page layout. 1. gvoke® pfs visual understanding gvoke pfs gvoke pfs contains a 1 mg dose of glucagon and is in a foil pouch. below is a picture of the pouch. see the gvoke pfs package for a full view of the quick-use guide. gvoke pfs (1 mg dose) pfs device note: gvoke pfs should be used one time and then thrown away (discarded). 2. important information you need to know before injecting gvoke® pfs make sure that relatives, close friends, or caregivers know that if you become unconscious, they should call for emergency medical help right away. gvoke pfs may have been prescribed so that relatives, close friends, and caregivers can give the injection if you become hypoglycemic (severe low blood sugar) and are unable to take sugar by mouth. if you are unconscious, gvoke pfs can be given while awaiting medical assistance. show your relatives, close friends, or caregivers where you store gvoke pfs and how to use it. they need to know how to use gvoke pfs before an emergency situation happens. indications for use gvoke pfs is for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes ages 2 years and above. symptoms of severe hypoglycemia include unconsciousness, and seizures or convulsions. give gvoke pfs if: milder cases of hypoglycemia should be treated promptly by eating sugar or a sugar sweetened product. (see information on hypoglycemia for more information on the symptoms of low blood sugar.) gvoke pfs will not work when taken by mouth (orally). information on hypoglycemia early symptoms of hypoglycemia (low blood sugar) include: if not treated, the patient may progress to severe hypoglycemia which can include: the occurrence of early symptoms calls for quick and, if necessary, repeated administration of some form of carbohydrate. patients should always carry a quick source of sugar, such as candy mints or glucose tablets. the prompt treatment of mild hypoglycemic symptoms can prevent severe hypoglycemic reactions. if the patient does not improve or if administration of carbohydrate is impossible, gvoke® pfs should be given or the patient should be treated with intravenous glucose by a medical professional. possible problems with gvoke pfs treatment common side effects in adults and pediatric patients are nausea and vomiting. the product may cause serious side effects including serious allergic reactions, fast heart beat and high blood pressure. people may be allergic to glucagon or to one of the inactive ingredients in gvoke pfs, or may experience fast heart-beat for a short while. if you experience any other reactions that may have been caused by gvoke pfs, please contact your healthcare provider. important: important warnings read and become familiar with the following instructions before an emergency happens. if you have questions about using gvoke pfs, talk with your healthcare provider or pharmacist. 3. preparing to inject gvoke® pfs step 1. remove gvoke pfs from foil pouch figure 1 step 2. check the expiration date figure 2 step 3. inspect the solution figure 3 4. injecting gvoke® pfs step 4. choose injection site and expose bare skin figure 4 figure 5 step 5. pull off the needle cap figure 6 step 6. pinch, insert and push to start injection figure 7 figure 8 figure 9 step 7. lift away from skin figure 10 step 8. turn patient onto side figure 11 step 9. make sure patient receives immediate medical attention after use 5. storing gvoke® pfs storage information 6. disposing of gvoke® pfs dispose of gvoke pfs in an fda cleared sharps disposal container to prevent injury caused from contact with the used needle, put the used syringe in a safe place until it can be disposed of into a fda cleared sharps container right away after use (see figure 12). 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: 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. always keep the sharps container out of the reach of children. if needed, make sure to get a refill of gvoke pfs. figure 12 7. additional information this instructions for use has been approved by the u.s. food and drug administration. distributed by: xeris pharmaceuticals, inc. chicago, il 60607 revised 04/2023 ©2023 by xeris pharmaceuticals, inc. gvoke kit [gee-voke k-it] glucagon injection subcutaneous injection this instructions for use contains information on how to inject gvoke® kit. section headings and other template-related items found in this ifu are for organization of the document only and are not intended for use in corresponding artwork/patient-facing ifu files. figure numbers in this content document may not correspond to figure numbers in artwork/patient-facing ifu files. gvoke ® kit visual understanding gvoke kit gvoke kit contains one (1) single-dose sterile syringe (29 g x ½” needle) with markings for 0.1 ml (0.5 mg pediatric dose) and 0.2 ml (1 mg adult dose), and one single-dose vial containing 0.2 ml of solution. storing gvoke kit storage information important information you need to know before injecting gvoke kit make sure that relatives, close friends, or caregivers know that if you become unconscious, they should call for emergency medical help right away. gvoke kit may have been prescribed so that relatives, close friends, and caregivers can give the injection if you become hypoglycemic (severe low blood sugar) and are unable to take sugar by mouth. if you are unconscious, gvoke kit can be given while awaiting medical assistance. show your relatives, close friends, or caregivers where you store gvoke kit and how to use it. they need to know how to use gvoke kit before an emergency happens. indications for use gvoke kit is for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes ages 2 years and above. symptoms of severe hypoglycemia include unconsciousness and seizures or convulsions. give gvoke kit if: milder cases of hypoglycemia should be treated promptly by eating sugar or a sugar-sweetened product. (see information on hypoglycemia for more information on the symptoms of low blood sugar.) gvoke kit will not work when taken by mouth (orally). information on hypoglycemia early symptoms of hypoglycemia (low blood sugar) include: if not treated, the patient may progress to severe hypoglycemia which can include: the occurrence of early symptoms of hypoglycemia calls for quick and, if necessary, repeated administration of some form of carbohydrate. patients should always carry a quick source of sugar, such as candy mints or glucose tablets. the prompt treatment of mild hypoglycemic symptoms can prevent severe hypoglycemic reactions. if the patient does not improve or if administration of carbohydrate is not possible, gvoke® kit should be used or the patient should be treated with intravenous glucose by a medical professional. possible problems with gvoke kit treatment common side effects in adults and pediatric patients are nausea and vomiting. the product may cause serious side effects including serious allergic reactions, fast heart-beat, and high blood pressure. people may be allergic to glucagon or to one of the inactive ingredients in gvoke kit or may experience fast heartbeat for a short while. if you experience any other reactions that may have been caused by gvoke kit, please contact your healthcare provider. important: important warnings read and become familiar with the following instructions before an emergency happens. if you have questions about using gvoke kit, talk with your healthcare provider or pharmacist. preparing to inject gvoke kit step 1. remove gvoke vial and syringe from carton figure a step 2. check the expiration date on gvoke vial figure b step 3. inspect the solution in gvoke® vial figure c step 4. prepare figure d figure e figure f figure g figure h figure i injecting gvoke® kit step 5. choose injection site and expose bare skin figure j figure k step 6. pinch, insert, and push to start injection figure l figure m important: do not aspirate (pull back on plunger rod) after inserting the needle. do not lift up the syringe until the injection is complete. figure n step 7. lift away from skin figure o step 8. turn patient onto side figure p step 9. make sure patient receives immediate medical attention after use disposing of gvoke kit disposing of gvoke kit after the injection, discard vial with unused medicine and place the used syringe in a safe place until it can be disposed of in an fda-cleared sharps container (see figure q). do not throw away (dispose of) loose needles and syringes in your household trash. if you do not have an fda-cleared sharps disposal container, you may use a household container that is: 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. always keep the sharps container out of the reach of children. if needed, make sure to get a refill of your gvoke kit. figure q additional information this instructions for use has been approved by the u.s. food and drug administration. distributed by: xeris pharmaceuticals, inc. chicago, il 60607 original approval 08/2021 ©2023 by xeris pharmaceuticals, inc.