Nazione: Unione Europea
Lingua: inglese
Fonte: EMA (European Medicines Agency)
Glucagon
Eli Lilly Nederland B.V.
H04AA01
glucagon
Pancreatic hormones, Glycogenolytic hormones
Diabetes Mellitus
Baqsimi is indicated for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 4 years and over with diabetes mellitus.
Revision: 1
Authorised
2019-12-16
23 B. PACKAGE LEAFLET 24 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT BAQSIMI 3 MG NASAL POWDER IN SINGLE-DOSE CONTAINER glucagon READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Baqsimi is and what it is used for 2. What you need to know before you are given Baqsimi 3. How Baqsimi is given 4. Possible side effects 5. How to store Baqsimi 6. Contents of the pack and other information 1. WHAT BAQSIMI IS AND WHAT IT IS USED FOR Baqsimi contains the active substance glucagon, which belongs to a group of medicines called glycogenolytic hormones. It is used to treat severe hypoglycaemia (very low blood sugar) in people with diabetes. It is for use in adults, adolescents, and children aged 4 years or older. Glucagon is a natural hormone produced by the pancreas. It works in the opposite way to insulin and raises blood sugar. It does this by converting stored sugar in the liver called glycogen to glucose (a form of sugar that the body uses for energy). The glucose then enters the bloodstream and raises the blood sugar level, so reducing the effects of hypoglycaemia. You should always carry Baqsimi with you and tell your friends and family that you are carrying it. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN BAQSIMI _ _ IMPORTANT INFORMATION If you are at risk of severe hypoglycaemia you should always have Baqsimi readily available: - show your family members, friends, or people you work with where you keep this medicine and explain when and how to use it. Delay in treatment may be harmful Leggi il documento completo
1 _ _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Baqsimi 3 mg nasal powder in single-dose container 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each single-dose container delivers nasal powder with 3 mg of glucagon. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Nasal powder in single-dose container (nasal powder). White to practically white powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Baqsimi is indicated for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 4 years and over with diabetes mellitus. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults, adolescents and children aged 4 years and over _ The recommended dose is 3 mg glucagon administered into one nostril. _Elderly _ (≥ 65 years) _ _ No dose adjustment is required based on age. Efficacy and safety data are very limited in patients aged 65 years and absent in patients aged 75 and above. _ _ _Renal and hepatic impairment _ No dose adjustment is required based on renal and hepatic function. _ _ _Paediatric population 0 - < 4 years _ The safety and efficacy of Baqsimi in infants and children aged 0 to < 4 years have not yet been established. No data are available. Method of administration Nasal use only. Glucagon nasal powder is given in a single nostril. Glucagon is passively absorbed through the nasal mucosa. It is not necessary to inhale or breathe deeply after dosing. INSTRUCTIONS FOR ADMINISTERING GLUCAGON NASAL POWDER 1. Remove the shrink wrap by pulling on the red stripe. 2. Remove the single-dose container from the tube. Do not press the plunger until ready to give the dose. 3. Hold the single-dose container between fingers and thumb. Do not test before use as it contains 3 only one dose of glucagon and cannot be reused. 4. Insert the tip of the single-dose container gently in one of the nostrils until finger(s) touch the outside of the nose. 5. Push the plunger all the way in. The dose is complete when the green line is no longer show Leggi il documento completo