국가: 유럽 연합
언어: 영어
출처: EMA (European Medicines Agency)
glibenclamide
Ammtek
A10BB01
glibenclamide
Drugs used in diabetes
Diabetes Mellitus
Amglidia is indicated for the treatment of neonatal diabetes mellitus, for use in newborns, infants and children.Sulphonylureas like Amglidia have been shown to be effective in patients with mutations in the genes coding for the β-cell ATP-sensitive potassium channel and chromosome 6q24-related transient neonatal diabetes mellitus.
Revision: 7
Authorised
2018-05-24
B. PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE USER AMGLIDIA 0.6 MG/ML ORAL SUSPENSION glibenclamide READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 or pharmacist. • This medicine has been prescribed for your child only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as those of your child. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What A mglidia is and what it is used for 2. What you need to know before you give Amglidia 3. How to give Amglidia 4. Possible side effects 5. How to store Amglidia 6. Contents of the pack and other information 1. WHAT AMGLIDIA IS AND WHAT IT IS USED FOR Amglidia contains the active substance called glibenclamide which belongs to a group of medicines called sulphonylureas used for lowering blood sugar (blood-glucose). Amglidia is used in newborns, infants and children to treat diabetes that occurs at birth (known as neonatal diabetes mellitus). Neonatal diabetes is a disease where the child’s body does not release enough insulin to control the level of blood sugar; Amglidia is used only in patients who still have some ability to make insulin. Sulphonylureas like glibenclamide have been shown to be effective in certain genetic mutations responsible for the genesis of neonatal diabetes. This medicine is an oral suspension, to be taken by mouth, which is a more convenient treatment for newborns and children compared to regular injections of insulin. You must talk to a doctor if your child does not feel better or if he/she feels worse after a few days. 2. WHAT YOU NEED TO KNOW BEFORE YOU GIVE AMGLIDIA DO NOT GIVE AMGLIDIA - if your child is allergic to glibenclamide or any of the other ingredients of this medicine (li 전체 문서 읽기
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT AMGLIDIA 0.6 mg/mL oral suspension AMGLIDIA 6 mg/mL oral suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION AMGLIDIA 0.6 mg/mL oral suspension Each mL contains 0.6 mg glibenclamide. AMGLIDIA 6 mg/mL oral suspension Each mL contains 6 mg glibenclamide. Excipient(s) with known effect Each mL contains 2.8 mg of sodium and 5 mg of benzoate (E211). For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Oral suspension. White suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS AMGLIDIA is indicated for the treatment of neonatal diabetes mellitus, for use in newborns, infants and children. Sulphonylureas like AMGLIDIA have been shown to be effective in patients with mutations in the genes coding for the β-cell ATP-sensitive potassium channel and chromosome 6q24-related transient neonatal diabetes mellitus. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Glibenclamide suspension therapy should be initiated by a physician experienced in the treatment of patients with very early onset diabetes. Prescription instructions _ _ Care should be taken when prescribing and administering AMGLIDIA to avoid dosing errors due to confusion between milligram (mg) and millilitre (mL). It should be ensured that the proper dose and strength are communicated and dispensed. Posology To avoid exceeding sodium benzoate acceptable daily dose, AMGLIDIA daily dose should not exceed 1 mL/kg/day. As a consequence, AMGLIDIA 0.6 mg/mL should not be used for posology higher than 0.6 mg/kg/day. To limit exposure to sodium benzoate and with respect to the mode of delivery (1 mL and 5 mL oral syringes), it is not recommended to use the AMGLIDIA 0.6 mg/mL strength for posologies higher than the ones described below: Table 1 : Maximum recommended posology BODY WEIGHT (KG) MAXIMUM RECOMMENDED POSOLOGY (EXPRESSED AS MG/KG/DAY) WHERE THE AMGLIDIA 0.6 MG/ML STRENGTH CAN BE USED Up to 10 0.6 11 0.5 12 0.5 13 0.4 14 0.4 15 0.4 16 0.3 17 0.3 18 0.3 19 0.3 20 0. 전체 문서 읽기