Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Midazolam
AS Kalceks
N05CD08
Midazolam
5 milligram(s)/millilitre
Solution for injection/infusion
midazolam
2020-05-01
PACKAGE LEAFLET: INFORMATION FOR THE USER MIDAZOLAM 1 MG/ML SOLUTION FOR INJECTION/INFUSION MIDAZOLAM 5 MG/ML SOLUTION FOR INJECTION/INFUSION midazolam 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 or nurse. - If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Midazolam is and what it is used for 2. What you need to know before you are given Midazolam 3. How Midazolam is given 4. Possible side effects 5. How to store Midazolam 6. Contents of the pack and other information 1. WHAT MIDAZOLAM IS AND WHAT IT IS USED FOR Midazolam belongs to a class of medicines called benzodiazepines (sedatives). It is a short-acting medicine that is used to induce sedation (a state of calm, drowsiness or sleep) and relieves anxiety and muscle tension. This drug is used for: - Conscious sedation (an awake state of calm or drowsiness) in adults and children. - Sedation of adults and children, in intensive care units. - Anaesthesia in adults (premedication before induction, induction of anaesthesia, as a sedative component with other medicines for maintenance of anaesthesia). - Premedication before induction of anaesthesia in children. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN MIDAZOLAM YOU SHOULD NOT BE GIVEN MIDAZOLAM: - if you are allergic to midazolam, other benzodiazepines or any of the other ingredients of this medicine (listed in section 6), - for conscious sedation, if you have severe breathing difficulties. WARNINGS AND PRECAUTIONS Talk to your doctor or nurse before you are given Midazolam if you: - are over 60 years of age, - have a long-term illness or are debilitated (e.g. chronic respiratory problems, kidney, liver or heart diseases), - have _myasthenia gravis _ (a neuromuscular disease characterized by muscle weakness Læs hele dokumentet
Health Products Regulatory Authority 18 October 2023 CRN00DRYX Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Midazolam 5 mg/ml solution for injection/infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of solution contains 5 mg of midazolam (as hydrochloride). One ampoule with 1 ml of solution contains 5 mg of midazolam. One ampoule with 3 ml of solution contains 15 mg of midazolam. One ampoule with 10 ml of solution contains 50 mg of midazolam. Excipient with known effect Each ml of solution contains 3.15 mg sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection/infusion. Clear, colourless solution. pH 2.9 ‑ 3.7 Osmolality 275 ‑ 305 mOsmol/kg 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Midazolam is a short-acting hypnotic with the following indications for use: ADULTS CONSCIOUS SEDATION with or without local anaesthesia before or during diagnostic or therapeutic procedures ANAESTHESIA o Premedication before the induction of anaesthesia o Induction of anaesthesia o As a sedative component in maintenance of anaesthesia SEDATION IN THE INTENSIVE CARE UNIT CHILDREN CONSCIOUS SEDATION with or without local anaesthesia before or during diagnostic or therapeutic procedures ANAESTHESIA o Premedication before the induction of anaesthesia SEDATION IN THE INTENSIVE CARE UNIT 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology STANDARD DOSAGES Midazolam is a potent sedative agent that requires slow administration and titration. Titration is strongly recommended to safely obtain the desired level of sedation according to clinical needs, physical status, age, and concomitant medication. For Health Products Regulatory Authority 18 October 2023 CRN00DRYX Page 2 of 15 patients over 60 years of age, debilitated patients or chronically ill patients and children the medicine should be administered with care and the risk factors related to each patient should be evaluated on an individual basis. Standard dosages a Læs hele dokumentet