Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
MIDAZOLAM HYDROCHLORIDE
Roche Products Limited
N05CD08
MIDAZOLAM HYDROCHLORIDE
10 MG/5ml
Solution for Injection
Product subject to prescription which may not be renewed (A)
Benzodiazepine derivatives
Authorised
1985-03-27
1 ie-pil-hypnovel-clean-170629-10mg-2ml&5ml-Inj PACKAGE LEAFLET: INFORMATION FOR THE PATIENT HYPNOVEL ® 10MG/2ML SOLUTION FOR INJECTION ROCHE HYPNOVEL ® 10MG/5ML SOLUTION FOR INJECTION Midazolam (as midazolam hydrochloride) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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. This medicine has been prescribed for you. 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Hypnovel is and what it is used for 2. What you need to know before you are given Hypnovel 3. How Hypnovel is given 4. Possible side effects 5. How to store Hypnovel 6. Contents of the pack and other information 1. WHAT HYPNOVEL IS AND WHAT IT IS USED FOR Hypnovel contains the active substance midazolam, which belongs to a group of medicines known as benzodiazepines. It is a short-acting medicine that is used to induce sedation (a very relaxed state of calm, drowsiness or sleep) and relieves anxiety and muscle tension. This medicine is used for: Conscious sedation (an awake but very relaxed state of calm or drowsiness during a medical test or procedure) in adults and children. Sedation of adults and children, in intensive care units. Anaesthesia in adults, used alone or with other medicines. Premedication (medicine used to cause relaxation, calm and drowsiness before an anaesthetic) in adults and children. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN HYPNOVEL YOU MUST NOT BE GIVEN HYPNOVEL IF: You are allergic (hypersensitive) to midazolam or any of the other ingredients of the medicine (listed in section 6). You are allergic to other benzodiazepine medicines, such as diazepam or nitrazepam. You have severe Lesen Sie das vollständige Dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Hypnovel 10mg/5ml Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 2 mg midazolam (as midazolam hydrochloride). One ampoule of 5ml contains 10mg midazolam. Excipient(s) with known effect: Sodium 3.48mg/ml For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Clear, colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypnovel is a short-acting sleep-inducing drug that is indicated: IN ADULTS CONSCIOUS SEDATION before and during diagnostic or therapeutic procedures with or without local anaesthesia. ANAESTHESIA Premedication before induction of anaesthesia Induction of anaesthesia As a sedative component in combined anaesthesia. SEDATION IN INTENSIVE CARE UNITS IN CHILDREN CONSCIOUS SEDATION before and during diagnostic or therapeutic procedures with or without local anaesthesia. ANAESTHESIA Premedication before induction of anaesthesia. SEDATION IN INTENSIVE CARE UNITS H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _1_ _5_ _/_ _0_ _5_ _/_ _2_ _0_ _1_ _8_ _C_ _R_ _N_ _ _ _2_ _1_ _9_ _4_ _8_ _9_ _9_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION STANDARD DOSAGE Midazolam is a potent sedative agent that requires titration and slow administration. Titration is strongly recommended to safely obtain the desired level of sedation according to the clinical need, physical status, ag Lesen Sie das vollständige Dokument