国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
MIDAZOLAM
Accord Healthcare Limited
N05CD08
MIDAZOLAM
5 Mg/Ml
Solution for Injection
Product subject to prescription which may not be renewed (A)
midazolam
Marketed
2009-03-06
PATIENT INFORMATION LEAFLET MIDAZOLAM 1 MG/ML SOLUTION FOR INJECTION OR INFUSION MIDAZOLAM 5 MG/ML SOLUTION FOR INJECTION OR INFUSION midazolam 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 your 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 or pharmacist 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 take midazolam 3. How to use midazolam 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 1 mg/ml & 5 mg/ml Solution for Injection or Infusion contains Midazolam. Midazolam belongs to a group of medicines known as benzodiazepines (sedatives). 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. - 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 TAKE MIDAZOLAM DO NOT USE MIDAZOLAM If you are allergic (hypersensitive) to midazolam, group of medicines known as benzodiazepines or any other ingridients in the midazolam solution for injection If you have severe difficulties with your breathing and that you are to undergo conscious sedation. You must not be 阅读完整的文件
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Midazolam 5 mg/ml Solution for Injection or Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution for injection or infusion contains 5 mg of midazolam (as Midazolam hydrochloride) Excipient: Contains 1.96 mg sodium (as sodium chloride) per ml of solution for injection or infusion. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Solution for Injection or Infusion. Clear, colorless to pale yellow solution with a pH in the range of 2.9-3.7 and 170 mOsm/kg to 230 mOsm/kg osmolality. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Midazolam is a short acting sleep-inducing active substance 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 components 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 Presentations 1 ml 3 ml 10 ml Amount of Midazolam 5 mg 15 mg 50 mg 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_ _9_ _/_ _0_ _7_ _/_ _2_ _0_ _1_ _8_ _C_ _R_ _N_ _ _ _2_ _2_ _0_ _6_ _1_ _9_ _9_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.2 POSOLOGY 阅读完整的文件