Страна: Мальта
Язык: английский
Источник: Medicines Authority
MIDAZOLAM HYDROCHLORIDE
Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland
N05CD08
MIDAZOLAM HYDROCHLORIDE 5 mg/ml
SOLUTION FOR INFUSION OR INJECTION
MIDAZOLAM HYDROCHLORIDE 5 mg/ml
POM
PSYCHOLEPTICS
Withdrawn
2009-01-22
Page 1 of 9 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. Прочитать полный документ
Page 1 of 19 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) Presentations 1 ml 3 ml 10 ml Amount of Midazolam 5 mg 15 mg 50 mg 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. • _Anaesthsia_ – 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. • _Anaesthsia_ – Premedication before induction of anaesthesia Page 2 of 19 • _Sedation in intensive care units_ _ _ 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, age and concomitant medication. In adults over 60 years, debilitated or chronically ill patients and paediatric patients, dose should be determined with caution and risk factors related to each patient should be taken into account. Standard dosages are provided in the table below. Additional details are provided in the text following the table. INDICATION ADULTS < 60 Y ADULTS ≥ 60Y / DEBILITATED Прочитать полный документ