국가: 이스라엘
언어: 영어
출처: Ministry of Health
MIDAZOLAM
A.L. MEDI-MARKET LTD.
N05CD08
SOLUTION FOR INJECTION / INFUSION
MIDAZOLAM 5 MG / 1 ML
I.M, I.V
Required
HBM PHARMA S.R.O., SLOVAKIA
MIDAZOLAM
Midazolam Kalceks 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 UNITSIn 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
2020-12-15
DOCTOR LEAFLET 1 NAME OF THE MEDICINAL PRODUCT Midazolam Kalceks 1 mg/ml Midazolam Kalceks 5 mg/ml 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Midazolam Kalceks _1 MG/ML _ 1 ml of solution contains 1 mg of midazolam. One ampoule with 5 ml of solution contains 5 mg of midazolam. Midazolam Kalceks _5 MG/ML _ 1 ml of solution contains 5 mg of midazolam. 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 a known effect Midazolam Kalceks _1 MG/ML _ Each ml of solution contains 3.50 mg sodium. Midazolam Kalceks _5 MG/ML _ Each ml of solution contains 3.15 mg sodium. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection/infusion. Clear, colourless solution. pH 2.9-3.7. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Midazolam is a short-acting sleep-inducing drug that is indicated: WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS • Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death (see section 4.5). • Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. • Limit dosages and durations to the minimum required. • Follow patients for signs and symptoms of respiratory depression and sedation. 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 4.2 POSOLOGY AND METHOD OF ADMINISTRATION STANDARD DOSAGE Midazolam is a potent sedat 전체 문서 읽기