Страна: Израел
Език: английски
Източник: Ministry of Health
MIDAZOLAM AS HYDROCHLORIDE
LAPIDOT MEDICAL IMPORT AND MARKETING LTD
N05CD08
SOLUTION FOR INJECTION / INFUSION
MIDAZOLAM AS HYDROCHLORIDE 5 MG / 1 ML
I.M, I.V
Required
B.BRAUN MELSUNGEN AG, GERMANY
MIDAZOLAM
midazolam 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
2023-11-30
DOCTOR LEAFLET 1 NAME OF THE MEDICINAL PRODUCT MIDAZOLAM B. BRAUN 1 MG/ML MIDAZOLAM B. BRAUN 5MG/ML 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient: midazolam 1mg/ml or 5 mg/ml for i.v., i.m. administration. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for INJECTION or INFUSION . 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Midazolam 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 o Premedication before induction of anaesthesia o Induction of anaesthesia o As a sedative component in combined anaesthesia • SEDATION IN INTENSIVE CARE UNITS 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. 2 IN CHILDREN • CONSCIOUS SEDATION before and during diagnostic or therapeutic procedures with or without local anaesthesia • ANAESTHESIA o Premedication before induction of anaesthesia • 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 TABLE 1 AND ADDITIONAL DETAILS ARE PROVIDED IN THE TEXT FOLLOWING TABLE 1. TAB Прочетете целия документ