Maa: Israel
Kieli: englanti
Lähde: Ministry of Health
MIDAZOLAM
RAFA LABORATORIES LTD
N05CD08
SOLUTION FOR INJECTION
MIDAZOLAM 5 MG/ML
I.M, I.V
Required
RAFA LABORATORIES LTD, JERUSALEM
MIDAZOLAM
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
2022-12-31
)תוחיטב עדימ( הרמחה לע העדוה )תוחיטב עדימ( הרמחה לע העדוה :ל חולשל( ( ALONIM.URGENT@MOH.HEALTH.GOV.IL :ךיראת 28 ב רבמבונ 2012 :תילגנאב רישכת םש MIDOLAM 1MG/ML, MIDOLAM 5 MG/ML :םושיר רפסמ 108 42 29066 , 108 43 29067 :םושירה לעב םש מ"עב אפר תודבעמ :עבצב םינמוסמ ןולעב םייונישה בוהצ ,הפסוה= קורי ,הקיחמ= לוחכ .םוקמ יוניש= תנווכתמ ןכרצל ןולע תנווכתמ ןכרצל ןולע אפורל ןולע אפורל ןולע )תוקירזל( )תוקירזל( ןולעב קרפ יחכונ טסקט שדח טסקט COMPOSITIO N Midazolam 1mg/ml in ampoules of 5 ml. Midazolam 5mg/ml in ampoules of 1,3,10 ml. (Preservative-free). Midazolam 1mg/ml in ampoules of 5 ml. Midazolam 5mg/ml in ampoules of 1,3,10 ml. (Preservative-free). LIST OF EXCIPIENTS : Sodium chloride, water for Injection, sodium hydroxide, HCl WARNINGS – )BOX( Midolam injection has been associated with severe cardiorespiratory adverse events including respiratory depression, apnea,respiratory arrest, and cardiac arrest, especially when used for conscious sedation and in concomitant use with opioid agonists or other sedatives, or when rapidly administered. In some cases, where this was not recognized promptly and treated effectively, death or hypoxic encephalopathy has resulted. Midolam should be used only in hospital or ambulatory care settings, including physicians’ offices, that provide for continuous monitoring of respiratory and cardiac function. Immediate availability of oxygen, resuscitative drugs and equipment and personnel trained in their use should be assured. Midolam should be administered intravenously as an induction agent only by a person trained in general anesthesia and should be used for conscious sedation only when a person skilled in maintaining a patent airway and supporting ventilation is present, because of possible respiratory depression. During intravenous administ Lue koko asiakirja
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT MIDOLAM ® 1MG/ML MIDOLAM ® 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. 4 CLINICAL PARTICULARS 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. 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 - 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 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. TABLE 1: STANDA Lue koko asiakirja