מדינה: ישראל
שפה: אנגלית
מקור: Ministry of Health
REMIFENTANIL AS HYDROCHLORIDE
LAPIDOT MEDICAL IMPORT AND MARKETING LTD
N01AH06
POWDER FOR CONCENTRATE FOR SOLUTION FOR INJECTION / INFUSION
REMIFENTANIL AS HYDROCHLORIDE 5 MG
I.V
Required
B.BRAUN MELSUNGEN AG, GERMANY
REMIFENTANIL
Remifentanil B.Braun is indicated as an analgesic agent for use during induction and/or maintenance of general anaesthesia under close supervision .Remifentanil B.Braun is indicated for provision of analgesia and sedation in mechanically ventilated intensive care patients 18 years of age and over.
2018-04-18
THE FORMAT OF THIS LEAFLET WAS DETERMINED BY THE MINISTRY OF HEALTH AND ITS CONTENT WAS CHECKED AND APPROVED BY IT ON NOVEMBER 2018 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Remifentanil B.Braun 1 mg, 2mg, 5mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Remifentanil B.Braun is a white to off white, compact powder, to be reconstituted before use. When reconstituted as directed, solutions of Remifentanil B.Braun contain 1 mg/ml, of remifentanil base as remifentanil hydrochloride. Remifentanil B.Braun for injection is available in glass vials containing 1 mg, 2 mg or 5 mg of remifentanil base. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for concentrate for solution for injection/infusion 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Remifentanil B.Braun is indicated as an analgesic agent for use during induction and/or maintenance of general anaesthesia under close supervision. Remifentanil B.Braun is indicated for provision of analgesia and sedation in mechanically ventilated intensive care patients 18 years of age and over. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Remifentanil B.Braun should be administered only in a setting fully equipped for the monitoring and support of respiratory and cardiovascular function and WARNING: RISKS FROM CONCOMITANT USE WITH WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS _ _ Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. 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. by persons specifically trained in the use of anaesthetic drugs and the recognition and management of the expected adverse effects of potent opioids, including respiratory and cardiac resuscitation. קרא את המסמך השלם