Страна: Израиль
Язык: английский
Источник: Ministry of Health
FLUMAZENIL
GENMEDIX , ISRAEL
V03AB25
SOLUTION FOR INJECTION
FLUMAZENIL 0.1 MG/ML
I.V
Required
MYLAN S.A.S., FRANCE
FLUMAZENIL
FLUMAZENIL
Benzodiazepine antagonist for reversal of benzodiazepine anesthesia, as well as for patients with benzodiazepine intoxication.
2023-05-31
העדוה העדוה לע לע הרמחה הרמחה ( ( עדימ עדימ ןולעב )תוחיטב ןולעב )תוחיטב ל ל אפור אפור :ךיראת 22/05/13 םש רישכת :תילגנאב Flumazenil Mylan 0.1 mg/ml רפסמ :םושיר 133 66 31544 00 םש לעב :םושירה Genmedix םיטרפ לע םי/יונישה םי/שקובמה קרפ ןולעב טסקט יחכונ טסקט שדח INDICATIONS 4.1 THERAPEUTIC INDICATIONS Flumazenil is indicated , _IN A HOSPITAL SETTING:_ .... In intensive care to neutralise the sedative effects of benzodiazepines on the central nervous system specific cancellation of the effects on the central nervous system by excessive benzodiazepine doses (re- establishment of spontaneous ventilation to avoid intubation or interrupt ventilatory assistance). …. 4.1 THERAPEUTIC INDICATIONS Flumazenil is indicated , Benzodiazepine antagonist for reversal of benzodiazepine anesthesia, as well as for patients with Benzodiazepine intoxication . _IN A HOSPITAL SETTING:_ .... In intensive care to neutralise the sedative effects of benzodiazepines on the central nervous system and treat a coma of unknown aetiology, in adults and children (including newborns) if the semiology is compatible with the hypothesis of a benzodiazepine or related substance- induced coma: diagnosis and/or treatment of intentional or accidental benzodiazepine overdose, aetiological diagnosis of an unexplained coma in order to differentiate what is caused by a benzodiazepine from another cause (pharmacological or neurological). specific cancellation of the effects on the central nervous system by excessive benzodiazepine doses (re- establishment of spontaneous ventilation to avoid intubation or interrupt ventilatory assistance). …. POSOLOGY AND ADMINISTRATION 4.2. POSOLOGY AND METHOD OF ADMINISTRATION b) In children over 6 years old 4.2. POSOLOGY AND METHOD OF ADMINISTRATION b) In children over 6 months old CONTRA- INDICATIONS 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS Прочитать полный документ
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT FLUMAZENIL MYLAN 0.1 MG/ML, SOLUTION FOR INJECTION 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Flumazenil .................................................................................................................................. 0.1 mg For 1 ml of solution for injection A 5 ml ampoule contains 0.5 mg of flumazenil. A 10 ml ampoule contains 1 mg of flumazenil. For excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Flumazenil is indicated, Benzodiazepine antagonist for reversal of benzodiazepine anesthesia, as well as for patients with Benzodiazepine intoxication. _IN A HOSPITAL SETTING:_ In anaesthesiology to neutralise the sedative effects of benzodiazepines on the central nervous system in adults and children older than 6 months : • reversal of sedative effect during general anaesthesia induced and maintained by benzodiazepines, • reversal of conscious sedation induced by benzodiazepines in short operations with a diagnostic or therapeutic objective. In intensive care to neutralise the sedative effects of benzodiazepines on the central nervous system and treat a coma of unknown aetiology, in adults and children (including newborns) if the semiology is compatible with the hypothesis of a benzodiazepine or related substance-induced coma: • diagnosis and/or treatment of intentional or accidental benzodiazepine overdose, • aetiological diagnosis of an unexplained coma in order to differentiate what is caused by a benzodiazepine from another cause (pharmacological or neurological). • specific cancellation of the effects on the central nervous system by excessive benzodiazepine doses (re-establishment of spontaneous ventilation to avoid intubation or interrupt ventilatory assistance). _ _ _IN AN EMERGENCY SITUATION OR MEDICAL TRANSPORT, IN ADULTS AND CHILDREN OLDER THAN 6 YEARS: _ • reversal of benzodiazepine-induced conscious sedation in case of r Прочитать полный документ