Expiration date: 09/2027
The composition and form of issue:
The intravenous solution. 1 vial contains:
flumazenil 0.5 mg
auxiliary substances: disodium edetate, acetic acid ice sodium chloride sodium hydroxide 0.1 M solution water for injection
in ampoules of 5 ml in a cardboard tray with 5 ampoules in a pack a cardboard 1 pallet.
Method of application and dose:
In/in (bolus or infusion), under the supervision of a qualified anesthesiologist or physician.
The standard dosing regimen
The drug is compatible with 5% dextrose solution or 0.9% sodium chloride solution. To preserve the sterility of Anexate should be recruited from the vial immediately before use. After dialing into the syringe or dilution of a 5% solution dekstrozy or 0.9% solution of sodium chloride, the drug should be used within 24 hours
The dose should be titrate to desired effect. Since the duration of action of some benzodiazepines may exceed that of flumazenil may require a re-introduction of the drug in case after regaining consciousness sedation occurs again.
Anesthesiology
The recommended initial dose is 0.2 mg IV over 15 s. If after 60 s after the first/in the dose of the desired recovery of consciousness occurs, it is possible to introduce a second dose (0.1 mg). If necessary, this procedure can be performed with 60-second intervals until reaching a total dose of 1 mg. the dose is equal to 0.3–0.6 mg, but individual requirements may vary considerably, depending on the dose and duration previously entered benzodiazepine and characteristics of the patient.
Intensive care and management of patients with loss of consciousness of unknown etiology
The recommended initial dose is 0.3 mg I/V. If the desired level of recovery of consciousness occurs, flumazenil can be administered repeatedly as described above until reaching a total dose of not more than 2 mg If recurrence of the confusion it is recommended the solution is administered the drug again either bolus or as in/in infusion at a speed of 0.1–0.4 mg/h infusion Rate selected individually to achieve the desired level of recovery of consciousness.
If, after repeated administration of flumazenil consciousness or respiratory function is restored enough, it should be assumed nebenzodiazepinova etiology of impaired consciousness.
Patients in intensive care units and in patients, long treated with high doses of benzodiazepines, individually tailored doses of flumazenil in the slow introduction should not cause withdrawal symptoms. If unwanted hyperstimulation symptoms/injected diazepam or midazolam, carefully titrating their dose depending on patient response.
Dosing in special cases
Children older than 1 year. To eliminate sedation with preservation of consciousness caused by benzodiazepines, the recommended initial dose is 0.01 mg/kg (up to 0.2 mg) IV over 15 s in If another 45 with the desired level of recovery of consciousness does not occur, you can still 0.01 mg/kg (up to 0.2 mg) with the 60-second intervals (but not more than 4 times) to a maximum total dose of 0.05 mg/kg, but not more than 1 mg. Dose choose individually depending on patient response.
