Posology : מינונים

4.2 Posology and method of administration
Posology
Adults:
Anaesthesia
The recommended starting dose is 0.2 mg administered intravenously over 15 seconds. If the required level of consciousness is not obtained within 60 seconds, a further dose of 0.1 mg can be injected and repeated at 60-second intervals, up to a maximum dose of 1.0 mg. The usual dose required lies between 0.3 and 0.6 mg, but may deviate depending on the patient’s characteristics and the benzodiazepine used.

Intensive Care
The recommended starting dose is 0.3 mg administered intravenously over 15 seconds. If the required level of consciousness is not obtained within 60 seconds, a further dose of 0.1 mg can be injected and repeated at 60-second intervals, up to a total dose of 2 mg or until the patient awakes.
If drowsiness recurs, a second bolus injection may be administered.
An intravenous infusion of 0.1 – 0.4 mg/h has also been shown to be useful. The dosage and rate of infusion should be adjusted individually to achieve the desired level of consciousness.

If no clear effect on awareness and respiration is obtained after repeated dosing, it should be considered that the intoxication is not due to benzodiazepines.
Infusion should be discontinued every 6 hours to verify whether resedation occurs.

To avoid withdrawal symptoms in patients treated for a long period of time with high doses of benzodiazepines in the intensive care unit, the dosage of flumazenil has to be titrated individually and the injection has to be administered slowly (see 4.4).

Elderly
In the absence of data on the use of flumazenil in elderly patients, it should be noted that this population is generally more sensitive to the effects of medicinal products and should be treated with due caution.

Patients with hepatic impairment
Since flumazenil is primarily metabolized in the liver, careful titration of dosage is recommended in patients with impaired hepatic function.

Patients with renal impairment
No dosage adjustments are required in patients with renal impairment.

Paediatric population
Children above 1 year of age
For the reversal of conscious sedation induced by benzodiazepines in children > 1 year of age, the recommended initial dose is 10 micrograms/kg (up to 200 micrograms), administered intravenously over 15 seconds. If the desired level of consciousness is not obtained after waiting an additional 45 seconds, further injection of 10 micrograms//kg may be administered (up to 200 micrograms) and repeated at 60 second intervals where necessary (a maximum of 4 times) to a maximum total dose of 50 micrograms/kg or 1 mg, whichever is lower. The dose should be individualised based on the patient’s response. No data are available on the safety and efficacy of repeated administration of flumazenil to children for re-sedation.

Children under the age of 1 year
There are insufficient data on the use of flumazenil in children under 1 year.
Therefore, flumazenil should only be administered in children under 1 year if the potential benefits to the patient outweigh the possible risk.
Method of administration
Flumazenil should be administered intravenously by an anaesthetist or experienced physician.
Flumazenil may be administered as infusion (see 6.6).
Flumazenil may be used concomitantly with other resuscitative measures.

For instructions on dilution of the medicinal product before administration, see section 6.6.