Medicinal Products

ANEXATE 1 mg / 10 ml 0.1 mg / mL

Generic drug of the therapeutic class: Toxicology
active ingredients: Flumazenil
laboratory: Roche

IV injectable solution
Box of 6 ampoules of 10 ml
All forms

Indication

Flumazenil is indicated,

In hospital:

In anesthesiology, to neutralize the sedative effects of benzodiazepines on the central nervous system in adults and children over 6 months of age:

· Reversal of a sedative effect during general anesthesia induced and maintained by benzodiazepines,

· Reversal of benzodiazepine-induced sedation during brief diagnostic or therapeutic interventions.

In intensive care, to neutralize the sedative effects of benzodiazepines on the central nervous system and management of a coma of unknown etiology, in adults and children (including the newborn) if the semiology is compatible with the hypothesis of a benzodiazepine or related coma:

· Diagnosis and / or treatment of an overdose - intentional or accidental - with benzodiazepines.

· Etiological diagnosis of an unexplained coma in order to distinguish what amounts to a benzodiazepine from another cause (pharmacological or neurological).

· Specific cancellation of effects on the central nervous system caused by excessive doses of benzodiazepines (restoration of spontaneous ventilation to prevent intubation or to interrupt ventilatory support).

In an emergency situation or in medical transport, for adults and children over 6:

· Reversal of benzodiazepine-induced vigilant sedation in cases of respiratory depression, apnea.

Dosage ANEXATE 1 mg / 10 ml 0.1 mg / ml Solution for injection IV Box of 6 ampoules of 10 ml

Flumazenil should be administered IV.

It is recommended to use the titration method (see below).

1. In anesthesiology

Flumazenil should be administered by an anesthesiologist / resuscitator.

a) In the adult

The recommended starting dose is 0.2 mg administered IV in 15 seconds. If the desired degree of consciousness is not achieved within 60 seconds, a second dose of 0.1 mg may be injected. If necessary, this procedure may be repeated at intervals of 60 seconds, the maximum total dose being 1 mg. The usual total dose is 0.3 to 0.6 mg, however interindividual variations may be observed depending on the dose and duration of action of the benzodiazepine administered and the characteristics of the patient.

b) In children older than 6 months

The recommended starting dose is 0.01 mg / kg (up to 0.2 mg per injection) administered IV over 15 seconds. If a satisfactory state of consciousness is not obtained after waiting an additional 45 seconds, other injections of 0.01 mg / kg (up to 0.2 mg per injection) may be administered and repeated every minute, if (up to 4 additional administrations), the maximum total dose being 0.05 mg / kg or 1 mg.

2. In intensive care

Flumazenil should be administered by an anesthesiologist / resuscitator.

a) In the adult

The recommended initial IV dose is 0.3 mg. If the desired level of consciousness is not achieved within 60 seconds, new 0.2 or 0.3 mg flumazenil injections may be given until signs of waking or up to a maximum total dose of 2 mg. If the state of consciousness of the patient and his respiratory function do not show a significant improvement after administration of this total dose of 2 mg, it must be admitted that the clinical picture is not due to benzodiazepines.

In the case of awakening, and to maintain the waking state, the administration of flumazenil in one or more IV injections of 0.3 mg or IV infusion of 0.1 to 0, 4 mg per hour can be continued. The infusion rate must be set individually according to the desired degree of arousal.

b) In the child (including the newborn)

The initial recommended dose is 0.01 mg / kg intravenously slowly every 2 minutes until signs of waking are observed and followed, if necessary, by continuous infusion with an hourly dose equal to the loading dose. total.

3. In an emergency situation or in medical transport for adults and children over 6 years

Flumazenil should be administered only by experienced physicians in emergency and medical transport.

The goal is the correction of respiratory depression, which is also treated by usual resuscitation measures (the use of flumazenil in hypoxia may increase the risk of convulsions or rhythm disorders).

a) in adults

The recommended starting dose is 0.2 mg administered IV in 15 seconds. If the desired degree of consciousness is not achieved within 60 seconds, a second dose of 0.1 mg may be injected. If necessary, this procedure may be repeated at intervals of 60 seconds, the maximum total dose being 1 mg. The usual total dose is 0.3 to 0.6 mg, however interindividual variations may be observed depending on the dose and duration of action of the benzodiazepine administered and the characteristics of the patient.

b) in children over 6 years old

The recommended starting dose is 0.01 mg / kg (up to 0.2 mg per injection) administered IV over 15 seconds. If a satisfactory state of consciousness is not obtained after waiting an additional 45 seconds, other injections of 0.01 mg / kg (up to 0.2 mg per injection) may be administered and repeated every minute, if (up to 4 additional administrations), the maximum total dose being 0.05 mg / kg or 1 mg.

Against indications

· Flumazenil is contraindicated in patients with known hypersensitivity or intolerance to this product (or benzodiazepines and its relatives) or to any other component of the product.

· Flumazenil is contraindicated in patients who have received benzodiazepines or the like for a life-threatening condition (increased intracranial pressure, status epilepticus).

Side effects Anexate 1 MG / 10 ML

In the administration of anesthesiology, rare cases of nausea and / or vomiting have been reported.

There has been occasional mention of anxiety, palpitations and anxiety. Usually, the side effects mentioned did not require any special treatment.

Seizures have been reported in some long-term benzodiazepine-treated patients, particularly in epileptic patients or in polydrug overdose.

Withdrawal symptoms may occur after rapid injection of flumazenil in patients whose extended benzodiazepine treatment was discontinued in the weeks prior to flumazenil administration.

Flumazenil may cause panic attacks in patients with antecedents.

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