Source: Υπουργείο Υγείας (CY) Revision Year: 2014 Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
Neuropsychiatric Emergencies:
Paedriatics:
Anesthesia:
Other indication:
Dosage will essentially depend on the clinical situation.
In adults, it ranges from 0,1 to 0,2 mg/kg per injection. 1 to 2 ampoules may be administered directly by slow IM or IV route.
This dose may be repeated up to 4 times per 24 hours, or even more in inpatient care.
Convulsive seizure in adults: Fast intravenous infusion of 2 mg/min up to 20 mg, then slow perfusion with 100 mg in 500 ml of glucose solution, at the rate of 40 ml/hour.
Administration by slow IV route.
The injection can be repeated after 10 to 20 minutes.
It is recommended to reduce the dosage, for example by half.
Slow intravenous or intramuscular injection or infusion or intrarectal administration.
Due to apnea risk in the case of rapid intravenous injection, the intravenous injection should be carried out slowly into a large vein. This apnea risk also exists for administration via the ίntrarectal route in infants and children. (see section 4.8). Facilities for respiratory assistance must be available.
Intramuscular injections should be deep. They are not appropriate for the treatment of crises or convulsive seizures intramuscular administration is not recommended for children.
Treatment should be as short as possible. In case of continuation by oral administration, the indication should be re-evaluated regularly.
Overdose may present a threat to life, in particular in cases of polyintoxication involving other central nervous system depressants (including alcohol).
In the event of massive ingestion, overdose is mainly manifested by a CNS depression ranging from drowsiness to coma according to the quantity ingested. In mild cases, symptoms include confusion and lethargy.
In more severe cases, symptoms include ataxia, hypotonia, hypotension, respiratory depression, and may exceptionally result in fatal outcome. In the event of oral overdose ingested less than one hour earlier, vomiting should be induced if the patient is conscious or, if he is unconscious, gastric lavage is performed with the airway protected. After this time limit, activated carbon should be given to reduce absorption. Particular attention should be paid to respiratory and cardiονascular functions in adequate clinical environment.
Symptomatic and supportive treatment is recommended.
The administration of flumazenil may be useful for diagnosis and/or treatment of an intentional or accidental overdose of benzodiazepines.
Benzodiazepine antagonism by flυmazeniΙ may produce neurologic disorders (convulsions), in particular in epileptic patients.
48 months.
Store below 25°C, in the original package.
Do not refrigerate or freeze.
Type I, 2 ml amber ampoules (primary package).
Boxes of 10 ampoules (2 blisters x 5 ampoules) and 100 ampoules (20 blisters x 5 ampoules).
Not all pack sizes may be marketed.
No special requirements for disposal.
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