Flumazenil 0.1 mg/ml Injection 5ml Amp x10

Solution for injection, concentrate for solution for infusion - clear colourless solution

Therapeutic indications
• Flumazenil is indicated for the complete or partial reversal of the central sedative effects of benzodiazepines. It may therefore be used in anaesthesia and in the intensive care in the following situations:
In anaesthesia:
• Termination of hypnosedative effects in general anaesthesia induced and/or maintained with benzodiazepines in hospitalised patients.
• Reversal of benzodiazepine sedation in short-term diagnostic and therapeutic procedures in ambulatory patients and hospitalised patients.
• For the reversal of conscious sedation induced with benzodiazepines in children > 1 year of age.
In intensive care situations:
• For the specific reversal of the central effects of benzodiazepines, in order to restore spontaneous respiration.
• For diagnosis and treatment of intoxications or overdose with only or mainly benzodiazepines.

Features

Nature and contents of container
• Carton boxes with 5 or 10 ampoules (glass Type I) containing 5 ml solution for injection.
• Carton boxes with 5 or 10 ampoules (glass Type I) containing 10 ml solution for injection.

Special precautions for storage
• Do not store above 25°C. Do not freeze.
• Keep the ampoules in the outer carton in order to protect from light.

Shelf life
Shelf life after first opening
• After first opening the medicinal product should be used immediately.
Shelf life after dilution
• Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C.
• From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

Patient Information Leaflet:
https://www.medicines.org.uk/emc/files/pil.6300.pdf