FLUMAZENIL-HAMELN INJECTION 0.1MG/ML

Product Information

Registration Status: Active

FLUMAZENIL-HAMELN INJECTION 0.1MG/ML is approved to be sold in Singapore with effective from 2019-07-23. It is marketed by ZYFAS MEDICAL CO, with the registration number of SIN15750P.

This product contains Flumazenil 0.1 mg/ml in the form of SOLUTION, STERILE. It is approved for INTRAVENOUS use.

This product is manufactured by Siegfried Hameln GmbH in GERMANY.

It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.

Flumazenil

Description

Fumazenil is an imidazobenzodiazepine derivative and a potent benzodiazepine receptor antagonist that competitively inhibits the activity at the benzodiazepine recognition site on the GABA/benzodiazepine receptor complex, thereby reversing the effects of benzodiazepine on the central nervous system.

Indication

For the complete or partial reversal of the sedative effects of benzodiazepines in cases where general anesthesia has been induced and/or maintained with benzodiazepines, and where sedation has been produced with benzodiazepines for diagnostic and therapeutic procedures. Also for the management of benzodiazepine overdose as an adjunct for appropriate supportive and symptomatic measures.

Mechanism of Action

Flumazenil, an imidazobenzodiazepine derivative, antagonizes the actions of benzodiazepines on the central nervous system. Flumazenil competitively inhibits the activity at the benzodiazepine recognition site on the GABA/benzodiazepine receptor complex. Flumazenil is a weak partial agonist in some animal models of activity, but has little or no agonist activity in man.

Clearance

* 1 L/hr/kg [healthy volunteers receiving a 5-minute infusion of a total of 1 mg]

Toxicity

In clinical studies, most adverse reactions to flumazenil were an extension of the pharmacologic effects of the drug in reversing benzodiazepine effects.

Active Ingredient/Synonyms

Flumazenilo | Flumazenilum | Flumazepil | Flumazenil |


Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.

References

  1. Health Science Authority of Singapore - Reclassified POM
  2. Drugbank