FLUMAZENIL INJECTION SDZ SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

FLUMAZENIL

Disponibil de la:

SANDOZ CANADA INCORPORATED

Codul ATC:

V03AB25

INN (nume internaţional):

FLUMAZENIL

Dozare:

0.1MG

Forma farmaceutică:

SOLUTION

Compoziție:

FLUMAZENIL 0.1MG

Calea de administrare:

INTRAVENOUS

Unități în pachet:

100

Tip de prescriptie medicala:

Ethical

Zonă Terapeutică:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Rezumat produs:

Active ingredient group (AIG) number: 0122202001; AHFS:

Statutul autorizaţiei:

CANCELLED PRE MARKET

Data de autorizare:

2017-08-01

Caracteristicilor produsului

_Flumazenil Injection SDZ _
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PRODUCT MONOGRAPH
FLUMAZENIL INJECTION SDZ
Flumazenil Injection, Manufacturer’s Standard
0.1
mg/mL
THERAPEUTIC CLASSIFICATION
BENZODIAZEPINE ANTAGONIST
Sandoz Canada Inc.
145, Jules-Léger
Date of Revision: July 4, 2012
Boucherville, QC, Canada
J4B 7K8
Control No: 154070
_Flumazenil Injection SDZ _
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_Page 2 of 27 _
FLUMAZENIL INJECTION SDZ
Flumazenil Injection, Manufacturer’s Standard
0.1 mg/mL
THERAPEUTIC CLASSIFICATION
Benzodiazepine Antagonist
ACTION AND CLINICAL PHARMACOLOGY
Flumazenil Injection SDZ, an imidazobenzodiazepine, is a
benzodiazepine antagonist which
blocks the central effects of agents that act via the benzodiazepine
receptor, by competitive
inhibition. The antagonism is specific, since in animal experiments
the effects of compounds
which have no affinity for the benzodiazepine receptor (e.g.
barbiturates, meprobamate, ethanol,
GABA-mimetics, and adenosine receptor agonists) were not affected by
flumazenil.
Flumazenil
does not reverse the central effects of opioids.
Following the intravenous administration of radiolabelled flumazenil
to human volunteers, the
distribution of radioactivity corresponded closely to the distribution
of benzodiazepine receptors
as determined by positron emission tomography.
The hypnotic-sedative effects of benzodiazepines are rapidly reversed
by flumazenil. However,
the residual effects may reappear gradually within a few hours,
depending on the dose and
plasma concentration of flumazenil, the time elapsed since the
benzodiazepine agonist was
given, and the dose and elimination half-life of the previously
administered benzodiazepine
agonist. Flumazenil has shown some weak intrinsic agonistic (e.g.
anticonvulsant) activity
without therapeutic relevance.
PHARMACOKINETICS
_ _
In young male volunteers, the pharmacokinetics of intravenous
flumazenil were linear over a
dose range of 2-100 mg. Increasing doses of flumazenil were
accompanied by a corresponding
increase in the area under the plasma concentration-time curve