DIAZEPAM AUTOINJECTOR LIQUID

Երկիր: Կանադա

Լեզու: անգլերեն

Աղբյուրը: Health Canada

Ակտիվ բաղադրիչ:

DIAZEPAM

Հասանելի է:

MERIDIAN MEDICAL TECHNOLOGIES INC.

ATC կոդը:

N05BA01

INN (Միջազգային անվանումը):

DIAZEPAM

Դոզան:

10MG

Դեղագործական ձեւ:

LIQUID

Կազմը:

DIAZEPAM 10MG

Կառավարման երթուղին:

INTRAMUSCULAR

Միավորները փաթեթում:

2 ML

Ռեկվիզորի տեսակը:

Targeted (CDSA IV)

Թերապեւտիկ տարածք:

BENZODIAZEPINES

Ապրանքի ամփոփագիր:

Active ingredient group (AIG) number: 0103614001; AHFS:

Լիազորման կարգավիճակը:

CANCELLED POST MARKET

Հաստատման ամսաթիվը:

2019-07-30

Ապրանքի հատկությունները

PRODUCT MONOGRAPH
DIAZEPAM AUTOINJECTOR, USP
5 mg/mL (2 mL/injector)
THERAPEUTIC CLASSIFICATION
Anxiolytic-Sedative
Meridian Medical Technologies, Inc.
2555 Hermelin Drive
St. Louis, Missouri 63144
USA
Distributed by:
King Pharma Canada Ltd.
Date of Preparation:
Kanata, Ontario K2K 1X5
January 18 2007
Control # 110954
2
PRODUCT MONOGRAPH
DIAZEPAM AUTOINJECTOR, USP
5 mg/mL (2 mL/injector)
THERAPEUTIC CLASSIFICATION
ANXIOLYTIC-SEDATIVE
ACTIONS AND CLINICAL PHARMACOLOGY
Diazepam is an anxiolytic-sedative drug useful in the symptomatic
relief of anxiety and tension states. It
has also adjunctive value in the relief of certain neurospastic
conditions and in certain cases, its
anticonvulsant activity has been found useful in controlling status
epilepticus.
The Diazepam Autoinjector is a sterile solution which is packaged
within a device that delivers its entire 2
mL content, which contains 10 mg diazepam, automatically upon
activation.
Pharmacokinetics
Absorption: Peak blood levels after the i.v. administration of
diazepam are reached within 15 minutes as
compared to 1 hour after a single oral dosing and are of the same
magnitude.
Distribution: Diazepam and its metabolites are highly bound to plasma
proteins (diazepam 98%). The
volume of distribution at steady state is 0.8 to 1.0 L/kg. In humans,
comparable blood levels of diazepam
were obtained in maternal and cord blood indicating rapid placental
transfer of the drug.
Metabolism: Diazepam is mainly metabolized to the pharmacologically
active metabolites such as N-
3
desmethyldiazepam, temazepam and oxazepam.
Elimination: The acute half-life is 2 to 3 hours with a slower decline
thereafter (half-life up to 48 hours).
Repeated doses further increase blood levels. The elimination
half-life of the active metabolite N-
desmethyldiazepam is up to 100 hours. Diazepam and its metabolites are
excreted mainly in the urine,
predominantly in their conjugated forms. The clearance of diazepam is
20 to 30 mL/min.
Pharmacokinetics in Special Clinical Situations: The elimination
half