DIAZEPAM INJECTION SDZ SOLUTION

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

DIAZEPAM

可用日期:

SANDOZ CANADA INCORPORATED

ATC代码:

N05BA01

INN（国际名称）:

DIAZEPAM

剂量:

10MG

药物剂型:

SOLUTION

组成:

DIAZEPAM 10MG

给药途径:

INTRAMUSCULAR

每包单位数:

10X2ML

处方类型:

Targeted (CDSA IV)

治疗领域:

BENZODIAZEPINES

產品總結:

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

授权状态:

CANCELLED POST MARKET

授权日期:

2020-07-20

产品特点

_Diazepam Injection SDZ _
_Page1of 10 _
PRODUCT MONOGRAPH
DIAZEPAM INJECTION SDZ
DIAZEPAM INJECTION BP
SOLUTION FOR INJECTION, 5 MG/ML
PRESERVATIVE FREE
ANXIOLYTIC–SEDATIVE
Sandoz Canada Inc.
Date of Revision: May 11, 2012
145, Jules-Léger
Boucherville, QC, Canada
J4B 7K8
Control No: 154076
_Diazepam Injection SDZ _
_Page2of 10 _
DIAZEPAM INJECTION SDZ
5 MG/ML
THERAPEUTIC CLASSIFICATION
Anxiolytic - Sedative
ACTIONS AND CLINICAL PHARMACOLOGY
Diazepam is an anxiolytic-sedative drug useful in the symptomatic
relief of anxiety and tension
states associated with psychoneurotic disorders. It also has
anticonvulsant properties and adjunctive
value in the relief of certain neurospastic conditions. As an
anticonvulsant, diazepam injectable has a
major use in the control of status epilepticus.
Peak blood levels are reached very rapidly after intravenous
administration of diazepam as
compared to one hour after a single oral dosing and are of the same
magnitude. The acute half-life is
2-3 hours with a slower decline thereafter, possibly due to tissue
storage. Repeated doses further
increase blood levels. In humans, comparable blood levels of diazepam
were obtained in maternal
and cord blood indicating rapid placental transfer of the drug
following parenteral administration.
INDICATIONS AND CLINICAL USE
Diazepam Injection SDZ is indicated when a rapid response to the use
of diazepam is desired and
may be useful:

To control prolonged seizure activity (status epilepticus) not
associated with acute neurologic
disorders.

To alleviate the symptoms of acute alcoholic withdrawal, including
delirium tremens.

In acute anxiety or tension states related to non-psychotic emotional
disorders and to relieve
spasticity in cerebral palsy, athetosis and the rare "Stiff Man
Syndrome".
CONTRAINDICATIONS
Diazepam Injection SDZ is contraindicated in myasthenia gravis, acute
narrow angle glaucoma, and
known hypersensitivity to benzodiazepines. It is also contraindicated
in infants.
WARNINGS AND PRECAUTIONS
_Diazepam Injection SDZ _