DBL DIAZEPAM

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

Diazepam

Disponibil de la:

Hospira Australia Pty Ltd

Clasă:

Medicine Registered

Prospect

 
DBL™ Diazepam Injection CMI 

Page  1 

DBL™ DIAZEPAM INJECTION 

Diazepam _(dye-AZ-eh-pam)_ 

CONSUMER MEDICINE INFORMATION_  _
_Date of Dispensing_ 
_Consumer Name _
_Pharmacist Name _
_Consumer Address _
_Pharmacist Address _

WHAT IS IN THIS LEAFLET 

This leaflet answers some 
common questions about DBL™ 
Diazepam Injection. 

It does not contain all the 
available information. 

It does not take the place of 
talking to your doctor or 
pharmacist. 

All medicines have risks and 
benefits
.
  Your doctor has 
weighed the risks of you being 
given DBL™ Diazepam Injection 
against the benefits they expect it 
will have for you. 

IF YOU HAVE ANY CONCERNS ABOUT 
THIS MEDICINE, ASK YOUR DOCTOR 
OR PHARMACIST. 

KEEP THIS LEAFLET IN A SAFE PLACE. 
You may need to read it again. 

WHAT DBL™ DIAZEPAM 
INJECTION IS USED FOR 

Diazepam belongs to a group of 
medicines known as 
benzodiazepines (_ben-zo-dye-_
_AZ-eh-peens)_. 

These medicines appear to have 
their effect by acting on certain 
areas of the brain. 

Diazepam has sedative and 
muscle relaxant effects. It is used 
for a number of conditions, 
including: 
•  tension and anxiety 
•  repeated or prolonged 
epileptic seizures 
(convulsions/fits) 
•  to help relax you before an 
operation (preoperative 
medication) 
• muscle 
spasm 
•  for the relief of symptoms of 
alcohol withdrawal 
•  muscle stiffness due to 
cerebral palsy or paraplegia. 

Your doctor may have prescribed 
diazepam for another reason.  
Ask your doctor if you have any 
questions about why DBL™ 
Diazepam Injection has been 
prescribed for you. 

In general, medicines such as 
DBL™ Diazepam Injection should 
be taken for short periods only 
(for example 2 - 4 weeks).  
Continuous long term use is not 
recommended unless advised by 
your doctor.  The use of this 
medicine may lead to 
dependence on diazepam. 

This means you may experienc

Caracteristicilor produsului

Product Information – Australia 

Version 7.0 

Page 1 
DBL
™
 DIAZEPAM INJECTION 

NAME OF THE MEDICINE 
Diazepam 

Benzodiazepine derivative.  Chemical name:
 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-
benzodiazepin-2-one.  MW:  284.74.  The CAS registry number of
diazepam is 439-14-5.  It is a 
colourless crystalline compound, insoluble in water.  The structure
of diazepam appears below: 

DESCRIPTION 
DBL
™
 Diazepam Injection is a clear colourless to pale yellow solution.
 Each 2 mL ampoule contains 
diazepam 10 mg and the following inactive ingredients: propylene
glycol 53% v/v, ethanol absolute 
31% v/v, in Water for Injections; pH 6.2 to 7.0. 

PHARMACOLOGY 
Diazepam is a member of the group of classical benzodiazepines and
exhibits anxiolytic, sedative, 
muscle relaxant and anticonvulsant effects.  This is presumed to be
the result of facilitating the action 
in the brain of gamma-aminobutyric acid (GABA),
a naturally occurring inhibitory neurotransmitter. 
The effects of diazepam may result from action in the limbic and
subcortical levels of the central 
nervous system (CNS).  Benzodiazepines are capable of producing all
levels of CNS depression (i.e. 
mild sedation to hypnosis to coma). 

PHARMACOKINETICS 
Diazepam may be given by intravenous (IV) or intramuscular (IM)
injection, but absorption following 
intramuscular administration may be slow and erratic, depending on
the muscle mass used and other 
factors.  When diazepam is injected into the deltoid muscle,
absorption is usually rapid and complete. 

Plasma concentrations of diazepam and its active metabolites exhibit
considerable interpatient 
variation, and therapeutic plasma concentrations are difficult to
define.  The plasma concentration 
time curve is biphasic; an initial rapid and extensive distribution
phase with a half life of up to three 
hours, followed by a prolonged terminal elimination phase (half life
20 to 48 hour