Hypnovel

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

Midazolam

Disponibil de la:

Roche Products Pty Ltd

Clasă:

Medicine Registered

Prospect

HYPNOVEL
®

_Midazolam_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about HYPNOVEL.
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 using HYPNOVEL
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT HYPNOVEL IS
USED FOR
HYPNOVEL may be injected as a
sedative during some short medical
procedures.
HYPNOVEL may be given to you by
injection before an operation to
produce sleepiness or drowsiness and
to relieve anxiety.
If you are in an intensive care unit,
you may receive an infusion of
HYPNOVEL over several hours or
days as a sedative.
HYPNOVEL belongs to a group of
medicines called benzodiazepines.
They are thought to work by their
action on brain chemicals.
HYPNOVEL can cause sedation,
hypnosis, amnesia and/or
anaesthesia, depending on the dose.
Your doctor, however, may have
prescribed HYPNOVEL for another
purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY HYPNOVEL
HAS BEEN PRESCRIBED FOR YOU.
HYPNOVEL is only given by a
doctor trained to use this medicine. If
you will be receiving HYPNOVEL
during surgery, your doctor will give
you the medicine and closely follow
your progress.
This medicine is available only with
a doctor's prescription.
BEFORE YOU RECEIVE
HYPNOVEL
_DO NOT USE HYPNOVEL IF_
•
YOU HAVE HAD AN ALLERGIC
REACTION TO HYPNOVEL, ANY
OTHER BENZODIAZEPINE MEDICINE,
OR ANY OF THE INGREDIENTS LISTED
AT THE END OF THIS LEAFLET
•
YOU HAVE SEVERE MUSCLE
WEAKNESS, ALSO KNOWN AS
MYASTHENIA GRAVIS
•
YOU HAVE A CONDITION CALLED
ACUTE NARROW ANGLE GLAUCOMA
•
YOU ARE SUFFERING FROM SHOCK,
COMA OR ACUTE ALCOHOLIC
INTOXICATION
IF YOU ARE NOT SURE WHETHER YOU
SHOULD BE GIVEN HYPNOVEL, TALK
TO YOUR DOCTOR.
DO NOT GIVE HYPNOVEL TO
CHILDREN.
Th

Caracteristicilor produsului



Hypnovel
®
 PI 130409 

1 of 16 
CDS 5.0 
NAME OF THE MEDICINE 
HYPNOVEL


(_midazolam_) 
CAS Registry Number: 59467-70-8 

Short-acting  sleep  inducing  agent  for  sedation  for short procedures, induction of anaesthesia, and for 
prolonged sedation in intensive care units. 
DESCRIPTION 
The active ingredient of HYPNOVEL is 8-chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo[1,5-a] [1,4] 
benzodiazepine (midazolam). 
HYPNOVEL is a benzodiazepine from the imidazobenzodiazepine group. 
The free base of the active substance of HYPNOVEL is a lipophilic substance with low solubility in 
water.  The basic nitrogen in position 2 of the imidazobenzodiazepine ring enables the active substance 
of HYPNOVEL to form water-soluble salts with acids.  These produce a stable injection solution. 
The  ampoules  contain,  per  mL:  midazolam  5  mg  or  1  mg  (as  hydrochloride),  sodium  chloride, 
hydrochloric acid (to produce hydrochloride) and sodium hydroxide in water for injection adjusted to 
pH 3.3. 
PHARMACOLOGY 
HYPNOVEL  is  a  short-acting  central  nervous  system  depressant  which  induces  sedation,  hypnosis, 
amnesia  and  anaesthesia.    Pharmacokinetic  and  pharmacodynamic  data  in  chronic  intravenous  (IV) 
usage are not available beyond 15 days. 
PHARMACODYNAMICS 
The mechanism of action of the benzodiazepines is under continuous investigation.  Benzodiazepines 
appear  to  intensify  the  physiological  inhibitory  mechanisms  mediated  by  gamma-aminobutyric  acid 
(GABA), the most common inhibitory neurotransmitter in the brain. 
The  effects  of  HYPNOVEL  on  the  CNS  are  dependent  on  the  dose  administered,  the  route  of 
administration and the presence or absence of other premedicati