KETALAR

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

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Download Bijsluiter (PIL)
16-06-2024
Download Productkenmerken (SPC)
16-06-2024

Werkstoffen:

Ketamine hydrochloride; Ketamine

Beschikbaar vanaf:

Hospira Australia Pty Ltd

klasse:

Medicine Listed (Export Only)

Bijsluiter

                                 
________________________________________________________________________________ 
KETALAR
®
 CMI
 
Page 1 
 
KETALAR
® 
 
 
KETAMINE AS HYDROCHLORIDE  _(KEY-TAR-MEAN)_ 
 
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 
KETALAR
®
. 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 Ketamine Injection 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 KETALAR
®
 IS 
USED FOR 
 
KETALAR
® 
is used to make the 
body insensitive to surgical 
treatment. It may be used in 
combination with other medicines 
to induce anaesthesia (an-es-
these-ee-ya). 
 
This medicine belongs to a group 
of medicines called anaesthetics  
(an-es-thet-icks). 
_ _
It works by stopping the brain 
from interpreting messages of 
pain._ _
 
ASK YOUR DOCTOR IF YOU HAVE 
ANY QUESTIONS ABOUT WHY THIS 
MEDICINE HAS BEEN PRESCRIBED 
FOR YOU
. 
Your doctor may have prescribed 
it for another reason.  
 
 
This medicine is addictive.  
 
Individuals with a history of drug 
abuse of dependence may 
develop KETALAR
® 
dependence 
and tolerance, however, addiction 
is unlikely to occur when 
ketamine as hydrochloride is 
used as prescribed for 
anaesthesia. 
_ _
It is available only with a doctor’s 
prescription. 
BEFORE YOU ARE GIVEN 
KETALAR
®
 INJECTION 
 
_WHEN YOU MUST NOT BE _
_GIVEN IT _
 
YOU MUST NOT BE GIVEN 
KETALAR
®
 INJECTION IF YOU 
HAVE AN ALLERGY TO: 
•  any medicine containing 
ketamine 
•  any
                                
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Productkenmerken

                                Product Information - Australia 
Version 4.0 
Page 1 of 9
 
 
KETALAR

 
 
NAME OF THE MEDICINE 
ketamine (as hydrochloride) 
 
 
DESCRIPTION 
KETALAR
®
 ketamine (as hydrochloride) (CAS number 1867-66-9) is a
non-barbiturate anaesthetic 
chemically designated dl-2-(o-chloro-phenyl)-2-(methylamino)
cyclohexanone hydrochloride. 
 
Ketamine is a racemic mixture.  The molecular weight is 274.2 and
the empirical formula is 
C
13
H
16
ClNO.HCl. 
C l
O
NHCH
3
 
It is formulated as an acid (pH 3.5 to 5.5) solution for intravenous
or intramuscular injection in 
concentrations containing the equivalent of 100 mg ketamine base
per millilitre and contains not more 
than 0.1 mg/mL benzethonium chloride (phemerol) as a preservative. 
 
KETALAR
®
 also contains benzethonium chloride and water for injections. 
Ketamine is freely soluble in water and methyl alcohol and is soluble
in alcohol. 
 
 
PHARMACOLOGY 
ACTIONS 
KETALAR
®
 is a rapid-acting, general anaesthetic producing an anaesthetic
state characterised by 
profound analgesia, normal pharyngeal-laryngeal reflexes, normal or
slightly enhanced skeletal 
muscle tone, cardiovascular and respiratory stimulation, and
occasionally, a transient and minimal 
respiratory depression. 
 
A patent airway is maintained, partly by virtue of relatively
unimpaired pharyngeal and laryngeal 
reflexes (see PRECAUTIONS). 
 
The anaesthetic state produced by KETALAR
®
 has been termed 'dissociative anaesthesia' in that it 
appears to selectively interrupt association pathways of the brain
before producing somaesthetic 
sensory blockade.  KETALAR
®
 may selectively depress the thalamoneocortical system before 
significantly obtunding the more ancient cerebral centres and pathways
(reticular-activating and limbic 
systems). 
 
Elevation of blood pressure begins shortly after injection, reaches a
maximum within a few minutes 
and usually returns to pre-anaesthetic values within 15 minutes
after injection.  Th
                                
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