KETAMINE APOTEX ketamine (as hydrochloride) 200 mg/ 2 mL solution for injection ampoule
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
ketamine hydrochloride
Available from:
Apotex Pty Ltd
INN (International Name):
Ketamine hydrochloride
Authorization status:
Registered
Patient Information leaflet
KETAMINE APOTEX
_SOLUTION FOR INJECTION_
_Ketamine hydrochloride_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about this medicine. 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 this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOU.
You may need to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is
Ketamine Apotex solution for
injection. It contains the active
ingredient ketamine hydrochloride.
Ketamine is used to make the body
insensitive to surgical treatment. It
may be used in combination with
other medicines to induce
anaesthesia.
Ketamine belongs to a group of
medicines called anaesthetics.
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 this
medicine for another reason.
THIS MEDICINE IS ADDICTIVE.
Individuals with a history of drug
abuse or dependence may develop
ketamine dependence and tolerance;
however, addiction is unlikely to
occur when ketamine is used as
prescribed for anaesthesia.
This medicine is available only with
a doctor's prescription.
BEFORE YOU ARE GIVEN
THIS MEDICINE
_WHEN YOU MUST NOT BE GIVEN_
_THIS MEDICINE_
YOU MUST NOT BE GIVEN THIS
MEDICINE IF YOU HAVE AN ALLERGY TO:
•
ketamine
•
any of the ingredients listed at the
end of the leaflet
Some of the symptoms of an allergic
reaction may include:
•
cough, shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue,
throat or other parts of the body
•
rash, itching or hives on the skin
YOU MUST NOT BE GIVEN THIS
MEDICINE IF YOU HAVE OR HAVE HAD
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Summary of Product characteristics
1
AUSTRALIAN PRODUCT INFORMATION – KETAMINE APOTEX
(KETAMINE HYDROCHLORIDE) SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Ketamine hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ketamine solution for injection contains ketamine 200 mg in 2 mL
Ketamine Apotex solution for injection 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.
EXCIPIENTS WITH KNOWN EFFECT
None stated
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Solution for injection,
The solution is clear and colourless to slightly yellow, essentially
free from visible particulate
matter.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
KETAMINE IS RECOMMENDED:
as the sole anaesthetic agent for diagnostic and surgical procedures
that do not
require skeletal muscle relaxation. Ketamine is best suited for short
procedures and
it can be used with additional doses, for longer procedures;
for the induction of anaesthesia prior to the administration of other
general
anaesthetic agents;
to supplement low-potency agents, such as nitrous oxide
.
4.2
DOSE AND METHOD OF ADMINISTRATION
Ketamine injection is intended for intravenous or intramuscular
injection.
Ketamine injection is for single use in one patient only. Discard any
residue.
PRE-OPERATIVE PREPARATION
While vomiting has been reported following ketamine administration,
airway protection is
usually afforded because of active laryngeal-pharyngeal reflexes.
However, because these
reflexes may also be diminished by supplementary anaesthetics or
muscle relaxants, the
possibility of aspiration must be considered. Ketamine is recommended
for use in the patient
whose stomach is not empty only when, in the judgment of the medical
practitioner, the
benefits of the drug outweigh the possible risks.
2
Atropine, hyoscine or other 'drying' agents should be given at an
appropriate interval prior to
induction.
DOSAGE
As with other g
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