KETAMINE-BAXTER 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)
02-06-2020
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
ketamine hydrochloride, Quantity: 115.34 mg/mL (Equivalent: ketamine, Qty 100 mg/mL)
Available from:
Baxter Healthcare Pty Ltd
INN (International Name):
Ketamine hydrochloride
Pharmaceutical form:
Injection, solution
Composition:
Excipient Ingredients: water for injections; nitrogen
Administration route:
Intravenous, Intramuscular
Units in package:
2 mL per ampoule, 25 ampoules, 2 ml per ampoule, 5 ampoules, 2 mL per ampoule, 10 ampoules
Prescription type:
(S8) Controlled Drug
Therapeutic indications:
KETAMINE-BAXTER is recommended: 1. as the sole anaesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation. Ketamine-Claris is best suited for short procedures and it can be used with additional doses, for longer procedures; 2. for the induction of anaesthesia prior to the administration of other general anaesthetic agents; 3. to supplement low-potency agents, such as nitrous oxide.
Product summary:
Visual Identification: Clear, colourless to slightly yellow solution essentially free from visible particle matter.; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Authorization status:
Licence status A
Authorization date:
2015-02-04
Patient Information leaflet
KETAMINE-CLARIS
_Ketamine(as hydrochloride) 200 mg/2 mL solution for injection _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Ketamine-Claris. 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-Claris 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 KETAMINE-CLARIS IS USED FOR
Ketamine-Claris is used to make the body insensitive to surgical
treatment. It may be used in
combination with other medicines to induce anaesthesia.
This medicine 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 it for another
reason.
This medicine is addictive. Individuals with a history of drug abuse
of dependence may
develop ketamine 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 KETAMINE-CLARIS
_WHEN YOU MUST NOT BE GIVEN IT _
YOU MUST NOT BE GIVEN KETAMINE-CLARIS IF YOU HAVE AN ALLERGY TO:
•
any medicine containing ketamine
•
any of the ingredients listed at the end of this leaflet
Some of the symptoms of an allergic reaction may include shortness of
breath, wheezing or
difficulty breathing; swelling of the face, lips, tongue 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 ANY OF THE
FOLLOWING
MEDICAL CONDITIONS:
•
poorly controlled blood pressure
•
severe heart disease
•
heart failure
•
a recent history of stroke
•
rec
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Summary of Product characteristics
KETAMINE-BAXTER (Ketamine)
Version 2.0
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AUSTRALIAN PRODUCT INFORMATION
KETAMINE -
BAXTER (KETAMINE HYDROCHLORIDE)
SOLUTION FOR
INJECTION
1.
NAME OF THE MEDICINE
Ketamine Hydrochloride.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient: Ketamine (as the hydrochloride) 200 mg/2 mL
List of excipients: water for injections and nitrogen.
3.
PHARMACEUTICAL FORM
Solution for Injection.
Clear, colourless to slightly yellow solution essentially free from
visible particle matter.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ketamine-Baxter is recommended:
1.
as the sole anaesthetic agent for diagnostic and surgical procedures
that do not require
skeletal muscle relaxation. Ketamine-Baxter is best suited for short
procedures and it can
be used with additional doses, for longer procedures;
2.
for the induction of anaesthesia prior to the administration of other
general anaesthetic
agents;
3.
to supplement low-potency agents, such as nitrous oxide.
4.2
DOSE AND METHOD OF ADMINISTRATION
PRE-OPERATIVE PREPARATION
1.
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-Baxter
is recommended for use in the patient whose stomach is not empty only
when, in the
judgement of the medical practitioner, the benefits of the drug
outweigh the possible
ATTACHMENT 2B
KETAMINE-BAXTER (Ketamine)
Version 2.0
2 of 15
risks.
2.
Atropine, hyoscine or other 'drying' agents should be given at an
appropriate interval
prior to induction.
DOSAGE
As with other general anaesthetic agents, the individual response to
Ketamine-Baxter is
somewhat varied depending on the dose, route of administration and age
of patient, so that the
dosage recommended cannot be absolutely determined in a fixed manner.
The drug should be
titrated against the patient's requirements.
ONSET A
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