KETAMINE INTERPHARMA ketamine (as hydrochloride) 100 mg/10 mL solution for injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ketamine hydrochloride, Quantity: 11.53 mg/mL (Equivalent: ketamine, Qty 10 mg/mL)

Available from:

Interpharma Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: water for injections; sodium chloride; sodium hydroxide; hydrochloric acid

Administration route:

Intravenous, Intravenous Infusion, Intramuscular

Units in package:

10 mL

Prescription type:

(S8) Controlled Drug

Therapeutic indications:

KETAMINE INTERPHARMA? is recommended:,1. as the sole anaesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation. KETAMINE INTERPHARMA ? 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 solution, free from visible particles.; 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:

Registered

Authorization date:

2019-12-16

Patient Information leaflet

KETAMINE INTERPHARMA CMI V1.0
Page 1
KETAMINE INTERPHARMA

KETAMINE 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
KETAMINE INTERPHARMA. 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 KETAMINE
INTERPHARMA IS
USED FOR
KETAMINE INTERPHARMA 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 KETAMINE
INTERPHARMA 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
INTERPHARMA
INJECTION
_WHEN YOU MUST NOT _
_BE GIVEN IT _
YOU MUST NOT BE GIVEN
KETAMINE INTERPHARMA
INJECTION 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 hiv

Summary of Product characteristics

Ketamine Interpharma V1.2 Dec 2019
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AUSTRALIAN PRODUCT INFORMATION – KETAMINE INTERPHARMA
10 MG/ML AND 50 MG/ML AMPOULES
(KETAMINE HYDROCHLORIDE
1.
NAME OF THE MEDICINE
Ketamine hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
KETAMINE
INTERPHARMA is formulated as an acid
(pH 3.5 to 5.5) solution for
intravenous or intramuscular injection in concentrations containing
the equivalent of 10 mg or
50 mg ketamine base per millilitre.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
KETAMINE
INTERPHARMA is a clear,
colourless solution for intravenous or intramuscular
injection.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
KETAMINE INTERPHARMA is recommended:
1.
as the sole anaesthetic agent for diagnostic and surgical procedures
that do not require
skeletal muscle relaxation.
KETAMINE INTERPHARMA
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
KETAMINE INJECTION IS FOR SINGLE USE IN ONE PATIENT ONLY. DISCARD ANY
RESIDUE. ALL DOSES ARE GIVEN
IN TERMS OF KETAMINE BASE.
PRE-OPERATIVE PREPARATION
1.
While
vomiting
has
been
reported
following
KETAMINE
INTERPHARMA
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
Ketamine Interpharma V1.2 Dec 2019
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considered. KETAMINE INTERPHARMA 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 risks.
2.
Atropine, hyoscine or other 'drying' agents should be given at an
appropriate interval
prior to induction.
DOSAGE
As
with
other
general
anaestheti