HOSPIRA KETAMINE INJECTION ketamine (as hydrochloride) 200 mg/2 mL concentrated solution for injection vial

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

ketamine hydrochloride

Dostupno od:

Hospira Australia Pty Ltd

INN (International ime):

Ketamine hydrochloride

Status autorizacije:

Registered

Uputa o lijeku

________________________________________________________________________________
Hospira
TM
Ketamine Injection
CMI
Page 1
HOSPIRA
TM KETAMINE INJECTION
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
Hospira
TM
Ketamine Injection. 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 HOSPIRA
TM
KETAMINE INJECTION IS
USED FOR
Hospira
TM
Ketamine Injection
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 Hospira
TM
Ketamine
Injection 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
HOSPIRA
TM KETAMINE
INJECTION
_WHEN YOU MUST NOT BE _
_GIVEN IT _
YOU MUST NOT BE GIVEN
HOSPIRA
TM KETAMINE 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 br

Svojstava lijeka

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Supersedes: Version 2.0
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AUSTRALIAN PRODUCT INFORMATION –
HOSPIRA™ KETAMINE INJECTION (KETAMINE
HYDROCHLORIDE
1.
NAME OF THE MEDICINE
Ketamine hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Hospira™
Ketamine
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
For the full list of excipients, see Section 6.1 List of excipients.
3. PHARMACEUTICAL FORM
Hospira™ Ketamine Injection is a clear, colourless solution for
intravenous or intramuscular
injection._ _
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hospira™ Ketamine Injection is recommended:
1.
as the sole anaesthetic agent for diagnostic and surgical procedures
that do not require
skeletal muscle relaxation. Hospira™ Ketamine Injection 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.
Hospira™ Ketamine (as
hydrochloride) 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.
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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
Hospira™ Ketamine
Injection is somewhat varied depending on the dose, ro