BIOMED KETAMINE ketamine (as hydrochloride) 100 mg/100 mL injection for IV infusion bag

Ország: Ausztrália

Nyelv: angol

Forrás: Department of Health (Therapeutic Goods Administration)

Aktív összetevők:

ketamine hydrochloride, Quantity: 115.3 mg (Equivalent: ketamine, Qty 100 mg)

Beszerezhető a:

Biomed Aust Pty Ltd

Gyógyszerészeti forma:

Injection, intravenous infusion

Összetétel:

Excipient Ingredients: sodium chloride; water for injections

Az alkalmazás módja:

Intravenous Infusion

db csomag:

1 x 100 mL bag

Recept típusa:

(S8) Controlled Drug

Terápiás javallatok:

1. As the sole anaesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation. BIOMED KETAMINE 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.

Termék összefoglaló:

Visual Identification: Clear colourless liquid; Container Type: Bag; Container Material: Plastic; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Engedélyezési státusz:

Registered

Engedély dátuma:

2020-06-22

Betegtájékoztató

BIOMED KETAMINE INJECTION FOR INTRAVENOUS INFUSION CMI
CONSUMER MEDICINE INFORMATION
BIOMED KETAMINE
(KETAMINE HYDROCHLORIDE) 100 MG PER 100 ML
INJECTION FOR INTRAVENOUS INFUSION
This leaflet answers some common questions about Biomed Ketamine. 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 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.
BIOMED KETAMINE IS USED FOR
Biomed Ketamine is used to make the body insensitive to surgical
treatment. It may be
used in combination with other medicines to induce anaesthesia. It
works by stopping
the brain from interpreting messages of pain.
ASK
YOUR
DOCTOR
IF
YOU
HAVE
ANY
QUESTIONS
WHY
THIS
MEDICINE
HAS
BEEN
PRESCRIBED FOR YOU. Your doctor may have prescribed it for another
reason.
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. Biomed Ketamine
is available
only with a doctor’s prescription. This medicine is addictive.
YOU MUST NOT BE GIVEN BIOMED KETAMINE 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
• recent heart attack
• brain haemorrhage
• brain trauma
YOU MUST NOT USE THIS MEDICINE AFTER THE EXPI

Termékjellemzők

AUSTRALIAN
PRODUCT
INFORMATION
–
BIOMED
KETAMINE
(KETAMINE
HYDROCHLORIDE) INJECTION FOR INTRAVENOUS INFUSION
Page 1 of 14
1.
NAME OF THE MEDICINE_ _
Ketamine hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION_ _
Biomed
Ketamine is formulated as an acid
(pH 3.5-5.5) solution for injection,
intravenous infusion in concentrations containing the equivalent of
100 mg ketamine
base per 100 millilitre.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
A clear, colourless isotonic solution for intravenous infusion.
4.
CLINICAL PARTICULARS_ _
4.1.
THERAPEUTIC INDICATIONS
Biomed Ketamine is recommended:
1.
as the sole anaesthetic agent for diagnostic and surgical procedures
that do not
require skeletal muscle relaxation. Biomed Ketamine 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 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 anaesthetic agents, the individual response to
Biomed
Ketamine is somewhat varied depending on the dose, route of
administration and
Biomed Ketamine
Product Information - Australia
Page 2 of 14
age of patient, so that the dosage recommended cannot be absolutely
determined in
a fixed manner.