KETALAR ketamine 200mg/2mL (as hydrochloride) injection vial

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

有効成分:

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

から入手可能:

Pfizer Australia Pty Ltd

医薬品形態:

Injection, solution

構図:

Excipient Ingredients: water for injections; benzethonium chloride

投与経路:

Intramuscular, Intravenous

パッケージ内のユニット:

5 x 2mL vials

処方タイプ:

(S8) Controlled Drug

適応症:

Ketalar is recommended: 1. as the sole anaesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation. Ketalar 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, and 3. to supplement low-potency agents, such as nitrous oxide.

製品概要:

Visual Identification: Clear colourless liquid; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

認証ステータス:

Licence status A

承認日:

2000-02-14

情報リーフレット

KETALAR
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I BEING TREATED WITH KETALAR?
KETALAR contains the active ingredient ketamine hydrochloride. KETALAR
belongs to a group of medicines called anaesthetics
and is used to make the body insensitive to surgical treatment. It may
be used in combination with other medicines to induce
anaesthesia.
For more information, see Section 1. Why am I being treated with
KETALAR? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE TREATMENT WITH KETALAR?
Do not use if you have ever had an allergic reaction to KETALAR or any
of the ingredients listed at the end of the CMI. Talk to your
doctor if you have any heart conditions, recent history of stroke,
brain haemorrhage or brain trauma.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before
treatment with KETALAR? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with KETALAR and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW IS KETALAR GIVEN?
•
KETALAR is given as an injection into a muscle or as a slow injection
into a vein by a nurse or doctor.
•
Your doctor will decide how much KETALAR is needed. It will depend on
your condition and other factors, such as your age,
weight, and other medicines that are being given.
More instructions can be found in Section 4. How is KETALAR given? in
the full CMI.
5.
WHAT SHOULD I KNOW DURING TREATMENT WITH KETALAR?
THINGS YOU
SHOULD DO
•
Tell any doctor or nurse giving you this medicine if you are about to
be started on any new medicine; you
are pregnant or planning to become pregnant; or you are breastfeeding
or planning to breastfeed.
THINGS YOU
SHOULD NOT DO
•
Wh

製品の特徴

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Page 1 of 14
AUSTRALIAN
PRODUCT
INFORMATION
–
KETALAR
 (KETAMINE HYDROCHLORIDE)
1.
NAME OF THE MEDICINE
Ketamine hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of KETALAR contains 100 mg ketamine base (ketamine
hydrochloride 115.3
mg/mL)
For the full list of excipients, see section
6.1 LIST OF EXCIPIENTS
.
3.
PHARMACEUTICAL FORM
KETALAR is a clear, colourless solution for intravenous or
intramuscular injection.
It is formulated as an acid (pH 3.5 to 5.5) solution.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
KETALAR is recommended:
1.
as the sole anaesthetic agent for diagnostic and surgical procedures
that do not require
skeletal muscle relaxation. KETALAR 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 KETALAR 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. KETALAR 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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Supersedes: pfpketai11020
Page 2 of 14
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
KETALAR 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 requi