Ketamine

Երկիր: Նոր Զելանդիա

Լեզու: անգլերեն

Աղբյուրը: Medsafe (Medicines Safety Authority)

Ակտիվ բաղադրիչ:

Ketamine hydrochloride 11.53 mg/mL equivalent to 10 mg/mL ketamine;  

Հասանելի է:

Biomed Limited

INN (Միջազգային անվանումը):

Ketamine hydrochloride 11.53 mg/mL (equivalent to 10 mg/mL ketamine)

Դոզան:

10 mg/mL

Դեղագործական ձեւ:

Solution for infusion

Կազմը:

Active: Ketamine hydrochloride 11.53 mg/mL equivalent to 10 mg/mL ketamine   Excipient: Sodium chloride Water for injection

Միավորները փաթեթում:

Syringe, polypropylene, 10 mL

Դաս:

Class C4 Controlled Drug

Ռեկվիզորի տեսակը:

Class C4 Controlled Drug

Պատրաստված է:

CU Chemie Uetikon GmbH

Թերապեւտիկ ցուցումներ:

Ketamine infusion is recommended: 1. as the sole anaesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation. 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.

Ապրանքի ամփոփագիր:

Package - Contents - Shelf Life: Syringe, polypropylene - 10 mL - 12 months from date of manufacture stored at or below 25°C. Do not refrigerate or freeze.

Հաստատման ամսաթիվը:

2011-01-31

Ապրանքի հատկությունները

NEW ZEALAND DATA SHEET
KETAMINE (BIOMED)
Page 1
1.
PRODUCT NAME_ _
Ketamine 100 mg per 100 mL
Ketamine 100 mg per 10 mL
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Each 100 mL of Ketamine 100 mg per 100 mL contains ketamine
hydrochloride equivalent to
100 mg ketamine base.
Each 10 mL of Ketamine 100 mg per 10 mL contains ketamine
hydrochloride equivalent to
100 mg ketamine base.
For the full list of excipients, see section 6.1.
_ _
3.
PHARMACEUTICAL FORM_ _
A clear, colourless isotonic solution for injection or infusion.
It contains no preservative. It is formulated as an acid (pH 3.5 to
5.5) solution.
_ _
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ketamine is recommended:
1.
as the sole anaesthetic agent for diagnostic and surgical procedures
that do not
require skeletal muscle relaxation. Ketamine
is best suited for short procedures. It
can be used for longer procedures with additional doses;
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.
_ _
DOSE
As with other general anaesthetic agents, the individual response to
ketamine
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 th