Ketalar

Država: Nova Zelandija

Jezik: angleščina

Source: Medsafe (Medicines Safety Authority)

Aktivna sestavina:

Ketamine hydrochloride 115.3 mg/mL equivalent to 100 mg/mL ketamine

Dostopno od:

Pfizer New Zealand Limited

INN (mednarodno ime):

Ketamine hydrochloride 115.3 mg/mL (Equiv to 100 mg/mL ketamine)

Odmerek:

100 mg/mL

Farmacevtska oblika:

Solution for injection

Sestava:

Active: Ketamine hydrochloride 115.3 mg/mL equivalent to 100 mg/mL ketamine Excipient: Benzethonium chloride Water for injection

Enote v paketu:

Vial, glass, 2mL vials, 5 dose units

Razred:

Class C4 Controlled Drug

Tip zastaranja:

Class C4 Controlled Drug

Izdeluje:

CU Chemie Uetikon GmbH

Terapevtske indikacije:

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.

Povzetek izdelek:

Package - Contents - Shelf Life: Vial, glass, 2mL vials - 5 dose units - 36 months from date of manufacture stored at or below 30°C - Vial, glass, 10mL, reintroduced - 10 mL - 36 months from date of manufacture stored at or below 30°C

Datum dovoljenje:

1970-02-19

Lastnosti izdelka

Version: pfdketai10821
Supersedes: pfdketai10919
Page 1 of 13
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
KETALAR

100 mg/mL solution for injection
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
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.
2.
Atropine, hyoscine or other 'drying' agents should be given at an
appropriate interval prior
to induction.
Version: pfdketai10821
Supersedes: pfdketai10919
Page 2 of 13
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 requirements.
ONSET AND DURATION
Because of rapid induction following th