Ketalar

País: Nova Zelândia

Língua: inglês

Origem: Medsafe (Medicines Safety Authority)

Ingredientes ativos:

Ketamine hydrochloride 57.5 mg/mL equivalent to 50 mg/mL ketamine

Disponível em:

Pfizer New Zealand Limited

DCI (Denominação Comum Internacional):

Ketamine hydrochloride 57.5 mg/mL (Equiv to 50 mg/mL ketamine)

Dosagem:

50 mg/mL

Forma farmacêutica:

Solution for injection

Composição:

Active: Ketamine hydrochloride 57.5 mg/mL equivalent to 50 mg/mL ketamine Excipient: Benzethonium chloride Water for injection

Unidades em pacote:

Vial, glass, 10 mL

Classe:

Prescription

Tipo de prescrição:

Prescription

Fabricado por:

Parke Davis Manufacturing, Division of Warner Lambert Co.

Resumo do produto:

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

Data de autorização:

1970-02-19

Características técnicas

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