Ketamine-Baxter

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Ketamine hydrochloride 115.34 mg/mL equivalent to Ketamine 100 mg/mL

Available from:

Baxter Healthcare Ltd

INN (International Name):

Ketamine hydrochloride 115.34 mg/mL (equivalent to Ketamine 100 mg/mL)

Dosage:

100 mg/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Ketamine hydrochloride 115.34 mg/mL equivalent to Ketamine 100 mg/mL Excipient: Nitrogen Water for injection

Prescription type:

Class C4 Controlled Drug

Manufactured by:

Supriya Lifescience Ltd

Therapeutic indications:

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

Product summary:

Package - Contents - Shelf Life: Ampoule, glass, Type I glass, 2mL - 5 dose units - 36 months from date of manufacture stored at or below 30°C protect from light - Ampoule, glass, Type I glass, 2mL - 10 dose units - 36 months from date of manufacture stored at or below 30°C protect from light - Ampoule, glass, Type I glass, 2mL - 25 dose units - 36 months from date of manufacture stored at or below 30°C protect from light

Authorization date:

2015-03-26

Summary of Product characteristics

NEW ZEALAND DATA SHEET
KETAMINE-BAXTER Data Sheet 13 February 2023
Page 1 of 12
Baxter Healthcare Ltd
1 PRODUCT NAME
KETAMINE-BAXTER (100mg/mL) ketamine hydrochloride, solution for
injection.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
_ACTIVE INGREDIENT _
Ketamine hydrochloride (115.34mg/mL equivalent to Ketamine 100mg/mL).
Each 2mL ampoule contains 200mg ketamine (as the hydrochloride).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection, intravenous or intramuscular.
_APPEARANCE _
A clear, colourless to slightly yellow solution essentially free from
particles.
Formulated as an acid solution KETAMINE-BAXTER has a pH of 3.5 –
5.5.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
KETAMINE-BAXTER is recommended:
1.
as the sole anaesthetic agent for diagnostic and surgical procedures
that do not require skeletal
muscle relaxation. KETAMINE-BAXTER 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-BAXTER 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
KETAMINE-BAXTER is
somewhat varied depending on the dose, route of administration and age
of patient, so that the
dosage r