Aerrane Inhalation Anaesthetic

Summary of Product characteristics

                                NEW ZEALAND DATA SHEET
AERRANE Data Sheet 4 March 2019
Page 1 of 13
Baxter Healthcare Ltd
1 AERRANE INHALATION ANAESTHETIC (100% volatile liquid for inhalation)
AERRANE INHALATION ANAESTHETIC, 100%, volatile liquid for inhalation.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Isoflurane 100% (USP) (1mL/mL).
3 PHARMACEUTICAL FORM
Volatile liquid for inhalation.
Isoflurane is a clear, colourless, stable volatile liquid containing
no additives or chemical stabilisers; it
has a mildly pungent, musty, ethereal odour. Isoflurane does not
decompose in the presence of
soda lime, and does not attack aluminium, tin, brass, iron or copper.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
AERRANE is a volatile halogenated anaesthetic for general inhalation
anaesthesia.
4.2
Dose and method of administration
AERRANE INHALATION ANAESTHETIC should be administered only by persons
trained in the
administration of general anaesthesia. Facilities for maintenance of a
patent airway, artificial
ventilation, oxygen enrichment, and circulatory resuscitation must be
immediately available.
In order to be able to accurately control the precise concentration of
AERRANE INHALATION
ANAESTHETIC, vaporisers that have been specially designed and
calibrated for isoflurane should be
used. Dosage for induction and maintenance must be individualized and
titrated to the desired
effect according to the patient’s age and clinical status.
With the exception of neonates, the minimum alveolar concentration
(MAC) of isoflurane decreases
with increasing patient age.
Minimum alveolar concentration (MAC) of AERRANE INHALATION ANAESTHETIC
in humans:
Age
O
2
100%
O
2
+ N
2
O (60%)
Neonates
1.60
–
1 – 6 months
1.87
–
7 – 11 months
1.80
–
1 – 2 years
1.60
–
3 – 5 years
1.62
–
6 – 10 years
1.40
0.58
10 – 15 years
1.16
0.53
Age
O
2
100%
O
2
+ N
2
O (70%)
26 ± 4 years
1.28
0.56
44 ± 7 years
1.15
0.50
64 ± 5 years
1.05
0.37
_ _
_ _
NEW ZEALAND DATA SHEET
AERRANE Data Sheet 4 March 2019
Page 2 of 13
Baxter Healthcare Ltd
_Induction of anaesth
                                
                                Read the complete document