AERRANE isoflurane 1mL/mL inhalation bottle

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

isoflurane, Quantity: 1 mL/mL

Disponible desde:

Baxter Healthcare Pty Ltd

formulario farmacéutico:

Inhalation, conventional

Composición:

Excipient Ingredients:

Vía de administración:

Inhalation

Unidades en paquete:

250mL, 100mL

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

Aerrane is a volatile halogenated anaesthetic for general inhalation anaesthesia.

Resumen del producto:

Visual Identification: Clear, colourless liquid.; Container Type: Bottle; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius

Estado de Autorización:

Licence status A

Fecha de autorización:

1996-07-17

Información para el usuario

AERRANE (isoflurane)
Consumer Medicine Information
AERRANE CMI Amended 060616
Page 1 of 4
Baxter
AERRANE
_WHAT IS AERRANE: _
AERRANE
is
one
of
a
family
of
drugs
called
halogenated
anaesthetics
which
are
administered by inhalation by an anaesthetist when you go for surgery.
It is a colourless
liquid supplied in an amber coloured glass bottle. It is given by your
anaesthetist using a
vaporiser specifically designed for use with AERRANE.
_WHAT AERRANE IS USED FOR: _
AERRANE is a special mixture of anaesthetic drug used for inducing and
maintaining heavy
sleep during surgery. It is administered by inhalation by your
anaesthetist. The medication
produces loss of consciousness and pain sensations during the surgery.
AERRANE is washed out quickly from the body via the lungs so that
recovery from the
anaesthetic is rapid once the drug has been stopped.
Your doctor will help you understand the benefits of taking AERRANE
during surgery in
your case.
_BEFORE YOU RECEIVE AERRANE: _
BEFORE YOU ARE DUE TO RECEIVE IT
_You must tell your doctor if: _
1.
You have previously had any problems with a general anaesthetic.
2.
You, or anyone in your family has malignant hyperthermia (a rare
special type of severe
fever).
3.
You have allergies to:
-
AERRANE (if you have had this anaesthetic before and experienced
allergic
reaction).
-
Halogenated anaesthetic agents which are breathed in to induce
anaesthesia.
4.
You have or have had the following medical conditions:
-
any problems with your liver, including hepatitis
-
myasthenia gravis, a rare disease causing severe muscle weakness
-
growth or abnormalities in your brain
AERRANE (isoflurane)
Consumer Medicine Information
AERRANE CMI Amended 060616
Page 2 of 4
Baxter
-
heart disease; for example coronary artery disease, high or low blood
pressure
-
Lung problems, for example asthma
-
any problems with your nerves and muscles (neuromuscular disease)
5.
You are on the following medications:
-
monoamine oxidase inhibitors; special drugs used for depression
-
drugs called beta-blockers, whi

Ficha técnica

AERRANE (Isoflurane)
Version 1.2
1 of 14
AUSTRALIAN PRODUCT INFORMATION
AERRANE ISOFLURANE
1
NAME OF THE MEDICINE
Isoflurane
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: isoflurane 1mL/mL.
3
PHARMACEUTICAL FORM
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
aluminum, 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
Isoflurane 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, 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
in humans:
AGE (YEARS)
O
2
– 100%
O
2
+ N
2
O (60%)
Neonates
1.60
-
1-6 months
187
-
7-11 months
1.80
-
1-2years
1.60
-
3-5 years
1.62
-
6-10 years
1.40
0.58
10-15years
1.16
0.53
AERRANE (Isoflurane)
Version 1.2
2 of 14
AGE (YEARS)
O
2
– 100%
O
2
+ N
2
O (70%)
26 ± 4
1.28
0.56
44 ± 7
1.15
0.50
64 ± 5
1.05
0.37
_ _
_INDUCTION OF ANAESTHESIA _
When using isoflurane for induction, it should be considered that the
risk of coughing,
breath
holding,
laryngospasm,
and
bronchospasm during
induction
increases
with
the
concentration of
isoflurane. If AERRANE is used for induction of anaesthesia, a
sta