SEVOFLURANE SANDOZ sevoflurane 1 mL/mL inhalation bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sevoflurane, Quantity: 1 mL/mL

Available from:

Sandoz Pty Ltd

Pharmaceutical form:

Inhalation

Composition:

Excipient Ingredients:

Administration route:

Inhalation

Units in package:

1

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Sevoflurane Sandoz may be used for induction and maintenance of general anaesthesia in adult and paediatric patients undergoing surgery

Product summary:

Visual Identification: Clear, colourless, volatile liquid inside a 250 mL, amber, Type III glass bottle with a collar on the neck, sealed with a poly-seal cap, and secured with PET film; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2020-03-12

Patient Information leaflet

SEVOFLURANE SANDOZ
1
SEVOFLURANE
SANDOZ®
_Sevoflurane _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about SEVOFLURANE
SANDOZ.
It does not contain all the
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking
SEVOFLURANE SANDOZ against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT
SEVOFLURANE
SANDOZ IS USED
FOR
Sevoflurane belongs to a group of
medicines called halogenated
anaesthetic agents, which are
breathed in to induce and/or maintain
anaesthesia.
This medicine is administered by an
anaesthetist in the air you breathe
when you for surgery. It is a
colourless liquid supplied in a bottle.
It is given by your anaesthetist using
a vaporiser, which turns the liquid
into a gas so that you can breathe it
in.
SEVOFLURANE SANDOZ is used
for inducing and maintaining heavy
sleep needed during surgery. The
medicine produces loss of
consciousness and pain sensations
during surgery.
ASK YOUR DOCTOR IF YOU HAVE
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
BEFORE YOU
RECEIVE
SEVOFLURANE
SANDOZ
_BEFORE YOU ARE DUE TO _
_RECEIVE SEVOFLURANE _
_SANDOZ _
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 TYPE OF SEVERE FEVER).
3. YOU HAVE RECENTLY HAD ANY OTHER
GENERAL ANAESTHETIC, OR HAD MORE
THAN ONE GENERAL ANAESTHETIC OVER A
SHORT PERIOD OF TIME
4. YOU HAVE HAD SEVOFLURANE
SANDOZ BEFORE AND EXPERIENCED
AN ALLERGIC REACTION.
5. YOU HAVE OR HAVE HAD THE
FOLLOWING MEDICAL CONDITIONS:
•
Any problems with your liver
including hepatitis
•
Growths or abnormalities in your
brain
•
Heart disease; for example
coronary artery disease, high or
low blood pressure
•
Lung problems, for example
asthma

Summary of Product characteristics

200706-sevoflurane-sandoz-pi
Page 1 of 20
AUSTRALIAN PRODUCT INFORMATION
SEVOFLURANE SANDOZ (SEVOFLURANE) INHALATION BOTTLE
1.
NAME OF THE MEDICINE
Sevoflurane
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sevoflurane is a non-flammable and non-explosive liquid administered
by vaporisation.
Sevoflurane Sandoz is a clear, colourless, stable liquid. At least 500
ppm of water is present to
provide protection
from
environmental
Lewis
acids.
No
other
additives
or
chemical
stabilisers are used. It is non-pungent. Some physical constants of
the compound are:
Specific gravity at 20
o
C
1.520 - 1.525
Boiling point (760 mm Hg)
58.6°C
Vapour pressure in mm Hg
157 mm Hg at 20°C
197 mm Hg at 25°C
317 mm Hg at 36°C
Distribution Partition Coefficients at 37°C:
Blood / Gas 0.63 - 0.69, Water / Gas 0.36,
Olive Oil / Gas 47.2 - 53.9, Brain / Gas 1.15
Mean Component/Gas Partition Coefficient at 25°C:
Conductive rubber 14.0, Isobutylene/isoprene copolymer (butyl rubber)
7.7, Polyvinyl chloride
17.4, Polyethylene 1.3
3.
PHARMACEUTICAL FORM
Sevoflurane is a non-flammable and non-explosive liquid administered
by vaporisation.
Sevoflurane Sandoz is a clear, colourless, stable liquid.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
Sevoflurane Sandoz may be used for induction and maintenance of
general anaesthesia in
adult and paediatric patients undergoing surgery.
4.2.
D
OSE AND METHOD OF ADMINISTRATION
The concentration of sevoflurane being delivered from a vaporiser
during anaesthesia should
be known.
This may be accomplished by using
a vaporiser
calibrated specifically for
sevoflurane.
PREMEDICATION
Premedication should be selected according to the need of the
individual patient, and at the
discretion of the anaesthetist.
200706-sevoflurane-sandoz-pi
Page 2 of 20
INDUCTION
Dosage should be individualised and titrated to the desired effect
according to the patient's
age and clinical status. A short acting barbiturate or other
intravenous induction agent may be
administered followed by inhalation of sevoflurane. Induction wi