DESFLURANE SANDOZ desflurane 1 mL/mL inhalation bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

desflurane, 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:

DESFLURANE SANDOZ is indicated as an inhalation agent for maintenance of anaesthesia. DESFLURANE SANDOZ is not recommended for mask induction of anaesthesia because of a high incidence of moderate to severe upper airway adverse events.

Product summary:

Visual Identification: Clear, colourless liquid inside a 250 mL amber plastic coated glass bottle, sealed with a valve assembly and aluminium ferrule, and secured with PET sealing film; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 36 Months; 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

Page 1
of
5
DESFLURANE SANDOZ
®
_Desflurane _
CONSUMER MEDICINE INFORMATION
DESFLURANE SANDOZ
®
WHAT IS IN THIS LEAFLET
What is DESFLURANE SANDOZ
®
?
What DESFLURANE SANDOZ
®
is used for
Before you receive DESFLURANE SANDOZ
®
•
before you are due to receive it
•
when you must not receive it
Using DESFLURANE SANDOZ
®
Side Effects
Product Description
How Can I Obtain More Facts About DESFLURANE SANDOZ
®
?
Manufacturer
WHAT IS DESFLURANE SANDOZ
®
DESFLURANE SANDOZ
®
is one of a family of drugs called halogenated methylethlyethers
which are administered by inhalation by an anaesthetist when you go
for surgery. It is a
colourless fluid supplied in an amber coloured glass bottle. It is
given by your anaesthetist
using a vaporiser specifically designed for use with DESFLURANE SANDOZ
®
.
WHAT DESFLURANE SANDOZ
® IS USED FOR
DESFLURANE SANDOZ
®
is a special mixture of anaesthetic drug used for maintaining
heavy sleep during surgery. It is administered by inhalation by your
anaesthetist. The
medication produces anaesthesia, a loss of consciousness and pain
sensations during the
surgery.
DESFLURANE SANDOZ
®
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 DESFLURANE
SANDOZ
®
during
Page 2
of
5
DESFLURANE SANDOZ
®
_Desflurane _
CONSUMER MEDICINE INFORMATION
surgery in your case.
BEFORE YOU RECEIVE DESFLURANE SANDOZ
®
BEFORE YOU ARE DUE TO RECEIVE IT
YOU MUST TELL YOUR DOCTOR IF:
•
You had previously had any problems with a general anaesthetic.
•
You, or anyone in your family, have had malignant hyperthermia, during
or shortly after
receiving an anaesthetic (see Side Effects)
•
You have allergies to:
o
DESFLURANE SANDOZ
®
(if you have had this anaesthetic before and
experienced an allergic reaction).
o
Halogenated anaesthetic agents which are breathed in to induce
anaesthesia.
•
You have the following medical conditions:
o
heart disease; for example coronary a

Summary of Product characteristics

200706-desflurane-sandoz-pi
Page 1 of 19
AUSTRALIAN PRODUCT INFORMATION
DESFLURANE SANDOZ (DESFLURANE)
1.
NAME OF THE MEDICINE
Desflurane
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Desflurane Sandoz contains 1 mL/mL desflurane.
There are no excipients present in this product.
3.
PHARMACEUTICAL FORM
Liquid for inhalation.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
Desflurane Sandoz is indicated as an inhalation agent for maintenance
of anaesthesia.
Desflurane Sandoz is
not
recommended for mask induction of anaesthesia because of a high
incidence of moderate to
severe
upper airway adverse
events.
4.2.
D
OSE AND METHOD OF ADMINISTRATION
Desflurane Sandoz is administered by inhalation. The concentration of
Desflurane Sandoz
should be administered by persons trained in the administration of
general anaesthesia and
delivered from a vaporiser specifically designed and designated for
use with desflurane (see
Section 4.4 Special warnings and precautions for use).
The vapour pressure of Desflurane Sandoz at room temperature (about
700 mm Hg) precludes
its use in commonly-used agent-specific vaporisers as such vaporisers
cannot provide a stable
and predictable delivered concentration. Unlike agent-specific
vaporisers, Desflurane Sandoz
requires a vaporiser which utilises a heated sump (enclosure
containing liquid desflurane) to
prevent condensation, which could occur should the temperature in the
sump fall below 22.8⁰C
at 1 atmosphere pressure (desflurane boiling point). To power the
heating elements, the
vaporiser must be connected to an electrical source. A vaporiser
designed for use with
Desflurane Sandoz must also include a filling port compatible with the
valve on the Desflurane
Sandoz bottle.
_PREMEDICATION_
The premedication should be chosen to suit the individual requirements
of the patient. Studies
to date with patients scheduled to be anaesthetised have frequently
received IV premedication
such as opioids and/or benzodiazepines, and these have not shown an
effect of premedication
on respiratory tract