SUPRANE desflurane 1g/g inhalation USP bottle

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

desflurane, Quantity: 1 g/g

Disponible des:

Baxter Healthcare Pty Ltd

Designació comuna internacional (DCI):

Desflurane

formulario farmacéutico:

Inhalation, conventional

Composición:

Excipient Ingredients:

Vía de administración:

Inhalation

Unidades en paquete:

240mL x 1

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

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

Resumen del producto:

Visual Identification: clear, colourless liquid; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Estat d'Autorització:

Registered

Data d'autorització:

1997-08-20

Informació per a l'usuari

SUPRANE (desflurane)
Consumer Medicine Information
SUPRANE CMI 080919 Page 1 of 5
Baxter
SUPRANE
WHAT IS IN THIS LEAFLET
What is SUPRANE?
What SUPRANE is used for
Before you receive SUPRANE

before you are due to receive it

when you must not receive it
Using SUPRANE
Side Effects
Product Description
How Can I Obtain More Facts About SUPRANE?
Manufacturer
WHAT IS SUPRANE
SUPRANE 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 SUPRANE.
WHAT SUPRANE IS USED FOR
SUPRANE 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.
SUPRANE 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 SUPRANE
during surgery in your
case.
SUPRANE (desflurane)
Consumer Medicine Information
SUPRANE CMI 080919 Page 2 of 5
Baxter
BEFORE YOU RECEIVE SUPRANE
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
SUPRANE (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 artery disease, high or low blood
pressure
o
brain disorder such as tumour, infection, or blood clot
o
any problems with your liver.
o
diabetes

You are on the following me

Fitxa tècnica

SUPRANE desflurane
Version 1.0
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AUSTRALIAN PRODUCT INFORMATION
SUPRANE (DESFLURANE)
1
NAME OF THE MEDICINE
Desflurane
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: desflurane 1g/g.
_List of excipients: _
none
3
PHARMACEUTICAL FORM
Liquid for inhalation.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
SUPRANE is indicated as an inhalation agent for maintenance of
anaesthesia. SUPRANE is
not recommended for mask induction of anaesthesia because of a high
incidence of moderate
to severe upper airway adverse events.
4.2
DOSE AND METHOD OF ADMINISTRATION
SUPRANE is administered by inhalation. The concentration of SUPRANE
should be
administered by persons trained in the administration of general
anaesthesia and delivered from
a vaporiser specifically designed and designated for use with SUPRANE
(see
4.4 SPECIAL
WARNINGS AND PRECAUTIONS FOR USE
).
The vapour pressure of SUPRANE 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,
SUPRANE 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 22.8°C 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 SUPRANE must
also include a filling port compatible with the valve on the SUPRANE
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 reactions associated with inhalational induction
of anaesthesia.
SUPRANE desflurane
Version 1.0
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_DOSAGE _
The minimum alveolar concent