PIRAMAL DESFLURANE desflurane 1 mL/mL inhalation bottle

Nchi: Australia

Lugha: Kiingereza

Chanzo: Department of Health (Therapeutic Goods Administration)

Viambatanisho vya kazi:

desflurane, Quantity: 1 mL/mL

Inapatikana kutoka:

Piramal Critical Care Pty Ltd

Dawa fomu:

Inhalation

Tungo:

Excipient Ingredients:

Njia ya uendeshaji:

Inhalation

Vitengo katika mfuko:

6 x 250 mL bottle

Dawa ya aina:

(S4) Prescription Only Medicine

Matibabu dalili:

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

Bidhaa muhtasari:

Visual Identification: Clear, colourless, mobile, heavy liquid; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Idhini hali ya:

Registered

Idhini ya tarehe:

2020-01-21

Taarifa za kipeperushi

PIRAMAL DESFLURANE
TM
_DESFLURANE _
Liquid for Inhalation Anaesthetic
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
What is PIRAMAL DESFLURANE
TM
?
What PIRAMAL DESFLURANE
TM
is used for
Before you receive PIRAMAL DESFLURANE
TM
•
before you are due to receive it
•
when you must not receive it
Using PIRAMAL DESFLURANE
TM
Side Effects
Product Description
How Can I Obtain More Facts About PIRAMAL DESFLURANE
TM
?
Manufacturer
WHAT IS PIRAMAL DESFLURANE
TM
PIRAMAL DESFLURANE
TM
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 PIRAMAL DESFLURANE
TM
.
WHAT PIRAMAL DESFLURANE
TM IS USED FOR
PIRAMAL DESFLURANE
TM
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.
PIRAMAL DESFLURANE
TM
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 PIRAMAL
DESFLURANE
TM
during
surgery in your case.
BEFORE YOU RECEIVE PIRAMAL DESFLURANE
TM
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:
▪
PIRAMAL DESFLURANE
TM
(if you have had this anaesthetic before and experienced an
allergic reaction).
▪
Halogenated anaesthetic agents which are breathed in to induce
anaesthesia.
•
You have the following medical conditions:
▪
heart disease; for example coronary artery disease, high or low blood
pressure
▪
brain dis

Tabia za bidhaa

AUSTRALIAN PRODUCT INFORMATION – PIRAMAL DESFLURANE
TM
(DESFLURANE)
1 .
NAME OF THE MEDICINE
Desflurane
2 .
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient of PIRAMAL DESFLURANE is 1 mL/mL desflurane.
List of excipients: None
3 .
PHARMACEUTICAL FORM
Liquid for inhalation
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
PIRAMAL DESFLURANE
TM
is indicated as an inhalation agent for maintenance of
anaesthesia. DESFLURANE 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
DESFLURANE is administered by inhalation. The concentration of
DESFLURANE
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 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE).
The vapour pressure of DESFLURANE 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
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
DESFLURANE
must also include a filling port compatible with the valve on the
DESFLURANE
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.
_DOSAGE _
The minimum al