BAXTER SEVOFLURANE sevoflurane 250mL inhalation liquid bottle

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

sevoflurane, Quantity: 250 mL

Διαθέσιμο από:

Baxter Healthcare Pty Ltd

INN (Διεθνής Όνομα):

Sevoflurane

Φαρμακοτεχνική μορφή:

Inhalation

Σύνθεση:

Excipient Ingredients:

Οδός χορήγησης:

Inhalation

Μονάδες σε πακέτο:

1 x 250mL

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

For induction and maintenance of general anaesthesia in adults and paediatric patients undergoing surgery.

Περίληψη προϊόντος:

Visual Identification: Clear colourless liquid.; Container Type: Bottle; Container Material: Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Καθεστώς αδειοδότησης:

Licence status A

Ημερομηνία της άδειας:

2004-08-03

Φύλλο οδηγιών χρήσης

SEVOFLURANE BAXTER (sevoflurane) Consumer Medicine Information
SEVOFLURANE BAXTER CMI 060501
Page 1 of 4
Baxter
SEVOFLURANE BAXTER
WHAT IS IN THIS LEAFLET?
This leaflet answers some common questions about sevoflurane.
It does not contain all the available 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 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 IS USED FOR.
Sevoflurane belongs to a group of medicines called halogenated
anaesthetic agents,
which are breathed in to induce (commence) and/or maintain
anaesthesia.
This medicine is added by an anaesthetist to the air you breathe when
you go 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 is used for inducing and maintaining heavy sleep needed
during surgery.
The drug produces loss of consciousness and loss of pain sensations
during surgery.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS
BEEN
PRESCRIBED FOR YOU.
BEFORE YOU RECEIVE SEVOFLURANE.
_ _
_Before you are due to receive sevoflurane. _
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 before and experienced an allergic reaction.
SEVOFLURANE BAXTER (sevoflurane) Consumer Medicine Information
SEVOFLURANE BAXTER CMI 060501
Page 2 of 4
Baxter
5.
You have or have had any of the following medical conditions:

Any problems with your liver including hepatitis.

Brain disorders

Αρχείο Π.Χ.Π.

Sevoflurane
Version 2.0
1 of 23
AUSTRALIAN PRODUCT INFORMATION
BAXTER SEVOFLURANE
1
NAME OF THE MEDICINE
Sevoflurane
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sevoflurane 100% w/v.
_List of excipients:_
None
3
PHARMACEUTICAL FORM
Sevoflurane volatile liquid for inhalation, a non-flammable and
nonexplosive liquid administered
by vaporization, is a halogenated general inhalation anaesthetic drug.
Sevoflurane is a clear,
colourless, stable liquid containing no additives or chemical
stabilizers.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Sevoflurane is indicated for induction and maintenance of general
anesthesia in adult and
paediatric patients undergoing surgery.
4.2
DOSE AND METHOD OF ADMINISTRATION
Sevoflurane 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.
Sevoflurane is administered by inhalation. The concentration of
Sevoflurane being delivered
from a vaporizer during anesthesia should be known. This may be
accomplished by using a
vaporizer calibrated specifically for sevoflurane. Filling occurs
directly from the bottle via an
integrated valve or in case of a bottle without integrated valve, with
the use of an appropriate
adaptor designed specifically to fit the sevoflurane vaporiser.
_REPLACEMENT OF DESICCATED CO_
_2_
_ ABSORBENTS: _
CO
2 ABSORBENTS SHOULD NOT BE ALLOWED TO DRY OUT WHEN INHALATIONAL
ANAESTHETICS ARE BEING
DELIVERED.
When a clinician suspects that the CO
2
absorbent may be desiccated, it should be
replaced before administration of sevoflurane. The exothermic reaction
that occurs with
sevoflurane and CO
2
absorbents is increased
WHEN THE CO
2 ABSORBENT BECOMES DESICCATED,
SUCH AS AFTER AN EXTENDED PERIOD OF DRY GAS FLOW THROUGH THE CO
2 ABSORBENT CANISTERS.
Extremely rare cases of extreme heat, smoke and/or spontaneous fire in
the respiratory circuit of
the anesthesia machine have been reported