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PATIENT INFORMATION LEAFLET
SCHEDULING STATUS:
PROPRIETARY NAME AND DOSAGE FORM:
ULTANE Liquid
Sevoflurane
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU RECEIVE ULTANE
Keep this leaflet. You may need to read it again.
If you have further questions, please ask your doctor or your
pharmacist
WHAT ULTANE CONTAINS:
ULTANE contains sevoflurane, which is a clear colourless liquid.
WHAT ULTANE IS USED FOR:
ULTANE is a breathed in (inhalation) anaesthetic used to induce and
maintain a deep, pain-free
sleep (general anaesthesia) in adults and children during an
operation.
BEFORE YOU RECEIVE ULTANE:
DO NOT RECEIVE ULTANE:
If you are hypersensitive (allergic) to sevoflurane or to any other
inhaled anaesthetic.
If you have a neuromuscular disease, especially one called Duchene
muscular
dystrophy.
S5
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If you or any member of your family has experienced a condition called
malignant
hyperthermia (rapid rise in body temperature) during an operation.
TAKE SPECIAL CARE WITH ULTANE:
Tell your doctor, surgeon or anaesthetist if you have previously been
exposed to general
anaesthetics, particularly if repeated over a short period of time.
Some anaesthetics can
cause problems in the liver which can cause yellowing of the skin
(jaundice).
Tell your doctor, surgeon or anaesthetist if you are suffering from
any illness, other than
those connected with your operation, such as kidney, brain or heart
problems, severe
headaches, nausea, vomiting, or a neuromuscular disease (a condition
that affects muscles
e.g. Duchenne muscular dystrophy).
PREGNANCY AND BREASTFEEDING:
Safety of ULTANE in pregnancy and breastfeeding has not been
established. The safety of
ULTANE in labour and delivery has not been demonstrated.
ULTANE may be used for anaesthesia during Caesarean section.
If you are pregnant or could be pregnant or breastfeeding your baby
while receiving ULTANE, it is
important to consult your ward doctor, surgeon or anaesthetist.
DRIVING AND USING MACHINERY:
You sho
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PACKAGE INSERT
SCHEDULING STATUS: S5
PROPRIETARY NAME AND DOSAGE FORM
ULTANE Liquid
COMPOSITION
Sevoflurane, which is chemically identified as
fluoromethyl-2,2,2-trifluoro-1-(trifluoromethyl)
ethyl ether.
Lewis Acid Degradation: At least 300 ppm of water is added as a Lewis
Acid inhibitor. No other
additives or chemical stabilisers are utilised.
PHARMACOLOGICAL CLASSIFICATION
A 2.1 - Anaesthetics
PHARMACOLOGICAL ACTION
PHARMACODYNAMIC PROPERTIES
Sevoflurane is a halogenated anaesthetic given by inhalation.
Sevoflurane depresses
respiratory function and blood pressure in a dose-related manner.
Sevoflurane is a dose-related cardiac depressant. Sevoflurane does not
produce increases in
heart rate at doses less than 2 minimum alveolar concentration (MAC).
A study investigating the epinephrine (adrenaline) induced
prodysrhythmogenic effect of
sevoflurane in adult patients undergoing transsphenoidal
hypophysectomy demonstrated that
the threshold dose of epinephrine (i.e. the dose at which the first
sign of dysrhythmia was
observed) producing multiple ventricular dysrhythmias was 5
micrograms/kg.
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Animal studies have shown that regional blood flow (e.g. hepatic,
renal, cerebral, coronary
circulations) is well maintained with sevoflurane.
Sevoflurane has minimal effect on neurodynamics or ICP (intracranial
pressure) and preserves
CO
2
responsiveness.
Sevoflurane does not affect renal concentrating ability.
MINIMUM ALVEOLAR CONCENTRATION (MAC):
The minimum alveolar concentration (MAC) is the concentration at which
50 % of the
population tested does not move in response to a single stimulus of
skin incision.
For MAC equivalents for sevoflurane for various age groups See DOSAGE
AND DIRECTIONS
FOR USE.
The MAC of sevoflurane in oxygen was determined to be 2,05 % for a 40
year old adult. MAC
decreases with age and with the addition of nitrous oxide
Tracheobronchial tree secretions are mildly stimulated.
PHARMACOKINETIC PROPERTIES
Solubility:
The low solubility of sevoflurane
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