Sevoflurane

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

SEVOFLURANE

Available from:

AbbVie Limited

ATC code:

N01AB08

INN (International Name):

SEVOFLURANE

Pharmaceutical form:

INHALATION VAPOUR, LIQUID

Composition:

SEVOFLURANE 100 % (W/W)

Prescription type:

POM

Therapeutic area:

ANESTHETICS

Authorization status:

Authorised

Authorization date:

2006-05-31

Patient Information leaflet

20005826
PACKAGE LEAFLET: INFORMATION
FOR THE USER
SEVOFLURANE
®
IMPORTANT
INFORMATION
Read all of this leaflet carefully
before you receive Sevoflurane.
• Keep this leaflet as you may
need to read it again.
• This leaflet provides a summary
of the information currently
available on Sevoflurane.
• For further information or advice,
ask your ward doctor or
anaesthetist.
• Tell your ward doctor or
anaesthetist if you experience any
side effects.
20005826
•
fever (pyrexia)
•
low body temperature (hypothermia)
•
abnormal sugar (glucose) level
•
abnormal liver function test*
•
white blood cell count abnormal
•
blood fluoride increased **
•
delirium
Uncommon frequency:
•
a decrease or increase in the number of certain white blood
cells. A decrease in the number of white blood cells may be
associated with dizziness, fatigue, weakness, mouth ulcers
and a tendency towards infections.
•
confusion
•
abnormal heart rhythm
•
pauses in breathing
•
inadequate amount of oxygen
•
asthma
•
difficulty in passing urine
•
glucose in the urine***
•
abnormal kidney function test*
Unknown frequency:
•
convulsions (fits), particularly in children
•
twitching and jerking movements
•
fluid in the lungs
•
inflammation or damage to the liver. People with liver
disease may have abdominal pain or fullness, dark urine,
pale or white-coloured stool, fatigue, general itching,
yellowing of the eyes, nausea and vomiting
•
kidney failure. People with kidney disease may have tiredness,
swelling or puffiness in the face, abdomen, thighs or ankles,
passing less urine or problems urinating and back pain
•
skin rashes
•
heart arrhythmia (irregular heartbeat or abnormal heart
rhythm) known as QT prolongation
*If you have a blood test, you may be told that you have changes
in your liver or kidney enzymes or other products found in the
blood. These will not normally cause any symptoms.
**Levels of fluoride in the blood may be raised slightly during
and immediately after anaesthesia, due to t

Summary of Product characteristics

Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Sevoflurane
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The finished product is comprised only of the active ingredient
(sevoflurane).
3
PHARMACEUTICAL FORM
Sevoflurane is a nonflammable volatile liquid. Sevoflurane is
administered via
inhalation of the vaporised liquid.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Sevoflurane is indicated for induction and maintenance of general
anaesthesia
in adult and paediatric patients for inpatient and outpatient surgery.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Premedication should be selected according to the need of the
individual
patient, and at the discretion of the anaesthetist.
SURGICAL ANAESTHESIA:
Sevoflurane should be delivered via a vaporiser specifically
calibrated for use
with sevoflurane so that the concentration delivered can be accurately
controlled. MAC (minimum alveolar concentration) values for
sevoflurane_ _
decrease with age and with the addition of nitrous oxide. The table
below
indicates average MAC values for different age groups.
Table 1: MAC values for Adults and Paediatric patients according to
age
Age of Patient (years)
Sevoflurane in Oxygen
Sevoflurane in 65%
N
2
O/35% O
2
0 – 1 months*
3.3%
2.0%**
1 - < 6 months
3.0%
6 months - < 3 years
2.8%
3 - 12
2.5%
25
2.6%
1.4%
40
2.1%
1.1%
60
1.7%
0.9%
80
1.4%
0.7%
* Neonates are full term gestational age. MAC in premature infants has
not
been determined.
** In 1 – <3 year old paediatric patients, 60% N
2
O/40% O
2
was used.
Page 2 of 17
INDUCTION:
Dosage should be individualised and titrated to the desired effect
according to
the patient's age and clinical status. A short acting barbiturate or
other
intravenous induction agent may be administered followed by inhalation
of
sevoflurane. Induction with sevoflurane may be achieved in oxygen or
in
combination with oxygen-nitrous oxide mixtures. In adults inspired
concentrations of up to 5% sevoflurane usually produce surgical
anaesthesia in
less than 2 minutes. In child