Isoflurane

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ISOFLURANE

Available from:

AbbVie Ltd Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, SL6 4UB, United Kingdom

ATC code:

N01AB06

INN (International Name):

ISOFLURANE 99.9 % (W/W)

Pharmaceutical form:

INHALATION VAPOUR, LIQUID

Composition:

ISOFLURANE 99.9 % (W/W)

Prescription type:

POM

Therapeutic area:

ANESTHETICS

Authorization status:

Suspended

Authorization date:

2006-11-29

Patient Information leaflet

•
Skin rash, swelling of the face
•
Rapid rise in body temperature, shivering or chills
•
Wheezing and breathlessness
•
Cardiac arrest
•
Abnormal levels of certain cells or products found in your
blood or urine.
•
Liver injury or the inability of your liver to function properly.
•
Changes to the heart rhythm including QT prolongation
and torsade de pointes.
Other side effects you may experience:
Those occurring at unknown frequency
•
Agitation
•
Alterations in mood, sometimes extreme, this may last
upto 6 days
•
Irregular heart beat or palpitations
•
Convulsions, mental impairment
•
Bleeding
•
Nausea and vomiting
•
Slow shallow breathing, shortness of breath, wheezing,
chest discomfort
•
Muscles of your intestine may stop working temporarily,
causing discomfort, bloating and vomiting.
Those that will be identified following tests:
•
Low blood pressure
•
Increases in blood fluoride levels (due to your body
breaking down isoflurane) or carbon monoxide levels
•
Fast or slow heart rate
REPORTING OF SIDE EFFECTS
If you get any side effects, talk to your doctor or anaesthetist.
This includes any possible side effects not listed in this
leaflet. You can also report side effects directly (see details
below). By reporting side effects you can help provide more
information on the safety of this medicine.
UNITED KINGDOM
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
MALTA
ADR Reporting
Website: www.medicinesauthority.gov.mt/adrportal
5. How to store Isoflurane
KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN.
Isoflurane should be stored in a tightly closed container NOT
above 25°C. Do NOT use after the expiry date printed on the
packaging.
Medicines should not be disposed of via wastewater or
household waste.
6. Contents of the pack and other information
WHAT ISOFL URANE CONTAINS:
The active ingredient is Isoflurane and it is supplied as a pure
liquid containing no other ingredients.
WHAT ISOFL URANE LOOKS LIKE AND CONTENTS OF THE PACK:
Isoflurane is an inhalation anaest

Summary of Product characteristics

Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Isoflurane
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Isoflurane 99.9% w/w
3
PHARMACEUTICAL FORM
Isoflurane is an inhalation anaesthetic with a mildly pungent ethereal
odour.
No additive or stabiliser present.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Isoflurane is indicated as a general anaesthetic by inhalation.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Vaporisers
specially
calibrated
for
isoflurane
should
be
used
so
that the
concentration of anaesthetic delivered can be accurately controlled.
MAC values for isoflurane vary with age. The table below indicates
average
MAC values for different age groups.
ADULTS
AGE
AVERAGE
MAC
VALUE
IN
100%
OXYGEN
70% N2O
26 ± 4 years
1.28%
0.56%
44 ± 7 years
1.15%
0.50%
64 ± 5 years
1.05%
0.37%
PAEDIATRIC POPULATION
AGE
AVERAGE
MAC
VALUE
IN
100%
OXYGEN
Preterm neonates < 32 weeks
gestational age
1.28%
Preterm
neonates
32-37
weeks
gestational age
1.41%
0-1 month
1.60%
1-6 months
1.87%
6-12 months
1.80%
1-5 years
1.60%
Page 2 of 12
PREMEDICATION: Drugs used for premedication should be selected for the
individual
patient
bearing
in
mind
the
respiratory
depressant
effect
of
isoflurane. The use of anticholinergic drugs is a matter of choice,
but may be
advisable for inhalation induction in paediatrics.
INDUCTION OF ANAESTHESIA IN
ADULTS:
A short-acting barbiturate or other
intravenous induction agent is usually administered followed by
inhalation of
the isoflurane mixture. Alternatively, isoflurane with oxygen or with
an
oxygen/nitrous oxide mixture may be used.
It is recommended that induction with isoflurane be initiated at a
concentration
of 0.5%. Concentrations of 1.5 to 3.0% usually produce surgical
anaesthesia
in 7 to 10 minutes.
INDUCTION OF ANAESTHESIA IN CHILDREN: Isoflurane is not recommended
for use
as
an
inhalation
induction
agent
in
infants
and
children
because
of
the
occurrence of cough, breath-holding, desaturation, increased
secretions and
laryngospasm (see section 4.4).
MAINT