Isoflurane volatile liquid

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Isoflurane

Available from:

AbbVie Ltd

ATC code:

N01AB06

INN (International Name):

Isoflurane

Dosage:

1ml/1ml

Pharmaceutical form:

Inhalation vapour

Administration route:

Inhalation

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 15010200; GTIN: 5013158012424

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.
•
There have been reports of rhabdomyolysis following use
of isoflurane. This may be identified by muscle pain and
dark urine.
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

Summary of Product characteristics

OBJECT 1
ISOFLURANE (INHALATION ANAESTHETIC)
Summary of Product Characteristics Updated 20-Apr-2018 | AbbVie
Limited
1. Name of the medicinal product
Isoflurane or Forane
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% N
2
O
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%
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, desa