Isoflurane inhalation vapour

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Isoflurane

Available from:

Teva UK 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: 5023497240327

Patient Information leaflet

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ISOFLURANE
100% Inhalation Vapour, Liquid
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You many need to read it again.
-
If you have any further questions, ask your doctor or nurse
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4
WHAT IS IN THIS LEAFLET
1.
What Isoflurane is and what it is used for
2.
What you need to know before you use Isoflurane
3.
How to use Isoflurane
4.
Possible side effects
5.
How to store Isoflurane
6.
Contents of the pack and other information
1.
WHAT ISOFLURANE IS AND WHAT IT IS USED FOR
Isoflurane is a general anaesthetic used which temporarily reduces the
activity of the body’s central
nervous system. This causes a complete loss of sensation in the body,
including loss of consciousness
allowing surgery to be carried out without pain or distress.
Isoflurane is a clear colourless liquid that when put into a special
anaesthetic machine (vaporiser)
becomes a gas which is mixed with oxygen and you will be breathing in
the mixture. It causes you to
fall into a deep, painless sleep (induction of anaesthesia). It also
maintains a deep, painless sleep during
which you can undergo surgery (maintenance of anaesthesia).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ISOFLURANE
DO NOT USE ISOFLURANE
•
if you are hypersensitive/ allergic to Isoflurane or any of the other
ingredients of this medicine
(listed in section 6).
•
You or anyone in your family, are susceptible to rapid rise in body
temperature during
anaesthesia (a condition known as malignant hyperthermia).
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before using Isoflurane:
•
You have previously been given an inhaled anaesthetic

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
ISOFLURANE 100% Inhalation vapour, liquid
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Isoflurane, 100% active
3
PHARMACEUTICAL FORM
Inhalation vapour, liquid.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Isoflurane is general inhalation anaesthetic for use in induction and
maintenance.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
MAC values for Isoflurane vary with age. The table below indicates
average MAC values for
different age groups.
ADULTS*
AVERAGE MAC VALUE
AGE 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%
Premedication: Premedication drugs should be selected according to the
needs of the patient.
The respiratory depressant effect of Isoflurane should be taken into
account. The use of
anticholinergic drugs is a matter of choice, but may we advisable for
inhalation induction in
paediatrics.
Induction: As Isoflurane has a mild pungency, inhalation should
usually be preceded by the
use of a short acting barbiturate, or other intravenous induction
agent, to prevent coughing.
Alternatively, Isoflurane with oxygen or with an oxygen/ nitrous oxide
mixture may be
administered.
It is recommended that induction with Isoflurane be initiated at a
concentration of 0.5%.
Concentrations of 1.5-3.0% usually produce surgical anaesthesia in
7-10 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).
Maintenance: Adequate anaesthesia for surgery may be sustained with an
inspired Isoflurane
concentration of 1.0% to 2.5% in an oxygen/nitrous oxide mixture.
Additional