AERRANE (ISOFLURANE), INHALATION VAPOUR, LIQUID 100 %v/v Inhalation Vapour Liquid

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

ISOFLURANE

Dostupno od:

Baxter Healthcare Limited

INN (International ime):

ISOFLURANE

Doziranje:

100 %v/v

Farmaceutski oblik:

Inhalation Vapour Liquid

Tip recepta:

Product subject to prescription which may not be renewed (A)

Status autorizacije:

Authorised

Datum autorizacije:

0000-00-00

Uputa o lijeku

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DATE
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BE-30-02-137
1
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 
THIS MEDICINE. IT CONTAINS IMPORTANT INFORMATION FOR 
YOU.
•  Keep this leaflet. You may need to read it again.
•  If you have any further questions, ask your doctor,
nurse or pharmacist.
•  If you get any side effects, talk to your doctor, nurse
or pharmacist. This includes any possible side effects
not listed in this leaflet
IN THIS LEAFLET:
1.  What AErrane is and what it is used for
2.  What you need to know before you are given
AErrane
3.  How you will be given AErrane
4.  Possible side effects
5.  How to store AErrane
6.  Contents of the pack and other information
1.  WHAT AERRANE IS AND WHAT IT IS  
USED FOR
AErrane contains isoflurane. AErrane is a general
anaesthetic used in surgery. It is an inhalation
anaesthetic (it is given to you as a vapour for you to
breathe in). Breathing in isoflurane vapour causes you to
fall into a deep, painless sleep.
It also maintains a deep, painless sleep (general
anaesthesia) during which you can undergo surgery.
2.  WHAT YOU NEED TO KNOW BEFORE YOU ARE 
GIVEN AERRANE
YOUR DOCTOR WILL NOT GIVE YOU AERRANE IF:
•  you are allergic (hypersensitive) to isoflurane or
other inhalation anaesthetics such as desflurane,
sevoflurane, halothane and enflurane
•  you, or any relative suffer from a condition called
malignant hyperthermia. Malignant hyperthermia is
when you suddenly develop a dangerously high body
temperature during or shortly after surgery.
•  following anaesthesia with AErrane or other
inhalation anaesthetics (e.g. desflurane, sevoflurane,
halothane) in the past, you have had:
–  liver problems
–  jaundice (yellowing of the skin and white of the
eyeballs)
–  unexplained fever
–  increased levels of white blood cells called
leucocytes (leucocytosis)
–  increased lev

Svojstava lijeka

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
AErrane (isoflurane), 100% v/v inhalation vapour, liquid
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Isoflurane 100% v/v.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Inhalation vapour, liquid
Clear, colourless liquid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Induction and maintenance of general anaesthesia in adults and children. Use of isoflurane in dental anaesthesia should be
restricted to hospitals or day care units only (see Contraindications, Section 4.3).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
In order to be able to accurately control the precise concentration of isoflurane, vaporisers that have been specially
calibrated for isoflurane should be used.
Induction
To avoid excitement and because of the irritant effects on the respiratory tract, an intravenous induction agent should be
administered, followed by inhalation of isoflurane.
Induction should be initiated at 0.5%. Concentrations of 1.5 - 3.0% in O
2
or O
2
/N
2
O usually produce surgical anaesthesia
in 7 -10 minutes.
Maintenance
The usual concentration is 1 - 2.5% in O
2
/N
2
O or 1.5 – 3.5% with O
2
alone.
For Caesarean section, 0.5 - 0.75% in a mixture of O
2
/N
2
O is suitable.
Recovery
The concentration of AErrane must be reduced to 0.5% at the end of the operation, or to 0% during closure of the wound to
allow prompt recovery.
If all administration of anaesthetic agents has been stopped, the air passages of the patient should be ventilated several
times with 100% oxygen until complete awakening occurs.
If the vector gas is a mixture of 50% O
2
and 50% N
2
O, the value of the minimum alveolar concentration of isoflurane is
approximately 0.65%.
IRISH MEDICINES BOARD
______________________________________________