Suprane Inhalation vapour, solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Desflurane

Available from:

Baxter Healthcare Limited

ATC code:

N01AB; N01AB07

INN (International Name):

Desflurane

Dosage:

100 percent volume/volume

Pharmaceutical form:

Inhalation vapour, solution

Prescription type:

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

Therapeutic area:

Halogenated hydrocarbons; desflurane

Authorization status:

Marketed

Authorization date:

1999-12-16

Patient Information leaflet

BE-30-02-917
1
*
B E 3 0 0 2 9 1 7 *
Read all of this leaflet carefully before you
are given this medicine because 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 or pharmacist.
• 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.
In this leaflet:
1. What Suprane is and what it is used for
2. What you need to know before you are given
Suprane
3. How you will be given Suprane
4. Possible side effects
5. How to store Suprane
6. Contents of the pack and other information
1. What Suprane is and what it is
used for
Suprane contains desflurane. Suprane 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 desflurane 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. In adults, Suprane is used for
induction and maintenance of anaesthesia.
In intubated infants and children under 12 years,
Suprane is used for maintenance of anaesthesia
only.
Intubation is when a tube is placed into the
airways to help breathing. Suprane can sometimes
be used for dental procedures in hospitals and day
care units.
2. What you need to know before you
are given Suprane
Your anaesthetist (doctor) will not give
you Suprane if:
• you are a child, to bring on (induce) anaesthesia.
This is because using Suprane in this way can
cause more unwanted side effects such as:
– coughing
– holding one’s breath
– stopping breathing (apnoea)
– a muscle spasm of the vocal chords
(voice box) called a laryngospasm
– increased secretions in the airways
• you are allergic (hypersensitive) to desflurane or
other inhalation anaesthetics such as isoflurane,
sevoflurane, halothane and enflurane
• there are medical reasons why you should not
be given a general anaest

Summary of Product characteristics

Health Products Regulatory Authority
11 March 2019
CRN008T3N
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Suprane Inhalation vapour, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Desflurane 100% v/v
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Inhalation vapour, solution.
A clear, colourless to practically odourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Desflurane is indicated as an inhalation agent for induction and
maintenance of anaesthesia in adults.
Desflurane is indicated for maintenance of anaesthesia in intubated
infants and children under 12 years.
Desflurane is not indicated for induction of anaesthesia in paediatric
patients. (See Section 4.3)
Use of desflurane in dental anaesthesia should be restricted to
hospitals and day care units only.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration
Desflurane is administered by inhalation. The concentration of
desflurane should be delivered from a vaporizer specifically
designed and designated for use with desflurane.
Premedication
The premedication should be chosen to suit the individual requirements
of the patient.
Studies to date have not shown an effect of premedication on
respiratory tract reactions associated with inhalational induction
of anaesthesia.
Individualization
The administration of general anaesthesia must be individualized based
on the patient's response.
Effects on Concomitant Therapy
Opioids or benzodiazepines decrease the amount of desflurane required
to produce anaesthesia.
Desflurane decreases the required doses of neuromuscular blocking
agents (see Table 2, section 4.5). If added relaxation is
required, supplemental doses of muscle relaxants may be used. (See
section 4.5)
Dosage
The minimum alveolar concentration (MAC) of desflurane decreases with
increasing patient age. The dose of desflurane should
be adjusted accordingly. The MAC has been determined as listed in
Table 1.
Health Products Regulatory Authority
11 March 2019
CRN008T3N