Sevoflurane 100% inhalation vapour, liquid

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Sevoflurane

Available from:

Chanelle Medical Unlimited Company

ATC code:

N01AB; N01AB08

INN (International Name):

Sevoflurane

Dosage:

100 percent

Pharmaceutical form:

Inhalation vapour, liquid

Prescription type:

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

Therapeutic area:

Halogenated hydrocarbons; sevoflurane

Authorization status:

Not marketed

Authorization date:

2017-04-07

Patient Information leaflet

ID:
PL
180M (IE)
VERSION:
03
REVISION DATE:
30/06/2022
Page 4 of 4
PACKAGE LEAFLET: INFORMATION FOR THE USER
SEVOFLURANE 100% INHALATION VAPOUR, LIQUID
Sevoflurane
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, surgeon or
anaesthetist.
•
If you get any side effects, talk to your doctor or anaesthetist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Sevoflurane is and what it is used for
2.
What you need to know before receiving Sevoflurane
3.
How Sevoflurane is given
4.
Possible side effects
5.
How to store Sevoflurane
6.
Contents of the pack and other information
1.
WHAT SEVOFLURANE IS AND WHAT IT IS USED FOR
Sevoflurane contains the active ingredient sevoflurane. Sevoflurane
belongs to a group of medicines
called anaesthetics.
Sevoflurane is an anaesthetic that is breathed in (inhaled), and is
used to induce and maintain a deep,
pain-free sleep (general anaesthesia) in adults and children during an
operation. If Sevoflurane is used
in dental operations these must be performed in a hospital or day care
unit.
2.
WHAT YOU NEED TO KNOW BEFORE RECEIVING SEVOFLURANE
DO NOT RECEIVE SEVOFLURANE:
•
If you have been told previously that you should not receive general
anaesthesia.
•
If you know that you are ALLERGIC
to sevoflurane or any other anaesthetics, or any of the other
ingredients in Sevoflurane.
•
If you or any member of your family has experienced a condition called
malignant hyperthermia
(rapid rise in body temperature) during an operation with Sevoflurane
or any other anaesthetic.
•
If you are undergoing dental procedures outside a hospital or day care
unit.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR ANAESTHETIST BEFORE RECEIVING SEVOFLURANE IF:
•
you have any other illness not connected to your operation, such as
kidney, brain or heart
problems

Summary of Product characteristics

Health Products Regulatory Authority
19 August 2022
CRN00D3HQ
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sevoflurane 100% inhalation vapour, liquid
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Contains sevoflurane 100 % w/v.
The medicinal product is comprised only of the active ingredient.
3 PHARMACEUTICAL FORM
Inhalation vapour, liquid
Clear, colourless, volatile liquid
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Sevoflurane is indicated for induction and maintenance of general
anaesthesia in adult and paediatric patients. Use of
sevoflurane in dental anaesthesia should be restricted to hospitals or
day care units only (see section 4.3).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Premedication should be selected according to the need of the
individual patient, and at the discretion of the anaesthesiologist.
SURGICAL ANAESTHESIA
Sevoflurane should be delivered via a vaporiser specifically
calibrated for use with sevoflurane so that the concentration
delivered can be accurately controlled. MAC (minimum alveolar
concentration) values for sevoflurane decrease with age and
with the addition of nitrous oxide. The table below indicates average
MAC values for different age groups.
TABLE 1. MAC VALUES FOR ADULTS AND PAEDIATRIC PATIENTS ACCORDING TO
AGE
AGE OF PATIENT (YEARS)
SEVOFLURANE IN OXYGEN SEVOFLURANE IN 65% N
2
0/35%0
2
0 – 1 months*
3.3%
1 - < 6 months
3.0%
6 months - < 3 years
2.8%
2.0%@
3 – 12
2.5%
25
2.6%
1.4%
40
2.1%
1.1%
60
1.7%
0.9%
80
1.4%
0.7%
* Neonates are full term gestational age. MAC in premature infants has
not been determined
@ In 1 - <3 year old paediatric patients, 60%N
2
O/40%O
2
was used
Sevoflurane is similar to Isoflurane in the sensitisation of the
myocardium to the arrhythmogenic effect of exogenously
administered adrenaline.
INDUCTION
Dosage should be individualised and titrated to the desired effect
according to the patient’s age and clinical status. A short
acting barbiturate or other intravenous induction agent may be
administered followed