Sevoflurane 100% Inhalation Vapour, liquid

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Sevoflurane

Available from:

Piramal Critical Care B.V.

ATC code:

N01AB; N01AB08

INN (International Name):

Sevoflurane

Dosage:

100 percent volume/volume

Pharmaceutical form:

Inhalation vapour, liquid

Therapeutic area:

Halogenated hydrocarbons; sevoflurane

Authorization status:

Marketed

Authorization date:

2012-01-13

Patient Information leaflet

INFORMATION FOR THE PATIENT
SEVOFLURANE 100% INHALATION VAPOUR, LIQUID
Sevoflurane
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 nurse.
-
If any of the side effects get serious, or if you notice any side
effects not listed in this
leaflet, please tell your doctor or nurse.
WHAT IS IN THIS LEAFLET:
1.
What Sevoflurane 100% Inhalation Vapour, liquid is and what it is used
for
2.
What you need to know before you are given Sevoflurane 100% Inhalation
Vapour, liquid
3.
How Sevoflurane 100% Inhalation Vapour, liquid will be given
4.
Possible side effects
5.
How to store Sevoflurane 100% Inhalation Vapour, liquid
6.
Contents of the pack and other information
1. WHAT SEVOFLURANE 100% INHALATION VAPOUR, LIQUID IS AND WHAT IT IS
USED FOR
The active ingredient in Sevoflurane 100% Inhalation Vapour, liquid is
sevoflurane, which is a
general anaesthetic used for surgical operations and other procedures.
It is an inhaled anaesthetic that is given to you as a vapour for you
to breathe in.
It causes you to fall into a deep sleep (induction of anaesthesia). It
also maintains a deep,
painless sleep during which you can undergo surgery (maintenance of
anaesthesia). You
must talk to a doctor if you do not feel better or if you feel worse.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN SEVOFLURANE 100%
INHALATION VAPOUR,
LIQUID
Sevoflurane should be administered only by healthcare professionals
appropriately trained in
the administration of general anaesthesia under the supervision of or
by an anaesthetist.
YOU SHOULD NOT BE GIVEN SEVOFLURANE 100% INHALATION VAPOUR, LIQUID IF
ANY OF
THE FOLLOWING APPLIES TO YOU, PLEASE TELL YOUR DOCTOR IF:
•
There are medical reasons why you should not be given a general
anaesthetic.
•
You have been told previously that you should not receive general
anaesthesia.
•
You are hypersensitive (or allergy) to sevofluran

Summary of Product characteristics

Health Products Regulatory Authority
27 July 2023
CRN00DJ49
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sevoflurane 100% Inhalation Vapour, liquid
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sevoflurane 100%.
Excipient with known effect: None
The finished product is comprised only of the active ingredient, see
section 6.1.
3 PHARMACEUTICAL FORM
Inhalation vapour, liquid
Clear, colourless, volatile liquid
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Induction and maintenance of general anaesthesia in adult and
paediatric patients of all ages, including full term neonates (see
section 4.2 for age details).
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 anaesthetist.
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.
Dosage should be individualised and titrated to the desired effect
according to the patient's age and clinical status. 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
100%
Inhalation
Vapour,
liquid in
Oxygen
Sevoflurane
100%
Inhalation
Vapour,
liquid in
65%
N2O/35%
O2
0 – 1 months*
3.3%
2.0%**
1 - < 6 months
3.0%
6 months - < 3 years
2.8%
​
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.
Health Products Regulatory Authority
27 July 2023
CRN00DJ49
Page 2 of 13
ANAESTHESIA INDUCTION
Dosage should be individualised and titrated to the desired effect
according to the patient's age and clinical