Sevoflurane Baxter, 100%, inhalation vapour, liquid

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Sevoflurane

Available from:

Baxter Holding B.V.

ATC code:

N01AB; N01AB08

INN (International Name):

Sevoflurane

Dosage:

100 percent

Pharmaceutical form:

Inhalation vapour, liquid

Therapeutic area:

Halogenated hydrocarbons; sevoflurane

Authorization status:

Marketed

Authorization date:

2010-05-21

Patient Information leaflet

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
SEVOFLURANE BAXTER 100% LIQUID INHALATION VAPOUR
Active substance: 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 pharmacist.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Sevoflurane Baxter is and what it is used for
2. What you need to know before you are given Sevoflurane Baxter
3. How you will be given Sevoflurane Baxter
4. Possible side effects
5. How to store Sevoflurane Baxter
6. Contents of the pack and other information
1. WHAT SEVOFLURANE BAXTER IS AND WHAT IT IS USED FOR
Sevoflurane Baxter contains sevoflurane. Sevoflurane is a general
anaesthetic used in surgery in adults
and children. It is an inhalation anaesthetic (it is given to you as a
vapour for you to breathe in).
Breathing in sevoflurane 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.
You must talk to a doctor if you do not feel better or if you feel
worse.
2.
WHAT YOU NEED TO KNOW
b
EFORE YOU ARE GIVEN SEVOFLURANE BAXTER
Sevoflurane should be administered only by healthcare professionals
appropriately trained in the
administration of general anaesthesia under the supervision of or by
an anaesthetist.
YOUR ANAESTHETIST (DOCTOR) WILL NOT GIVE YOU SEVOFLURANE BAXTER IF:
-
you are allergic (hypersensitive) to sevoflurane or other inhalation
anaesthetics.
-
you have a history of confirmed inflamed liver (hepatitis) due to
sevoflurane or other inhalation
anaesthetics or you have a history of unexplained liver problems with
jaundice, fever, and an
increased number of a certain type of white blood cells.
-
you have a known or suspected susceptibility to malignant h

Summary of Product characteristics

Health Products Regulatory Authority
04 March 2024
CRN00DHXV
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sevoflurane Baxter, 100%, inhalation vapour, liquid
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sevoflurane 100%
Excipient with known effect: None
The medicinal product is comprised only of the active substance, 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.
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
The concentration of sevoflurane being delivered from a vaporizer
during anaesthesia should be known. This may be
accomplished by using a vaporizer calibrated specifically for
Sevoflurane.
Anaesthesia 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 by inhalation of sevoflurane.
Induction with sevoflurane may be achieved by inhalation of 0.5-1.0%
sevoflurane in oxygen (O
2
) with or without nitrous oxide
(N
2
O), increasing by increments of 0.5-1.0% sevoflurane, to a maximum of
8% in adults and children until the required depth of
anaesthesia is achieved. In adults inspired concentrations of up to 5%
sevoflurane usually produce surgical anaesthesia in less
than two minutes. In children, inspired concentrations of up to 7%
sevoflurane usually produce surgical anaesthesia in less
than two minutes.
_Maintenance of anaesthesia_
Surgical levels of anaesthesia may be maintained by inhalation of
0.5-3% sevoflurane in O
2
with or without concomitant use of
N
2
O.
_Emergence_
Emergence times are generally short following sevoflurane anesthesia.
Therefore, patients may require post-operative pain
relief ear