Sevoflurane 100% Inhalation Vapour, liquid

Maa: Malta

Kieli: englanti

Lähde: Medicines Authority

Aktiivinen ainesosa:

SEVOFLURANE

Saatavilla:

Piramal Critical Care Limited

ATC-koodi:

N01AB08

INN (Kansainvälinen yleisnimi):

SEVOFLURANE

Lääkemuoto:

INHALATION VAPOUR, LIQUID

Koostumus:

SEVOFLURANE 100 % (W/W)

Prescription tyyppi:

POM

Terapeuttinen alue:

ANESTHETICS

Valtuutuksen tilan:

Authorised

Pakkausseloste

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:
You have been told previously
that you should not receive general anaesthesia.


you are hypersensitive (or allergy) to sevoflurane or other similar
anaesthetic.


You, or anyone in your family, ar

Valmisteyhteenveto

Page 1 of 21
SUMMARY OF PRODUCT CHARACTERISTICS
SEVOFLURANE 100% INHALATION VAPOUR, LIQUID
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 vaporizer 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.
Page 2 of 21
Table 1: MAC values for Adults and Paediatric patients
according to age
Sevoflurane
100% Inhalation
Vapour, liquid in
Oxygen
Sevoflurane
100% Inhalation
Vapour, liquid in
65%
N
2
O/35% O
2
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. 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 i