Sevoflurane 100% Inhalation Vapour, liquid

Maa: Malta

Kieli: englanti

Lähde: Medicines Authority

Aktiivinen ainesosa:

SEVOFLURANE

Saatavilla:

Piramal Critical Care B.V. Rouboslaan 32 (ground floor), 2252 TR, Voorschoten, Netherlands

ATC-koodi:

N01AB08

INN (Kansainvälinen yleisnimi):

SEVOFLURANE 100 %

Lääkemuoto:

INHALATION VAPOUR, LIQUID

Koostumus:

SEVOFLURANE 100 %

Prescription tyyppi:

POM

Terapeuttinen alue:

ANESTHETICS

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2012-02-24

Pakkausseloste

Page 1 of 9
PACKAGE 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 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.
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 hypersensitiv

Valmisteyhteenveto

Page 1 of 19
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
Posology
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.
Page 2 of 19
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% 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 inhalati