SEVOFLURANE 100 %v/v Inhalation Vapour Liquid

Country: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

SEVOFLURANE

Disponibbli minn:

Piramal Healthcare UK Limited

Kodiċi ATC:

N01AB08

INN (Isem Internazzjonali):

SEVOFLURANE

Dożaġġ:

100 %v/v

Għamla farmaċewtika:

Inhalation Vapour Liquid

Tip ta 'preskrizzjoni:

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

Żona terapewtika:

Halogenated hydrocarbons

L-istatus ta 'awtorizzazzjoni:

Authorised

Data ta 'l-awtorizzazzjoni:

2012-01-13

Fuljett ta 'informazzjoni

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, are susceptibl

Karatteristiċi tal-prodott

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 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.
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 O/35% O
0 – 1 months*
3.3%
2.0%**
1 - < 6 months
3.0%
6 months - < 3
2.8%
2
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