Sevorane 100% v/v Inhalation Gas

מדינה: מלטה

שפה: אנגלית

מקור: Medicines Authority

מרכיב פעיל:

SEVOFLURANE

זמין מ:

AbbVie Limited Citywest Business Campus, Dublin 24, Ireland

קוד ATC:

N01AB08

INN (שם בינלאומי):

SEVOFLURANE 100 % (V/V)

טופס פרצבטיות:

INHALATION GAS

הרכב:

SEVOFLURANE 100 % (V/V)

סוג מרשם:

POM

איזור תרפויטי:

ANESTHETICS

מצב אישור:

Authorised

תאריך אישור:

2006-05-31

עלון מידע

PACKAGE LEAFLET: INFORMATION FOR THE USER
SEVORANE 100% V/V INHALATION GAS
(SEVOFLURANE)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have further questions, ask your doctor, surgeon or
anaesthetist.
-
If you get any side effects, talk to your doctor or anaesthetist. This
includes any possible side effects not
listed in this leaflet. See section 4.
What is in this leaflet:
1.
What Sevorane is and what it is used for
2.
What you need to know before receiving Sevorane
3.
How Sevorane is given
4.
Possible side effects
5.
How to store Sevorane
6.
Contents of the pack and other information
1.
WHAT SEVORANE IS AND WHAT IT IS USED
FOR
Sevorane contains the active ingredient sevoflurane. Sevoflurane
belongs to a group of medicines called
anaesthetics.
Sevorane is an anaesthetic that is breathed in (inhaled), and is used
to induce and maintain a deep, pain-
free sleep (general anaesthesia) in adults and children during an
operation. If Sevorane is used in dental
operations these must be performed in a hospital or day care unit.
2.
WHAT YOU NEED TO KNOW BEFORE RECEIVING SEVORANE
DO NOT RECEIVE SEVORANE;
•
If you have been told previously that you should not receive general
anaesthesia.
•
If you know that you are ALLERGIC to sevoflurane or any other
anaesthetics, or any of the other
ingredients in Sevorane.
•
If you or any member of your family has experienced a condition called
malignant hyperthermia (rapid
rise in body temperature) during an operation with Sevorane or any
other anaesthetic.
•
If you are undergoing dental procedures outside a hospital or day care
unit.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR ANAESTHETIST BEFORE RECEIVING SEVORANE IF;
•
you have any other illness not connected to your operation, such as
kidney, brain or heart problems,
severe headaches, feeling sick or being sick.
•
you have liver problems. Some anaesthetics can occasionally cause
probl

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Sevorane 100% v/v Inhalation Gas
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Contains Sevoflurane 100% v/v.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Inhalation gas.
Nonflammable, volatile liquid
_ _
for administration as an inhalation anaesthetic.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Sevoflurane is indicated for induction and maintenance of general
anaesthesia in adult and
paediatric patients. Use of sevoflurane in dental anaesthesia should
be restricted to hospitals
or day care units only (see section 4.3).
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:
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. 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 IN
OXYGEN
SEVOFLURANE IN 65%
N
2
0/35%0
2
0 – 1 months*
3.3%
1 - < 6 months
3.0%
6 months - < 3 years
2.8%
2.0%@
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
0/40%0
2
was used
Sevoflurane is similar to Isoflurane in the sensitisation of the
myocardium to the
arrhythmogenic effect of exogenously administered adrenaline. 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