Amiodarone Ibigen 150mg/3 ml Concentrate for Solution for Injection/Infusion

Pays: Malte

Langue: anglais

Source: Medicines Authority

Achète-le

Ingrédients actifs:

AMIODARONE HYDROCHLORIDE

Disponible depuis:

Ibigen S.r.L Via Fossignano, 2, 04011 Aprilia (LT), Italy

Code ATC:

C01BD01

DCI (Dénomination commune internationale):

AMIODARONE HYDROCHLORIDE 150 mg

forme pharmaceutique:

CONCENTRATE FOR SOLUTION FOR INFUSION OR INJECTION

Composition:

AMIODARONE HYDROCHLORIDE 150 mg

Type d'ordonnance:

POM

Domaine thérapeutique:

CARDIAC THERAPY

Statut de autorisation:

Authorised

Date de l'autorisation:

2012-11-27

Notice patient

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PACKAGE LEAFLET: INFORMATION FOR THE USER
AMIODARONE IBIGEN 150MG/3ML CONCENTRATE FOR SOLUTION FOR
INJECTION/INFUSION
Amiodarone hydrochloride
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, pharmacist or
nurse
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Amiodarone Ibigen is and what it is used for
2.
What you need to know before you use Amiodarone Ibigen
3.
How to use Amiodarone Ibigen
4.
Possible side effects
5.
How to store Amiodarone Ibigen
6.
Contents of the pack and other information
1.
WHAT AMIODARONE IBIGEN IS AND WHAT IT IS USED FOR
Amiodarone Ibigen 150mg/3ml Concentrate for Solution for
Injection/Infusion (called Amiodarone
Ibigen in this leaflet) contains a medicine called amiodarone
hydrochloride. This belongs to a group
of medicines called anti-arrhythmics.
It works by controlling the uneven beating of your heart (called
‘arrhythmias’). Having the injection
helps your heartbeat to return to normal.
Amiodarone Ibigen is normally only given in a hospital when a quick
response is needed or when
tablets cannot be given.
Amiodarone Ibigen can be used to:
•
Treat uneven heartbeats where other medicines either have not worked
or cannot be used
•
Treat an illness called Wolff-Parkinson-White Syndrome. This is where
your heart beats
unusually fast
•
Treat other types of fast or uneven heartbeats known as ‘atrial
flutter’ or ‘atrial fibrillation’.
Amiodarone Ibigen is used only when other medicines can not be used
•
Treat fast heartbeats which may happen suddenly and may be uneven.
Amiodarone Ibigen is
used only when other medicines cannot be used
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE AMIODARONE IBIGEN
DO NOT USE THIS MEDICINE AND TELL YOUR DOCTOR, PHARMACI
                                
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Résumé des caractéristiques du produit

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Amiodarone Ibigen 150 mg/3 ml Concentrate for Solution for
Injection/Infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 3 ml ampoule contains 150 mg amiodarone hydrochloride.
Excipient with known effect
Benzyl alcohol
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for Solution for Injection/Infusion.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment should be initiated and normally monitored only under
hospital or specialist supervision.
Amiodarone Ibigen is indicated only for the treatment of severe rhythm
disorders not responding to
other therapies or when other treatments cannot be used:

tachyarrhythmias associated with Wolff-Parkinson-White syndrome

all
other
types
of
tachyarrhythmias
including
supraventricular,
nodal
and
ventricular
tachycardias, atrial flutter and fibrillation, ventricular
fibrillation, when other drugs cannot be
used.
Amiodarone Ibigen can be used where a rapid response is required or
where oral administration is
not possible.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Amiodarone Ibigen should only be used when facilities exist for
cardiac monitoring, defibrillation,
and cardiac pacing (see section 6.6).
Amiodarone Ibigen may be used prior to direct current (DC)
cardioversion.
Posology
Adults
_Infusion _
_Loading dose_
:
The standard recommended dose is 5mg/kg bodyweight given by
intravenous infusion over a period
of 20 minutes to 2 hours. This should be administered as a dilute
solution in 250 ml 5% dextrose.
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This may be followed by repeat infusion up to 1200 mg (approximately
15 mg/kg bodyweight) in
up to 500 ml 5% dextrose per 24 hours, the rate of infusion being
adjusted on the basis of clinical
response (see section 4.4).
The therapeutic effect is visible in the first minutes, then decreased
gradually, and should be
followed by a maintenance infusion.
_Maintenance dose: _
10 - 20 mg per kg bw in physiological glucose solution ev
                                
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