Cordarone X Intravenous, 150mg/3ml, Concentrate for solution for infusion or slow injection

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Amiodarone hydrochloride

Boleh didapati daripada:

Sanofi-Aventis Ireland Limited T/A SANOFI

Kod ATC:

C01BD; C01BD01

INN (Nama Antarabangsa):

Amiodarone hydrochloride

Dos:

150mg/3 millilitre(s)

Borang farmaseutikal:

Concentrate for solution for infusion

Jenis preskripsi:

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

Kawasan terapeutik:

Antiarrhythmics, class III; amiodarone

Status kebenaran:

Marketed

Tarikh kebenaran:

1984-02-20

Risalah maklumat

PACKAGE LEAFLET: INFORMATION FOR THE USER
CORDARONE® X INTRAVENOUS
150MG/3ML, CONCENTRATE FOR SOLUTION FOR
INFUSION OR SLOW INJECTION
amiodarone hydrochloride
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READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START HAVING THIS
MEDICINE
•
Keep this leaflet. You may need to read it again
•
If you have any further questions, ask your doctor, nurse or
pharmacist
•
This medicine has been prescribed for you. Do not pass it on to oth-
ers. It may harm them, even if their symptoms are the same as yours
•
If any of the side effects gets serious, or if you notice any side
effects
not listed in this leaflet, please tell your doctor or pharmacist
IN THIS LEAFLET:
1. What Cordarone X is and what it is used for
2. What you need to know before you take Cordarone X
3. How Cordarone X is given
4. Possible side effects
5. How to store Cordarone X
6. Further information
1. WHAT CORDARONE X IS AND WHAT IT IS USED FOR
Cordarone X Intravenous 150mg/3ml concentrate for solution for infu-
sion or slow injection (called Cordarone X 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
‘arrhyth-
mias’). Having the injection helps your heartbeat to return to
normal.
Cordarone X is normally only given in a hospital when a quick response
is needed or when tablets cannot be given. Cordarone X 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’. Cordarone X is used only when
other
medicines can not be used
•
Treat fast heartbeats which may happen suddenly and may be uneven.
Cordarone X is used only when other medicines cannot be used 2. WHAT YOU NEED TO KNOW BEFORE

Ciri produk

Health Products Regulatory Authority
10 June 2022
CRN00CZ71
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cordarone X Intravenous, 150mg/3ml, Concentrate for solution for
infusion or slow injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 3 ml ampoule contains 150mg Amiodarone Hydrochloride (50mg/ml).
Excipients: contains benzyl alcohol 20mg/ml (60mg per 3ml ampoule).
_For a full list of excipients, see section 6.1._
3 PHARMACEUTICAL FORM
Concentrate for Solution for infusion or slow injection (sterile
concentrate).
Colourless glass ampoule containing a clear, pale yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment should be initiated and normally monitored only under
hospital or specialist supervision. Cordarone X Intravenous 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.
Atrial flutter and fibrillation when other drugs cannot be used.
All types of tachyarrhythmias including supraventricular, nodal and
ventricular tachycardias, ventricular fibrillation, when other
drugs cannot be used.
Intravenous Cordarone can be used where a rapid response is required
or where oral administration is not possible.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Cordarone X Intravenous should only be used when facilities exist for
cardiac monitoring, defibrillation and cardiac pacing.
Cordarone X Intravenous may be used prior to DC cardioversion.
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 250ml 5% dextrose.
This may be followed by repeat infusions up to 1200mg,
(approximately 15mg/kg bodyweight) in up to 500ml 5% dextrose per 24
hours, the rate of infusion being adjusted on the
basis of clinical response. (_See Section 4.4_).
In extreme clinical emergency the drug may, at the discretion