CORDARONE INJECTION 150 mg3 ml

Land: Singapore

Språk: engelska

Källa: HSA (Health Sciences Authority)

Aktiva substanser:

AMIODARONE HCl

Tillgänglig från:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

ATC-kod:

C01BD01

Dos:

150 mg/3 ml

Läkemedelsform:

INJECTION

Sammansättning:

AMIODARONE HCl 150 mg/3 ml

Administreringssätt:

INTRAVENOUS

Receptbelagda typ:

Prescription Only

Tillverkad av:

SANOFI WINTHROP INDUSTRIE

Bemyndigande status:

ACTIVE

Tillstånd datum:

1988-05-06

Bipacksedel

CORDARONE 
AMIODARONE HYDROCHLORIDE 150MG/3ML 
SOLUTION FOR INJECTION IN AMPOULES 
[SANOFI LOGO] 
COMPOSITION: 
Each 3ml ampoule contains 150mg amiodarone hydrochloride. 

PHARMACEUTICAL FORM 
Solution for injection. 

CLINICAL PARTICULARS 
THERAPEUTIC INDICATIONS 
Treatment should be initiated and normally monitored only under
hospital or specialist supervision. 
Cordarone 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. 
All types of tachyarrhythmias including supraventricular, nodal and
ventricular tachycardias; atrial flutter 
and fibrillation; ventricular fibrillation; when other drugs cannot
be used. 
Cordarone Intravenous can be used where a rapid response is
required or where oral administration is 
not possible. 
Cardiopulmonary resuscitation in the event of cardiac arrest related
to ventricular fibrillation resistant to 
external electric shock. 

POSOLOGY AND METHOD OF ADMINISTRATION 
Cordarone Intravenous should only be used when facilities exist for
cardiac monitoring, defibrillation, and 
cardiac pacing. 
Cordarone 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 infusion 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 Special _
_Warnings and Special Precautions for Use). _
In extreme clinical emergency the drug may, at the discretion of
the clinician, be given as a slow injection 
of 150-300mg in 10-20ml 5% dextrose over a minimum of 3 minutes.
This should not be repeated for at 
l

Produktens egenskaper

Cordarone
Amiodarone Hydrochloride 150mg/3ml
Solution for injection in ampoules
[sanofi logo]
Composition:
Each 3ml ampoule contains 150mg amiodarone hydrochloride.
Pharmaceutical Form
Solution for injection.
Clinical Particulars
Therapeutic Indications
Treatment should be initiated and normally monitored only under
hospital or specialist supervision.
Cordarone 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.
All types of tachyarrhythmias including supraventricular, nodal and
ventricular tachycardias; atrial flutter
and fibrillation; ventricular fibrillation; when other drugs cannot be
used.
Cordarone Intravenous can be used where a rapid response is required
or where oral administration is
not possible.
Cardiopulmonary resuscitation in the event of cardiac arrest related
to ventricular fibrillation resistant to
external electric shock.
Posology and Method of Administration
Cordarone Intravenous should only be used when facilities exist for
cardiac monitoring, defibrillation, and
cardiac pacing.
Cordarone 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 infusion 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 Special
Warnings and Special Precautions for Use).
In extreme clinical emergency the drug may, at the discretion of the
clinician, be given as a slow injection
of 150-300mg in 10-20ml 5% dextrose over a minimum of 3 minutes. This
should not be repeated for at
least 15 minutes. Patients treated in this way with Cordarone
Intravenous must be closely monitored, e.g.
in an intensive care unit. (see Special Warning