Cordarone 150mg/3ml, Solution for IV Injection in ampoules

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

AMIODARONE HYDROCHLORIDE

Available from:

Sanofi S.R.L Viale L. Bodio, 37/b 20158, Milan, Italy

ATC code:

C01BD01

INN (International Name):

AMIODARONE HYDROCHLORIDE 50 mg/ml

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

AMIODARONE HYDROCHLORIDE 50 mg/ml

Prescription type:

POM

Therapeutic area:

CARDIAC THERAPY

Authorization status:

Authorised

Authorization date:

2005-11-30

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CORDARONE 150 MG/3 ML SOLUTION FOR (IV) INJECTION IN AMPOULES,
AMIODARONE HYDROCHLORIDE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Cordarone 150 mg/3 mL solution for (IV) injection in ampoules is
and what it is used for
2.
What you need to know before you use Cordarone 150 mg/3 mL solution
for (IV) injection in
ampoules
3.
How to use Cordarone 150 mg/3 mL solution for (IV) injection in
ampoules
4.
Possible side effects
5.
How to store Cordarone 150 mg/3 mL solution for (IV) injection in
ampoules
6.
Contents of the pack and other information
1.
WHAT CORDARONE 150 MG/3 ML SOLUTION FOR (IV) INJECTION IN AMPOULES IS
AND WHAT IT IS USED FOR
PHARMACOTHERAPEUTIC GROUP: CLASS III ANTIARRHYTHMICS, ATC CODE:
C01BD01
This medicine is used to treat certain serious heartbeat problems and
to resuscitate patients experiencing
cardiac arrest where a defibrillator has not worked to stop
ventricular fibrillation.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE CORDARONE 150 MG/3 ML SOLUTION
FOR (IV) INJECTION IN
AMPOULES
DO NOT USE CORDARONE 150 MG/3 ML SOLUTION FOR (IV) INJECTION IN
AMPOULES:
•
If you are allergic to iodine.
•
If you are allergic to the active substance, amiodarone, or any of the
other ingredients of Cordarone
150 mg/3 mL solution for (IV) injection in ampoules. See section 6 for
the full list of ingredients.
•
If you have hyperthyroidism (disease of the thyroid gland).
•
If you have certain problems with your heartbeat or problems with the

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Cordarone 150 mg/3 mL solution for (IV) injection in ampoules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Amiodarone hydrochloride
...........................................................................................................
150 mg
For one 3 mL ampoule.
Excipient with known effect: benzyl alcohol 60 mg in each 3 mL ampoule
(see section 4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Treatment of serious rhythm disorders when oral treatment cannot be
used, i.e.:
•
Atrial arrhythmias with ventricular tachycardia.
•
Tachycardias associated with Wolff-Parkinson-White syndrome.
•
Documented, symptomatic and incapacitating ventricular arrhythmias.
Cardiopulmonary resuscitation of shock-resistant ventricular
fibrillation in patients experiencing cardiac
arrest.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
For reasons related to the pharmaceutical form of the medicinal
product, concentrations used must not be
less than the equivalent of 2 ampoules per 500 mL. Use only isotonic
glucose solution as the infusion
vehicle.
Do not add any other products to the infusion vehicle.
Amiodarone must be administered via the central venous route, except
during cardiopulmonary
resuscitation of shock-resistant ventricular fibrillation in patients
experiencing cardiac arrest, in which case
the peripheral route may be used if the central venous route is not
available (see section 4.4 “Special
warnings and precautions for use”).
Serious arrhythmias when treatment via the oral route is not
appropriate, except during cardiopulmonary
resuscitation of shock-resistant ventricular fibrillation in patients
experiencing cardiac arrest:
Infusion via the central venous route
•
LOADING DOSE:
The usual loading dose is 5 mg/kg in glucose solution, preferably
using an electric
syringe, administered over a period of between 20 minutes to 2 hours .
This may b