Cordarone Solution for IV Injection 150mg/3ml

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

AMIODARONE HYDROCHLORIDE

Available from:

Sanofi Malta Limited

ATC code:

C01BD01

INN (International Name):

AMIODARONE HYDROCHLORIDE

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

AMIODARONE HYDROCHLORIDE 150 milligram(s)

Prescription type:

POM

Therapeutic area:

CARDIAC THERAPY

Authorization status:

Authorised

Authorization date:

2005-11-30

Patient Information leaflet

1
READ ALL OF THIS LEAFLET CAREFULLY BEFORE TAKING THIS MEDICINE. IT
CONTAINS IMPORTANT INFORMATION
REGARDING YOUR TREATMENT.
•
Keep this leaflet as 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. Do not pass it on to
others. It may harm them, even
if their symptoms 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.
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 ANTIARRHYTHMIC - ATC CODE:
C01DX12
This medicine is used to treat certain serious heartbeat problems and
to resuscitate patients
experiencing cardiac arrest where a defibrillator (medical device that
delivers electric shocks to
restore normal heartbeat) has not worked to stop ventricular
fibrillation (heartbeat problem that
stops the heart from pumping blood properly).
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 IN THE
FOLLOWING SITUATIONS:
•
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 a full list of
ingredients.
• if you have hyperthyroidism (disease of the thyroid gland),
• if you have certain problems with your heartbe

Summary of Product characteristics

1 of 16
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
Excipients : benzyl alcohol
For the full list of excipients, see Section 6.1.
3. PHARMACEUTICAL FORM
solution for injection
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Cordarone solution for IV injection is indicated for the 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 formulation of the 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 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: on average 5 mg/kg in glucose solution, preferably
using an electric syringe, administered over 20
minutes to 2 hours and repeated 2 or 3 times per 24-hour period.
The eff