CORDARONE X 200 TABLET

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Sanofi-Aventis South Africa (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

TABLET

Composition:

EACH TABLET CONTAINS AMIODARONE HYDROCHLORIDE 200 mg

Authorization status:

Canceled

Authorization date:

1983-06-05

Patient Information leaflet

Safety Update CDS 12-15: original submission submitted 02.05.2013
BAU-resubmission: Response to 1
st
and 2
nd
CCR (rec 07.04.2016 re-included and 27.06.2019) + CCDS vs 16-21 +
format change
Date submitted 12.01.2021
To be implemented: 12.04.2021
PROPOSED PATIENT INFORMATION LEAFLET (CLEAN COPY)
Page 1 of 13
NADIA LE HANIE
_Regulatory Affairs Manager _
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS:
CORDARONE X INTRAVENOUS concentrated solution for infusion/injection
Each 3 ml ampoule also contains:
organic iodine: approximately 56 mg
benzyl alcohol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU RECEIVE CORDARONE X
INTRAVENOUS:
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, please ask your doctor or your
pharmacist.
•
CORDARONE X INTRAVENOUS has been prescribed for you personally and you
should
not share your medicine with other people. It may harm them, even if
their symptoms are
the same as yours.
WHAT IS IN THIS LEAFLET:
1. What CORDARONE X INTRAVENOUS is and what it is used for
2. What you need to know before you receive CORDARONE X INTRAVENOUS
3. How to receive CORDARONE X INTRAVENOUS
4. Possible side effects
5. How to store CORDARONE X INTRAVENOUS
6. Contents of the pack and other information
PHCR: sanofi aventis south africa (pty) ltd
Product name: CORDARONE X INTRAVENOUS
Re-submission of CCCR response, format change and safety update
(abridged review)
Type 1B amendment
Sequence number: 0003
Safety Update CDS 12-15: original submission submitted 02.05.2013
BAU-resubmission: Response to 1
st
and 2
nd
CCR (rec 07.04.2016 re-included and 27.06.2019) + CCDS vs 16-21 +
format change
Date submitted 12.01.2021
To be implemented: 12.04.2021
PROPOSED PATIENT INFORMATION LEAFLET (CLEAN COPY)
Page 2 of 13
NADIA LE HANIE
_Regulatory Affairs Manager _
1 WHAT CORDARONE X INTRAVENOUS IS AND WHAT IT IS USED FOR:
WHAT CORDARONE X INTRAVENOUS IS USED FOR
CORDARONE X INTRAVENOUS is an antidysrhythmic medicine and is used to
control an
irregular or rapid heart rate where other simi

Summary of Product characteristics

Safety Update CDS 12-15: original submission submitted 02.05.2013
BAU-resubmission: Response to 1
st
and 2
nd
CCR (rec 07.04.2016 and 27.06.2019) re-included + CCDS vs 16-21 +
format change
DATE SUBMITTED 12.01.2021
TO BE IMPLEMENTED: 12.04.2021
PROPOSED PROFESSIONAL INFORMATION (CLEAN COPY)
NADIA LE HANIE
_Regulatory Affairs Specialist _
Page 1 of 26
SCHEDULING STATUS:
S4
1. NAME OF THE MEDICINE:
CORDARONE X
® INTRAVENOUS (Concentrated solution for intravenous (IV)
infusion/injection)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each 3 ml ampoule contains 150 mg amiodarone hydrochloride (50 mg/ml)
organic iodine: approximately 56 mg
Excipient with a known effects: benzyl alcohol
For excipients, see section 6.1.
3. PHARMACEUTICAL FORM:
Clear, pale yellow concentrated solution for intravenous
injection/infusion.
4 CLINICAL PARTICULARS:
4.1 THERAPEUTIC INDICATIONS:
Where rapid response is required in the control of tachydysrhythmias
associated with Wolff-
Parkinson-White-syndrome and other types of tachydysrhythmias of
paroxysmal nature including
supraventricular, nodal and ventricular tachycardias, atrial flutter
and atrial fibrillation and
ventricular fibrillation which have proved to be resistant to other
antidysrhythmic therapy.
PHCR: sanofi aventis south africa (pty) ltd
Product name: CORDARONE X INTRAVENOUS
Re-submission of CCCR response, format change and safety update
(abridged review)
Type 1B amendment
Sequence number: 0003
Safety Update CDS 12-15: original submission submitted 02.05.2013
BAU-resubmission: Response to 1
st
and 2
nd
CCR (rec 07.04.2016 and 27.06.2019) re-included + CCDS vs 16-21 +
format change
DATE SUBMITTED 12.01.2021
TO BE IMPLEMENTED: 12.04.2021
PROPOSED PROFESSIONAL INFORMATION (CLEAN COPY)
NADIA LE HANIE
_Regulatory Affairs Specialist _
Page 2 of 26
Cardiopulmonary resuscitation in the event of cardiac arrest in
adults, caused by ventricular
fibrillation resistant to external electric shock.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION:
POSOLOGY:
Compatibility: Only 5 % dextrose should