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sanofi-aventis
1 Onslow Street, Guildford, Surrey, GU1 4YS, UK
Telephone: +44 (0)1483 505 515
Fax: +44 (0)1483 535 432
Medical Information e-mail: uk-medicalinformation@sanofi-aventis.com

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 01/12/2011
SPC Cordarone X Intravenous

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 01/12/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
Date of revision of text on the SPC:   22-Jul-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 1 - name changed to

Cordarone X 150mg/3ml Solution for Injection
Updated on 26/07/2011 and displayed until 01/12/2011
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   22-Jun-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


The product name in the SPC has been updated in line with the rest of the product literature.
Updated on 15/04/2011 and displayed until 26/07/2011
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
Date of revision of text on the SPC:   06-Apr-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
section 4.2 - data on paediatric doses moved to 5.1 and 5.2. addition of contraindication for use in neonate and infants upto 3 years old
Section 4.3 - contraindication for use in neonates etc.
Section 4.4 - Addition of statement noting that product contains benzyl alcohol.
Section 5.1 and 5.2 - addition of paediatric statement and data
Updated on 15/03/2011 and displayed until 15/04/2011
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   28-Feb-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
The following changes have been made to the SPC for Cordarone X IV,

Section 4.4- Following wording added-

Endocrine disorders (see section 4.8)

Amiodarone IV may induce hyperthyroidism, particularly in patients with a personal history of thyroid disorders or patients who are taking/have previously taken oral amiodarone. Serum usTSH level should be measured when thyroid dysfunction is suspected.

 

Amiodarone contains iodine and thus may interfere with radio-iodine uptake. However, thyroid function tests (free-T3, free-T4, usTSH) remain interpretable. Amiodarone inhibits peripheral conversion of levothyroxine (T4) to triiodothyronine (T3) and may cause isolated biochemical changes (increase in serum free-T4, free-T3 being slightly decreased or even normal) in clinically euthyroid patients. There is no reason in such cases to discontinue amiodarone treatment if there is no clinical or further biological (usTSH) evidence of thyroid disease.


Section 4.8- new section added for endocrine disorders and following text added: Frequency unknown: hyperthyroidism (see section 4.4)

Section 10- revision date changed to 28/02/2011
Updated on 19/01/2011 and displayed until 15/03/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   05-Jan-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Update to Section 4.8 to include "back pain"
Updated on 17/08/2010 and displayed until 19/01/2011
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
  • Change of Marketing Authorisation Holder
Date of revision of text on the SPC:   31-Jul-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change of ownership from Aventis Pharma Limited to Sanofi- aventis and hence there have been subsequent changes to sections 7,8,9 and 10.

The above mentioned sections have been changed to the following:

7: Marketing authouristaion holder changed to sanofi-aventis at One Onslow street, Guildford, Surrey, GU1 4YS

8: Marketing authourisation Number changed to- PL 04425/0643

9: Date of first authourisation/renewal changed to 31/07/2010

10: Date of revision of the text changed to 31/07/2010

 




 

The above mentioned sections have been changed to the following:7: Marketing authouristaion holder changed to sanofi-aventis at One Onslow street, Guildford, Surrey, GU1 4YS8: Marketing authourisation Number changed to- PL 04425/06439: Date of first authourisation/renewal changed to 31/07/201010: Date of revision of the text changed to 31/07/2010
Updated on 07/05/2009 and displayed until 17/08/2010
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   30-Mar-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.5: addition to section on interaction of drugs metabolised by CYP450 3A4 concerning statins - increased risk of muscle toxicity.

Section 4.8: addition of urticaria to skin and subcutaneous disorders

Section 10. Change of date to 30 March 2009
Updated on 26/09/2008 and displayed until 07/05/2009
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   01-Nov-2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.8 (undesirable effects): Information regarding angioedema and bone marrow granulomas has been added
Updated on 16/09/2008 and displayed until 26/09/2008
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   01-Nov-2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.8 addition of text:

Blood and lymphatic system disorders: Bone marrow granulomas.

Immune system disorders: Angioedema.
Updated on 08/08/2007 and displayed until 16/09/2008
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   07/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
addition of  'Fluoroquinolones should be avoided in patients receiving amiodarone'
Updated on 19/09/2006 and displayed until 08/08/2007
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   04/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 7 (Marketing Authorisation Holder): Change to MA Holder's address
Updated on 03/05/2006 and displayed until 19/09/2006
Reasons for adding or updating:
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
Date of revision of text on the SPC:   1/4/06
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.5 - Addition of potential interaction with grapefruit juice
Updated on 20/12/2005 and displayed until 03/05/2006
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 5.1 - Pharmacodynamic Properties
Updated on 17/09/2004 and displayed until 20/12/2005
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 (date of (partial) revision of the text
Updated on 26/09/2003 and displayed until 17/09/2004
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.8 - Undesirable Effects
Updated on 06/06/2003 and displayed until 26/09/2003
Reasons for adding or updating:
  • Change to section 4.3 - Contra-indications
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
Updated on 31/01/2003 and displayed until 06/06/2003
Reasons for adding or updating:
  • Change to section 4.3 - Contra-indications
  • Change to section 6.2 - Incompatibilities
Updated on 16/07/2002 and displayed until 31/01/2003
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic Indications
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
Updated on 19/08/2001 and displayed until 16/07/2002
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder

Active Ingredients/Generics

 
  amiodarone hydrochloride