Cordarone X Intravenous, 150mg/3ml, Concentrate for solution for infusion or slow injection
*Company:
SANOFIStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 23 July 2024
File name
1.3.2 Cordarone X IV PIL.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 23 July 2024
File name
1.3.2 Cordarone X IV PIL.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - use in children and adolescents
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - dose and frequency
- Change to section 3 - use in children/adolescents
- Change to section 3 - how to take/use
- Change to section 3 - duration of treatment
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Updated on 26 February 2024
File name
cord.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 04 October 2023
File name
1.3.2 Cordarone X IV PIL.pdf
Reasons for updating
- New PIL for medicines.ie
Updated on 30 June 2022
File name
1.3.1.1 Ireland Cordarone X IV SmPC.pdf
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 24 March 2022
File name
Ireland Cordarone X IV PIL.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - use in children and adolescents
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 2 - driving and using machines
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
Free text change information supplied by the pharmaceutical company
Updated on 24 March 2022
File name
1.3.1.1 Ireland Cordarone X IV SmPC.pdf
Reasons for 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 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 02 September 2020
File name
Ireland Cordarone X IV PIL (1).pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 5 - how to store or dispose
Updated on 17 August 2020
File name
1.3.1.1 Ireland Cordarone X IV SmPC.pdf
Reasons for updating
- Change to section 9 - Date of first authorisation/renewal of the authorisation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 05 June 2020
File name
1.3.2.1 Ireland Cordarone IV PIL.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - use in children and adolescents
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
Free text change information supplied by the pharmaceutical company
Updated on 05 June 2020
File name
1.3.1.1 Ireland Cordarone X IV SmPC.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 30 September 2019
File name
1.3.2.1 Ireland IE925 CCDS v21 Aug 19 Cordarone X IV PIL HPRA Approved (25-Sep-2019).pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
Updated on 30 September 2019
File name
1.3.1.1 Ireland IE925 CCDS v21 Aug 19 Cordarone X IV SmPC HPRA Approved (25-Sep-2019).pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Anaesthesia (see sections 4.5 and 4.8):
Before surgery, the anaesthetist should be informed that the patient is taking amiodarone.
Primary Graft Dysfunction post cardiac transplant
In retrospective studies, amiodarone use in the transplant recipient prior to heart transplant has been associated with an increased risk of primary graft dysfunction (PGD).
PGD is a life-threatening complication of heart transplantation that presents as left, right or biventricular dysfunction occurring within the first 24 hours of transplant surgery for which there is no identifiable secondary cause (see Section 4.8). Severe PGD may be irreversible.
For patients who are on the heart transplant waiting list, consideration should be given to use an alternative antiarrhythmic drug as early as possible before transplant.
Section 4.8
Musculoskeletal and Connective Tissue Disorders:
- Not known
Lupus like syndrome.
Injury, poisoning and procedural complications - Frequency not known:
Primary graft dysfunction post cardiac transplant (see Section 4.4)
Updated on 07 May 2019
File name
PIL Cordarone X IV IE805 .pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 28 November 2016
File name
PIL_13362_196.pdf
Reasons for updating
- New PIL for new product
Updated on 28 November 2016
Reasons for updating
- Change to section 6 - manufacturer
Updated on 03 August 2016
Reasons for updating
- Change to warnings or special precautions for use
Updated on 14 June 2016
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 14 June 2016
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 12 February 2016
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Gastrointestinal disorders:
Common- constipation
Unommon- dry mouth
Not know- pancreatitis/ acute pancreatitis
Updated on 22 October 2015
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 17 September 2015
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Severe bradycardia
Cases of severe, potentially life-threatening bradycardia and heart block have been observed when amiodarone is used in combination with sofosbuvir alone or in combination with another hepatitis C virus (HCV) direct acting antiviral (DAA), such as daclatasvir, simeprevir, or ledipasvir. Therefore, coadministration of these agents with amiodarone is not recommended.
If concomitant use with amiodarone cannot be avoided, it is recommended that patients are closely monitored when initiating sofosbuvir alone or in combination with other DAAs. Patients who are identified as being at high risk of bradyarrhythmia should be continuously monitored for at least 48 hours in an appropriate clinical setting after initiation of the concomitant treatment with sofosbuvir.
Due to the long half-life of amiodarone, appropriate monitoring should also be carried out for patients who have discontinued amiodarone within the past few months and are to be initiated on sofosbuvir alone or in combination with other direct DAA’s.
Patients receiving these hepatitis C medicines with amiodarone, with or without other medicines that lower heart rate, should be warned of the symptoms of bradycardia and heart block and should be advised to seek urgent medical advice if they experience them.
Section 4.5 updated with the following:
OTHER DRUG INTERACTIONS WITH CORDARONE
Coadministration of amiodarone with sofosbuvir alone or in combination with another HCV direct acting antiviral (such as daclatasvir, simeprevir or ledipasvir) is not recommended as it may lead to serious symptomatic bradycardia.
If coadministration cannot be avoided, cardiac monitoring is recommended.
Updated on 30 July 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 11 May 2015
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
· Very rare
Syndrome of inappropriate antidiuretic hormone secretion (SIADH)
Updated on 07 November 2014
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Severe bullous reactions
Life threatening or even fatal cutaneous reactions Stevens-Johnson syndrome (SJS), Toxic Epidermal Necrolysis (TEN) (see section 4.8). If symptoms or signs of SJS, TEN (e.g. progressive skin rash often with blisters or mucosal lesions) are present amiodarone treatment should be discontinued immediately.
Section 4.5 updated to add 'e.g. rhabdomyolsis' under CYP P450 3A4 substrates, Statins.
Section 4.8 to add the following:
Under 'Blood and lymphatic system disorders': Neutropenia, agranulocytosis as Not known.
Under 'Gastrointestinal disorders': Pancreatitis/acute pancreatitis, dry mouth, constipation as Not known.
Under 'Nervous system disorders': Parkinsomism, parosmia as Not known.
New paragraph 'Psychiatric disorders' which includes Confusional state/delirium, hallucination as not known.
Under 'Reproductive system and breast disorders': Libido decreased as not known.
Under 'Skin and subcutaneous tissue disorders, new text after urticaria.
Under 'Immune system disorders': anaphylactic/anaphylactoid reaction including shock as not known
New paragraph 'Metabolism and nutrition disorders'.
Reporting of suspected adverse reactions updated.
Updated on 05 November 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 01 July 2014
Reasons for updating
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 13 December 2013
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Bulk Type II. I.C.4 variation submitted following a Global Labelling Review for Amiodarone. The updates reflect safety data presented in CCDS versions 14 & 15 and relate to sections 4.4, 4.5, 4.8 & 5.2 of the SPC.
Updated on 09 December 2013
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 10 September 2013
Reasons for updating
- 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 4.2 - Posology and method of administration
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Bulk Type IB variation to update the SPCs in line with Article 45
Updated on 29 August 2013
Reasons for 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
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The safety and efficacy of Cordarone X Intravenous in children has not been established. Currently available data are described in sections 5.1 and 5.2.
Due to the presence of benzyl alcohol, Cordarone X Intravenous administration is contraindicated in newborns or premature neonates, infants and children up to 3 years old.
The safety and efficacy of amiodarone in paediatric patients have not been established. It is not recommended for use in children and is contra-indicated for children under the age of 3 years (see section 4.3).
Section 4.3 updated to include:
Due to the presence of benzyl alcohol, which has been associated with reports of fatal 'gasping syndrome' in neonates, Cordarone X Intravenous is contraindicated in newborns or premature neonates, infants and young children up to 3 years old. (One ampoule contains 60mg of benzyl alcohol)
Section 4.4 - Paediatric patients section updated:
Cordarone X IV contains benzyl alcohol (20 mg/ml).
Benzyl alcohol may cause toxic reactions and allergic reactions in infants and children up to 3 years old.
The safety and efficacy of amiodarone in paediatric patients have not been established. Therefore its use in paediatric patients is not recommended.
Cordarone X IV ampoules contain benzyl alcohol.There have been reports of fatal 'gasping syndrome' in neonates (children less than one month of age) following the administration of intravenous solutions containing this preservative benzyl alcohol. Symptoms include a striking onset of gasping syndrome, hypotension, bradycardia, and cardiovascular collapse (see section 4.3).
Section 5.1 updated to include:
No controlled paediatric studies have been undertaken.
In published studies the safety of amiodarone was evaluated in 1118 paediatric patients with various arrhythmias. The following doses were used in paediatric clinical trials.
Oral
- Loading dose: 10 to 20 mg/kg/day for 7 to 10 days (or 500 mg/m2/day if expressed per square meter)
- Maintenance dose: the minimum effective dosage should be used; according to individual response, it may range between 5 to 10 mg/kg/day (or 250 mg/m2/day if expressed per square meter)
Intravenous
- Loading dose: 5 mg/kg body weight over 20 minutes to 2 hours,
- Maintenance dose: 10 to 15 mg/kg/day from few hours to several days
If needed oral therapy may be initiated concomitantly at the usual loading dose.
Section 5.2 updated to include:
No controlled paediatric studies have been undertaken. In the limited published data available in paediatric patients, there were no differences noted compared to adults.
Updated on 23 August 2013
Reasons for updating
- Change to, or new use for medicine
Updated on 27 November 2012
Reasons for updating
- Change of manufacturer
Updated on 13 April 2012
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 08 April 2011
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.4: Special Warnings and Precautions for use
Section 4.5: Interaction with other medicinal products and other forms of interaction
Updated on 07 April 2011
Reasons for updating
- Change to drug interactions
Updated on 21 July 2009
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update Section 4.8 - addition of urticaria as side effect
Updated on 17 July 2009
Reasons for updating
- Change due to user-testing of patient information
Updated on 14 July 2008
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 14 July 2008
Reasons for updating
- New PIL for medicines.ie
Updated on 26 March 2008
Reasons for 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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 12 February 2008
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 06 February 2008
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
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Updated on 21 November 2007
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 3 - Pharmaceutical form
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 06 July 2007
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 14 March 2007
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 17 May 2005
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 03 August 2004
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 01 July 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 26 June 2003
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)