CORDARONE X Solution for injection (2017)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Cordarone X 150mg/3ml Solution for Injection.
Qualitative and quantitative composition
Each 3ml ampoule contains 150mg amiodarone hydrochloride. For excipients, see 6.1.
Pharmaceutical form
Solution for injection.
Therapeutic indications
Treatment should be initiated and normally monitored only under hospital or specialist supervision. Cordarone X Intravenous is indicated only for the treatment of severe rhythm disorders not responding ...
Posology and method of administration
Cordarone X Intravenous should only be used when facilities exist for cardiac monitoring, defibrillation, and cardiac pacing. Cordarone X Intravenous may be used prior to DC cardioversion. The standard ...
Contraindications
Sinus bradycardia and sino-atrial heart block. In patients with severe conduction disturbances (high grade AV block, bifascicular or trifascicular block) or sinus node disease, Cordarone X should be used ...
Special warnings and precautions for use
Amiodarone injection 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 administration of medications containing ...
Interaction with other medicinal products and other forms of interaction
Drugs inducing Torsade de Pointes or prolonging the QT interval Some of the more important drugs that interact with amiodarone include warfarin, digoxin, phenytoin and any drug which prolongs the QT interval. ...
Pregnancy and lactation
Pregnancy There are insufficient data on the use of amiodarone during pregnancy in humans to judge any possible toxicity. However, in view of its effect on the foetal thyroid gland, amiodarone is contraindicated ...
Effects on ability to drive and use machines
Not relevant.
Undesirable effects
The following adverse reactions are classified by system organ class and ranked under heading of frequency using the following convention: very common (>=10%), common (≥1% and <10%); uncommon (≥0.1% and ...
Overdose
There is no information regarding overdosage with intravenous amiodarone. Little information is available regarding acute overdosage with oral amiodarone. Few cases of sinus bradycardia, heart block, attacks ...
Pharmacodynamic properties
Cordarone is a product for the treatment of tachyarrhythmias and has complex pharmacological actions. Its effects are anti-adrenergic (partial alpha and beta blocker). It has haemodynamic effects (increased ...
Pharmacokinetic properties
Amiodarone is metabolised mainly by CYP3A4, and also by CYP2C8, however the pharmacokinetics of amiodarone are unusual and complex, and have not been completely elucidated. Absorption following oral administration ...
Preclinical safety data
In a 2-years carcinogenicity study in rats, amiodarone caused an increase in thyroid follicular tumours (adenomas and/or carcinomas) in both sexes at clinical relevant exposures. Since mutagenicity findings ...
List of excipients
Benzyl alcohol Polysorbate Water for injections
Incompatibilities
Cordarone X Intravenous is incompatible with saline and should be administered solely in 5% dextrose solution. Cordarone X Intravenous, diluted with 5% dextrose solution to a concentration of less than ...
Shelf life
24 months.
Special precautions for storage
Do not store above 25°C. Store in the original container.
Nature and contents of container
Cordarone X 150mg/3ml Solution for Injection is supplied in boxes containing 6 or 10 glass ampoules. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
Refer to 4.2 above.
Marketing authorization holder
Aventis Pharma Limited, One Onslow Street, Guildford, Surrey, GU1 4YS, UK or trading as: Sanofi-aventis or Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
Marketing authorization number(s)
PL 04425/0643
Date of first authorization / renewal of the authorization
Date of first authorisation: 31 July 2010
Date of revision of the text
06 April 2017
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