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ADENOCOR Solution for injection (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Adenocor 3 mg/ml Solution for injection.

Qualitative and quantitative composition

Each vial contains 6 mg of adenosine per 2 ml (3 mg/ml). For the full list of excipients, see section 6.1.

Pharmaceutical form

Solution for injection. Clear, colourless solution.

Therapeutic indications

Rapid conversion to a normal sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory by-pass tracts (Wolff-Parkinson-White Syndrome). Paediatric population ...

Posology and method of administration

Adenocor is intended for hospital use only with monitoring and cardiorespiratory resuscitation equipment available for immediate use. Method of administration It should be administered by rapid IV bolus ...

Contraindications

Adenocor is contraindicated for patients presenting: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Sick sinus syndrome, second or third degree Atrio-Ventricular ...

Special warnings and precautions for use

Special warnings Due to the possibility of transient cardiac arrhythmias arising during conversion of the supraventricular tachycardia to normal sinus rhythm, administration should be carried out in a ...

Interaction with other medicinal products and other forms of interaction

Dipyridamole inhibits adenosine cellular uptake and metabolism, and potentiates the action of adenosine. In one study dipyridamole was shown to produce a 4 fold increase in adenosine actions. Asystole ...

Pregnancy and lactation

Pregnancy There are no or limited amount of data from the use of adenosine in pregnant women. Animal studies are insufficient with respect to reproductive toxicity. Adenosine is not recommended during ...

Effects on ability to drive and use machines

Not applicable.

Undesirable effects

These side effects are generally mild, of short duration (usually less than 1 minute) and well tolerated by the patient. However severe reactions can occur. Methylxanthines, such as IV aminophylline or ...

Overdose

Overdose would cause severe hypotension, bradycardia or asystole. The half-life of adenosine in blood is very short, and side effects (when they occur) would quickly resolve. Administration of IV aminophylline ...

Pharmacodynamic properties

Pharmacotherapeutic group: Other Cardiac Preparations ATC Code: C01EB10 Endogenous nucleoside with peripheral vasodilator/antiarrhythmic effect; antiarrhythmic drug. Adenosine is a purine nucleoside which ...

Pharmacokinetic properties

Adenosine is impossible to study via classical ADME protocols. It is present in various forms in all cells of the body where it plays an important role in energy production and utilisation systems. An ...

Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

List of excipients

Sodium chloride Water for injections

Incompatibilities

Compatibility with other medicines is not known.

Shelf life

Shelf life: 3 years. Any portion of the vial not used at once should be discarded.

Special precautions for storage

Do not refrigerate.

Nature and contents of container

Clear, type I glass vials with chlorobutyl rubber closures secured with aluminium caps. Packs of 6 vials in plastic trays in cardboard cartons.

Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Marketing authorization number(s)

PL 04425/0159

Date of first authorization / renewal of the authorization

Date of first authorisation: 01 September 2010

Date of revision of the text

15 August 2019

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