Updated on 20/12/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 1 -Name of the Medicinal product
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Change to section 2 - Qualitative and quantitative composition
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Change to section 4.3 - Contraindications
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 6. 3 - Shelf Life
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Change to section 6. 6 - Instructions for use, handling and disposal
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 13-Dec-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| To update sections 1, 2, 4.3, 4.6, 5.1, 6.3, 6.6 and 10 of the SPC and consequently the leaflet in line with QRD template and EU guidelines.
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Updated on 08/03/2011 and displayed until 20/12/2011
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Change to section 4.2 - Posology and method of administration
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Change to section 4.3 - Contraindications
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 23-Feb-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.2- section has been re-formatted and following text added under peadiatric section: The safety and efficacy of adenosine in children aged 0-18 years old have not been established. No data are available.
Section 4.3: Text has been re-formatted and italicised text has been added;
Known hypersensitivity to adenosine or to any of the excipients.
- Sick sinus syndrome, second or third degree Atrio-Ventricular (AV) block (except in patients with a functioning artificial pacemaker).
- Chronic obstructive lung disease with evidence of bronchospasm (e.g. asthma bronchiale)
- Long QT syndrome
- Severe hypotension
- Decompensated states of heart failure
Section 4.3-
First paragraph- wording of administration should be carried out in hospital with electrocardiographic monitoring, has been replaced with:
out in a hospital setting with monitoring and cardio-respiratory resuscitation equipment available for immediate use if necessary. During administration, continuous ECG monitoring is necessary as life-threatening arrhythmia might occur. (section 4.2).
In paragraph 5- following text has been added at end: especially in patients with prolonged QT intervals.
Paragraph 8: following text has been added: if use of Adenocor is essential, dipyridamole should be stopped 24 hours before hand, or the dose of Adenocor should be greatly reduced.
Under Precautions section- paragraph 1: following guidance has been added: Adenosine may trigger convulsions in patients who are susceptible to convulsions.
Following text has been added under precautions: Adenosine contains 9 mg sodium chloride per ml. (corresponding to 3.54 mg sodium per ml). To be taken into consideration by patients on a controlled sodium diet.
Section 4.5- text has been changed to read:
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 has been reported following concomitant administration.
It is therefore suggested that Adenocor should not be administered to patients receiving dipyridamole; if use of Adenocor is essential, dipyridamole should be stopped 24 hours before hand, or the dose of Adenocor should be greatly reduced. See Section 4.4 Special Warnings and Precautions for Use.
Aminophylline, theophylline and other xanthines are competitive adenosine antagonists and should be avoided for 24 hours prior to use of adenosine.
Food and drinks containing xanthines (tea, coffee, chocolate and cola) should be avoided for at least 12 hours prior to use of adenosine.
section 4.6: guidance has been re-worded and now reads:
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 pregnancy unless the physician considers the benefits to outweigh the potential risks.
Lactation
It is unknown whether adenosine metabolites are excreted in human milk Adenocor should not be used during breast-feeding.
Section 4.8- undersirable effects- frequencies provided for side effects, and side effects have now been added into a table.
Section 4.9- following text has been added: Overdosage 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 or theophylline may be needed.
Section 10: date revised to: 23/02/2011
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Updated on 20/09/2010 and displayed until 08/03/2011
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 01-Sep-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Changes to sections 7,8,9 due to change of ownership
New date of revision
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Updated on 12/05/2009 and displayed until 20/09/2010
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Reasons for adding or updating:
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Change to section 4.3 - Contraindications
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 10-Mar-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.3
Addition of long QT syndrome, severe hypotension and decompensated heart failure
Section 4.4
Addition of wording to reference to section 4.3 for the contraindications in long QT syndrome
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Updated on 06/01/2009 and displayed until 12/05/2009
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 01-Dec-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Addition of text to section 4.4:
Because it has the potential to cause significant hypotension, adenosine should be used with caution in patients with left main coronary stenosis, uncorrected
hypovolemia, stenotic valvular heart disease, left to right shunt, pericarditis or
pericardial effusion, autonomic dysfunction or stenotic carotid artery disease with cerebrovascular insufficiency.
Adenosine should be used with caution in patients with recent myocardial
infarction, heart failure, or in patients with minor conduction defects (first degree A-V block, bundle branch block) that could be transiently aggravated during infusion. Adenosine should be used with caution in patients with atrial fibrillation or flutter and especially in those with an accessory by-pass tract since particularly the latter may develop increased conduction down the anomalous pathway.
Some cases of severe bradycardia have been reported. Some occurred in early post heart transplant patients; in the other cases, occult sino-atrial disease was present. The occurrence of severe bradycardia should be taken as a warning of underlying disease and could potentially favour the occurrence of torsades de pointes.
In patients with recent heart transplantation (less than 1 year) an increased sensitivity of the heart to adenosine has been observed.
Update section 4.8 of the SPC in line with MedDRA organ/class system
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Updated on 03/08/2007 and displayed until 06/01/2009
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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| Date of revision of text on the SPC: 10/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Use of sanofi aventis trading style
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Updated on 19/05/2005 and displayed until 03/08/2007
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Change to section 10 (date of (partial) revision of the text
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Updated on 30/07/2004 and displayed until 19/05/2005
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Change to section 10 (date of (partial) revision of the text
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Updated on 06/06/2003 and displayed until 30/07/2004
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Reasons for adding or updating:
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Change to section 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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Updated on 26/09/2002 and displayed until 06/06/2003
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Reasons for adding or updating:
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Change to section 10 (date of (partial) revision of the text
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Updated on 19/08/2001 and displayed until 26/09/2002
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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