sanofi-aventis

Section 4.2: following text has been added: hospitals with monitoring and cardio-respiratory resuscitation equipment available for immediate use if necessary. 

Subheading changed from Children to paediatric population and text changed from the absence of data, the use of Adenoscan^® in children cannot be recommended. To now read;

 
The safety and efficacy of adenosine in children aged 0-18 years old have not been established. No data are available.

Section 4.3: change in wording so that text now reads: Hypersensitivity to the active substance or to any of the excipients. Rather than just known hypersensitivity to adenosine. Also following text added: atrioventricular (AV) and see section 4.5.

Section 4.4: first paragraph has been re-formatted and new paragraph added which reads:

Because it has the potential to cause significant hypotension, Adenoscan^® 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. Adenoscan^® infusion should be discontinued in any patient who develops persistent or symptomatic hypotension

Information on use in paediatric patients has been deleted from this section.

Also additionional information added re: sodium content; 9 mg sodium chloride per ml (corresponding to 3.54 mg sodium per ml).

Section 4.5: following text has been deleted; Adenosine can safely be co-administered with other cardioactive or vasoactive drugs (see Section 5.1) and replaced with

Adenosine may interact with drugs tending to impair cardiac conduction

Section 4.6: text has been reformatted and re-worded but the guidance remains unchanged.

Section 4.7: Not known replaced with Not relevant

Section 4.8: under frequencies- additional criteria for Not known (cannot be estimated from available data). Hypotension specified to be sometimes severe and AV block added under common side effects.

Under cardiac disorders- bradycardia changed from rare to uncommon. And Following text added alongside asystole/ cardiac arrest: especially in patients with underlying ischemic heart disease/cardiac disorders.

Gastrointestinal disorders: abdominal discomfort changed from common to very common. Dry mouth is now classified as common, metallic taste as uncommon and incidence of nausea and vomiting is not known.

 Under general disorders, feeling of thoracic constriction/oppression is now listed as a very common side effect., and feeling of general discomfort, weakness/pain

Are listed as uncommon.

4.9: Following text deleted no case of overdosage identified. And section 10- date changed to 27/04/2011

Section 2: addition of following text: Each 10ml vial of Adenoscan contains 30mg of adenosine (3mg/ml)

Section 4.1: addition of (IV)

Section 5.1: text re-formatted

Section 5.3: following text added: No controlled reproductive studies were conducted in animals with adenosine.

6.3- text re-formatted. ‘see section 6.3’ changed from italicized to not italicized.

6.6: text amended to- Any unused product or waste material should be disposed of in accordance with local requirements.

Section 10 changes to - 3 May 2010

Please note that RED mainly indicates additional info, GREEN changes, and BLUE deleted items

4.4.      Special warnings and precautions for use

The occurrence of respiratory failure (potentially fatal), asystole/cardiac arrest (potentially fatal), angina, severe bradycardia or severe hypotension should also lead to treatment discontinuation.

Adenosine may precipitate or aggravate bronchospasm (see sections 4.3 and 4.8).

4.8.      Undesirable effects

Cardiac Disorders: (previously Cardiovascular system)

- common: Hypotension (see section 4.4), AV block, ST segment depression, sustained or non-sustained ventricular tachycardia. (arrhythmias deleted)

- rare: bradycardia sometimes severe (see section 4.4)

- not known: asystole /Cardiac arrest (some cases with fatal outcome, see section 4.4): sinus tachycardia, atrial fibrillation, ventricular fibrillation  

Respiratory, thoracic and mediastinal disorders: (previously Respiratory system)

- very common: dyspnea (or the urge to breathe deeply)

- rare: bronchospasm (see section 4.4), nasal congestion

- very rare: respiratory failure (see section 4.4) (apnoea moved)

- not known: apnea/respiratory arrest

Cases with fatal outcome of respiratory failure, of bronchospasm, and of apnea / respiratory arrest have been reported (deleted:  usually in patients with evidence of pre-existing asthma / COPD)

Nervous system disorders: (previously Central nervous system)

- very common: headache

- common: dizziness, light-headedness (previously ‘or feeling light-headed)

- uncommon: paraesthesia,

- rare: tremor, drowsiness (previously tremors and drowsiness was listed under pshychiatric sidorders)

- not known: loss of consciousness / syncope, convulsions, especially in predisposed patients (see section 4.4)

Eye disorders:

   - rare: blurred vision (previously listed under Special senses – that no longer exists)

Ear and labyrinth disorders:

   - rare: tinnitus (previously listed under Special senses)

Psychiatric disorders:

- uncommon: nervousness

            Gastro-intestinal disorders: (previously gastro-intestinal system disorders)

- common: nausea, vomiting, abdominal discomfort

- uncommon: metallic taste, dry mouth (previously listed under Special senses)

Renal and Urinary disorders: (previously Genital / Urinary system)

- rare: urinary urgency

Reproductive system and breast disorders:

   - rare: nipple discomfort (previously listed under Genital / Urinary system)

Vascular disorders:

   - very common: flushing

General disorders and administration site conditions:

- very common: chest pain or pressure (previously listed under ‘Body as a whole’ – that no longer exists)

- common: throat, neck and jaw discomfort (previously listed under ‘Body as a whole’ and abdominal deleted)

- uncommon: sweating, discomfort in the leg, arm or back, weakness (previously listed under ‘Body as a whole’)

- very rare: injection site reactions (previously listed under Application site disorders’ – that no longer exists)

5.1.      Pharmacodynamic properties

ATC Code:  Other Cardiac Preparations C01EB 10

Endogenous nucleoside with peripheral vasodilator / antiarrhythmic effect

10.       DATE OF REVISION OF THE TEXT