Χώρα: Μάλτα
Γλώσσα: Αγγλικά
Πηγή: Medicines Authority
ADENOSINE
Sanofi Malta Limited Level2, Fort Business Centre, Mriehel Bypass, Birkirkara, Malta
C01EB10
ADENOSINE 3 mg/ml
SOLUTION FOR INJECTION
ADENOSINE 3 mg/ml
POM
CARDIAC THERAPY
Withdrawn
2006-01-05
ADENOCOR 3MG/ML SOLUTION FOR INJECTION Adenosine The following information is extracted from the SPC. TECHNICAL INFORMATION FOR THE ADMINISTRATION OF ADENOCOR 3MG/ML SOLUTION FOR INJECTION 1. TRADE NAME OF MEDICINAL PRODUCT Adenocor 3mg/ml Solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 6mg of adenosine per 2ml (3mg/ml). For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Solution for injection Clear, colourless solution 4.2 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 injection according to the ascending dosage schedule below. To be certain the solution reaches the systemic circulation administer either directly into a vein or into an IV line. If given into an IV line it should be injected as proximally as possible, and followed by a rapid saline flush. Adenocor should only be used when facilities exist for cardiac monitoring. Patients who develop high-level AV block at a particular dose should not be given further dosage increments. POSOLOGY Adult: Initial dose: 3mg given as a rapid intravenous bolus (over 2 seconds). Second dose: If the first dose does not result in elimination of the supraventricular tachycardia within 1 to 2 minutes, 6mg should be given also as a rapid intravenous bolus. Third dose: If the second dose does not result in elimination of the supraventricular tachycardia within 1 to 2 minutes. 12mg should be given also as a rapid intravenous bolus. Additional or higher doses are not recommended. Paediatric population During administration of adenosine cardio-respiratory resuscitation equipment must be available for immediate use if necessary. Adenosine is intended for use with continuous monitoring and ECG recording during administration. The dosing recommended for the treatment o Διαβάστε το πλήρες έγγραφο
Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1. TRADE NAME OF MEDICINAL PRODUCT Adenocor 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 6mg of adenosine per 2ml (3mg/ml). For excipients, see 6.1 3. PHARMACEUTICAL FORM Solution for injection Clear, colourless solution 4. CLINICAL PARTICULARS 4.1 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 Rapid conversion to a normal sinus rhythm of paroxysmal supraventricular tachycardia in children aged 0 to 18 years. Diagnostic Indications Aid to diagnosis of broad or narrow complex supraventricular tachycardias. Although Adenocor will not convert atrial flutter, atrial fibrillation or ventricular tachycardia to sinus rhythm, the slowing of AV condition helps diagnosis of atrial activity. Sensitisation of intra-cavitary electrophysiological investigations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adenocor is intended for hospital use only with monitoring and cardiorespiratory resuscitation equipment available for immediate use. It should be administered by rapid IV bolus injection according to the ascending dosage schedule below. To be certain the solution reaches the systemic circulation administer either directly into a vein or into an IV line. If given into an IV line it should be injected as proximally as possible, and followed by a rapid saline flush. Adenocor should only be used when facilities exist for cardiac monitoring. Patients who develop high-level AV b Διαβάστε το πλήρες έγγραφο