Страна: Сінгапур
мова: англійська
Джерело: HSA (Health Sciences Authority)
ADENOSINE
SANOFI-AVENTIS SINGAPORE PTE. LTD.
C01EB10
6.0mg/2 ml
INJECTION
ADENOSINE 6.0mg/2 ml
INTRAVENOUS
Prescription Only
Famar Health Care Services Madrid, S.A.U.
ACTIVE
1994-04-05
ADENOCOR _Adenosine _ SOLUTION FOR INJECTION [SANOFI LOGO] 1. TRADE NAME OF MEDICINAL PRODUCT Adenocor 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 6 mg of adenosine per 2 ml (3 mg/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). 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 conduction 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 block at a particular dose should not be given further dosage increments. THERAPEUTIC DOSE Adult: Initial dose: 3 mg 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, 6 mg should be given also as a rapid intravenous bolus. Third dose: If the second dose does not re Прочитайте повний документ
ADENOCOR _Adenosine _ SOLUTION FOR INJECTION [SANOFI LOGO] 1. TRADE NAME OF MEDICINAL PRODUCT Adenocor 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 6 mg of adenosine per 2 ml (3 mg/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). 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 conduction 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 block at a particular dose should not be given further dosage increments. THERAPEUTIC DOSE Adult: Initial dose: 3 mg 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, 6 mg 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 dose Прочитайте повний документ