Country: Israel
Bahasa: Inggeris
Sumber: Ministry of Health
ADENOSINE
SANOFI - AVENTIS ISRAEL LTD
C01EB10
SOLUTION FOR INJECTION
ADENOSINE 6 MG / 2 ML
I.V
Required
SANOFI AVENTIS, FRANCE
ADENOSINE
ADENOSINE
Rapid conversion to a normal sinus rhythm of paroxysmal supraventicular tachycardias including those associated with accessory bypass tracts (wolf parkinson-white syndrome).
2013-06-30
העדוה העדוה לע לע הרמחה הרמחה ( ( עדימ עדימ ןולעב )תוחיטב ןולעב )תוחיטב ל ל אפור אפור ךיראת 04.2013 םש רישכת תילגנאב ADENOCOR רפסמ םושיר 1284929054 םושירה לעב םש SANOFI-AVENTIS ISRAEL LTD םיטרפ לע םי/יונישה םי/שקובמה קרפ ןולעב טסקט יחכונ טסקט שדח 4.2 POSOLOGY AND METHOD OF ADMINISTRATION טסקט ,בוהצב ןמוסמ ףסוהש שדח טסקט חסונ יוניש ,הקיחמ וק םע םודאב ןמוסמ רסוהש עיפומ הז קרפ לש אלמ טסקט .קוריב םינמוסמ םכרושיאל החלשנש ןולע תעצהב THERAPEUTIC DOSE 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, followed by a rapid saline flush …. Children No controlled pediatric study has been undertaken. Published uncontrolled studies show similar effects of adenosine in adults and children: effective doses for children were between 0.0375 and 0.25mg/kg. The level of evidence does not allow a recommended posology. ………………………….. Hepatic / Renal impairment As adenosine requires no hepatic or renal function for its activation or inactivation, hepatic and/or renal failure would not be expected to alter efficacy or tolerance . 4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE רסוהש טסקט ,בוהצב ןמוסמ ףסוהש שדח טסקט םינמוסמ חסונ יוניש ,הקיחמ וק םע םודאב ןמוסמ ןולע תעצהב עיפומ הז קרפ לש אלמ טסקט .קוריב .םכרושיאל החלשנש 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 hospital with electrocardiographic monitoring… Baca dokumen lengkap
1 ADENOCOR 1. NAME OF THE MEDICINAL PRODUCT Adenocor 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 6 mg of adenosine per 2 ml (3 mg/ml). For excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear, colorless 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). 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: _ 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,12 mg should be given also as a rapid 2 intravenous bolus. Additional or higher doses are not recommended. Children: The level of evidence does not allow a recommended posology. Elderly: See dosage recommendations for adults. Hepatic / Renal impairment: As adenosine requires no hepatic or renal function for its activation or inactivation, hepatic and/or renal failure would not be expected to alter efficacy or tolerance. 4.3 CONTRAINDICATIONS Baca dokumen lengkap