Страна: Нова Зеландія
мова: англійська
Джерело: Medsafe (Medicines Safety Authority)
Flecainide acetate 100.008mg;
Teva Pharma (New Zealand) Limited
Flecainide acetate 100.008 mg
100 mg
Modified release capsule
Active: Flecainide acetate 100.008mg Excipient: Capsugel black 01.911 Capsugel grey OP.C006 Capsugel white OP Colloidal silicon dioxide Crospovidone Macrogol 400 Magnesium stearate Methacrylic acid copolymer Microcrystalline cellulose Povidone Purified talc
Blister pack, PVC/PVdC/aluminium, 30 capsules
Prescription
Prescription
Quimica Sintetica SA
In patients without structural heart disease and without myocardial infarction, flecainide controlled release capsules are indicated for the prevention of: 1. Supraventricular arrhythmias · Paroxysmal supraventricular tachycardias (PSVT) including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms; · Paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms. 2. Ventricular arrhythmias · Documented life-threatening ventricular arrhythmias such as sustained ventricular tachycardia (VT) if they are considered life-threatening in the judgement of the attending physician. Not indicated for less severe ventricular arrhythmias even if symptomatic.
Package - Contents - Shelf Life: Blister pack, PVC/PVdC/aluminium - 30 capsules - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVdC/aluminium - 60 capsules - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVdC/aluminium - 90 capsules - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVdC/aluminium - 100 capsules - 24 months from date of manufacture stored at or below 25°C
2011-12-02
Version 1.1 1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME Flecainide Controlled Release (Teva) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Flecainide Controlled Release (Teva), 100 mg capsules contain 100 mg of flecainide acetate. Flecainide Controlled Release (Teva), 200 mg capsules contain 200 mg of flecainide acetate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Flecainide Controlled Release (Teva), 100 mg capsules: Hard gelatine opaque capsule with a grey body and white cap, containing white or almost white round micro-tablets. Flecainide Controlled Release (Teva), 200 mg capsules: Hard gelatine opaque capsule with a grey body and pink cap, containing white or almost white round micro-tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In patients without structural heart disease and without myocardial infarction Flecainide Controlled Release capsules are indicated for the prevention of: SUPRAVENTRICULAR ARRHYTHMIAS • Paroxysmal supraventricular tachycardias (PSVT) including atrioventricularnodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms; • Paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms. VENTRICULAR ARRHYTHMIAS • Documented life-threatening ventricular arrhythmias such as sustained ventricular tachycardia (VT) if they are considered life-threatening in the judgement of the attending physician. Not indicated for less severe ventricular arrhythmias even if symptomatic. Use of flecainide in chronic atrial fibrillation has not been adequately studied and is not recommended. 4.2 DOSE AND METHOD OF ADMINISTRATION The following regimen is suggested as a guideline. However, dosage may need to be modified as dictated by the weight, age or clinical status of the patient. GENERAL CONSIDERATIONS • Prior to treatment perform an adequate clinical assessment of the patient to establish that there is no structural heart disease or left Прочитайте повний документ