Flecainide Controlled Release (Teva)

Land: New Zealand

Språk: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv ingrediens:

Flecainide acetate 100.008mg;  

Tilgjengelig fra:

Teva Pharma (New Zealand) Limited

INN (International Name):

Flecainide acetate 100.008 mg

Dosering :

100 mg

Legemiddelform:

Modified release capsule

Sammensetning:

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

Enheter i pakken:

Blister pack, PVC/PVdC/aluminium, 30 capsules

Klasse:

Prescription

Resept typen:

Prescription

Produsert av:

Quimica Sintetica SA

Indikasjoner:

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.

Produkt oppsummering:

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

Autorisasjon dato:

2011-12-02

Preparatomtale

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