IVABRADINE GPPL ivabradine (as hydrochloride) 7.5 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Active ingredient:

ivabradine hydrochloride, Quantity: 8.085 mg (Equivalent: ivabradine, Qty 7.5 mg)

Available from:

Arrotex Pharmaceuticals Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: colloidal anhydrous silica; lactose monohydrate; maltodextrin; magnesium stearate; maize starch; titanium dioxide; hypromellose; iron oxide yellow; iron oxide red; macrogol 4000

Administration route:

Oral

Units in package:

56, 14

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of chronic stable angina Symptomatic treatment of chronic stable angina due to atherosclerotic coronary artery disease in patients with normal sinus rhythm and heart rate at or above 70 bpm, who are unable to tolerate or have a contraindication to the use of beta-blockers, OR in combination with atenolol 50mg once daily when angina is inadequately controlled.,Treatment of chronic heart failure Treatment of symptomatic chronic heart failure of NYHA Classes II or III and with documented left ventricular ejection fraction (LVEF) ? 35% in adult patients in sinus rhythm and with heart rate at or above 77 bpm, in combination with optimal standard chronic heart failure treatment.

Product summary:

Visual Identification: Ivabradine 7.5 mg is light salmon, round (7 mm diameter), biconvex film-coated tablet.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2018-01-11