Negara: Australia
Bahasa: Inggris
Sumber: Department of Health (Therapeutic Goods Administration)
ivabradine hydrochloride, Quantity: 8.085 mg (Equivalent: ivabradine, Qty 7.5 mg)
Arrotex Pharmaceuticals Pty Ltd
Tablet, film coated
Excipient Ingredients: magnesium stearate; maize starch; colloidal anhydrous silica; lactose monohydrate; maltodextrin; titanium dioxide; hypromellose; iron oxide yellow; iron oxide red; macrogol 4000
Oral
56, 14
(S4) Prescription Only Medicine
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.
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
Registered
2018-01-11
APO-IVABRADINE 1 APO-IVABRADINE _Ivabradine hydrochloride _ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about ivabradine. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of taking ivabradine against the benefits they expect it will have for you. If you have any concerns about taking this medicine, ask your doctor or pharmacist. Keep this leaflet with the medicine. You may need to read it again. WHAT THIS MEDICINE IS USED FOR Ivabradine is used to treat: • symptomatic stable angina in adult patients whose heart rate is over or equal to 70 beats per minute (bpm) • heart failure Stable angina: Stable angina typically occurs when you exert yourself and is usually relieved with medication or rest. Angina is a pain or uncomfortable feeling in the chest. This pain or feeling can also spread to the arms and neck and sometimes also to the shoulders and back. Angina is caused by too little blood and oxygen getting to the heart. Ivabradine relieves stable angina by lowering the heart rate. Ivabradine is not for the relief of a sudden attack of angina. Your doctor will have given you other medication to treat this. Heart failure: Heart failure means that the heart muscle cannot pump blood strongly enough to supply all the blood needed throughout the body. Heart failure is not the same as heart attack and does not mean that the heart stops working. Some people develop heart failure after having had a heart attack. However, there are also other causes of heart failure. Heart failure may start off with no symptoms, but as the condition progresses, you may feel short of breath or may get tired easily after light physical activity such as walking. You may wake up short of breath at night. Fluid may collect in different parts of the body, often first noticed as swollen ankles a Baca dokumen lengkapnya
1 AUSTRALIAN PRODUCT INFORMATION – APO- IVABRADINE (IVABRADINE HYDROCHLORIDE) FILM COATED TABLETS 1 NAME OF THE MEDICINE Ivabradine hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each APO-Ivabradine 5 mg film coated tablet contains 5 mg of Ivabradine (as hydrochloride) Each APO-Ivabradine 7.5 mg film coated tablet contains 7.5 mg of Ivabradine (as hydrochloride) EXCIPIENTS WITH KNOWN EFFECT Contains sugars (as lactose monohydrate) For the full list of excipients see section 6.1 LIST OF EXCIPIENTS 3 PHARMACEUTICAL FORM APO-Ivabradine 5 mg: light salmon, capsule shape, biconvex film-coated tablet scored on one side. APO-Ivabradine 7.5 mg: light salmon, round, biconvex film-coated tablet. 4 CLINICAL PARTICULARS 4.1 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. 4.2 DOSE AND METHOD OF ADMINISTRATION SYMPTOMATIC TREATMENT OF CHRONIC STABLE ANGINA: It is recommended that the decision to initiate or titrate treatment takes place with the availability of serial heart rate measurements, ECG or ambulatory 24-hour monitoring. The starting dose of ivabradine for patients with stable angina, alone or in combination with atenolol 50 mg, should not exceed 5 mg twice daily (BD) in patients aged below 75 years. when heart rate is at or above 70 bpm. After three to four weeks of treatment, if the patient is still symptomatic, if the initial dose is well tolerate Baca dokumen lengkapnya