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**4.1 Therapeutic indications** Oncaspar is indicated as a component of antineoplastic combination therapy in acute lymphoblastic leukaemia (ALL).

**Therapeutic indications** Treatment of acute hemorrhoidal attacks.

**4.1 Therapeutic indications** Carivalan is indicated as substitution therapy in adult patients with normal sinus rhythm already controlled by ivabradine and carvedilol taken concomitantly at the same doses level for: - the symptomatic treatment of chronic stable angina pectoris in coronary artery disease patients - the treatment of chronic heart failure (II–IV NYHA-class) with systolic dysfunction

**4.1 Therapeutic indications** Carivalan is indicated as substitution therapy in adult patients with normal sinus rhythm already controlled by ivabradine and carvedilol taken concomitantly at the same doses level for: - the symptomatic treatment of chronic stable angina pectoris in coronary artery disease patients - the treatment of chronic heart failure (II–IV NYHA-class) with systolic dysfunction

**4.1 Therapeutic indications** Carivalan is indicated as substitution therapy in adult patients with normal sinus rhythm already controlled by ivabradine and carvedilol taken concomitantly at the same doses level for: - the symptomatic treatment of chronic stable angina pectoris in coronary artery disease patients - the treatment of chronic heart failure (II–IV NYHA-class) with systolic dysfunction

**4.1 Therapeutic indications** Carivalan is indicated as substitution therapy in adult patients with normal sinus rhythm already controlled by ivabradine and carvedilol taken concomitantly at the same doses level for: - the symptomatic treatment of chronic stable angina pectoris in coronary artery disease patients - the treatment of chronic heart failure (II–IV NYHA-class) with systolic dysfunction

**4.1 Therapeutic indications** Carivalan is indicated as substitution therapy in adult patients with normal sinus rhythm already controlled by ivabradine and carvedilol taken concomitantly at the same doses level for: - the symptomatic treatment of chronic stable angina pectoris in coronary artery disease patients - the treatment of chronic heart failure (II–IV NYHA-class) with systolic dysfunction

**4.1 Therapeutic indications** Carivalan is indicated as substitution therapy in adult patients with normal sinus rhythm already controlled by ivabradine and carvedilol taken concomitantly at the same doses level for: - the symptomatic treatment of chronic stable angina pectoris in coronary artery disease patients - the treatment of chronic heart failure (II–IV NYHA-class) with systolic dysfunction

<p><strong>6 INDICATION AND USAGE</strong></p> <p>ONIVYDE pegylated liposomal is indicated:</p> <ul class="dash"> <li>in combination with oxaliplatin, 5-fluorouracil (5-FU) and leucovorin (LV) for the first-line<br />treatment of adult patients with metastatic adenocarcinoma of the pancreas,</li> <li>in combination with 5-FU and LV for the treatment of metastatic adenocarcinoma of the pancreas in adult patients who have progressed following gemcitabine-based therapy.</li> </ul> <p>Limitation of Use: ONIVYDE pegylated liposomal is not indicated as a single agent for the treatment of patients with metastatic adenocarcinoma of the pancreas <em>[see Clinical Studies (5)</em> &ndash; <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>.</p>

**4.1 Therapeutic indications** Cosyrel 5 mg/5 mg and Cosyrel 10 mg/5 mg Cosyrel 5 mg/5 mg and Cosyrel 10 mg/5 mg are indicated as substitution therapy for treatment of hypertension and/or stable coronary artery disease (in patients with a history of myocardial infarction and/or revascularisation) and/or stable chronic heart failure with reduced systolic left ventricular function in adult patients adequately controlled with bisoprolol and perindopril given concurrently at the same dose level. Cosyrel 5 mg/10 mg and Cosyrel 10 mg/10 mg Cosyrel 5 mg/10 mg and Cosyrel 10 mg/10 mg are indicated as substitution therapy for treatment of hypertension and/or stable coronary artery disease (in patients with a history of myocardial infarction and/or revascularisation) in adult patients adequately controlled with bisoprolol and perindopril given concurrently at the same dose level.