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<p><strong>1. INDICATIONS AND USAGE</strong></p> <p><em><strong>Hypercholesterolaemia</strong></em><br> ATOZET is indicated as adjunctive therapy to diet for use in adults with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia where use of a combination product is appropriate</p> <ul> <li>patients not appropriately controlled with a statin alone</li> <li>patients already treated with a statin and ezetimibe</li> </ul> <p>ATOZET contains ezetimibe and atorvastatin. Atorvastatin has been shown to reduce the frequency of cardiovascular events <em>[see 10. CLINICAL STUDIES</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>. A beneficial effect of ATOZET or ezetimibe on cardiovascular morbidity and mortality has not yet been demonstrated.</p> <p><em><strong>Homozygous Familial Hypercholesterolemia (HoFH)</strong></em><br> ATOZET is indicated for the reduction of elevated total-C and LDL-C levels in patients with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis).</p>
<p><strong>1. INDICATIONS AND USAGE</strong></p> <p><em><strong>Hypercholesterolaemia</strong></em><br> ATOZET is indicated as adjunctive therapy to diet for use in adults with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia where use of a combination product is appropriate</p> <ul> <li>patients not appropriately controlled with a statin alone</li> <li>patients already treated with a statin and ezetimibe</li> </ul> <p>ATOZET contains ezetimibe and atorvastatin. Atorvastatin has been shown to reduce the frequency of cardiovascular events <em>[see 10. CLINICAL STUDIES</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>. A beneficial effect of ATOZET or ezetimibe on cardiovascular morbidity and mortality has not yet been demonstrated.</p> <p><em><strong>Homozygous Familial Hypercholesterolemia (HoFH)</strong></em><br> ATOZET is indicated for the reduction of elevated total-C and LDL-C levels in patients with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis).</p>
<p><strong>1. INDICATIONS AND USAGE</strong></p> <p><em><strong>Hypercholesterolaemia</strong></em><br> ATOZET is indicated as adjunctive therapy to diet for use in adults with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia where use of a combination product is appropriate</p> <ul> <li>patients not appropriately controlled with a statin alone</li> <li>patients already treated with a statin and ezetimibe</li> </ul> <p>ATOZET contains ezetimibe and atorvastatin. Atorvastatin has been shown to reduce the frequency of cardiovascular events <em>[see 10. CLINICAL STUDIES</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>. A beneficial effect of ATOZET or ezetimibe on cardiovascular morbidity and mortality has not yet been demonstrated.</p> <p><em><strong>Homozygous Familial Hypercholesterolemia (HoFH)</strong></em><br> ATOZET is indicated for the reduction of elevated total-C and LDL-C levels in patients with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis).</p>
<p><strong>1. INDICATIONS AND USAGE</strong></p> <p><em><strong>Hypercholesterolaemia</strong></em><br> ATOZET is indicated as adjunctive therapy to diet for use in adults with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia where use of a combination product is appropriate</p> <ul> <li>patients not appropriately controlled with a statin alone</li> <li>patients already treated with a statin and ezetimibe</li> </ul> <p>ATOZET contains ezetimibe and atorvastatin. Atorvastatin has been shown to reduce the frequency of cardiovascular events <em>[see 10. CLINICAL STUDIES</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>. A beneficial effect of ATOZET or ezetimibe on cardiovascular morbidity and mortality has not yet been demonstrated.</p> <p><em><strong>Homozygous Familial Hypercholesterolemia (HoFH)</strong></em><br> ATOZET is indicated for the reduction of elevated total-C and LDL-C levels in patients with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis).</p>
**III. INDICATIONS** _**Primary Hypercholesterolemia**_ ZIENT, administered with an HMG-CoA reductase inhibitor (statin) or alone, is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C) and apolipoprotein B (Apo B) in patients with primary (heterozygous familial and non-familial) hypercholesterolemia. ZIENT, administered in combination with fenofibrate, is indicated as adjunctive therapy to diet for the reduction of elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with mixed hyperlipidemia. _**Homozygous Familial Hypercholesterolemia (HoFH)**_ ZIENT, administered with atorvastatin or simvastatin, is indicated for the reduction of elevated total-C and LDL-C levels in patients with HoFH, as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable. _**Homozygous Sitosterolemia (Phytosterolemia)**_ ZIENT is indicated as adjunctive therapy to diet for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolemia.
<p><strong>INDICATIONS</strong></p> <p>Essential hypertensive patients not adequately controlled with amlodipine or losartan monotherapy.</p>
**4.1 Therapeutic Indications** **ZENHALE**, administered twice daily, is indicated for the maintenance treatment of asthma, in adults and children 12 years of age and older with reversible obstructive airway disease, whose asthma cannot be adequately controlled on asthma controller medications. **ZENHALE** is not indicated for patients whose asthma can be managed by occasional use of a rapid onset, short duration, inhaled beta2-agonist or for patients whose asthma can be successfully managed by inhaled corticosteroids along with occasional use of a rapid onset, short duration, inhaled beta2-agonist. **ZENHALE** should be used for patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting beta2-agonists or whose disease severity clearly warrants initiation of treatment with two maintenance therapies. **ZENHALE** may also be used in patients already adequately controlled on both inhaled corticosteroid and long-acting beta2-agonist. **ZENHALE** contains a long-acting beta2-agonist and should not be used as a rescue medication. To relieve acute asthmatic symptoms, a rapid onset, short duration inhaled bronchodilator (e.g., salbutamol) should be used. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g., discontinue **ZENHALE**) if possible without loss of asthma control, and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use **ZENHALE** for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids.
**4.1 Therapeutic Indications** **ZENHALE**, administered twice daily, is indicated for the maintenance treatment of asthma, in adults and children 12 years of age and older with reversible obstructive airway disease, whose asthma cannot be adequately controlled on asthma controller medications. **ZENHALE** is not indicated for patients whose asthma can be managed by occasional use of a rapid onset, short duration, inhaled beta2-agonist or for patients whose asthma can be successfully managed by inhaled corticosteroids along with occasional use of a rapid onset, short duration, inhaled beta2-agonist. **ZENHALE** should be used for patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting beta2-agonists or whose disease severity clearly warrants initiation of treatment with two maintenance therapies. **ZENHALE** may also be used in patients already adequately controlled on both inhaled corticosteroid and long-acting beta2-agonist. **ZENHALE** contains a long-acting beta2-agonist and should not be used as a rescue medication. To relieve acute asthmatic symptoms, a rapid onset, short duration inhaled bronchodilator (e.g., salbutamol) should be used. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g., discontinue **ZENHALE**) if possible without loss of asthma control, and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use **ZENHALE** for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids.
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