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<p><strong>4.1 Therapeutic indications</strong><br> Prophylaxis of venous thromboembolic disease (prevention of blood clot formation in the veins), in particular those which may be associated with orthopedic or general surgery.</p> <p>Prophylaxis of venous thromboembolic disease in medical patients bedridden due to acute illnesses.</p> <p>Treatment of established deep vein thrombosis.</p> <p>Prevention of thrombus formation in extracorporeal circulation during haemodialysis.</p> <p>Treatment of unstable angina and non-Q-wave myocardial infarction, administered concurrently with aspirin.</p> <p>Treatment of acute ST-segment Elevation Myocardial Infarction (STEMI), in combination with a thrombolytic agent, in patients to be managed medically or with subsequent Percutaneous Coronary Intervention (PCI).</p>
<p><strong>4.1 Therapeutic indications</strong><br> Prophylaxis of venous thromboembolic disease (prevention of blood clot formation in the veins), in particular those which may be associated with orthopedic or general surgery.</p> <p>Prophylaxis of venous thromboembolic disease in medical patients bedridden due to acute illnesses.</p> <p>Treatment of established deep vein thrombosis.</p> <p>Prevention of thrombus formation in extracorporeal circulation during haemodialysis.</p> <p>Treatment of unstable angina and non-Q-wave myocardial infarction, administered concurrently with aspirin.</p> <p>Treatment of acute ST-segment Elevation Myocardial Infarction (STEMI), in combination with a thrombolytic agent, in patients to be managed medically or with subsequent Percutaneous Coronary Intervention (PCI).</p>
<p><strong>4.1 Therapeutic indications</strong></p> <p>Palliative treatment of patients with advanced hormone-dependent prostate carcinoma.</p>
<p><strong>4.1 Therapeutic indications</strong><br> Parecoxib is indicated for the short term treatment of acute post-operative pain.</p> <p>There is limited clinical experience with parecoxib treatment beyond three days.</p>
**4.1 Therapeutic indications** _Hypercholesterolaemia_ Atorvastatin is indicated as an adjunct to diet for reduction of elevated total-cholesterol (total-C), low density lipoprotein cholesterol (LDL-C), apolipoprotein B (apo B) and triglycerides (TG) in adults, adolescents and children aged 10 years or older with primary hypercholesterolemia, heterozygous familial hypercholesterolemia or combined (mixed) hyperlipidaemia (Fredrickson Types IIa and IIb), elevated serum triglyceride (TG) levels (Fredrickson Type IV), and for patients with dysbetalipoproteinemia (Fredrickson Type III) when response to diet and other non-pharmacological measures is inadequate. Atorvastatin also raises high density lipoprotein cholesterol (HDL-C) and lowers the LDL/HDL and total cholesterol/HDL ratios. Atorvastatin is also indicated to reduce total-C and LDL-C in adults with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable. _Prevention of cardiovascular disease_ Atorvastatin is indicated to reduce the risk of myocardial infarction (MI) in adult hypertensive patients without clinically evident coronary heart disease, but with at least three additional risk factors for coronary heart disease (CHD) such as age ≥ 55 years, male sex, smoking, left ventricular hypertrophy, other specified abnormalities on electrocardiogram (ECG), microalbuminuria or proteinuria, ratio of plasma total cholesterol (total-C) to HDL-cholesterol ≥ 6, or premature family history of coronary heart disease (CHD). In adults with type 2 diabetes and without clinically evident coronary heart disease (CHD), but with multiple risk factors for coronary heart disease (CHD) such as retinopathy, albuminuria, smoking or hypertension, Atorvastatin is indicated to: - Reduce the risk of myocardial infarction (MI) - Reduce the risk of stroke In adults with clinically evident coronary heart disease (CHD), atorvastatin is indicated to: - Reduce the risk of non-fatal myocardial infarction - Reduce the risk of fatal and non-fatal stroke - Reduce the risk for revascularization procedures - Reduce the risk of hospitalization for congestive heart failure (CHF) - Reduce the risk of angina
**4.1 Therapeutic indications** _Hypercholesterolaemia_ Atorvastatin is indicated as an adjunct to diet for reduction of elevated total-cholesterol (total-C), low density lipoprotein cholesterol (LDL-C), apolipoprotein B (apo B) and triglycerides (TG) in adults, adolescents and children aged 10 years or older with primary hypercholesterolemia, heterozygous familial hypercholesterolemia or combined (mixed) hyperlipidaemia (Fredrickson Types IIa and IIb), elevated serum triglyceride (TG) levels (Fredrickson Type IV), and for patients with dysbetalipoproteinemia (Fredrickson Type III) when response to diet and other non-pharmacological measures is inadequate. Atorvastatin also raises high density lipoprotein cholesterol (HDL-C) and lowers the LDL/HDL and total cholesterol/HDL ratios. Atorvastatin is also indicated to reduce total-C and LDL-C in adults with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable. _Prevention of cardiovascular disease_ Atorvastatin is indicated to reduce the risk of myocardial infarction (MI) in adult hypertensive patients without clinically evident coronary heart disease, but with at least three additional risk factors for coronary heart disease (CHD) such as age ≥ 55 years, male sex, smoking, left ventricular hypertrophy, other specified abnormalities on electrocardiogram (ECG), microalbuminuria or proteinuria, ratio of plasma total cholesterol (total-C) to HDL-cholesterol ≥ 6, or premature family history of coronary heart disease (CHD). In adults with type 2 diabetes and without clinically evident coronary heart disease (CHD), but with multiple risk factors for coronary heart disease (CHD) such as retinopathy, albuminuria, smoking or hypertension, Atorvastatin is indicated to: - Reduce the risk of myocardial infarction (MI) - Reduce the risk of stroke In adults with clinically evident coronary heart disease (CHD), atorvastatin is indicated to: - Reduce the risk of non-fatal myocardial infarction - Reduce the risk of fatal and non-fatal stroke - Reduce the risk for revascularization procedures - Reduce the risk of hospitalization for congestive heart failure (CHF) - Reduce the risk of angina
<p><strong>4.1 Therapeutic indications</strong><br> <em><u>Hypercholesterolaemia</u></em><br> Atorvastatin is indicated as an adjunct to diet for reduction of elevated total-cholesterol (total-C), low density lipoprotein cholesterol (LDL-C), apolipoprotein B (apo B) and triglycerides (TG) in adults, adolescents and children aged 10 years or older with primary hypercholesterolemia, heterozygous familial hypercholesterolemia or combined (mixed) hyperlipidaemia (Fredrickson Types IIa and IIb), elevated serum triglyceride (TG) levels (Fredrickson Type IV), and for patients with dysbetalipoproteinemia (Fredrickson Type III) when response to diet and other non-pharmacological measures is inadequate.</p> <p>Atorvastatin also raises high density lipoprotein cholesterol (HDL-C) and lowers the LDL/HDL and total cholesterol/HDL ratios.</p> <p>Atorvastatin is also indicated to reduce total-C and LDL-C in adults with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable.</p> <p><em><u>Prevention of cardiovascular disease</u></em><br> Atorvastatin is indicated to reduce the risk of myocardial infarction (MI) in adult hypertensive patients without clinically evident coronary heart disease, but with at least three additional risk factors for coronary heart disease (CHD) such as age ≥ 55 years, male sex, smoking, left ventricular hypertrophy, other specified abnormalities on electrocardiogram (ECG), microalbuminuria or proteinuria, ratio of plasma total cholesterol (total-C) to HDL-cholesterol ≥ 6, or premature family history of coronary heart disease (CHD).</p> <p>In adults with type 2 diabetes and without clinically evident coronary heart disease (CHD), but with multiple risk factors for coronary heart disease (CHD) such as retinopathy, albuminuria, smoking or hypertension, Atorvastatin is indicated to:</p> <ul> <li>Reduce the risk of myocardial infarction (MI)</li> <li>Reduce the risk of stroke</li> </ul> <p>In adults with clinically evident coronary heart disease (CHD), atorvastatin is indicated to:</p> <ul> <li>Reduce the risk of non-fatal myocardial infarction</li> <li>Reduce the risk of fatal and non-fatal stroke</li> <li>Reduce the risk for revascularization procedures</li> <li>Reduce the risk of hospitalization for congestive heart failure (CHF)</li> <li>Reduce the risk of angina</li> </ul>
<p><strong>4.1 Therapeutic indications</strong><br> <em><u>Hypercholesterolaemia</u></em><br> Atorvastatin is indicated as an adjunct to diet for reduction of elevated total-cholesterol (total-C), low density lipoprotein cholesterol (LDL-C), apolipoprotein B (apo B) and triglycerides (TG) in adults, adolescents and children aged 10 years or older with primary hypercholesterolemia, heterozygous familial hypercholesterolemia or combined (mixed) hyperlipidaemia (Fredrickson Types IIa and IIb), elevated serum triglyceride (TG) levels (Fredrickson Type IV), and for patients with dysbetalipoproteinemia (Fredrickson Type III) when response to diet and other non-pharmacological measures is inadequate.</p> <p>Atorvastatin also raises high density lipoprotein cholesterol (HDL-C) and lowers the LDL/HDL and total cholesterol/HDL ratios.</p> <p>Atorvastatin is also indicated to reduce total-C and LDL-C in adults with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable.</p> <p><em><u>Prevention of cardiovascular disease</u></em><br> Atorvastatin is indicated to reduce the risk of myocardial infarction (MI) in adult hypertensive patients without clinically evident coronary heart disease, but with at least three additional risk factors for coronary heart disease (CHD) such as age ≥ 55 years, male sex, smoking, left ventricular hypertrophy, other specified abnormalities on electrocardiogram (ECG), microalbuminuria or proteinuria, ratio of plasma total cholesterol (total-C) to HDL-cholesterol ≥ 6, or premature family history of coronary heart disease (CHD).</p> <p>In adults with type 2 diabetes and without clinically evident coronary heart disease (CHD), but with multiple risk factors for coronary heart disease (CHD) such as retinopathy, albuminuria, smoking or hypertension, Atorvastatin is indicated to:</p> <ul> <li>Reduce the risk of myocardial infarction (MI)</li> <li>Reduce the risk of stroke</li> </ul> <p>In adults with clinically evident coronary heart disease (CHD), atorvastatin is indicated to:</p> <ul> <li>Reduce the risk of non-fatal myocardial infarction</li> <li>Reduce the risk of fatal and non-fatal stroke</li> <li>Reduce the risk for revascularization procedures</li> <li>Reduce the risk of hospitalization for congestive heart failure (CHF)</li> <li>Reduce the risk of angina</li> </ul>
**4.1. Therapeutic indications** VELTEZOM is indicated as part of combination therapy for the treatment of patients with previously untreated multiple myeloma. VELTEZOM is indicated as monotherapy for the treatment of patients with multiple myeloma who have received at least 1 prior therapy. VELTEZOM is indicated as monotherapy for the treatment of patients with mantle cell lymphoma who have received at least 1 prior therapy. VELTEZOM in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.
**4.1 Therapeutic indications** Prophylaxis of transplant rejection in adult kidney or liver allograft recipients and treatment of kidney or liver allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients.
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