EURODRUG LABORATORIES SINGAPORE PTE. LTD.

**5\. Therapeutic indications** 1. Treatment of hypercholesterolaemia Rosuvastatin is indicated for patients with primary hypercholesterolaemia and mixed dyslipidaemia (including Fredrickson Type IIa, IIb; and heterozygous familial hypercholesterolaemia) as an adjunct to diet when response to diet and exercise is inadequate. Rosuvastatin is indicated to treat patients with primary dysbetalipoproteinaemia (Fredrickson Type III hyper lipoproteinaemia) as an adjunct to diet when response to diet and exercise is inadequate. Rosuvastatin reduces elevated LDL-cholesterol, total cholesterol and triglycerides and increases HDL-cholesterol, thereby enabling most patients to achieve relevant treatment guidelines. Rosuvastatin also lowers ApoB, non HDL-C, VLDL-C, VLDL-TG, the LDL-C/HDL-C, total C/HDL-C, non HDL-C/HDL-C, ApoB/ApoA-I ratios and increases ApoA-I. Rosuvastatin is also indicated in patients with homozygous familial hypercholesterolaemia, either alone or as an adjunct to diet and other lipid-lowering treatments (e.g., LDL apheresis). 2. Prevention of cardiovascular events Primary prevention of cardiovascular disease: Rosuvastatin is indicated in individuals without clinically evident coronary heart disease but with an increased risk of cardiovascular disease based on age ≥ 50 years old in men and ≥ 60 years old in women, hsCRP ≥ 2 mg/L, and the presence of at least one additional cardiovascular disease risk factor such as hypertension, low HDL-C, smoking, or a family history of premature coronary heart disease, Rosuvastatin is indicated to: - reduce the risk of stroke - reduce the risk of myocardial infarction - reduce the risk of arterial revascularization procedures 3. Treatment of hypercholesterolaemia in children and adolescents 10 to 17 years of age Rosuvastatin is indicated in children and adolescents 10 to 17 years of age as an adjunct to diet to reduce Total-C, LDL-C and ApoB levels in adolescent boys and girls, who are at least one year postmenarche, 10–17 years of age with heterozygous familial hypercholesterolaemia if after an adequate trial of diet therapy the following findings are present: LDL-C > 190 mg/dL or > 160 mg/dL and there is a positive family history of premature cardiovascular disease (CVD) or two or more other CVD risk factors. Paediatric studies were conducted mainly in the non-Asian population and data on Asian children/adolescents is limited.

**4.1 Therapeutic indications** MONASAL® is indicated for use in adults and children 2 years of age and older to treat the symptoms of seasonal or perennial allergic rhinitis. In patients who have a history of moderate to severe symptoms of seasonal allergic rhinitis, prophylactic treatment with MONASAL® is recommended two to four weeks prior to the anticipated start of the pollen season. MONASAL® is indicated for the treatment of nasal polyps in adults 18 years of age and older. Treatment of nasal polyps in paediatric patients less than 18 years of age has not been established. MONASAL® is indicated for the treatment of symptoms associated with mild to moderate uncomplicated acute rhinosinusitis in patients 12 years of age and older without signs and symptoms of severe bacterial infection.

<p><strong>INDICATION:</strong><br> <strong>10mg:</strong> Ebastine (Kestine&reg;) is indicated in the treatment of allergic rhinitis (seasonal and perennial) with or without allergic conjunctivitis and chronic idiopathic urticaria.<br> <strong>20mg:</strong> Ebastine (Kestine&reg;) is indicated in the treatment of allergic rhinitis (seasonal and perennial) with or without allergic conjunctivitis.</p>