Land: Nieuw-Zeeland
Taal: Engels
Bron: Medsafe (Medicines Safety Authority)
Ezetimibe 10mg; Simvastatin 20mg
Merck Sharp & Dohme (New Zealand) Limited
Ezetimibe 10 mg
10/20mg
Tablet
Active: Ezetimibe 10mg Simvastatin 20mg Excipient: Butylated hydroxyanisole Citric acid monohydrate Croscarmellose sodium Hypromellose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Propyl gallate
Blister pack, PVC/Aclar x 10 tablets, 10 tablets
Prescription
Prescription
MSD International GmbH (Singapore Branch)
Homozygous familial hypercholesterolaemia VYTORIN is indicated for the reduction of elevated total-C and LDL-C levels in adult and adolescent (10 to 17 years of age) patients with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis).
Package - Contents - Shelf Life: Blister pack, PVC/Aclar - 10 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Aclar - 30 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, HDPE - 10 tablets - 18 months from date of manufacture stored at or below 25°C - Bottle, HDPE - 30 tablets - 18 months from date of manufacture stored at or below 25°C
2003-10-10
VYTORIN ® tablets Page 1 of 9 NEW ZEALAND CONSUMER MEDICINE INFORMATION VYTORIN ® _ezetimibe/simvastatin _ 10/10 mg, 10/20 mg, 10/40 mg & 10/80 mg tablets WHAT IS IN THIS LEAFLET This leaflet answers some common questions about VYTORIN. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking VYTORIN 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 VYTORIN IS USED FOR VYTORIN helps to lower high LDL (bad) cholesterol and triglyceride levels, and raises levels of HDL (good) cholesterol. VYTORIN is for adults and adolescents (10 to 17 years of age) who cannot control their cholesterol levels by diet alone. You should stay on a cholesterol-lowering diet while taking this medicine. Everyone has cholesterol and triglycerides in their blood. They are types of blood fat needed by the body for many things. CHOLESTEROL Some of the reasons cholesterol is needed by the body include; building cell walls making bile acids (which help to digest food) and certain hormones. However, too much cholesterol can be a problem. Your body makes cholesterol, but it also comes from food. Normally the body balances the cholesterol it makes with the cholesterol it gets from food. This means if more cholesterol comes from food, less is made by the body. However, if you eat a diet high in fat, your body may not keep this balance and your cholesterol levels rise. High cholesterol is more likely to occur with certain diseases or if you have a family history of Lees het volledige document
VYTORIN Datasheet A20130212v5 Page 1 of 19 (0653A-NZL-2012-005584/ 0653A-NZL-2013-005641) NAME OF MEDICINE VYTORIN ® _ezetimibe/simvastatin _ 10/10 mg, 10/20 mg, 10/40 mg & 10/80 mg tablets PRESENTATION 10/10 mg tablet: A white to off white, capsule shaped, biconvex compressed tablet marked 311 on one side. Dimensions are 8.48 mm x 4.24 mm. 10/20 mg tablet: A white to off white, capsule shaped, biconvex compressed tablet marked 312 on one side. Dimensions are 10.66 mm x 5.33 mm. 10/40 mg tablet: A white to off white, capsule shaped, biconvex compressed tablet marked 313 on one side. Dimensions are 13.86 mm x 5.98 mm. 10/80 mg tablet: A white to off white, capsule shaped, biconvex compressed tablet marked 315 on one side. Dimensions are 17.46 mm x 7.53 mm. THERAPEUTIC CLASS VYTORIN (ezetimibe/simvastatin) is a lipid-lowering product that selectively inhibits the intestinal absorption of cholesterol and related plant sterols and inhibits the endogenous synthesis of cholesterol. INDICATIONS PRIMARY HYPERCHOLESTEROLAEMIA VYTORIN is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and non-high-density lipoprotein cholesterol (non-HDL-C), and to increase high-density lipoprotein cholesterol (HDL-C) in adult and adolescent (10 to 17 years of age) patients with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia in patients not adequately treated on a statin alone. HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLAEMIA (HOFH) VYTORIN is indicated for the reduction of elevated total-C and LDL-C levels in adult and adolescent (10 to 17 years of age) patients with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis). DOSAG Lees het volledige document