Ország: Új-Zéland
Nyelv: angol
Forrás: Medsafe (Medicines Safety Authority)
Simvastatin 5mg;
Aurobindo Pharma NZ Limited
Simvastatin 5 mg
5 mg
Film coated tablet
Active: Simvastatin 5mg Excipient: Ascorbic acid Butylated hydroxyanisole Citric acid monohydrate Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry yellow 20A52229 Starch
Blister pack, PVC/PE/PVDC/Al, 30 tablets
Prescription
Prescription
Southwest Synthetic Pharmaceuticals Corporation, Limited
Paediatric Patients with Heterozygous Familial Hypercholesterolaemia: Simvastatin is indicated as an adjunct to diet to reduce total-C, LDL-C, TG, and Apo B levels in adolescent boys and girls who are at least one year post-menarche, 10-17 years of age, with heterozygous familial hypercholesterolaemia (HeFH).
Package - Contents - Shelf Life: Blister pack, PVC/PE/PVDC/Al - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PE/PVDC/Al - 90 tablets - 36 months from date of manufacture stored at or below 25°C
2010-09-24
AURO-SIMVASTATIN CONSUMER MEDICINE INFORMATION Ver 1.1 Page 1 of 5 AURO-SIMVASTATIN 5, 10, 20, 40 & 80 Simvastatin CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about AURO- SIMVASTATIN. 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 AURO-SIMVASTATIN 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 AURO-SIMVASTATIN IS USED FOR AURO-SIMVASTATIN helps to lower cholesterol and triglyceride levels. AURO-SIMVASTATIN is used in people who have coronary heart disease (CHD) or who are at high risk of CHD (for example, if they have diabetes, a history of stroke, or other blood vessel disease). AURO-SIMVASTATIN may be used in these people, regardless of their cholesterol level to: help prolong your life by reducing the risk of a heart attack reduce the risk of stroke reduce the need for surgery to increase blood flow to the heart reduce the need for hospitalisation due to angina. CHOLESTEROL Everyone has cholesterol and triglycerides in their blood. They are types of blood fat needed by the body for many things, including 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 high cholesterol. When you have high levels of cholesterol, it m Olvassa el a teljes dokumentumot
Data Sheet: AURO-SIMVASTATIN (Simvastatin tablets 5 mg, 10 mg, 20 mg, 40 mg & 80 mg) Ver 2.1 Page 1 of 21 NAME OF MEDICINE AURO-SIMVASTATIN 5 (5 MG SIMVASTATIN TABLETS) AURO-SIMVASTATIN 10 (10 MG SIMVASTATIN TABLETS) AURO-SIMVASTATIN 20 (20 MG SIMVASTATIN TABLETS) AURO-SIMVASTATIN 40 (40 MG SIMVASTATIN TABLETS) AURO-SIMVASTATIN 80 (80 MG SIMVASTATIN TABLETS) PRESENTATION AURO-SIMVASTATIN 5 Yellow coloured, round shaped, biconvex, film coated tablets, debossed with ‘A’ on one side and ‘15’ on the other side. AURO-SIMVASTATIN 10 Light pink coloured, round shaped, biconvex, film coated tablets debossed with ‘A’ on one side and ‘01’ on the other side. AURO-SIMVASTATIN 20 Light pink coloured, round shaped, biconvex, film coated tablets, debossed with ‘A’ on one side and ‘02’ on the other side. AURO-SIMVASTATIN 40 Pink coloured, round shaped, biconvex, film coated tablets, debossed with ‘A’ on one side and ‘03’ on the other side. AURO-SIMVASTATIN 80 Pink coloured, capsule shaped, biconvex, film coated tablets, debossed with ‘A’ on one side and ‘04’ on the other side. In addition to simvastatin, each AURO-SIMVASTATIN tablet contains the following inactive ingredients: ascorbic acid, lactose, cellulose microcrystalline cellulose (PH 101 & 112), pregelatinised starch, citric acid monohydrate, butylated hydroxyanisole, magnesium stearate, Opadry yellow 20A52229-Proprietary ingredient ARTG number 12350 (AURO-SIMVASTATIN 5 mg), Opadry pink 20A54239-Proprietary ingredient ARTG number 11891 (AURO-SIMVASTATIN 10 mg & 20 mg) and Opadry pink 20A54211-Proprietary ingredient ARTG number 12531 (AURO-SIMVASTATIN 40 mg & 80 mg). THERAPEUTIC CLASS Simvastatin is a lipid lowering agent derived synthetically from a fermentation product of Aspergillus terreus. Data Sheet: AURO-SIMVASTATIN (Simvastatin tablets 5 mg, 10 mg, 20 mg, 40 mg & 80 mg) Ver 2.1 Page 2 of 21 INDICATIONS PATIENTS AT HIGH RISK OF CORONARY HEART DISEASE (CHD) OR WITH EXISTING CHD In patients at high risk of CHD (with or without h Olvassa el a teljes dokumentumot