Страна: Новая Зеландия
Язык: английский
Источник: Medsafe (Medicines Safety Authority)
Aspirin 100mg (2 x 50mg); ; Atorvastatin calcium trihydrate 21.69mg (2 x 10.845mg (equivalent to 20mg atorvastatin)); ; Ramipril 2.5mg;
Te Arai BioFarma Limited
Aspirin 100 mg (2 x 50mg)
100mg/20mg/2.5mg
Combination capsule
Active: Aspirin 100mg (2 x 50mg) Excipient: Microcrystalline cellulose Opadry White OY-B-28920 AMB Purified talc Sodium starch glycolate Active: Atorvastatin calcium trihydrate 21.69mg (2 x 10.845mg (equivalent to 20mg atorvastatin)) Excipient: Calcium carbonate Colloidal silicon dioxide Crospovidone Hyprolose Lactose monohydrate Magnesium stearate Opadry green 06O21881 Polysorbate 80 Pregelatinised maize starch Active: Ramipril 2.5mg Excipient: Hypromellose Microcrystalline cellulose Opadry yellow 80W32039 Sodium stearyl fumarate Starch Black ink (Trinomia) Gelatin Iron oxide black Titanium dioxide
Prescription
Shandong Xinhua Pharmaceutical Company
Trinomia is indicated for the secondary prevention of cardiovascular accidents as substitution therapy in adult patients adequately controlled with the mono-components given concomitantly at equivalent therapeutical doses
Package - Contents - Shelf Life: Blister pack, OPA/Aluminium/PVC, Closure: Al foil with polyvalent lacquer - 28 capsules - 36 months from date of manufacture stored at or below 25°C
2016-04-22
New Zealand Consumer Medicine Information TRINOMIA ACETYLSALICYLIC ACID/ATORVASTATIN /RAMIPRIL 100 MG/20 MG/10 MG HARD CAPSULES 100 MG/20 MG/5 MG HARD CAPSULES 100 MG/20 MG/2.5 MG HARD CAPSULES WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start using Trinomia. This leaflet answers some common questions about Trinomia. 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 pharmacist or doctor will be able to advise you about the risks and benefits of using Trinomia. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR PHARMACIST OR DOCTOR. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT IS TRINOMIA USED FOR Trinomia capsules contain three substances called acetylsalicylic acid, atorvastatin and ramipril. • Acetylsalicylic acid belongs to a group of substances called antiplatelet agents that help prevent your blood cells sticking together and forming a blood clot. • Atorvastatin belongs to a group of substances called statins, which are lipid (fat) regulating medicines that are used to lower lipids known as cholesterol and triglycerides in the blood when a low fat diet and life style changes on their own have failed. If you are at an increased risk of heart disease, atorvastatin can also be used to reduce such risk even if your cholesterol levels are normal. You should maintain a standard cholesterol lowering diet during treatment. • Ramipril belongs to a group of substances called ACE inhibitors (Angiotensin Converting Enzyme Inhibitors) that works by decreasing your body’s production of substances that could raise your blood pressure; making your blood vessels relax and widen and making it easier for your heart to pump blood around your body. Trinomia is used as substitution therapy in adult patients adequately controlled with the three substances (acetylsalicylic acid, atorvastatin and ramipril) taken at the New Zealand Consumer Medicine In Прочитать полный документ
1 NEW ZEALAND DATA SHEET 1. NAME OF THE MEDICINAL PRODUCT Trinomia 100 mg/20 mg/10 mg hard capsules Trinomia 100 mg/20 mg/5 mg hard capsules Trinomia 100 mg/20 mg/2.5 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _Trinomia 100 mg/20 mg/10 mg hard capsules _ Each capsule contains 100 mg of acetylsalicylic acid, 20 mg of atorvastatin (as 21.69 mg of atorvastatin calcium trihydrate) and 10 mg of ramipril. _Trinomia 100 mg/20 mg/5 mg hard capsules _ Each capsule contains 100 mg of acetylsalicylic acid, 20 mg of atorvastatin (as 21.69 mg of atorvastatin calcium trihydrate) and 5 mg of ramipril. _Trinomia 100 mg/20 mg/ 2.5 mg hard capsules _ Each capsule contains 100 mg of acetylsalicylic acid, 20 mg of atorvastatin (as 21.69 mg of atorvastatin calcium trihydrate) and 2.5 mg of ramipril. Excipient(s) with known effect: Contains 73.61 mg of lactose monohydrate and 0.48 mg of soya lecithin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. _Trinomia 100 mg/20 mg/ 10 mg hard capsules _ Size 0 hard shell gelatine capsules (approx. length: 21.7 mm) with opaque pale pink-coloured body and cap, imprinted with “AAR 100/20/10” containing two 50 mg acetylsalicylic white or nearly white film-coated tablet engraved “AS”, two 10 mg atorvastatin greenish-brownish film-coated tablets engraved “AT” and one 10 mg ramipril pale yellow film-coated tablet engraved “R1”. _Trinomia 100 mg/20 mg/ 5 mg hard capsules _ Size 0 hard shell gelatine capsules (approx. length: 21.7 mm) with opaque pale pink-coloured cap and opaque light grey-coloured body, imprinted with “AAR 100/20/5” containing two 50 mg acetylsalicylic white or nearly white film-coated tablet engraved “AS”, two 10 mg atorvastatin greenish-brownish film- coated tablets engraved “AT” and one 5 mg ramipril pale yellow film-coated tablet engraved “R5”. _Trinomia 100 mg/20 mg/ 2.5 mg hard capsules _ Size 0 hard shell gelatine capsules (approx. length: 21.7 mm) with opaque light grey-coloured body and c Прочитать полный документ