Riik: Armeenia
keel: inglise
Allikas: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
acetylsalicylic acid
Coral Laboratories Ltd.
acetylsalicylic acid
100mg
tablets gastro-resistant
OTC
PRODUCT : ASPICOR 100 (Gastro-resistant Acetylsalicylic acid Tablets BP 100 mg) COUNTRY : REPUBLIC OF ARMENIA THE SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT : TRADE NAME : ASPICOR 100 DOSE : 100 mg DOSAGE FORM : Gastro-resistant Tablet For Oral Use. 2. COMPLETE QUALITATIVE AND QUANTITATIVE COMPOSITION OF THE PRODUCT COMPOSITION : Each gastro-resistant tablet contains : acetylsalicylic acid 100 mg Excipients q.s. Colour : Titanium Dioxide SR. NO. APPROVED NAME (INN) LABEL CLAIM PER TABLET (IN MG) OVERAGES QTY./TABLET IN MG COATING OF PURIFIED TALC 1 Stearic Acid 2.00 --- 2.00 2 Purified Talc 8.00 --- 8.00 3 Isopropyl Alcohol 0.4902 --- 0.4902 4 Dichloromethane 0.9803 --- 0.9803 LUBRICATION 5 Acetylsalicylic acid (Directly Compressible Granules) 100.00 --- 100.00 6 Calcium Hydrogen Phosphate 23.00 --- 23.00 7 Microcrystalline Cellulose 15.00 --- 15.00 8 Croscarmellose Sodium 5.00 --- 5.00 TOTAL 153.00 --- 153.00 ENTERIC COATING 9 Cellulose Acetate Phthalate 15.30 --- 15.30 10 Isopropyl Alcohol 75.00 --- 75.00 11 Dichloromethane 200.00 --- 200.00 12 Titanium Dioxide 1.50 --- 1.50 PRODUCT : ASPICOR 100 (Gastro-resistant Acetylsalicylic acid Tablets BP 100 mg) COUNTRY : REPUBLIC OF ARMENIA 3. PHARMACEUTICAL FORM Tablets 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Gastro-resistant acetylsalicylic acid Tablets BP indicated in the following: -Secondary prevention of myocardial infarction. - Prevention of cardiovascular morbidity in patients suffering from stable angina pectoris. - History of unstable angina pectoris, except during the acute phase. - Prevention of graft occlusion after Coronary Artery Bypass Grafting (CABG). - Coronary angioplasty, except during the acute phase. - Secondary prevention of transient ischaemic attacks (TIA) and ischaemic cerebrovascular accidents (CVA), provided intracerebral haemorrhages have been ruled out. Gastro-resistant Acetylsalicylic acid Tablets BP is not recommended in emergency situations. It is restricted to secondary prevention with chronic treat Lugege kogu dokumenti