מדינה: ארמניה
שפה: אנגלית
מקור: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
esomeprazole (esomeprazole magnesium)
Apotex Inc.
A02BC05
esomeprazole (esomeprazole magnesium)
20mg
tablets delayed-release
(30/3x10/) blisters
Prescription
Registered
2015-06-09
APPENDIX 1.9 THE SUMMARY OF THE PRODUCT CHARACTERISTICS (SMPC) _ _ Page 1 of 22 1. NAME OF THE MEDICINAL PRODUCT Apo-Esomeprazole Tablets 20 mg and 40 mg (Esomeprazole Magnesium Delayed Release Tablets) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION COMPONENT FUNCTION % W/W MG/TABLET % W/W MG/TABLET 20 MG 40 MG CORE Esomeprazole Magnesium IH # Active 10.35 20.7 10.35 41.4 Copovidone (Kollidon VA64) ## Binder 87.8 175.6 87.8 351.2 Colloidal Silicon Dioxide NF Glidant/Anti- Adherent 0.25 0.5 0.25 1.0 Magnesium Stearate NF (Vegetable Source) Lubricant 1.6 3.2 1.6 6.4 TOTAL CORE WEIGHT 100 200 100 400 COATING Triethyl Citrate NF (Citroflex 2) Plasticizer 0.70 0.75 0.70 0.9 Talc 500 mesh USP Glidant / Anti- caking Agent 1.64 1.75 1.64 2.1 Titanium Dioxide USP Pigment/ Opacifier 3.72 3.96 3.67 4.7 Red-Ferric Oxide NF (Orange Shade #34690) Colouring Agent 0.03 0.03 0.20 0.25 Yellow Ferric Oxide NF Colouring Agent 0.01 0.01 0.04 0.05 Methacrylic Acid Copolymer NF Dispersion (30% Solids) Polymer 23.47 25(**7.5) 23.44 30(**9.0) Purified Water USP * Solvent / Carrier 70.42 75.0 70.31 90.0 TOTAL COATING SOLUTION 100 14 100 17 TOTAL TABLET WEIGHT -- 214 -- 417 # 20.7 mg and 41.4 mg Esomeprazole Magnesium is equivalent to 20 mg and 40 mg Esomeprazole respectively. ## The amount of Copovidone added is adjusted based on the potency of Esomeprazole Magnesium. * Purified water evaporates during the coating procedure. ** Methacrylic Acid Copolymer Dispersion NF contains 30% solids. The amounts in the brackets represent the solid content of Methacrylic Acid Copolymer Dispersion NF. 3. PHARMACEUTICAL FORM Delayed-Release Tablets 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ADULTS APO-ESOMEPRAZOLE (esomeprazole magnesium) is indicated for treatment of conditions where a reduction in gastric acid secretion is required such as: APPENDIX 1.9 THE SUMMARY OF THE PRODUCT CHARACTERISTICS (SMPC) _ _ Page 2 of 22 reflux esophagitis maintenance treatment of patients with reflux esophagitis nonerosive reflux disease (NERD) (i.e. קרא את המסמך השלם