Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
omeprazole
Hankook Korus Pharm Co.
A02BC01
omeprazole
20mg
capsules
(30/3x10/) and (100/10x10/) in blister
Prescription
Registered
2017-06-05
_Summary of Product Characteristics_ 1. NAME OF THE MEDICINAL PRODUCT 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Excipient(s) 3. PHARMACEUTICAL FORM 4. CLINICAL PARTICULARS 4.1 Therapeutic indications 4.2 Posology and method of administration 4.3 Contraindications 4.4 Special warnings and precautions 4.5 Interaction with other medicinal products and other forms of interaction. 4.6 Fertility, pregnancy and lactation 4.7 Effects on ability to drive and use machines 4.8 Undesirable effects 5. PHARMACOLOGICAL PROPERIES 5.1 Pharmacodynamic properties Pharmacotherapeutic group:, ATC code: 5.2 Pharmacokinetic properties. 5.3 Preclinical safety data 6. PHARMACEUTICAL PARTICULARS 6.1 Excipients 6.2 Incompatibilities 6.3 Shelf life 6.4 Special precautions for storage 6.5 Nature and contents of container 6.6 Special precautions for disposal and other handing 7. Marketing authorisation holder 8. Marketing authorisation number(s) 9. Date of first authorisation/renewal of the authorisation 10. Date of revision of the text _Summary of Product Characteristics_ 1. NAME OF THE MEDICINAL PRODUCT Omeprazole-Asteria Cap. 20mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient No. Chemical Name Quantity/ Cap. Use 1 Omerpazole 20mg Active ingredient Excipient(s) No. Chemical Name Quantity/ Cap. Use 1 Sucrose 161.63mg Inactive 2 Anhydrous Lactose 8mg Inactive 3 Hypromellose 9.08mg Inactive 4 Hydoxypropyl Cellulose 6mg Inactive 5 Sodium Lauryl Sulfate 0.5mg Inactive 6 Sodium Phosphate 0.8mg Inactive (dehydrate) 7 Hypromellose Phthalate 26.83mg Inactive 8 Diethyl Phthalate 0.16mg Inactive 9 Acetone - Inactive 10 Ethanol - Inactive 3. PHARMACEUTICAL FORM Hard capsule _Summary of Product Characteristics_ 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Duodenal Ulcer (adults) : Omeprazole capsule is indicated for short-term treatment of active duodenal ulcer in adults. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy. Omeprazole capsule in combination with clarithromycin and Прочитать полный документ