Quốc gia: Armenia
Ngôn ngữ: Tiếng Anh
Nguồn: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
pancreatin (lipase, amylase, protease)
Berlin-Chemie AG
A09AA02 կենսաբանական դեղ
pancreatin (lipase, amylase, protease)
3500IU+ 4200IU+ 250IU (20/2x10/) in blister, (20/1x20/) in blister, (40/4x10/) in blister, (40/2x20/) in blister, (80/8x10/) in
tablets film-coated
3500IU+4200IU+250IU (20/2x10/) in blister, (20/1x20/) in blister, (40/4x10/) in blister, (40/2x20/) in blister, (80/8x10/) in bl
OTC
Registered
2019-01-18
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Mezym® forte 3,500 Ph. Eur. Units of lipase film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains 93.33 - 107.69 mg porcine pancreas powder with: Minimum lipolytic activity 3,500 Ph. Eur. U./tablet Minimum amylolytic activity 4,200 Ph. Eur. U./tablet Minimum total proteolytic activity 250 Ph. Eur. U./tablet Excipient(s) with known effect One film coated tablet contains 0.076 mg azorubine (E122). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Pink, flat cylindrical film-coated tablets with almost biplanar surfaces and bevelled edges. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Disturbances to exocrine pancreatic function that are accompanied by maldigestion. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Recommended dose per meal: 1 - 2 tablets are generally taken at the beginning of a meal. The dosage of Mezym® forte is dictated by the severity of the digestive disturbance. The appropriate dose is usually to be defined individually. Depending on the type of meal and on the known or estimated severity of the digestive disorder, further 2 - 4 tablets are to be taken during the meal. The required dose may also be substantially above that. An increase in the dose should take place only under the supervision of a doctor and be aimed at an improvement in the symptoms (e.g. steatorrhoea, stomachache). In case an increase in dose is deemed necessary other dosage forms with a higher amount of active-substance viz. pancreatin are available. A daily enzyme dose of 10,000 units of lipase per kg of body weight should not be exceeded. Particularly in patients with cystic fibrosis, the dose should not exceed the enzyme dose necessary for adequate fat absorption, accounting for the quantity and composition of meals. _Paediatric population_ The doctor should decide as to the dosage in children. Method of administration The film-coated tablets should be swallowed w Đọc toàn bộ tài liệu