Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
ademetionine
AbbVie S.r.l.
A16AA02
ademetionine
400mg
tablets gastro-resistant
(20/2x10/) in blister
Prescription
Registered
2016-08-11
Abbott Confidential Information This information is confidential SUMMARY OF PRODUCT CHARACTERISTICS ADEMETIONINE 1 NAME OF THE MEDICINAL PRODUCT Heptral 400 mg, gastro-resistant tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Heptral 400 mg tablets One tablet contains 400 mg of Ademetionine.3 PHARMACEUTICAL FORM Heptral 400 mg , gastro-resistant tablets Practically white to yellowish, oval tablet, free from foreign particles 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Heptral is indicated for treatment of adults with: • Intrahepatic cholestasis in pre-cirrhotic and cirrhotic states • Intrahepatic cholestasis in pregnancy • Depressive symptoms Relief of Fatigue Caused by Chronic Liver Disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment is usually started with parenteral administration of the drug and continued using the drug in the form of tablets or immediately with the use of tablets. Tablets should be swallowed whole, and not chewed. For better absorption of the active ingredient and complete therapeutic effect, ademetionine tablets should not be taken with meals. Heptral tablets should be extracted from the blister package immediately before use. If the tablets appear other than white to yellowish in color (due to presence of holes in the aluminum wrapper), it is recommended the product not be used. Depression _Initial therapy _ IV or IM: The recommended dosing is 5-12 mg/kg/day. The usual starting dose is 400 mg/day IV or IM, total daily dose not to exceed 1000 mg. Duration of initial parenteral therapy is 15-20 days. Oral: The recommended dosing is 10-25 mg/kg/day orally. The usual starting dose is 400-800 mg/day, total daily dose not to exceed 1600 mg. _Maintenance therapy_ Oral: 500 - 1600 mg/day. Intrahepatic cholestasis _Initial therapy _ IV or IM: The recommended dosing is 5-12 mg/kg/day. The usual starting dose is 400 mg/day IV or IM, total daily dose not to exceed 1000 mg. Duration of initial parenteral therapy is 2 weeks. Ora Прочитать полный документ