Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
silymarin
Madaus GmbH
A05BA03
silymarin
140mg
capsules
(20/2x10/), (30/3x10/) and (60/6x10/) in blister
OTC
Registered
2017-11-07
Summary of P r od u c t C h a r a c t e r i s t i c s 1. N A M E OF THE MEDICINAL P R O D U C T LEGALON® 140 (active ingredient:) dried extract of milk thistle f ru i t s 2. QUALITATIVE AND QU A N T I T A T I V E COMPOSITION 1 capsule con t ai n s : 173.0 mg - 186.7 mg of d r i e d extract of milk thistle fruits ( 3 6 -44 : 1 ) , corresponding to 140 mg of silymarin (DNPH), corresponding to 108.2 mg of silymarin (HPLC) calculated as silibinin (solvent: ethyl acetate). - For excipients, see section 6.1. 3. P H A RM A C E U T I C AL F O R M C a ps u l es . Brown hard g e l a t i n capsules w i t h yellow powder as c on t e n t. 4. CLINICAL P A R T I CU L A R S 4.1 Therapeutic indications Toxic liver damage: for supportive treatment in patients with chronic inflammatory diseases of the liver or hepatic cirrhosis. Note: This medicine is not suitable for treating cases of acute poisoning. 4.2 P o s ol o g y and method of a d m i n i s t r a t i o n Unless otherwise p r e scr i b ed : adults and children over 12 years old are recommended 1 capsule 3 t i me s d a il y , corresponding to 420 mg ( 3 2 4 . 6 mg) o f s il ym a r i n d a il y . The capsules are to be swallowed whole and unchewed w i t h an a pp r o p r i a t e amount of liquid. The doctor will decide on the d u r a t i o n of the t r e a t m e nt. _Use in children under 12 years of age: _ This medicine is not intended for use in children under 12 years of age. _Method of administration and duration of treatment: _ For oral use the hard capsules are to be taken unchewed with an appropriate amount of liquid. The duration of treatment is determined by the doctor individually, depending on the nature and characteristics of the course of the disease. 4.3 C o n t r a in d i c a t i o n s Legalon 1 4 0 should n ot be administered i n cases of known h y pe r s e n s i t i v i ty against milk t h i s t l e fr u i t s , other composites or any of the e x c i p i e n t s . 4 . 4 Special warnings and special p r e c a u t i o n s for use The t r ea t m e n t with this Прочитать полный документ