Country: Armenia
Language: English
Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
benfotiamine, pyridoxine (pyridoxine hydrochloride)
Mauermann-Arzneimittel KG Heinrich-Knote-Strasse 2
առկա չէ (A11DB)
benfotiamine, pyridoxine (pyridoxine hydrochloride)
100mg+ 100mg
tablets coated
(30/2x15/) in blister, (60/4x15/) in blister
Prescription
Registered
2022-10-12
1. NAME OF THE MEDICINAL PRODUCT Milgamma 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ 1 coated tablet contains 100 mg benfotiamine (lipoid-soluble vitamin B 1 derivative) and 100 mg pyridoxine hydrochloride (Vitamin B 6 ). Excipient with known effect: each coated tablet contains 92.399 mg saccharose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Coated tablets. White , round biconvex coated tablets with smooth surface. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Systemically neurological diseases caused by a proven deficiency of vitamins B 1 and B 6 . 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology _ _Children and adolescents _ There are no adequate studies on the use of benfotiamine and pyridoxine in the dosage of Milgamma_ _in children and adolescents below 18 years of age. Therefore, Milgamma_ _should not be used in children and adolescents below 18 years of age. _ _ _Adults _ Unless otherwise prescribed adults should take 1 coated tablet Milgamma daily. In acute conditions the dose can be increased after consultation with the physician up to 1 coated tablet Milgamma 3x daily. Elderly: Normal Dosage regimens are recommended in the elderly. On the basis of the available data no restrictions on the use of Benfotiamine 100 mg, Pyridoxine 100 mg, coated tablets in elderly at the recommended dosage are required. _Duration of treatment _ After 4 weeks the physician should decide whether the increased dosage of Vitamin B 6 and B 1 (3x 1 coated tablet daily) is still necessary. Where appropriate, the dosage should be decreased to 1 coated tablet Milgamma daily to reduce the risk of neuropathies associated with Vitamin B 6 . The duration of administration is determined by the therapeutic response. Milgamma is initially taken over a period of at least 4 weeks in cases of vitamin B1/B6 deficiency and over a period of at least 4-6 weeks in cases of diabetic and alcoholic polyneuropathy and in cases of supportive treatment of painful nerve disorders, respectively. Thereafter maint Read the complete document