Milgamma protekt tablets film-coated

מדינה: ארמניה

שפה: אנגלית

מקור: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

מרכיב פעיל:

benfotiamine

זמין מ:

Dragenopharm Apotheker Puschl GmbH

קוד ATC:

A11DA03

INN (שם בינלאומי):

benfotiamine

כמות:

300mg

טופס פרצבטיות:

tablets film-coated

יחידות באריזה:

(30/3x10/) in blister

סוג מרשם:

OTC

מצב אישור:

Registered

תאריך אישור:

2022-06-10

מאפייני מוצר

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
MILGAMMA PROTEKT
Active substance: Benfotiamine 300 mg
Film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 film-coated scored tablet contains 300 mg of benfotiamine
(lipid-soluble vitamin B
1
derivative).
For excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
White oblong film-coated tablet with score line on both sides
The tablets can be divided into two equal halves.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The only established therapeutic indication of the mono-preparations
is the treatment or prophylaxis
of clinical vitamin B
1
deficiency conditions, if these cannot be resolved by dietary means.
Clinically diagnosed vitamin B
1
deficiency can occur in:
Deficient diet and malnutrition (e.g. beriberi), long-term parenteral
nutrition, null diet, haemodialysis,
malabsorption, chronic alcoholism (alcohol toxic cardiomyopathy,
Wernicke encephalopathy,
Korsakov syndrome), increased requirement (e.g. pregnancy and
lactation).
Treatment of neuropathies and cardiovascular disorders that are caused
by vitamin B
1
deficiency.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
Unless otherwise prescribed, the usual dosage in the treatment of
clinical vitamin B
1
deficiency is
300 mg Milgamma protekt once a day.
The usual dosage in the prophylaxis of clinical vitamin B
1
deficiency conditions (e.g. neuropathies
and cardiovascular disorders), if these cannot be reached by dietary
means, is 150 mg Milgamma
protekt once a day.
The duration of administration is determined by the therapeutic
response.
_ _
Milgamma protekt is initially taken over a period of at least 3 weeks
in cases of vitamin B
1
deficiency.
Thereafter maintenance treatment is governed by therapeutic response
with 150 or 300 mg Milgamma
2
protekt. In case of missing or insufficient therapeutic response after
3 weeks in cases of vitamin B
1
deficiency therapy should be reconsidered.
_Paediatric Population _
Safety and efficacy in children