Enterol 250 powder for oral suspension

البلد: أرمينيا

اللغة: الإنجليزية

المصدر: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

العنصر النشط:

lyophilized cells of saccharomyces boulardii

متاح من:

Biocodex

ATC رمز:

A07FA02

INN (الاسم الدولي):

lyophilized cells of saccharomyces boulardii

جرعة:

250mg

الشكل الصيدلاني:

powder for oral suspension

الوحدات في الحزمة:

(10) sachets

نوع الوصفة الطبية :

OTC

الوضع إذن:

Registered

تاريخ الترخيص:

2018-03-26

خصائص المنتج

- 1 -
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
ENTEROL
® 250
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Saccharomyces boulardii_ CNCM I-745
........................................................... 250.00 mg
(lyophilized cells of _Saccharomyces boulardii_ CNCM I-745)
Excipient with known effect: lactose, fructose, sorbitol (contained in
tutti-frutti aroma)
For the full list of excipients: see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for oral suspension in sachets.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
ENTEROL is indicated for the prevention and treatment of diarrhea of
different etiologies in adults
and children, such as:
- Symptomatic treatment of diarrhoea
- Prevention of antibiotic-induced diarrhoea
- Prevention of diarrhoea, e.g. when travelling
- Addition to vancomycin/metronidazole treatment to prevent recurrence
of Clostridium difficile-
induced diarrhoea
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology _
New-born: not more than 1 sachet per day under supervision, strictly
follow the advises of your
physician.
Children under 6 years: 1 sachet 1-2 times per day
Adults and children over 6 years old: 1-2 sachets 2 times per day.
_Recommended period of treatment: _
_Short-term symptomatic treatment of diarrhoea:_ for one week.
Prevention of antibiotic-induced diarrhoea:
Treatment should be started within 48 to 72 hours of the beginning of
treatment with antibiotics
and it should continue for at least three days and not longer than
four weeks after the treatment
with antibiotics is ended.
_Prevention of diarrhoea e.g. when travelling: _
Treatment should be started couple of days before travelling and
should be continued as long as
travelling.
_Addition to vancomycin/metronidazole treatment to prevent recurrence
of Clostridium difficile-_
_induced diarrhoea: _Treatment should be started as soon possible
after the beginning of antibiotic
treatment and it should continue for 4 weeks.
- 2 -
_Method of administration _
Pour the contents of the sachet in a little w