Moviprep powder for oral solution

Држава: Арменија

Језик: Енглески

Извор: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активни састојак:

sachet A-macrogol (macrogol 3350), sodium sulfate, sodium chloride, potassium chloride; sachet B-ascorbic acid, sodium ascorbate

Доступно од:

Norgine Limited

АТЦ код:

A06AD65

INN (Међународно име):

sachet A-macrogol (macrogol 3350), sodium sulfate, sodium chloride, potassium chloride; sachet B-ascorbic acid, sodium ascorbate

Дозирање:

sachet A-100g+ 7.5g+ 2.691g+ 1.015g

Фармацеутски облик:

powder for oral solution

Јединице у пакету:

sachet B-4.7g+5.9g; (4/(2) sachetA(111.896 g) + (2) sachetB(10.6 g)/)

Тип рецептора:

OTC

Статус ауторизације:

Registered

Датум одобрења:

2020-09-05

Карактеристике производа

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Movprep,
powder for oral solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The ingredients of Movprep are contained in two separate sachets.
SACHET A
contains the following active substances:
Macrogol 3350
100 g
Sodium sulfate anhydrous
7.500 g
Sodium chloride
2.691 g
Potassium chloride
1.015 g
SACHET B
contains the following active substances:
Ascorbic acid
4.700 g
Sodium ascorbate
5.900 g
The concentration of electrolyte ions when both sachets are made up to
one litre of solution is as
follows:
Sodium
181.6 mmol/L (of which not more than 56.2 mmol is
absorbable)
Sulfate
52.8 mmol/L
Chloride
59.8 mmol/L
Potassium
14.2 mmol/L
Ascorbate
29.8 mmol/L
Excipient(s) with known effect:
This product contains 0.233 g of aspartame per sachet A.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for oral solution.
Free flowing white to yellow powder in Sachet A.
Free flowing white to light brown powder in Sachet B.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Movprep
is indicated in adults for bowel cleansing prior to any clinical
procedures requiring a
clean bowel e.g. bowel endoscopy or radiology.
2
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ADULTS AND OLDER PEOPLE _
A course of treatment consists of two litres of
Movprep
. It is strongly recommended that one
litre of clear liquid, which may include water, clear soup, fruit
juice without pulp, soft drinks,
tea and/or coffee without milk, is also taken during the course of
treatment.
A litre of
Movprep
consists of one 'sachet A' and one 'sachet B' dissolved together in
water to
make one litre of solution. The reconstituted solution should be drunk
over a period of one to
two hours. This process should be repeated with a second litre of
Movprep
to complete this
course.
This course of treatment can be taken either as divided or as single
doses and timing is
dependent on whether the clinical procedure is conducted with or
without general anaesthesia as
specifi