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:

առկա չէ (A06AD)

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:

2020-04-06

Карактеристике производа

SUMMARY
OF PRODUCT
CHARACTERISTICS
1.
NAME
OF
THE
MEDICINAL
PRODUCT
Moviprep,
powder for
oral
solution
2.
QUALITATIVE AND
QUANTITATIVE COMPOSITION
The
ingredients
of
Moviprep
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
S
odium
ascorbate
5.900
g
T
he
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
Moviprep
is
indicated
in
adults
for
bowel
cleansing
prior
to
any
clinical
procedures requiring
a
clean
bowel
e.g.
bowel
endoscopy
or
radiology.
4.2
POSOLOGY
AND
METHOD
OF ADMINISTRATION
Posology
_ADULTS _
_AND_
_ _
_OLDER PEOPLE_
A
course
of
treatment
consists
of
two
litres
of Moviprep.
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
Moviprep
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
Moviprep
to
complete
this
course.This
course
of
treatment can
be
taken
either
as
divided
or
as
single
doses
as
specified
below:
1.
Divided doses:
one
litre
of
Moviprep
in
the
evening
before
and
one
litre
of
Moviprep