MOVIPREP

Country: Iżrael

Lingwa: Ingliż

Sors: Ministry of Health

Ingredjent attiv:

ASCORBIC ACID; MACROGOLS; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS

Disponibbli minn:

PADAGIS ISRAEL AGENCIES LTD, ISRAEL

Kodiċi ATC:

B05XA31

Għamla farmaċewtika:

POWDER FOR SOLUTION

Kompożizzjoni:

POTASSIUM CHLORIDE 1.015 G; SODIUM ASCORBATE 5.9 G; MACROGOLS 100 G; SODIUM CHLORIDE 2.691 G; SODIUM SULFATE ANHYDROUS 7.5 G; ASCORBIC ACID 4.7 G

Rotta amministrattiva:

PER OS

Tip ta 'preskrizzjoni:

Required

Manifatturat minn:

NORGINE LIMITED UK

Grupp terapewtiku:

ELECTROLYTES IN COMBINATION WITH OTHER DRUGS

Żona terapewtika:

ELECTROLYTES IN COMBINATION WITH OTHER DRUGS

Indikazzjonijiet terapewtiċi:

For bowel cleansing prior to any clinical procedures requiring a clean bowel e.g. bowel endoscopy or radiology.

Data ta 'l-awtorizzazzjoni:

2016-01-31

Fuljett ta 'informazzjoni

Norgine Item No.:
Proof No.:
Change Control No.:
Product Name (including flavour):
Date:
Market:
Component Type:
Manufacturing Site:
Technical Drawing No.:
Dimensions (mm):
Pharmacode:
Material Number:
Va iable data p ompts info mation:
Schawk Job No.:
Profile
Technical Info
Pre-printed (as part of artwork)
Printed on-line
10070408
3
MVP_2021_12_20_290;
MVP_2021_10_22_01
17/08/2023
Israel
-
-
PIL
HENGOED
NOR-LFT77-V2
UNFOLDED 210 x 640mm
FOLDED 210 x 40mm
730
N/A
N/A
108920016 / 403360344 0313
MOVIPREP
Black
:لمشت ةيفاضإ ةيبناج ضارعأ
:10 نيب نم دحاو مدختسم نم رثكأ ىدل رهظت
ضارعأ - ا
ً
دج ةعئاش ةيبناج ضارعأ
.ةنوخس ,نايثغ ,جرشلا ةحتف يف ملاآ ,ءيس
ماع روعش ,بعت ,نطبلا يف خافتنا ,نطبلا يف
ملاآ
:10 نيب نم دحاو مدختسم ىتح ىدل رهظت
ضارعأ - ةعئاش ةيبناج ضارعأ
.ةريرعشق ,شطع ,مضه تابوعص ,تا
ّ
ؤيقت ,سأر ملاآ ,راود ,مونلا يف لكاشم
,عوج
:100 نيب نم دحاو مدختسم ىتح ىدل رهظت
ضارعأ - ةعئاش ريغ ةيبناج ضارعأ
.دبكلا لمع فئاظو تاصوحف جئاتن يف
تارييغت ,علبلا يف تابوعص ,ةحار مدع
:)دعب اهعويش ديدحت
ّ
متي مل ضارعأ ( فورعم ريغ اهعويش هيبناج
ضارعأ
تابرض( بــلقلا ناــقفخ وأ مـ
ـظتنم رـ
ـيغ بــلق مـ
ـظن ,مدــلا طـ
ـغض يــف تــقؤم عاــفترا ,)ءاــعمأ
تازاــغ( نـ
ـطبلا يــف تازاــغ
ةــضفخنم موــيدوص بــسن ,)ؤــيقتلل
دوــهجمب ماــيقلا( حاــجنلا نود
ؤــيقتلا ةــلواحم ,فاــفج ,)كــبلق
تاــقدب رعــشت ,بــلق
يــف طوــبه لــثم مدــلا يــف
حلاــملأا تايوتــسم يــف تارــييغتو
)تاــبون( تاــجلاتخا �

Karatteristiċi tal-prodott

1
PRESCRIBING INFORMATION
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 1 contains the following active substances:
Macrogol 3350
100g
Sodium sulfate anhydrous
7.500g
Sodium chloride
2.691g
Potassium chloride
1.015g
SACHET 2 contains the following active substances:
Ascorbic acid
4.700g
Sodium ascorbate
5.900g
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
56.5 mmol/L
Excipient(s) with known effect:
This product contains 0.233g of aspartame per sachet 1.
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 1.
Free flowing white to light brown powder in Sachet 2.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Moviprep is indicated 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 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
1
’ and one ‘sachet
2
’
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
and timing is
dependent on whether the clinical procedure is conducted with or
without general anaesthesia as
specified below:
FO