MOVIPREP POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

POLYETHYLENE GLYCOL 3350; SODIUM SULFATE ANHYDROUS; SODIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ASCORBATE; ASCORBIC ACID

Available from:

ARALEZ PHARMACEUTICALS CANADA INC

ATC code:

A06AD65

INN (International Name):

MACROGOL, COMBINATIONS

Dosage:

100G; 7.5G; 2.691G; 1.015G; 5.9G; 4.7G

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

POLYETHYLENE GLYCOL 3350 100G; SODIUM SULFATE ANHYDROUS 7.5G; SODIUM CHLORIDE 2.691G; POTASSIUM CHLORIDE 1.015G; SODIUM ASCORBATE 5.9G; ASCORBIC ACID 4.7G

Administration route:

ORAL

Units in package:

1 PCK

Prescription type:

Ethical

Therapeutic area:

CATHARTICS AND LAXATIVES

Product summary:

Active ingredient group (AIG) number: 0652827001; AHFS:

Authorization status:

APPROVED

Authorization date:

2010-11-18

Summary of Product characteristics

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_MOVIPREP _
_Page 1 of 34_
PRODUCT MONOGRAPH
MOVIPREP®
_Macrogol 3350, Sodium sulphate anhydrous, Sodium chloride, _
_Potassium chloride, Ascorbic acid, Sodium ascorbate_
Powder for oral solution
Sachet A
_Macrogol (Polyethylene glycol) 3350 100 g _
_Sodium sulphate anhydrous _
_ 7.5 g _
_Sodium chloride _
_ _
_ 2.691 g _
_Potassium chloride _
_ 1.015 g _
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Sachet B
_Ascorbic acid _
_ 4.7 g _
_Sodium ascorbate 5.9 g _
OSMOTIC LAXATIVE
Aralez Pharmaceuticals Canada Inc.*
6733 Mississauga Road, Suite 800
Date of revision:
August 20, 2021
Mississauga, ON, Canada
L5N 6J5
SUBMISSION CONTROL NUMBER: 247990
*Doing business as (d/b/a) Miravo Healthcare
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_MOVIPREP _
_Page 2 of 34_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION.......................................... 3
SUMMARY PRODUCT INFORMATION
........................................................ 3
INDICATIONS AND CLINICAL USE
............................................................. 3
CONTRAINDICATIONS..................................................................................
4
WARNINGS AND PRECAUTIONS
................................................................. 4
ADVERSE REACTIONS
..................................................................................
8
DRUG INTERACTIONS
................................................................................
11
DOSAGE AND ADMINISTRATION
............................................................. 13
OVERDOSAGE..............................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
............................................. 15
STORAGE AND STABILITY
........................................................................
16
SPECIAL HANDLING INSTRUCTIONS
....................................................... 16
DOSAGE FORMS, COMPOSITION AND PACKAGING...............................
16
PART II: SCIENTIFIC INFORMATION
.............................................................. 18
PHARMAC