ORAL PURGATIVE POWDER FOR SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE

Διαθέσιμο από:

ODAN LABORATORIES LTD

Φαρμακολογική κατηγορία (ATC):

A06AB58

INN (Διεθνής Όνομα):

SODIUM PICOSULFATE, COMBINATIONS

Δοσολογία:

12G; 3.5G; 10MG

Φαρμακοτεχνική μορφή:

POWDER FOR SOLUTION

Σύνθεση:

CITRIC ACID 12G; MAGNESIUM OXIDE 3.5G; SODIUM PICOSULFATE 10MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

100

Τρόπος διάθεσης:

Ethical

Θεραπευτική περιοχή:

CATHARTICS AND LAXATIVES

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0350181002; AHFS:

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2017-06-22

Αρχείο Π.Χ.Π.

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_Page 1 of 13_
PRESCRIBING INFORMATION
ORAL PURGATIVE
Magnesium oxide, citric acid and sodium picosulfate
Powder for oral solution
Purgative
Odan Laboratories Ltd.
Date of Revision:
325 Stillview Avenue
March 21, 2013
Pointe-Claire, Quebec
H9R 2Y6
CONTROL NO.: 162616
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_Page 2 of 13_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................4
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................7
DRUG INTERACTIONS
....................................................................................................8
DOSAGE AND ADMINISTRATION
................................................................................8
OVERDOSAGE
..................................................................................................................9
STORAGE AND STABILITY
..........................................................................................10
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................10
PART II: CONSUMER INFORMATION
...............................................................................11
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_Page 3 of 13_
ORAL PURGATIVE
Magnesium oxide, citric acid and sodium picosulfate
Powder for oral solution
Purgative
PART I: HEALTH PROFESSIONAL INFORMATION
SUMMARY PRODUCT INFORMATION
ROUTE OF
ADMINISTRATION
DOSAGE FORM / STRENGTH
CLINICALLY RELEVANT NONMEDICINAL
INGREDIENTS
Oral
Each sachet contains:
Powder : citric acid 12g;
magnesium oxide 3.5 g;
sodium picosulfate 10 mg
For a complete li