PEGLYTE POWDER POWDER FOR SOLUTION

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

MACROGOL; SODIUM SULFATE; SODIUM BICARBONATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE

Tillgänglig från:

PENDOPHARM DIVISION OF PHARMASCIENCE INC

ATC-kod:

A06AD10

INN (International namn):

MINERAL SALTS IN COMBINATION

Dos:

238.18G; 22.96G; 6.76G; 5.85G; 3.05G

Läkemedelsform:

POWDER FOR SOLUTION

Sammansättning:

MACROGOL 238.18G; SODIUM SULFATE 22.96G; SODIUM BICARBONATE 6.76G; SODIUM CHLORIDE 5.85G; POTASSIUM CHLORIDE 3.05G

Administreringssätt:

ORAL

Enheter i paketet:

280G - 4X70G

Receptbelagda typ:

Ethical

Terapiområde:

CATHARTICS AND LAXATIVES

Produktsammanfattning:

Active ingredient group (AIG) number: 0516978006; AHFS:

Bemyndigande status:

APPROVED

Tillstånd datum:

2012-07-24

Produktens egenskaper

PRESCRIBING INFORMATION
PEGLYTE
® POWDER
Polyethylene Glycol 3350 and Electrolytes for Oral Solution, USP
GASTROINTESTINAL LAVAGE AND LAXATIVE
PENDOPHARM, Division of Pharmascience Inc.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
DATE OF REVISION:
October 2, 2015
Submission Control No: 179538
® Registered trademark of Pharmascience Inc.
_PegLyte_
_®_
_ Prescribing Information _
_Page 2 of 20 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................5
DRUG INTERACTIONS
....................................................................................................6
DOSAGE AND ADMINISTRATION
................................................................................7
OVERDOSAGE
..................................................................................................................8
ACTION AND CLINICAL PHARMACOLOGY
..............................................................8
STORAGE AND STABILITY
............................................................................................9
DOSAGE FORMS, COMPOSITION AND PACKAGING
...............................................9
PART II: SCIENTIFIC INFORMATION
...............................................................................11
PHARMACEUTICAL INFORMATION
..........................................................................11
CLINICAL TRIALS
..................................................................