PEGLYTE POWDER POWDER FOR SOLUTION

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

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

Dostępny od:

PENDOPHARM DIVISION OF PHARMASCIENCE INC

Kod ATC:

A06AD10

INN (International Nazwa):

MINERAL SALTS IN COMBINATION

Dawkowanie:

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

Forma farmaceutyczna:

POWDER FOR SOLUTION

Skład:

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

Droga podania:

ORAL

Sztuk w opakowaniu:

280G - 4X70G

Typ recepty:

Ethical

Dziedzina terapeutyczna:

CATHARTICS AND LAXATIVES

Podsumowanie produktu:

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

Status autoryzacji:

APPROVED

Data autoryzacji:

2012-07-24

Charakterystyka produktu

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
..................................................................