PEGLYTE POWDER POWDER FOR SOLUTION

Country: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

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

Fáanlegur frá:

PENDOPHARM DIVISION OF PHARMASCIENCE INC

ATC númer:

A06AD10

INN (Alþjóðlegt nafn):

MINERAL SALTS IN COMBINATION

Skammtar:

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

Lyfjaform:

POWDER FOR SOLUTION

Samsetning:

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

Stjórnsýsluleið:

ORAL

Einingar í pakka:

280G - 4X70G

Gerð lyfseðils:

Ethical

Lækningarsvæði:

CATHARTICS AND LAXATIVES

Vörulýsing:

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

Leyfisstaða:

APPROVED

Leyfisdagur:

2012-07-24

Vara einkenni

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