PEGLYTE POWDER POWDER FOR SOLUTION

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

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

זמין מ:

PENDOPHARM DIVISION OF PHARMASCIENCE INC

קוד ATC:

A06AD10

INN (שם בינלאומי):

MINERAL SALTS IN COMBINATION

כמות:

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

טופס פרצבטיות:

POWDER FOR SOLUTION

הרכב:

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

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

280G - 4X70G

סוג מרשם:

Ethical

איזור תרפויטי:

CATHARTICS AND LAXATIVES

leaflet_short:

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

מצב אישור:

APPROVED

תאריך אישור:

2012-07-24

מאפייני מוצר

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