PEGLYTE POWDER POWDER FOR SOLUTION

Country: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

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

Доступно од:

PENDOPHARM DIVISION OF PHARMASCIENCE INC

АТЦ код:

A06AD10

INN (Међународно име):

MINERAL SALTS IN COMBINATION

Дозирање:

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

Фармацеутски облик:

POWDER FOR SOLUTION

Састав:

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

Пут администрације:

ORAL

Јединице у пакету:

280G - 4X70G

Тип рецептора:

Ethical

Терапеутска област:

CATHARTICS AND LAXATIVES

Резиме производа:

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

Статус ауторизације:

APPROVED

Датум одобрења:

2012-07-24

Карактеристике производа

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