PEGLYTE POWDER POWDER FOR SOLUTION

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

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

Disponível em:

PENDOPHARM DIVISION OF PHARMASCIENCE INC

Código ATC:

A06AD10

DCI (Denominação Comum Internacional):

MINERAL SALTS IN COMBINATION

Dosagem:

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

Forma farmacêutica:

POWDER FOR SOLUTION

Composição:

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

Via de administração:

ORAL

Unidades em pacote:

280G - 4X70G

Tipo de prescrição:

Ethical

Área terapêutica:

CATHARTICS AND LAXATIVES

Resumo do produto:

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

Status de autorização:

APPROVED

Data de autorização:

2012-07-24

Características técnicas

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