RELISTOR SOLUTION

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

METHYLNALTREXONE BROMIDE

Dostępny od:

SALIX PHARMACEUTICALS INC

Kod ATC:

A06AH01

INN (International Nazwa):

METHYLNALTREXONE BROMIDE

Dawkowanie:

20MG

Forma farmaceutyczna:

SOLUTION

Skład:

METHYLNALTREXONE BROMIDE 20MG

Droga podania:

SUBCUTANEOUS

Sztuk w opakowaniu:

0.6ML

Typ recepty:

Prescription

Dziedzina terapeutyczna:

MISCELLANEOUS GI DRUGS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0152456001; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2010-09-17

Charakterystyka produktu

_ _
PRODUCT MONOGRAPH
PR
RELISTOR
®
Methylnaltrexone bromide injection, 20 mg /mL
For Subcutaneous use
μ-opioid receptor antagonist
Salix Pharmaceuticals, a division of Valeant
Pharmaceuticals North America, LLC
400 Somerset Corporate Boulevard
Bridgewater, NJ 08807
Date of Revision: July 25, 2018
Submission Control No: 208302
_ _
_RELISTOR_
_® _
_Product Monograph _
_ _
_Page 2 of 70_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION................................................................3
SUMMARY PRODUCT INFORMATION
....................................................................................3
INDICATIONS AND CLINICAL USE
..........................................................................................3
CONTRAINDICATIONS
...............................................................................................................4
WARNINGS AND PRECAUTIONS
..............................................................................................4
ADVERSE REACTIONS
................................................................................................................6
DRUG INTERACTIONS
..............................................................................................................18
DOSAGE AND ADMINISTRATION
..........................................................................................19
ACTION AND CLINICAL PHARMACOLOGY
........................................................................21
STORAGE AND STABILITY
......................................................................................................25
SPECIAL HANDLING INSTRUCTIONS
...................................................................................25
DOSAGE FORMS, COMPOSITION AND PACKAGING
.........................................................25
PART II: SCIENTIFIC INFORMATION
.....................................................................................28
PHARMACEUTICAL INFORMATION
..................................................................