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:

4 SYR/8 SYR

Typ recepty:

Prescription

Dziedzina terapeutyczna:

MISCELLANEOUS GI DRUGS

Podsumowanie produktu:

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

Status autoryzacji:

APPROVED

Data autoryzacji:

2012-02-03

Charakterystyka produktu

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PRODUCT MONOGRAPH
PR
RELISTOR
®
Methylnaltrexone bromide injection, 20 mg /mL
For Subcutaneous use
μ-opioid receptor antagonist
Salix Pharmaceuticals, Inc.
8510 Colonnade Center Drive
Raleigh, NC 27615
Date of Preparation: February 1, 2012
Submission Control No: 152267
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_RELISTOR_
_® _
_Product Monograph _
_Page 2 of 66_
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
..............................................................................................................17
DOSAGE AND
ADMINISTRATION..........................................................................................18
ACTION AND CLINICAL PHARMACOLOGY
........................................................................20
STORAGE AND
STABILITY......................................................................................................24
SPECIAL HANDLING INSTRUCTIONS
...................................................................................24
DOSAGE FORMS, COMPOSITION AND PACKAGING
.........................................................24
PART II: SCIENTIFIC
INFORMATION.....................................................................................26
PHARMACEUTICAL
INFORMATION......................................................................................26
CLINICAL
TRIALS............................