RELISTOR SOLUTION

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

METHYLNALTREXONE BROMIDE

Fáanlegur frá:

SALIX PHARMACEUTICALS INC

ATC númer:

A06AH01

INN (Alþjóðlegt nafn):

METHYLNALTREXONE BROMIDE

Skammtar:

20MG

Lyfjaform:

SOLUTION

Samsetning:

METHYLNALTREXONE BROMIDE 20MG

Stjórnsýsluleið:

SUBCUTANEOUS

Einingar í pakka:

4 SYR/8 SYR

Gerð lyfseðils:

Prescription

Lækningarsvæði:

MISCELLANEOUS GI DRUGS

Vörulýsing:

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

Leyfisstaða:

APPROVED

Leyfisdagur:

2012-02-03

Vara einkenni

_ _
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
_ _
_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............................