AMITIZA CAPSULE

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

LUBIPROSTONE

Tilgjengelig fra:

SUCAMPO PHARMA AMERICAS LLC

ATC-kode:

A06AX03

INN (International Name):

LUBIPROSTONE

Dosering :

24MCG

Legemiddelform:

CAPSULE

Sammensetning:

LUBIPROSTONE 24MCG

Administreringsrute:

ORAL

Enheter i pakken:

60

Resept typen:

Prescription

Terapeutisk område:

MISCELLANEOUS GI DRUGS

Produkt oppsummering:

Active ingredient group (AIG) number: 0157490001; AHFS:

Autorisasjon status:

CANCELLED PRE MARKET

Autorisasjon dato:

2020-12-17

Preparatomtale

_AMITIZA® Product Monograph _
_ _
_ _
_Page 1 of 21 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
AMITIZA
®
Lubiprostone capsules
Soft gel capsules, 24 mcg
Selective ClC-2 Chloride Channel Activator
Manufactured by:
Sucampo Pharma Americas, LLC
Date of Preparation:
October 13, 2015
805 King Farm Boulevard, Suite 550
Rockville, Maryland 20850, USA
Imported and Distributed by:
Takeda Canada Inc.
435 North Service Road West
Oakville, Ontario L6M 4X8, Canada
Submission Control No: 179333
AMITIZA
®
is a registered trademark of Sucampo AG and used by Takeda Canada Inc.
under license
from Sucampo AG. © 2015 Sucampo AG.
_AMITIZA® Product Monograph _
_ _
_ _
_Page 2 of 21 _
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....................................................................................................
7
DOSAGE AND ADMINISTRATION
...............................................................................
8
OVERDOSAGE
..................................................................................................................
9
ACTION AND CLINICAL PHARMACOLOGY
.............................................................. 9
STORAGE AND STABILITY
.........................................................................................
10
SPECIAL HANDLING INSTRUCTIONS
.......................................................................
1