País: Canadá
Idioma: inglés
Fuente: Health Canada
LUBIPROSTONE
SUCAMPO PHARMA AMERICAS LLC
A06AX03
LUBIPROSTONE
24MCG
CAPSULE
LUBIPROSTONE 24MCG
ORAL
60
Prescription
MISCELLANEOUS GI DRUGS
Active ingredient group (AIG) number: 0157490001; AHFS:
CANCELLED PRE MARKET
2020-12-17
_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 Leer el documento completo