Riik: Kanada
keel: inglise
Allikas: Health Canada
AMYLASE; LIPASE; PROTEASE
APTALIS PHARMA CANADA ULC
A09AA02
MULTIENZYMES (LIPASE, PROTEASE ETC)
88200UNIT; 20700UNIT; 80000UNIT
CAPSULE (DELAYED RELEASE)
AMYLASE 88200UNIT; LIPASE 20700UNIT; PROTEASE 80000UNIT
ORAL
100
Prescription
DIGESTANTS
Active ingredient group (AIG) number: 0302964036; AHFS:
CANCELLED PRE MARKET
2016-12-06
_ _ _ULTRESA_ _®_ _ – Pancrelipase Capsules _ _ _ _ _ _ _ _ _ _ _ _ _ _Page 1 of 18 _ PRODUCT MONOGRAPH PR ULTRESA ® (Pancrelipase USP) Capsule (Delayed- Release) 13,800, 20,700 and 23,000 USP units of lipase USP Pancreatic enzymes A09AA02 Aptalis Pharma Canada Inc. 597 Sir-Wilfrid-Laurier Blvd. Mont-Saint-Hilaire, Québec Canada J3H 6C4 Date of Approval: June 05, 2015 Submission Control No: 173148 _ _ _ULTRESA_ _®_ _ – Pancrelipase Capsules _ _ _ _ _ _ _ _ _ _ _ _ _ _Page 2 of 18 _ 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 ....................................................................................................8 DOSAGE AND ADMINISTRATION ................................................................................8 OVERDOSAGE ................................................................................................................10 ACTION AND CLINICAL PHARMACOLOGY ............................................................10 STORAGE AND STABILITY ..........................................................................................11 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................11 PART II: SCIENTIFIC INFORMATION ...............................................................................13 PHARMACEUTICAL INFORMATION ..........................................................................13 CLINIC Lugege kogu dokumenti