ULTRESA CAPSULE (DELAYED RELEASE)

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

PROTEASE; AMYLASE; LIPASE

Beschikbaar vanaf:

APTALIS PHARMA CANADA ULC

ATC-code:

A09AA02

INN (Algemene Internationale Benaming):

MULTIENZYMES (LIPASE, PROTEASE ETC)

Dosering:

88900UNIT; 98000UNIT; 23000UNIT

farmaceutische vorm:

CAPSULE (DELAYED RELEASE)

Samenstelling:

PROTEASE 88900UNIT; AMYLASE 98000UNIT; LIPASE 23000UNIT

Toedieningsweg:

ORAL

Eenheden in pakket:

100

Prescription-type:

Prescription

Therapeutisch gebied:

DIGESTANTS

Product samenvatting:

Active ingredient group (AIG) number: 0302964035; AHFS:

Autorisatie-status:

APPROVED

Autorisatie datum:

2000-06-08

Productkenmerken

_ _
_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