ULTRESA CAPSULE (DELAYED RELEASE)

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

AMYLASE; LIPASE; PROTEASE

זמין מ:

APTALIS PHARMA CANADA ULC

קוד ATC:

A09AA02

INN (שם בינלאומי):

MULTIENZYMES (LIPASE, PROTEASE ETC)

כמות:

88200UNIT; 20700UNIT; 80000UNIT

טופס פרצבטיות:

CAPSULE (DELAYED RELEASE)

הרכב:

AMYLASE 88200UNIT; LIPASE 20700UNIT; PROTEASE 80000UNIT

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

100

סוג מרשם:

Prescription

איזור תרפויטי:

DIGESTANTS

leaflet_short:

Active ingredient group (AIG) number: 0302964036; AHFS:

מצב אישור:

CANCELLED PRE MARKET

תאריך אישור:

2016-12-06

מאפייני מוצר

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_ULTRESA_
_®_
_ – Pancrelipase Capsules _
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_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 _
_ _
_ _
_ _
_ _
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_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