ULTRESA CAPSULE (DELAYED RELEASE)

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

LIPASE; PROTEASE; AMYLASE

Saadav alates:

APTALIS PHARMA CANADA ULC

ATC kood:

A09AA02

INN (Rahvusvaheline Nimetus):

MULTIENZYMES (LIPASE, PROTEASE ETC)

Annus:

13800UNIT; 53400UNIT; 58800UNIT

Ravimvorm:

CAPSULE (DELAYED RELEASE)

Koostis:

LIPASE 13800UNIT; PROTEASE 53400UNIT; AMYLASE 58800UNIT

Manustamisviis:

ORAL

Ühikuid pakis:

100

Retsepti tüüp:

Prescription

Terapeutiline ala:

DIGESTANTS

Toote kokkuvõte:

Active ingredient group (AIG) number: 0302964034; AHFS:

Volitamisolek:

CANCELLED POST MARKET

Loa andmise kuupäev:

2016-12-06

Toote omadused

_ _
_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