PANCREASE MT 10 CAPSULE (DELAYED RELEASE)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

AMYLASE; PROTEASE; LIPASE

Available from:

VIVUS LLC.

ATC code:

A09AA02

INN (International Name):

MULTIENZYMES (LIPASE, PROTEASE ETC)

Dosage:

43750UNIT; 25000UNIT; 10500UNIT

Pharmaceutical form:

CAPSULE (DELAYED RELEASE)

Composition:

AMYLASE 43750UNIT; PROTEASE 25000UNIT; LIPASE 10500UNIT

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

DIGESTANTS

Product summary:

Active ingredient group (AIG) number: 0302964029; AHFS:

Authorization status:

APPROVED

Authorization date:

1999-05-03

Summary of Product characteristics

_Pancrease MT (pancrelipase) _
_Page 1 of 18_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PANCREASE® MT 2
2,600 USP UNITS LIPASE/10,850 USP UNITS AMYLASE/6,200 USP UNITS
PROTEASE /ORAL CAPSULE
PR
PANCREASE® MT 4
4,200 USP UNITS LIPASE/17,500 USP UNITS AMYLASE/10,000 USP UNITS
PROTEASE/ORAL CAPSULE
PR
PANCREASE® MT 10
10,500 USP UNITS LIPASE/43,750 USP UNITS AMYLASE/25,000 USP UNITS
PROTEASE /ORAL CAPSULE
PR
PANCREASE® MT 16
16,800 USP UNITS LIPASE/70,000 USP UNITS AMYLASE/40,000 USP UNITS
PROTEASE /ORAL CAPSULE
PR
PANCREASE® MT 20
21,000 USP UNITS LIPASE/61,000 USP UNITS AMYLASE/37,000 USP UNITS
PROTEASE /ORAL CAPSULE
Pancrelipase
Delayed-Release Capsules
Digestant
Vivus LLC
900 East Hamilton Avenue, Suite #550,
Campbell, California, USA 95008
Date of Initial Authorization:
December 31, 1988
Date of Revision:
September 5, 2023
Submission Control Number: 273267
_ _
_Pancrease MT (pancrelipase) _
_Page 2 of 18_
RECENT MAJOR LABEL CHANGES
TABLE OF CONTENTS
Sections or subsections that are not applicable at the time of
authorization are not listed.
RECENT MAJOR LABEL CHANGES
..........................................................................................
2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 4
1
INDICATIONS
.............................................................................................................
4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
........................................................