PANCREASE MT 10 CAPSULE (DELAYED RELEASE)

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

AMYLASE; PROTEASE; LIPASE

Tersedia dari:

VIVUS LLC.

Kode ATC:

A09AA02

INN (Nama Internasional):

MULTIENZYMES (LIPASE, PROTEASE ETC)

Dosis:

43750UNIT; 25000UNIT; 10500UNIT

Bentuk farmasi:

CAPSULE (DELAYED RELEASE)

Komposisi:

AMYLASE 43750UNIT; PROTEASE 25000UNIT; LIPASE 10500UNIT

Rute administrasi :

ORAL

Unit dalam paket:

100

Jenis Resep:

Prescription

Area terapi:

DIGESTANTS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

1999-05-03

Karakteristik produk

_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
............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 4
1
INDICATIONS
.............................................................................................................
4
1.1
Pediatrics
..................................................................................................................
4
1.2
Geriatrics
..................................................................................................................
4
2
CONTRAINDICATIONS
................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
........................................................