AG-PANTOPRAZOLE TABLET (DELAYED-RELEASE)

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM SESQUIHYDRATE)

Disponible depuis:

ANGITA PHARMA INC.

Code ATC:

A02BC02

DCI (Dénomination commune internationale):

PANTOPRAZOLE

Dosage:

40MG

forme pharmaceutique:

TABLET (DELAYED-RELEASE)

Composition:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM SESQUIHYDRATE) 40MG

Mode d'administration:

ORAL

Unités en paquet:

30/100/500

Type d'ordonnance:

Prescription

Domaine thérapeutique:

PROTON-PUMP INHIBITORS

Descriptif du produit:

Active ingredient group (AIG) number: 0133229001; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2018-07-13

Résumé des caractéristiques du produit

_Page 1 of 39_
PRODUCT MONOGRAPH
PR
AG-PANTOPRAZOLE
Pantoprazole Sodium Delayed Release Tablets USP
20 and 40 mg pantoprazole (as pantoprazole sodium sesquihydrate)
H
+
, K
+
-ATPase Inhibitor
Control Number: 214737
Angita Pharma Inc.
1310 Nobel Street
Boucherville, Quebec
J4B 5H3
Date of Revision:
July 13, 2018
_Page 2 of 39_
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
......................................................................................................
7
DRUG INTERACTIONS
....................................................................................................
11
DOSAGE AND ADMINISTRATION
................................................................................
12
OVERDOSE
........................................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
............................................................... 14
STORAGE AND STABILITY
............................................................................................
16
SPECIAL HANDLING INSTRUCTIONS
..........................................................................
16
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................ 16
PART II: SCIENTIFIC INFORMATION
...................................................................................
17
PHARMACEUTICAL INFORMATION
............................................................................
17
CLINICAL TRIA