MYLAN-PANTOPRAZOLE TABLET (DELAYED-RELEASE)

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM SESQUIHYDRATE)

Disponible depuis:

MYLAN PHARMACEUTICALS ULC

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:

100/500

Type d'ordonnance:

Prescription

Domaine thérapeutique:

PROTON-PUMP INHIBITORS

Descriptif du produit:

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

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2018-07-12

Résumé des caractéristiques du produit

MYLAN-PANTOPRAZOLE (pantoprazole sodium)
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PRODUCT MONOGRAPH
PR
MYLAN-PANTOPRAZOLE
Pantoprazole sodium enteric-coated tablets
40 mg pantoprazole (as pantoprazole sodium sesquihydrate)
H
+
, K
+
-ATPase Inhibitor
Mylan Pharmaceuticals ULC
85 Advance Rd.
Etobicoke, Ontario
M8Z 2S6
Submission Control Number: 211159
Date of Revision: December 14, 2017
MYLAN-PANTOPRAZOLE (pantoprazole sodium)
2 of 37
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
..........................................................................................
13
OVERDOSAGE
..............................................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
.......................................................................
15
STORAGE AND STABILITY
......................................................................................................
17
SPECIAL HANDLING INSTRUCTIONS
...................................................................................
17
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................................... 17
PART II: SCIENTIFIC INFORMATION
..............