ABBOTT-PANTOPRAZOLE TABLET (DELAYED-RELEASE)

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM)

Disponibil de la:

ABBOTT LABORATORIES, LIMITED

Codul ATC:

A02BC02

INN (nume internaţional):

PANTOPRAZOLE

Dozare:

40MG

Forma farmaceutică:

TABLET (DELAYED-RELEASE)

Compoziție:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM) 40MG

Calea de administrare:

ORAL

Unități în pachet:

100/500

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

PROTON-PUMP INHIBITORS

Rezumat produs:

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

Statutul autorizaţiei:

CANCELLED POST MARKET

Data de autorizare:

2015-12-31

Caracteristicilor produsului

_ _
_Abbott-Pantoprazole Product Monograph _
_Page 1 of 39 _
PRODUCT MONOGRAPH
PR
ABBOTT-PANTOPRAZOLE
Pantoprazole Sodium Delayed Release Tablets USP
20 and 40 mg pantoprazole (as pantoprazole sodium sesquihydrate)
H
+
, K
+
-ATPase Inhibitor
Abbott Laboratories, Limited
8401 Trans-Canada Highway
Saint-Laurent, Quebec
H4S 1Z1
Date of Preparation:
September 18, 2013
Date of Revision:
June 3, 2015
Submission Control No.: 184223
_ _
_Abbott-Pantoprazole Product Monograph _
_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
OVERDOSAGE
................................................................................................................14
ACTION AND CLINICAL PHARMACOLOGY
............................................................14
STORAGE AND STABILITY
..........................................................................................16
SPECIAL HANDLING INSTRUCTIONS
.......................................................................16
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................16
PART II: SCIENTIFIC INFORMATION
...............................................................................18
PHARMACEUTIC