ABBOTT-PANTOPRAZOLE TABLET (DELAYED-RELEASE)

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM)

Prieinama:

ABBOTT LABORATORIES, LIMITED

ATC kodas:

A02BC02

INN (Tarptautinis Pavadinimas):

PANTOPRAZOLE

Dozė:

40MG

Vaisto forma:

TABLET (DELAYED-RELEASE)

Sudėtis:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM) 40MG

Vartojimo būdas:

ORAL

Vienetai pakuotėje:

100/500

Recepto tipas:

Prescription

Gydymo sritis:

PROTON-PUMP INHIBITORS

Produkto santrauka:

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

Autorizacija statusas:

CANCELLED POST MARKET

Leidimo data:

2015-12-31

Prekės savybės

_ _
_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