ABBOTT-PANTOPRAZOLE TABLET (DELAYED-RELEASE)

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM)

Διαθέσιμο από:

ABBOTT LABORATORIES, LIMITED

Φαρμακολογική κατηγορία (ATC):

A02BC02

INN (Διεθνής Όνομα):

PANTOPRAZOLE

Δοσολογία:

40MG

Φαρμακοτεχνική μορφή:

TABLET (DELAYED-RELEASE)

Σύνθεση:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM) 40MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

100/500

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

PROTON-PUMP INHIBITORS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2015-12-31

Αρχείο Π.Χ.Π.

_ _
_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