PANTOPRAZOLE TABLET (DELAYED-RELEASE)

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM)

Διαθέσιμο από:

MELIAPHARM INC

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:

2014-06-25

Αρχείο Π.Χ.Π.

PRODUCT MONOGRAPH
PR
PANTOPRAZOLE
Pantoprazole Sodium Delayed-Release Tablets, House Standard
(as pantoprazole 20 mg, 40 mg)
H
+
, K
+
-ATPase Inhibitor
MELIAPHARM INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
Date of Revision:
January 17, 2014
Submission Control No: 170312
_ _
_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
................................................................................................................13
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 TRIALS
...................................