RATIO-PANTOPRAZOLE TABLET (DELAYED-RELEASE)

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM SESQUIHYDRATE)

Boleh didapati daripada:

RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED

Kod ATC:

A02BC02

INN (Nama Antarabangsa):

PANTOPRAZOLE

Dos:

20MG

Borang farmaseutikal:

TABLET (DELAYED-RELEASE)

Komposisi:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM SESQUIHYDRATE) 20MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

100

Jenis preskripsi:

Prescription

Kawasan terapeutik:

PROTON-PUMP INHIBITORS

Ringkasan produk:

Active ingredient group (AIG) number: 0133229002; AHFS:

Status kebenaran:

CANCELLED POST MARKET

Tarikh kebenaran:

2015-10-26

Ciri produk

_ratio-PANTOPRAZOLE (pantoprazole sodium extended release tablets) _
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PRODUCT MONOGRAPH
Pr
ratio-PANTOPRAZOLE
Pantoprazole as Pantoprazole Sodium Sesquihydrate enteric-coated
tablets
(as Pantoprazole 20mg and 40 mg)
H
+
, K
+
-ATPase Inhibitor
Submission Control No: 133971
ratiopharm inc.
17 800, Lapointe
Mirabel, Quebec
Canada, J7J 1P3
Date of Revision:
November 24, 2009
_ratio-PANTOPRAZOLE (pantoprazole sodium extended release tablets) _
_Page 2 of 29_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..................................................... 3
SUMMARY PRODUCT
INFORMATION....................................................................
3
INDICATIONS AND CLINICAL
USE.........................................................................
3
CONTRAINDICATIONS.............................................................................................
3
WARNINGS AND
PRECAUTIONS.............................................................................
4
ADVERSE
REACTIONS..............................................................................................5
DRUG INTERACTIONS
............................................................................................
.8
DOSAGE AND
ADMINISTRATION..........................................................................
9
OVERDOSAGE..........................................................................................................
10
ACTION AND CLINICAL
PHARMACOLOGY..........................................................
11
STORAGE AND
STABILITY.....................................................................................
13
DOSAGE FORMS, COMPOSITION AND
PACKAGING............................................ 13
PART II: SCIENTIFIC INFORMATION
............................................................................
14
PHARMACEUTICAL
INFORMATION......................................................................
14
CLINICAL
TRIALS...........................................................................