AG-PANTOPRAZOLE TABLET (DELAYED-RELEASE)
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
13-07-2018
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Aktiv ingrediens:
PANTOPRAZOLE (PANTOPRAZOLE SODIUM SESQUIHYDRATE)
Tilgjengelig fra:
ANGITA PHARMA INC.
ATC-kode:
A02BC02
INN (International Name):
PANTOPRAZOLE
Dosering :
40MG
Legemiddelform:
TABLET (DELAYED-RELEASE)
Sammensetning:
PANTOPRAZOLE (PANTOPRAZOLE SODIUM SESQUIHYDRATE) 40MG
Administreringsrute:
ORAL
Enheter i pakken:
30/100/500
Resept typen:
Prescription
Terapeutisk område:
PROTON-PUMP INHIBITORS
Produkt oppsummering:
Active ingredient group (AIG) number: 0133229001; AHFS:
Autorisasjon status:
APPROVED
Autorisasjon dato:
2018-07-13
Preparatomtale
_Page 1 of 39_
PRODUCT MONOGRAPH
PR
AG-PANTOPRAZOLE
Pantoprazole Sodium Delayed Release Tablets USP
20 and 40 mg pantoprazole (as pantoprazole sodium sesquihydrate)
H
+
, K
+
-ATPase Inhibitor
Control Number: 214737
Angita Pharma Inc.
1310 Nobel Street
Boucherville, Quebec
J4B 5H3
Date of Revision:
July 13, 2018
_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
OVERDOSE
........................................................................................................................
14
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 TRIA
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