AVA-OMEPRAZOLE CAPSULE (DELAYED RELEASE)
País: Canadà
Idioma: anglès
Font: Health Canada
Fitxa tècnica
(SPC)
31-03-2011
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ingredients actius:
OMEPRAZOLE
Disponible des:
AVANSTRA INC
Codi ATC:
A02BC01
Designació comuna internacional (DCI):
OMEPRAZOLE
Dosis:
20MG
formulario farmacéutico:
CAPSULE (DELAYED RELEASE)
Composición:
OMEPRAZOLE 20MG
Vía de administración:
ORAL
Unidades en paquete:
100/500
tipo de receta:
Prescription
Área terapéutica:
PROTON-PUMP INHIBITORS
Resumen del producto:
Active ingredient group (AIG) number: 0121643001; AHFS:
Estat d'Autorització:
CANCELLED POST MARKET
Data d'autorització:
2014-08-21
Fitxa tècnica
PRODUCT MONOGRAPH
PR
AVA-OMEPRAZOLE
OMEPRAZOLE DELAYED-RELEASE CAPSULES
20 MG
H
+
, K
+ -ATPASE INHIBITOR
AVANSTRA INC.
DATE OF PREPARATION:
10761 – 25
th
NE, Suite 110, Building “B”
February 21, 2011
Calgary, Alberta
T2C 3C2
Control No.: 145190
TABLE OF CONTENTS
ACTIONS AND CLINICAL PHARMACOLOGY
............................................................ 1
INDICATIONS AND CLINICAL
USE.............................................................................
4
CONTRAINDICATIONS................................................................................................
6
WARNINGS
.................................................................................................................
6
PRECAUTIONS
............................................................................................................
6
ADVERSE
REACTIONS...............................................................................................
11
SYMPTOMS AND TREATMENT OF OVERDOSAGE
................................................. 13
DOSAGE AND ADMINISTRATION
..............................................................................
13
PHARMACEUTICAL
INFORMATION...........................................................................
16
AVAILABILITY OF DOSAGE FORMS
..........................................................................
16
INFORMATION FOR THE
PATIENT............................................................................
17
PHARMACOLOGY
.......................................................................................................
22
TOXICOLOGY
..............................................................................................................
26
BIBLIOGRAPHY
...........................................................................................................
29
Page 1 of 30
PRODUCT MONOGRAPH
NAME OF DRUG
Pr
AVA-OMEPRAZOLE
Omeprazole Delayed-Release Capsules
20 mg
THERAPEUTIC CLASSIFICATION
H
+
, K
+
-ATPase Inhibitor
NOTE: When used in combination with amoxicillin,
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