PMS-LANSOPRAZOLE CAPSULE (DELAYED RELEASE)

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

LANSOPRAZOLE

Disponibil de la:

PHARMASCIENCE INC

Codul ATC:

A02BC03

INN (nume internaţional):

LANSOPRAZOLE

Dozare:

30MG

Forma farmaceutică:

CAPSULE (DELAYED RELEASE)

Compoziție:

LANSOPRAZOLE 30MG

Calea de administrare:

ORAL

Unități în pachet:

100

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

PROTON-PUMP INHIBITORS

Rezumat produs:

Active ingredient group (AIG) number: 0127666001; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2012-10-31

Caracteristicilor produsului

PRODUCT MONOGRAPH
PR
PMS-LANSOPRAZOLE
Lansoprazole Delayed-Release Capsules
15 mg and 30 mg, USP
H+, K+-ATPASE INHIBITOR
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Canada
H4P 2T4
Date of Revision:
October 23, 2017
www.pharmascience.com
Submission Control No: 209856
_ _
_pms-LANSOPRAZOLE Product Monograph _
_Page 2 of 87_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT
INFORMATION........................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
...................................................................................................
5
WARNINGS AND PRECAUTIONS
.................................................................................
6
ADVERSE REACTIONS
.................................................................................................
12
DRUG INTERACTIONS
.................................................................................................
22
DOSAGE AND ADMINISTRATION
.............................................................................
25
OVERDOSAGE
................................................................................................................
28
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 29
STORAGE AND STABILITY
.........................................................................................
34
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 34
PART II: SCIENTIFIC INFORMATION
..............................................................................
35
PHARMACEUTICAL INFORMATION
.........................................................................
35
CLINICAL TRIALS
.........................................................................................................
36
DETAILED PHARMACOLOGY
...........