PMS-LANSOPRAZOLE CAPSULE (DELAYED RELEASE)

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

LANSOPRAZOLE

متاح من:

PHARMASCIENCE INC

ATC رمز:

A02BC03

INN (الاسم الدولي):

LANSOPRAZOLE

جرعة:

15MG

الشكل الصيدلاني:

CAPSULE (DELAYED RELEASE)

تركيب:

LANSOPRAZOLE 15MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

100

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

PROTON-PUMP INHIBITORS

ملخص المنتج:

Active ingredient group (AIG) number: 0127666002; AHFS:

الوضع إذن:

APPROVED

تاريخ الترخيص:

2012-10-31

خصائص المنتج

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
...........