Q-LANSOPRAZOLE CAPSULE (DELAYED RELEASE)

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

LANSOPRAZOLE

متاح من:

QD PHARMACEUTICALS ULC

ATC رمز:

A02BC03

INN (الاسم الدولي):

LANSOPRAZOLE

جرعة:

15MG

الشكل الصيدلاني:

CAPSULE (DELAYED RELEASE)

تركيب:

LANSOPRAZOLE 15MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

100/500

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

PROTON-PUMP INHIBITORS

ملخص المنتج:

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

الوضع إذن:

CANCELLED PRE MARKET

تاريخ الترخيص:

2015-08-21

خصائص المنتج

Page 1 of 67
PRODUCT MONOGRAPH
PR
Q-LANSOPRAZOLE
lansoprazole delayed-release capsules
15 mg and 30 mg
USP
H
+
, K
+
-ATPase Inhibitor
QD Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Submission Control No.: 186456
Date of Revision: August 18, 2015
Page 2 of 67
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
.........................................................................................................
8
DRUG INTERACTIONS
.......................................................................................................
18
DOSAGE AND ADMINISTRATION
..................................................................................
21
OVERDOSAGE
......................................................................................................................
23
ACTION AND CLINICAL PHARMACOLOGY
............................................................... 24
STORAGE AND STABILITY
..............................................................................................
29
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................... 29
PART II: SCIENTIFIC INFORMATION
........................................................................
30
PHARMACEUTICAL INFORMATION
.............................................................................
30
CLINICAL TRIALS
...............................................................................................................
31
DETAILED PHARMACOLOGY
...........................