PMS-AMIODARONE TABLET

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

AMIODARONE HYDROCHLORIDE

متاح من:

PHARMASCIENCE INC

ATC رمز:

C01BD01

INN (الاسم الدولي):

AMIODARONE

جرعة:

200MG

الشكل الصيدلاني:

TABLET

تركيب:

AMIODARONE HYDROCHLORIDE 200MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

100

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

CLASS III ANTIARRYTHMICS

ملخص المنتج:

Active ingredient group (AIG) number: 0118593001; AHFS:

الوضع إذن:

APPROVED

تاريخ الترخيص:

2000-07-07

خصائص المنتج

PRODUCT MONOGRAPH
PR
PMS-AMIODARONE
Amiodarone Tablets, BP
100 mg & 200 mg amiodarone hydrochloride
ANTIARRHYTHMIC AGENT
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
www.pharmascience.com
DATE OF REVISION:
June 20, 2016
Submission Control No.: 195599
_pms-AMIODARONE Product Monograph _
_Page 2 of 75 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
4
WARNINGS AND PRECAUTIONS
.........................................................................................
5
ADVERSE REACTIONS
.........................................................................................................
20
DRUG INTERACTIONS
.........................................................................................................
26
DOSAGE AND ADMINISTRATION
.....................................................................................
31
OVERDOSAGE
.......................................................................................................................
33
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 34
STORAGE AND STABILITY
.................................................................................................
37
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 38
PART II: SCIENTIFIC INFORMATION
................................................................................39
PHARMACEUTICAL INFORMATION
.................................................................................
39
CLINICAL TRIALS
......................................................