MARINOL CAP 10MG CAPSULE

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

DRONABINOL

متاح من:

SOLVAY PHARMA INC

ATC رمز:

A04AD10

INN (الاسم الدولي):

DRONABINOL

جرعة:

10MG

الشكل الصيدلاني:

CAPSULE

تركيب:

DRONABINOL 10MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

60

نوع الوصفة الطبية :

Narcotic (CDSA II)

المجال العلاجي:

MISCELLANEOUS ANTIEMETICS

ملخص المنتج:

Active ingredient group (AIG) number: 0116400002; AHFS:

الوضع إذن:

CANCELLED POST MARKET

تاريخ الترخيص:

2008-07-24

خصائص المنتج

_N_
_MARINOL_
_® _
_ _
Page 1 of 31
PRODUCT MONOGRAPH
N
MARINOL
®
dronabinol (delta-9-tetrahydrocannabinol; ∆
9
-THC)
2.5 mg, 5 mg, and 10 mg capsules
Antiemetic
DATE OF PREPARATION:
December 3, 2002
DATE OF REVISION:
May 4, 2007
Control No.: 112007
_N_
_MARINOL_
_® _
_ _
Page 2 of 31
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................3
SUMMARY OF PRODUCT
INFORMATION..........................................................................3
INDICATIONS AND CLINICAL
USE......................................................................................3
CONTRAINDICATIONS
...........................................................................................................4
WARNINGS AND
PRECAUTIONS..........................................................................................5
DRUG ABUSE AND DEPENDENCE
.......................................................................................6
ADVERSE REACTIONS
...........................................................................................................8
DRUG
INTERACTIONS..........................................................................................................10
DOSAGE AND
ADMINISTRATION......................................................................................11
OVERDOSAGE
........................................................................................................................13
ACTION AND CLINICAL PHARMACOLOGY
....................................................................14
STORAGE AND
STABILITY..................................................................................................17
DOSAGE FORMS, COMPOSITION AND PACKAGING
.....................................................17
PART II: SCIENTIFIC INFORMATION
...........................................................................18
PHARMACEUTICAL INFORMATION
.................................................................................18
CLINICAL
TRIALS..