MARINOL CAP 10MG CAPSULE
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
28-05-2007
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Active ingredient:
DRONABINOL
Available from:
SOLVAY PHARMA INC
ATC code:
A04AD10
INN (International Name):
DRONABINOL
Dosage:
10MG
Pharmaceutical form:
CAPSULE
Composition:
DRONABINOL 10MG
Administration route:
ORAL
Units in package:
60
Prescription type:
Narcotic (CDSA II)
Therapeutic area:
MISCELLANEOUS ANTIEMETICS
Product summary:
Active ingredient group (AIG) number: 0116400002; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2008-07-24
Summary of Product characteristics
_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..
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