MARINOL CAPSULE
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
13-06-2011
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Active ingredient:
DRONABINOL
Available from:
ABBOTT LABORATORIES, LIMITED
ATC code:
A04AD10
INN (International Name):
DRONABINOL
Dosage:
2.5MG
Pharmaceutical form:
CAPSULE
Composition:
DRONABINOL 2.5MG
Administration route:
ORAL
Units in package:
60
Prescription type:
Prescription
Therapeutic area:
MISCELLANEOUS ANTIEMETICS
Product summary:
Active ingredient group (AIG) number: 0116400003; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2012-02-24
Summary of Product characteristics
PRODUCT MONOGRAPH
N
MARINOL
®
dronabinol (delta-9-tetrahydrocannabinol; Δ
9
-THC)
2.5 mg and 5 mg capsules
Antiemetic
Abbott Laboratories, Limited
8401 Trans-Canada Highway
Saint-Laurent, Quebec
H4S 1Z1
DATE OF PREPARATION:
January 1, 2011
Control No.: 143312
Registered Trade-mark Unimed Pharmaceuticals Inc., Licensed use by
Abbott Laboratories, Limited, Saint-Laurent,
Quebec, H4S 1Z1
_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......................................................................................12
OVERDOSAGE
........................................................................................................................13
ACTION AND CLINICAL PHARMACOLOGY
....................................................................14
STORAGE AND
STABILITY..................................................................................................17
DOSAGE FORMS, COMPOSITION AND PACKAGING
.....................................................17
PART II: SCIENTIFIC INFORMATION
......................................................................
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