ACT NABILONE CAPSULE

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

NABILONE

Διαθέσιμο από:

TEVA CANADA LIMITED

Φαρμακολογική κατηγορία (ATC):

A04AD11

INN (Διεθνής Όνομα):

NABILONE

Δοσολογία:

1MG

Φαρμακοτεχνική μορφή:

CAPSULE

Σύνθεση:

NABILONE 1MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

50/100/500

Τρόπος διάθεσης:

Narcotic (CDSA II)

Θεραπευτική περιοχή:

MISCELLANEOUS ANTIEMETICS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0115009001; AHFS:

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2022-11-11

Αρχείο Π.Χ.Π.

______________________________________________________________________________________________
_
_ Page 1 of 20_
PRODUCT MONOGRAPH
N
ACT NABILONE
Nabilone Capsules
0.5 mg and 1 mg
Antiemetic
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada M1B2K9
Date of Revision:
April 30, 2020
Submission Control No.: 238098
_ _
_ _
_Page 2 of 20_
PRODUCT MONOGRAPH
NAME OF DRUG
N
ACT NABILONE
Nabilone Capsules 0.5 mg and 1 mg
THERAPEUTIC CLASSIFICATION
Antiemetic Agent
ACTION
Nabilone is a synthetic cannabinoid with antiemetic properties which
have been found to be of
value in the management of some patients with nausea and vomiting
associated with cancer
chemotherapy. It also has sedative and psychotropic effects.
After oral administration, comparable peak plasma levels of nabilone
and of its carbinol
metabolite were attained within 2 hours. The combined plasma
concentrations of nabilone and of
its carbinol metabolite accounted for, at most, 10 to 20% of the total
radiocarbon concentration
in plasma. The plasma half-life of nabilone was approximately 2 hours,
while that of the total
radiocarbon was of the order of 35 hours.
Of the two major possible metabolic pathways, stereo-specific
enzymatic reduction and direct
enzymatic oxidation, the latter appears to be the more important in
man.
The drug and its metabolites are eliminated mainly in the feces
(approximately 65%) and to a
lesser extent in the urine (approximately 20%). The major excretory
pathway is the bilary
system.
______________________________________________________________________________________________
_
_ Page 3 of 20_
CLINICAL TRIALS
COMPARATIVE BIOAVAILABILITY STUDIES
A blinded, single-dose, randomized, two-period, two-sequence,
two-treatment, crossover
bioequivalence study of ACT NABILONE 1 mg capsules and the Canadian
Reference Product,
Cesamet
®
(Nabilone capsules, 1 mg, Valeant Canada Limited), was conducted under
fasting
conditions in 26 normal, healthy, male and female volunteers. A
summary of the bioavailability
data is presented in the t