TEVA-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:

1.0MG

Φαρμακοτεχνική μορφή:

CAPSULE

Σύνθεση:

NABILONE 1.0MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

50

Τρόπος διάθεσης:

Narcotic (CDSA II)

Θεραπευτική περιοχή:

MISCELLANEOUS ANTIEMETICS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2012-05-01

Αρχείο Π.Χ.Π.

PRODUCT MONOGRAPH
TEVA-NABILONE
Nabilone
0.5 mg and 1 mg Capsules
Antiemetic
Teva Canada Limited
Date of Preparation:
30 Novopharm Court
April 30, 2012
Toronto, Ontario
M1B 2K9
Submission Control No: 139940
N
2
TEVA-NABILONE
Nabilone
0.5 mg and 1 mg Capsules
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.
INDICATIONS
ADULTS: > 18 YEARS
TEVA-NABILONE (nabilone) is indicated for the management of severe
nausea and vomiting
associated with cancer chemotherapy.
PEDIATRICS: < 18 YEARS
The safety and efficacy of nabilone in the pediatric population have
not been established and its
use is not recommended in this patient population.
GERIATRICS: > 65 YEARS
TEVA-NABILONE should be used with caution in the elderly. (See
PRECAUTIONS).
N
3
CONTRAINDICATIONS
Nabilone is contraindicated in patients with known sensitivity to
marijuana or other cannabinoid
agents, and in those with a history of psychotic reactions.
WARNINGS
Nabilone should be used with extreme caution in patients with severe
liver dysfunction and in
those with a history of non-psychotic emotional disord