TEVA-NABILONE CAPSULE

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

NABILONE

Tilgjengelig fra:

TEVA CANADA LIMITED

ATC-kode:

A04AD11

INN (International Name):

NABILONE

Dosering :

0.25MG

Legemiddelform:

CAPSULE

Sammensetning:

NABILONE 0.25MG

Administreringsrute:

ORAL

Enheter i pakken:

50

Resept typen:

Narcotic (CDSA II)

Terapeutisk område:

MISCELLANEOUS ANTIEMETICS

Produkt oppsummering:

Active ingredient group (AIG) number: 0115009003; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2012-09-07

Preparatomtale

PRODUCT MONOGRAPH
TEVA-NABILONE
(Nabilone)
0.25 mg Capsules
Antiemetic
Teva Canada Limited
Date of Preparation:
30 Novopharm Court
August 31, 2012
Toronto, Ontario
M1B 2K9
Submission Control No: 148518
N
2
TEVA-NABILONE
Nabilone
0.25 mg Capsules
ACTION
TEVA-NABILONE (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
TEVA-NABILONE (nabilone) is contraindicated in patients with known
sensitivity to marijuana
or other cannabinoid agents, and in those with a history of psychotic
reactions.
WARNINGS
TEVA-NABILONE (nabilone) should be used with extreme caution in
patients with severe liver
dysfunction and in those with a histor