PMS-NABILONE CAPSULE

Երկիր: Կանադա

Լեզու: անգլերեն

Աղբյուրը: Health Canada

Ակտիվ բաղադրիչ:

NABILONE

Հասանելի է:

PHARMASCIENCE INC

ATC կոդը:

A04AD11

INN (Միջազգային անվանումը):

NABILONE

Դոզան:

1.0MG

Դեղագործական ձեւ:

CAPSULE

Կազմը:

NABILONE 1.0MG

Կառավարման երթուղին:

ORAL

Միավորները փաթեթում:

50/100

Ռեկվիզորի տեսակը:

Narcotic (CDSA II)

Թերապեւտիկ տարածք:

MISCELLANEOUS ANTIEMETICS

Ապրանքի ամփոփագիր:

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

Լիազորման կարգավիճակը:

APPROVED

Հաստատման ամսաթիվը:

2012-03-25

Ապրանքի հատկությունները

PRODUCT MONOGRAPH
N PMS-NABILONE
Nabilone
Capsules: 0.25 mg, 0.5 mg, 1 mg
Professed Standard
ANTIEMETIC
PHARMASCIENCE INC.
6111 Royalmount, Suite 100
Montréal, Québec
H4P 2T4
DATE OF PREPARATION:
February 29, 2012
Submission Control No.: 138763
2
N PMS-NABILONE
Nabilone Capsules
THERAPEUTIC CLASSIFICATION
Antiemetic Agent
ACTION
pms-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.
_ _
3
COMPARATIVE BIOAVAILABILITY STUDIES
A single dose 2-way cross-over comparative bioavailability study of
pms-NABILONE
1 mg Capsules (nabilone, Pharmascience Inc.), was performed versus
CESAMET
(nabilone) 1 mg Capsules (Valeant Canada Ltd.) administered as 1 x 1
mg dose to healthy
male volunteers in the fasting state (n=18). The results are
summarized in the following
table:
SUMMARY TABLE OF THE COMPARATIVE BIOAVAILABILITY DATA
Nabilone
(1 x 1 mg capsule)
From measured data
UNCORRECTED FOR POTENCY
Geometric Mean
Arithmetic Mean (CV %)
Parameter
Test
*
Reference
†
% Ratio of
Geometric Means
90% Confidence Interval
AUC
T
(pg·h/mL)
3163.1
3226.6 ( 29.4)
2868.1
2956.4 (