ACT NABILONE CAPSULE

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

NABILONE

Доступна з:

TEVA CANADA LIMITED

Код атс:

A04AD11

ІПН (Міжнародна Ім'я):

NABILONE

Дозування:

1MG

Фармацевтична форма:

CAPSULE

Склад:

NABILONE 1MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

50/100/500

Тип рецепту:

Narcotic (CDSA II)

Терапевтична области:

MISCELLANEOUS ANTIEMETICS

Огляд продуктів:

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

Статус Авторизація:

CANCELLED POST MARKET

Дата Авторизація:

2022-11-11

Характеристики продукта

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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
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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.
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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