Ülke: Kanada
Dil: İngilizce
Kaynak: Health Canada
NABILONE
TEVA CANADA LIMITED
A04AD11
NABILONE
0.25MG
CAPSULE
NABILONE 0.25MG
ORAL
50
Narcotic (CDSA II)
MISCELLANEOUS ANTIEMETICS
Active ingredient group (AIG) number: 0115009003; AHFS:
APPROVED
2012-09-07
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 Belgenin tamamını okuyun