Land: Canada
Språk: engelsk
Kilde: Health Canada
NABILONE
BAUSCH HEALTH, CANADA INC.
A04AD11
NABILONE
1MG
CAPSULE
NABILONE 1MG
ORAL
15G/50G
Narcotic (CDSA II)
MISCELLANEOUS ANTIEMETICS
Active ingredient group (AIG) number: 0115009001; AHFS:
APPROVED
2000-04-12
PRODUCT MONOGRAPH N CESAMET ® Nabilone Capsules; 1 mg, 0.5 mg, 0.25 mg ANTIEMETIC BAUSCH HEALTH, CANADA INC. 2150 St-Elzear West Laval, Quebec H7L 4A8 DATE OF REVISION: May 24, 2019 Submission Control No.: 226983 _N_ _CESAMET_ _®_ _ Product Monograph _ _ Page 2 of 16_ NAME OF DRUG N CESAMET ® capsules (nabilone) THERAPEUTIC CLASSIFICATION Antiemetic Agent ACTION N CESAMET ® (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 biliary system. INDICATIONS ADULTS: > 18 YEARS N CESAMET ® (nabilone) is indicated for the management of severe nausea and vomiting associated with cancer chemotherapy. PEDIATRICS: < 18 YEARS The safety and efficacy of N CESAMET ® in the pediatric population have not been established and its use is not recommended in this patient population. GERIATRICS: > 65 YEARS N CESAMET ® should be used with caution in the elderly (see PRECAUTIONS). _N_ _CESAMET_ _®_ _ Product Monograph Page 3 of 16_ CONTRAINDICATIONS N CESAMET ® (nabilone) is contraindicated in patients with known sensitivity to marijuana or other cannabinoid agents, and in those with a histor Les hele dokumentet