ANZEMET INJECTION 20 MG/ML SOLUTION

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

DOLASETRON MESYLATE

Dostępny od:

SANOFI-AVENTIS CANADA INC

Kod ATC:

A04AA04

INN (International Nazwa):

DOLASETRON

Dawkowanie:

20MG

Forma farmaceutyczna:

SOLUTION

Skład:

DOLASETRON MESYLATE 20MG

Droga podania:

INTRAVENOUS

Sztuk w opakowaniu:

5ML

Typ recepty:

Prescription

Dziedzina terapeutyczna:

5-HT3 RECEPTOR ANTAGONISTS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0132936003; AHFS:

Status autoryzacji:

CANCELLED POST MARKET

Data autoryzacji:

2011-08-15

Charakterystyka produktu

PRODUCT MONOGRAPH
PR
ANZEMET
®
(DOLASETRON MESYLATE)
20 MG/ML INTRAVENOUS INJECTION
50 AND 100 MG TABLETS
ANTIEMETIC
(5-HT
3 RECEPTOR ANTAGONIST)
sanofi-aventis Canda Inc.
Date of Revision:
2150 St. Elzéar Blvd. West
October 12, 2006
Laval, Quebec H7L 4A8
Submission Control No. 107318
s-a Version
2.0 dated
2
PRODUCT MONOGRAPH
PR
ANZEMET
®
(Dolasetron Mesylate)
20 mg/mL Intravenous Injection
50 and 100 mg Tablets
Antiemetic
(5-HT
3
receptor antagonist)
ACTION AND CLINICAL PHARMACOLOGY
Dolasetron and its active metabolite, hydrodolasetron (MDL 74156), are
selective 5-HT
3
receptor antagonists
shown not to have activity at other known serotonin receptors and with
low affinity for dopamine receptors. The
serotonin 5-HT
3
receptors are located on the nerve terminals of the vagus in the
periphery and centrally in the
chemoreceptor trigger zone of the area postrema. It is thought that
chemotherapeutic agents produce nausea
and vomiting by releasing serotonin from the enterochromaffin cells of
the small intestine, and that serotonin
then activates the 5-HT
3
receptors located on vagal afferents to initiate the vomiting reflex.
Acute, reversible, ECG changes (PR and QTc; QRS widening), caused by
dolasetron, have been observed in
controlled clinical trials. Dolasetron appears to prolong both
depolarization and, to a lesser extent,
repolarization time. Although QTc prolongation is primarily due to QRS
widening, JT prolongation has also
been observed. The magnitude and frequency of the ECG changes
increased with dose (related to the peak
plasma concentration of hydrodolasetron but not the parent compound).
These ECG changes usually returned
to baseline within 6 to 8 hours, but in some patients have lasted 24 h
or longer. Dolasetron mesylate
administration has little or no effect on blood pressure.
In healthy volunteers (N=4), dolasetron mesylate in single intravenous
doses up to 5 mg/kg produced no effect
on pupil size or meaningful changes in EEG tracings. Results from
neuropsychiatric tests revealed that
dolasetron mesy