APO-ONDANSETRON SOLUTION

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE)

Disponível em:

APOTEX INC

Código ATC:

A04AA01

DCI (Denominação Comum Internacional):

ONDANSETRON

Dosagem:

4MG

Forma farmacêutica:

SOLUTION

Composição:

ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 4MG

Via de administração:

ORAL

Unidades em pacote:

15G/50G

Tipo de prescrição:

Prescription

Área terapêutica:

5-HT3 RECEPTOR ANTAGONISTS

Resumo do produto:

Active ingredient group (AIG) number: 0131120002; AHFS:

Status de autorização:

APPROVED

Data de autorização:

2020-07-08

Características técnicas

_APO-ONDANSETRON (ondansetron hydrochloride dihydrate) _
_Page 1 of 37 _
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-ONDANSETRON
Ondansetron Oral Solution
Oral Solution, 4 mg /5 mL ondansetron (as ondansetron hydrochloride
dihydrate), Oral
USP
Antiemetic
5-HT
3
receptor antagonist
ATC Code A04AA01
Apotex Inc
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
February 16, 2007
Date of Revision:
September 9, 2022
Submission Control Number: 261676
_APO-ONDANSETRON (ondansetron hydrochloride dihydrate) _
_Page 2 of 37 _
_ _
RECENT MAJOR LABEL CHANGES
1 INDICATIONS, Adults
09/2022
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and
Dosage Adjustment
09/2022
7 WARNINGS AND PRECAUTIONS, Cardiovascular, Myocardial
Ischemia and Coronary Artery Spasm
09/2022
7 WARNINGS AND PRECAUTIONS, Special Populations, 7.1.1
Pregnant Women
07/2021
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL
CHANGES……………………………………………………………………………………………2
TABLE OF
CONTENTS……………………………………………………………………………………………………………..2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
..................................................................................................................
4
1.1
Pediatrics (<18 years of age)
...........................................................................................
4
1.2
Geriatrics (>65 years of age)
...........................................................................................
4
2
CONTRAINDICATIONS
.....................................................................................................
4
4
DOSAGE AND ADMINISTRATION
.....................................................................................
5
4.1
Dosing Considerations
........