JAMP-ONDANSETRON TABLET

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

ONDANSETRON (ONDANSETRON HYDROCHLORIDE)

Dostupné z:

JAMP PHARMA CORPORATION

ATC kód:

A04AA01

INN (Medzinárodný Name):

ONDANSETRON

Dávkovanie:

4MG

Forma lieku:

TABLET

Zloženie:

ONDANSETRON (ONDANSETRON HYDROCHLORIDE) 4MG

Spôsob podávania:

ORAL

Počet v balení:

10/100

Typ predpisu:

Prescription

Terapeutické oblasti:

5-HT3 RECEPTOR ANTAGONISTS

Prehľad produktov:

Active ingredient group (AIG) number: 0131120003; AHFS:

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2008-09-04

Súhrn charakteristických

JAMP-Ondansetron(Product Monograph) Page 1 of 35
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
JAMP-ONDANSETRON
Ondansetron Tablets
Tablets, 4 mg and 8 mg ondansetron (as ondansetron hydrochloride),
oral
USP
Antiemetic
5-HT3 receptor antagonist
ATC code A04AA01
Date of Initial Authorization:
September 04, 2008
Date of Revision:
November 17, 2022
Submission Control Number: 269251
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
JAMP-Ondansetron(Product Monograph) Page 2 of 35
RECENT MAJOR LABEL CHANGES
1 INDICATIONS
11/2022
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose
and Dosage Adjustment
11/2022
7 WARNINGS AND PRECAUTIONS, Cardiovascular,
Myocardial Ischemia and Coronary Artery Spasm
11/2022
7 WARNINGS AND PRECAUTIONS, Special Populations,
7.1.1 Pregnant Women
11/2022
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
.............................................................................................
5
4.2
Recommended Dose and Do