AG-ONDANSETRON TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

ONDANSETRON (ONDANSETRON HYDROCHLORIDE)

Dostopno od:

ANGITA PHARMA INC.

Koda artikla:

A04AA01

INN (mednarodno ime):

ONDANSETRON

Odmerek:

4MG

Farmacevtska oblika:

TABLET

Sestava:

ONDANSETRON (ONDANSETRON HYDROCHLORIDE) 4MG

Pot uporabe:

ORAL

Enote v paketu:

10/100

Tip zastaranja:

Prescription

Terapevtsko območje:

5-HT3 RECEPTOR ANTAGONISTS

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2011-08-22

Lastnosti izdelka

_ _
_AG-Ondansetron Product Monograph _
_Page 1 of 35 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AG-ONDANSETRON
Ondansetron Tablets
Tablets, 4 mg and 8 mg ondansetron (as ondansetron hydrochloride),
oral
USP
Antiemetic
5-HT3 receptor antagonist
ATC code A04AA01
Angita Pharma Inc.
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Date of Initial Authorization:
August 22, 2011
Date of Revision:
NOV 16, 2022
Submission Control Number: 268929 _ _
_ _
_AG-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
10/2021
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
.............................................................................................
5
4.2
Recommended Dose and