AURO-ONDANSETRON INJECTION SOLUTION

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE)

Dostopno od:

AURO PHARMA INC

Koda artikla:

A04AA01

INN (mednarodno ime):

ONDANSETRON

Odmerek:

2MG

Farmacevtska oblika:

SOLUTION

Sestava:

ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 2MG

Pot uporabe:

INTRAVENOUS

Enote v paketu:

15G/50G

Tip zastaranja:

Prescription

Terapevtsko območje:

5-HT3 RECEPTOR ANTAGONISTS

Povzetek izdelek:

Active ingredient group (AIG) number: 0131120004; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2019-08-14

Lastnosti izdelka

ONDANSETRON INJECTION BP/AURO-ONDANSETRON INJECTION PRODUCT MONOGRAPH
PAGE 1 OF 46
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR ONDANSETRON INJECTION BP
Sterile Solution, 2 mg / mL ondansetron (as ondansetron hydrochloride
dihydrate), Intravenous
BP
PR AURO-ONDANSETRON INJECTION
Ondansetron Injection
Sterile Solution, 2 mg / mL ondansetron (as ondansetron hydrochloride
dihydrate), Intravenous
BP
Antiemetic (5-HT3 receptor antagonist)
ATC code A04AA01
Auro Pharma Inc.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8
CANADA
Date of Initial Authorization:
February 7, 2017
Date of Revision:
March 9, 2023
Submission Control Number: 268107
ONDANSETRON INJECTION BP/AURO-ONDANSETRON INJECTION PRODUCT MONOGRAPH
PAGE 2 OF 46
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Cardiovascular,
Myocardial Ischemia and Coronary Artery Spasm
03/2023
7 WARNINGS AND PRECAUTIONS, Special Populations,
7.1.1 Pregnant Women
02/2021
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
................................................................................................................
4
1.2 Geriatrics (≥65 years of age)
.......................................................................................
4
2 CONTRAINDICATIONS
.......................................................................................................
5
4 DOSAGE AND ADMINISTRATION
.......................................................................