ZOFRAN TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE)

Mevcut itibaren:

NOVARTIS PHARMACEUTICALS CANADA INC

ATC kodu:

A04AA01

INN (International Adı):

ONDANSETRON

Doz:

4MG

Farmasötik formu:

TABLET

Kompozisyon:

ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 4MG

Uygulama yolu:

ORAL

Paketteki üniteler:

10/100

Reçete türü:

Prescription

Terapötik alanı:

5-HT3 RECEPTOR ANTAGONISTS

Ürün özeti:

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

Yetkilendirme durumu:

CANCELLED POST MARKET

Yetkilendirme tarihi:

2017-03-14

Ürün özellikleri

_Product Monograph _
_ _
_ZOFRAN_
_®_
_(ondansetron hydrochloride dihydrate) _
_ZOFRAN_
_®_
_ODT_
_(ondansetron) _
_Page 1 of 50_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ZOFRAN®
ondansetron hydrochloride dihydrate
Tablets, 4 mg and 8 mg, oral
Oral solution, 4 mg/5 mL, oral
Injection, 2 mg/mL, intravenous
PR
ZOFRAN
®
ODT
ondansetron
Orally disintegrating tablets, 4 mg and 8 mg, oral
Antiemetic
5-HT3 receptor antagonist
ATC code A04AA01
Novartis Pharmaceuticals Canada Inc.
385 Bouchard Blvd.
Dorval, Quebec
H9S 1A9
www.novartis.ca
Date of Initial Authorization:
Mar 30, 1998
Date of Revision:
November 9, 2021
Submission Control Number: 252778
ZOFRAN is a registered trademark
_*All trademarks and registered trademarks are the property of their
respective owners _
_ _
_ _
_Product Monograph _
_ _
_ZOFRAN_
_®_
_ (ondansetron hydrochloride dihydrate) _
_ZOFRAN_
_®_
_ ODT (ondansetron) _
_Page 2 of 50 _
RECENT MAJOR LABEL CHANGES
7 WARNING AND PRECAUTIONS, Cardiovascular, Myocardial
Ischemia and Coronary Artery Spasm
11/2021
7 WARNING AND PRECAUTIONS, Special Populations, 7.1.1
Pregnant Women
10/2020
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
..................................................