MYLAN-LANSOPRAZOLE FDT TABLET (DELAYED-RELEASE)

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

LANSOPRAZOLE

Dostupné z:

MYLAN PHARMACEUTICALS ULC

ATC kód:

A02BC03

INN (Medzinárodný Name):

LANSOPRAZOLE

Dávkovanie:

15MG

Forma lieku:

TABLET (DELAYED-RELEASE)

Zloženie:

LANSOPRAZOLE 15MG

Spôsob podávania:

ORAL

Počet v balení:

30/100

Typ predpisu:

Prescription

Terapeutické oblasti:

PROTON-PUMP INHIBITORS

Prehľad produktov:

Active ingredient group (AIG) number: 0127666002; AHFS:

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2019-07-29

Súhrn charakteristických

_MYLAN-LANSOPRAZOLE, MYLAN-LANSOPRAZOLE FDT Product Monograph _
_Page 1 of 79 _
_(lansoprazole delayed-release capsules, lansoprazole
fast-disintegrating delayed-release tablets) _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MYLAN-LANSOPRAZOLE
Lansoprazole Delayed-Release Capsules
Capsule (delayed-release), 15 mg and 30 mg, Oral
USP
PR
MYLAN-LANSOPRAZOLE FDT
Lansoprazole Fast-Disintegrating, Delayed-Release Tablets
Tablet (delayed-release), 15 mg and 30 mg, Nasogastric and Oral
Proton-Pump Inhibitors
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Submission Control Number: 267100
Date of Initial Authorization:
JUN 18, 2010
Date of Revision:
JAN 09, 2023
_MYLAN-LANSOPRAZOLE, MYLAN-LANSOPRAZOLE FDT Product Monograph _
_Page 2 of 79 _
_(lansoprazole delayed-release capsules, lansoprazole
fast-disintegrating delayed-release tablets) _
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, 7.1.3 Pediatrics
03/2021
7 Warnings and Precautions, Carcinogenesis and Mutagenesis
01/2023
7 Warnings and Precautions, Endocrine and Metabolism
01/2023
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 (6 to 17 years of
age)........................................................................................4
1.2
Geriatrics..........................................................................................................................4
2
CONTRAINDICATIONS
...........................................................