RIVA-LANSOPRAZOLE CAPSULE (DELAYED RELEASE)

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

LANSOPRAZOLE

Dostopno od:

LABORATOIRE RIVA INC.

Koda artikla:

A02BC03

INN (mednarodno ime):

LANSOPRAZOLE

Odmerek:

30MG

Farmacevtska oblika:

CAPSULE (DELAYED RELEASE)

Sestava:

LANSOPRAZOLE 30MG

Pot uporabe:

ORAL

Enote v paketu:

100

Tip zastaranja:

Prescription

Terapevtsko območje:

PROTON-PUMP INHIBITORS

Povzetek izdelek:

Active ingredient group (AIG) number: 0127666001; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2015-03-09

Lastnosti izdelka

_RIVA-LANSOPRAZOLE _
_(lansoprazole delayed-release capsules) _
_Page 1 of 81_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR RIVA-LANSOPRAZOLE
Lansoprazole Delayed-Release Capsules
Delayed-Release Capsules, 15 mg and 30 mg, Oral
USP
Proton Pump Inhibitors
LABORATOIRE RIVA INC.
660 Boul. Industriel
Blainville, Quebec
J7C 3V4
www.labriva.com
Date of Initial Authorization:
APR 23, 2014
Date of Revision:
DEC 20, 2023
Submission Control Number: 281674
_RIVA-LANSOPRAZOLE _
_(lansoprazole delayed-release capsules) _
_Page 2 of 81_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Immune
12/2023
7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism
12/2023
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
.....................................................................
5
1
INDICATIONS
..................................................................................................................
5
1.1
Pediatrics
.....................................................................................................................
5
1.2
Geriatrics
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5
2
CONTRAINDICATIONS
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6
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
................................................................. 6
4
DOSAGE AND ADMINISTRATION
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6
4.1
Dosing Considerations
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6
4.2
Recommended Dose and