AG-PANTOPRAZOLE SODIUM TABLET (DELAYED-RELEASE)

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM SESQUIHYDRATE)

Dostopno od:

ANGITA PHARMA INC.

Koda artikla:

A02BC02

INN (mednarodno ime):

PANTOPRAZOLE

Odmerek:

40MG

Farmacevtska oblika:

TABLET (DELAYED-RELEASE)

Sestava:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM SESQUIHYDRATE) 40MG

Pot uporabe:

ORAL

Enote v paketu:

15G/50G

Tip zastaranja:

Prescription

Terapevtsko območje:

PROTON-PUMP INHIBITORS

Povzetek izdelek:

Active ingredient group (AIG) number: 0133229001; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2018-10-11

Lastnosti izdelka

AG-PANTOPRAZOLE SODIUM Page 1 of 46
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AG-PANTOPRAZOLE SODIUM
Pantoprazole Sodium Delayed-Release Tablets
Delayed-Release Tablet, 20 mg and 40 mg pantoprazole
(as pantoprazole sodium sesquihydrate), Oral
USP
Proton Pump Inhibitor
Angita Pharma Inc
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Date of Initial Authorization:
October 11, 2018
Date of Revision:
September 27, 2023
Submission Control Number: 273071
AG-PANTOPRAZOLE SODIUM Page 2 of 46
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, Endocrine and Metabolism
09/2023
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 (< 18 years of age)
..................................................................................
4
1.2
Geriatrics
................................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
4
DOSAGE AND ADMINISTRATION
.................................................................................
5
4.1
Dosing Considerations
............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
....................................................... 5
4.4
Administration
.......................................................................................................
6
4.5
Missed