AG-PANTOPRAZOLE SODIUM TABLET (DELAYED-RELEASE)

দেশ: কানাডা

ভাষা: ইংরেজি

সূত্র: Health Canada

সক্রিয় উপাদান:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM SESQUIHYDRATE)

থেকে পাওয়া:

ANGITA PHARMA INC.

এটিসি কোড:

A02BC02

INN (আন্তর্জাতিক নাম):

PANTOPRAZOLE

ডোজ:

20MG

ফার্মাসিউটিকাল ফর্ম:

TABLET (DELAYED-RELEASE)

রচনা:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM SESQUIHYDRATE) 20MG

প্রশাসন রুট:

ORAL

প্যাকেজ ইউনিট:

100

প্রেসক্রিপশন টাইপ:

Prescription

থেরাপিউটিক এলাকা:

PROTON-PUMP INHIBITORS

পণ্য সারাংশ:

Active ingredient group (AIG) number: 0133229002; AHFS:

অনুমোদন অবস্থা:

APPROVED

অনুমোদন তারিখ:

2018-10-11

পণ্য বৈশিষ্ট্য

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