RIVA SITAGLIPTIN TABLET

দেশ: কানাডা

ভাষা: ইংরেজি

সূত্র: Health Canada

সক্রিয় উপাদান:

SITAGLIPTIN (SITAGLIPTIN PHOSPHATE MONOHYDRATE)

থেকে পাওয়া:

LABORATOIRE RIVA INC.

এটিসি কোড:

A10BH01

INN (আন্তর্জাতিক নাম):

SITAGLIPTIN

ডোজ:

25MG

ফার্মাসিউটিকাল ফর্ম:

TABLET

রচনা:

SITAGLIPTIN (SITAGLIPTIN PHOSPHATE MONOHYDRATE) 25MG

প্রশাসন রুট:

ORAL

প্যাকেজ ইউনিট:

100

প্রেসক্রিপশন টাইপ:

Prescription

পণ্য সারাংশ:

Active ingredient group (AIG) number: 0152414002; AHFS:

অনুমোদন অবস্থা:

APPROVED

অনুমোদন তারিখ:

2023-04-06

পণ্য বৈশিষ্ট্য

_RIVA-STIGALIPTIN (sitagliptin) _
_Page 1 of 60_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
RIVA SITAGLIPTIN
Sitagliptin Tablets
Tablets, 25 mg, 50 mg and 100 mg sitagliptin (as sitagliptin phosphate
anhydrous), Oral
House Standard
ATC Code: A10BH01
Dipeptidyl peptidase 4 (DPP-4) inhibitors
LABORATOIRE RIVA INC.
660 Boul. Industriel
Blainville, Quebec
J7C 3V4
www.labriva.com
Submission Control Number: 273422
Date of Initial Authorization:
JAN 5, 2023
Date of
Revision:
APR 6, 2023
_RIVA-STIGALIPTIN (sitagliptin) _
_Page 2 of 60_
RECENT MAJOR LABEL CHANGES
1 INDICATIONS
04/2023
4 DOSAGE AND ADMINISTRATION
04/2023
7 WARNINGS AND PRECAUTIONS
04/2023
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
..................................................................................................................
4
1.2
Geriatrics
..................................................................................................................
4
2
CONTRAINDICATIONS
................................................................................................
4
4
DOSAGE AND ADMINISTRATION
................................................................................
4
4.1
Dosing Considerations
.............................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
........................................................ 5
4.4
Administration
........................................