Quốc gia: Canada
Ngôn ngữ: Tiếng Anh
Nguồn: Health Canada
SITAGLIPTIN (SITAGLIPTIN PHOSPHATE MONOHYDRATE); METFORMIN HYDROCHLORIDE
SIVEM PHARMACEUTICALS ULC
A10BD07
METFORMIN AND SITAGLIPTIN
50MG; 500MG
TABLET
SITAGLIPTIN (SITAGLIPTIN PHOSPHATE MONOHYDRATE) 50MG; METFORMIN HYDROCHLORIDE 500MG
ORAL
15G/50G
Prescription
Active ingredient group (AIG) number: 0252656001; AHFS:
APPROVED
2023-01-05
_ _ _SITAGLIPTIN-METFORMIN (Sitagliptin and metformin hydrochloride tablets) _ _Page 1 of 72_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr SITAGLIPTIN-METFORMIN Sitagliptin and metformin hydrochloride tablets Tablets, 50 mg/500 mg, 50 mg/850 mg and 50 mg/1000 mg sitagliptin (as sitagliptin phosphate monohydrate) / metformin hydrochloride, Oral Combinations of oral blood glucose lowering drugs Sivem Pharmaceuticals ULC 4705 Dobrin Street Saint-Laurent, Quebec, Canada H4R 2P7 www.sivem.ca Submission Control Number: 279764 Date of Initial Authorization: JAN 5, 2023 Date of Revision: OCT 20, 2023 _ _ _SITAGLIPTIN-METFORMIN (Sitagliptin and metformin hydrochloride tablets) _ _Page 2 of 72_ RECENT MAJOR LABEL CHANGES 1 Indications 10/2023 4 Dosage and Administration 10/2023 7 Warnings and Precautions 10/2023 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED. PART I: HEALTH PROFESSIONAL INFORMATION ..................................................................... 4 1 INDICATIONS .............................................................................................................. 4 1.1 Pediatrics ................................................................................................................... 4 1.2 Geriatrics ................................................................................................................... 4 2 CONTRAINDICATIONS ................................................................................................. 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 5 4 DOSAGE AND ADMINISTRATION ................................................................................. 6 4.1 Dosing Considerations .............................................................................................. 6 4.2 Recommended Dose and Dosage Adjustment ......................................................... 6 4.4 Administration ...................... Đọc toàn bộ tài liệu