Pays: Canada
Langue: anglais
Source: Health Canada
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
AURO PHARMA INC
A10BD15
METFORMIN AND DAPAGLIFLOZIN
5MG; 1000MG
TABLET
DAPAGLIFLOZIN 5MG; METFORMIN HYDROCHLORIDE 1000MG
ORAL
15G/50G
Prescription
Active ingredient group (AIG) number: 0257650002; AHFS:
APPROVED
2023-05-16
_Auro-Dapagliflozin / Metformin Product Monograph _ _ _ Page 1 of 70 _ _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR AURO-DAPAGLIFLOZIN / METFORMIN Dapagliflozin and Metformin hydrochloride tablets Tablets, 5 mg dapagliflozin and 850 mg metformin hydrochloride, 5 mg dapagliflozin and 1000 mg metformin hydrochloride, oral Combination of oral blood glucose lowering drugs AURO PHARMA INC. 3700 Steeles Avenue West, Suite # 402 Woodbridge, Ontario, L4L 8K8, CANADA Date of Initial Authorization: May 16, 2023 Date of Revision: September 1, 2023 Submission Control Number: 275247 _Auro-Dapagliflozin / Metformin Product Monograph _ _ _ Page 2 of 70 _ _ RECENT MAJOR LABEL CHANGES 1 INDICATIONS, 1.2 Geriatrics 09/2023 2 CONTRAINDICATIONS 09/2023 4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations 09/2023 4_DOSAGE_AND_ADMINISTRATION,4.2_Recommended_Dose_and_Dosage _Adjustment,Considerations for Special Populations 09/2023 4_DOSAGE_AND_ADMINISTRATION, 4.4_Administration 09/2023 7 WARNINGS AND PRECAUTIONS, Driving and Operating Machinery, Endocrine and Metabolism, Hypothyroidism, Vitamin B12 levels, Hepatic/Biliary/Pancreatic, Monitoring and Laboratory Tests, Neurologic and Renal 09/2023 7_WARNINGS_AND_PRECAUTIONS, 7.1.4_Geriatrics 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 ................................................................................................................. 4 1.2 Geriatrics .............................................. Lire le document complet