PMS-DAPAGLIFLOZIN TABLET
Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
Tabia za bidhaa
(SPC)
29-09-2022
Hati zingine za bidhaa hii hazipatikani kwa sasa, unaweza kutuma ombi kwa huduma ya wateja wetu na tutakuarifu mara tu tutakapopata.
Tuma ombi.
Tuma ombi.
Viambatanisho vya kazi:
DAPAGLIFLOZIN
Inapatikana kutoka:
PHARMASCIENCE INC
ATC kanuni:
A10BK01
INN (Jina la Kimataifa):
DAPAGLIFLOZIN
Kipimo:
5MG
Dawa fomu:
TABLET
Tungo:
DAPAGLIFLOZIN 5MG
Njia ya uendeshaji:
ORAL
Vitengo katika mfuko:
15G/50G
Dawa ya aina:
Prescription
Bidhaa muhtasari:
Active ingredient group (AIG) number: 0156370001; AHFS:
Idhini hali ya:
APPROVED
Idhini ya tarehe:
2023-05-15
Tabia za bidhaa
pms-DAPAGLIFLOZIN (dapagliflozin)
Page 1 of 78
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
pms-DAPAGLIFLOZIN
Dapagliflozin Tablets
Tablet, 5 mg and 10 mg, Oral
ATC Code: A10BK01
Sodium-glucose co-transporter 2 (SGLT2) inhibitors
Pharmascience Inc.
6111 Royalmount, Suite 100
Montreal, Canada, H4P 2T4
Date of Initial Authorization:
SEP 29, 2022
Submission Control Number: 257964
pms-DAPAGLIFLOZIN (dapagliflozin)
Page 2 of 78
RECENT MAJOR LABEL CHANGES
_None at time of authorization._
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
TABLE OF CONTENTS
............................................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
...................................................................................
4
1
INDICATIONS
...........................................................................................................................
4
1.1
Pediatrics
.............................................................................................................................
4
1.2
Geriatrics
.............................................................................................................................
5
2
CONTRAINDICATIONS
...............................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
...........................................................................
5
4
DOSAGE AND ADMINISTRATION
...............................................................................................
5
4.1
Dosing Considerations
.........................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
.................................................................... 6
4.5
Missed Dose
...............................................................................................
Soma hati kamili
