AA-RISEDRONATE DR TABLET (DELAYED-RELEASE)
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
08-09-2023
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Aktiva substanser:
RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE)
Tillgänglig från:
AA PHARMA INC
ATC-kod:
M05BA07
INN (International namn):
RISEDRONIC ACID
Dos:
35MG
Läkemedelsform:
TABLET (DELAYED-RELEASE)
Sammansättning:
RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 35MG
Administreringssätt:
ORAL
Enheter i paketet:
15G/50G
Receptbelagda typ:
Prescription
Terapiområde:
BONE RESORPTION INHIBITORS
Produktsammanfattning:
Active ingredient group (AIG) number: 0135301003; AHFS:
Bemyndigande status:
APPROVED
Tillstånd datum:
2023-09-08
Produktens egenskaper
_Page 1 of 42_
_AA-RISEDRONATE DR (Risedronate Sodium Delayed-Release Tablets)_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AA-RISEDRONATE DR
Risedronate Sodium Delayed-Release Tablets
Delayed-Release Tablets, 35 mg (as the hemi-pentahydrate), Oral
Bisphosphonates (ATC Code: M05BA07)
Submission Control Number:
278226
AA PHARMA INC.
1165 Creditstone Road, Unit #1
Vaughan, Ontario
L4K 4N7
Date of Initial Authorization:
SEP
08, 2023
_AA-RISEDRONATE DR (Risedronate Sodium Delayed-Release Tablets) _
_Page 2 of 42 _
RECENT MAJOR LABEL CHANGES
Not Applicable
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
...........................................................................
5
4.1
Dosing Considerations
...........................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
......................................................... 5
4.4
Administration.......................................................................................................
5
4.5
Missed Dose
.........................................
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