RISEDRONATE TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE)

Διαθέσιμο από:

PRO DOC LIMITEE

Φαρμακολογική κατηγορία (ATC):

M05BA07

INN (Διεθνής Όνομα):

RISEDRONIC ACID

Δοσολογία:

35MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 35MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

4

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

BONE RESORPTION INHIBITORS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0135301003; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2020-04-22

Αρχείο Π.Χ.Π.

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_ Risedronate (risedronate sodium) Page 1 of 40 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
RISEDRONATE
Risedronate Sodium Tablets
Tablets, 35 mg risedronate sodium (as the hemi-pentahydrate), oral
Bisphosphonates
(ATC Code: M05BA07)
Pro Doc Ltée
2925 boul. Industriel
Laval, QC
H7L 3W9
Submission Control Number: 275305
Date
of Initial Authorization:
SEP
30, 2010
Date of
Revision:
JUN 02, 2023
______________________________________________________________________________________________
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_ Risedronate (risedronate sodium) Page 2 of 40 _
RECENT MAJOR LABEL CHANGES
1 INDICATIONS
06/2023
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage
Adjustment
06/2023
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
....................................................................................................
5
4
DOSAGE AND ADMINISTRATION
....................................................................................
5
4.1
Dosing Considerations
..................................................................................................
5
4.2
Recommended Dose