RISEDRONATE TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE)

Disponibil de la:

PRO DOC LIMITEE

Codul ATC:

M05BA07

INN (nume internaţional):

RISEDRONIC ACID

Dozare:

35MG

Forma farmaceutică:

TABLET

Compoziție:

RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) 35MG

Calea de administrare:

ORAL

Unități în pachet:

4

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

BONE RESORPTION INHIBITORS

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2020-04-22

Caracteristicilor produsului

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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