APO-RISEDRONATE TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE)

Disponibil de la:

APOTEX INC

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:

4/30

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:

2012-06-19

Caracteristicilor produsului

_APO-RISEDRONATE (Risedronate Sodium tablets) _
_ _
_Page 1 of 42_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-RISEDRONATE
Risedronate Sodium Tablets
Tablets, 35 mg risedronate sodium (as risedronate sodium
hemi-pentahydrate), Oral
USP
Bisphosphonates
(ATC Code: M05BA07)
APOTEX INC.
150 Signet Drive
Toronto Ontario
M9L 1T9
Date of Initial Authorization:
JUN 19, 2012
Date of revision:
JUN 23, 2023
Submission Control Number: 272008
_APO-RISEDRONATE (Risedronate Sodium tablets) _
_ _
_Page 2 of 42_
RECENT MAJOR LABEL CHANGES
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 and Dosage Adjustment
........................................................... 5
4.4
Administration
......................................................................