TEVA-RISEDRONATE TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

RISEDRONATE SODIUM (RISEDRONATE SODIUM MONOHYDRATE)

Pieejams no:

TEVA CANADA LIMITED

ATĶ kods:

M05BA07

SNN (starptautisko nepatentēto nosaukumu):

RISEDRONIC ACID

Deva:

150MG

Zāļu forma:

TABLET

Kompozīcija:

RISEDRONATE SODIUM (RISEDRONATE SODIUM MONOHYDRATE) 150MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

1;3

Receptes veids:

Prescription

Ārstniecības joma:

BONE RESORPTION INHIBITORS

Produktu pārskats:

Active ingredient group (AIG) number: 0135301005; AHFS:

Autorizācija statuss:

APPROVED

Autorizācija datums:

2013-10-10

Produkta apraksts

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TEVA-RISEDRONATE
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Page 1 of 54
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-RISEDRONATE
Risedronate sodium tablets
Tablets, 5 mg, 30 mg, 35 mg and 150 mg (as the monohydrate), Oral
Teva Standard
Bisphosphonates (ATC Code: M05BA07)
Teva Canada Limited
30 Novopharm Court
Toronto, ON
M1B 2K9
Canada
www.tevacanada.com
Date of Initial Authorization:
October 10, 2013
Date of Revision:
April 18, 2023
Submission Control Number: 269246
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TEVA-RISEDRONATE
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Page 2 of 54
RECENT MAJOR LABEL CHANGES
1 INDICATIONS
04/2023
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage
Adjustment
04/2023
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
....................................................................................................................
5
1.2
Geriatrics
.....................................................................................................................
5
2
CONTRAINDICATIONS
..........................................................................................................
5
4
DOSAGE AND ADMINISTRATION
.........................................................................................
5
4.1
Dosing Considerations
.................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
.............................................................. 5
4.4
Administration...................................