TEVA-RISEDRONATE TABLET

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

RISEDRONATE SODIUM (RISEDRONATE SODIUM MONOHYDRATE)

可用日期:

TEVA CANADA LIMITED

ATC代码:

M05BA07

INN（国际名称）:

RISEDRONIC ACID

剂量:

150MG

药物剂型:

TABLET

组成:

RISEDRONATE SODIUM (RISEDRONATE SODIUM MONOHYDRATE) 150MG

给药途径:

ORAL

每包单位数:

1;3

处方类型:

Prescription

治疗领域:

BONE RESORPTION INHIBITORS

產品總結:

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

授权状态:

APPROVED

授权日期:

2013-10-10

产品特点

_ _
TEVA-RISEDRONATE
_ _
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
_ _
TEVA-RISEDRONATE
_ _
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...................................