SANDOZ CINACALCET TABLET

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

CINACALCET (CINACALCET HYDROCHLORIDE)

可用日期:

SANDOZ CANADA INCORPORATED

ATC代码:

H05BX01

INN（国际名称）:

CINACALCET

剂量:

90MG

药物剂型:

TABLET

组成:

CINACALCET (CINACALCET HYDROCHLORIDE) 90MG

给药途径:

ORAL

每包单位数:

30

处方类型:

Prescription

治疗领域:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

產品總結:

Active ingredient group (AIG) number: 0150282003; AHFS:

授权状态:

CANCELLED PRE MARKET

授权日期:

2021-04-21

产品特点

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_Sandoz Cinacalcet _
_Page 1 of 26 _
PRODUCT MONOGRAPH
PR
SANDOZ CINACALCET
Cinacalcet Tablets
30 mg, 60 mg and 90 mg cinacalcet (as cinacalcet hydrochloride)
Calcimimetic agent
Sandoz Canada Inc.
110 Rue de Lauzon
Boucherville, QC, Canada
J4B 1E6
Date of revision:
December 9, 2019
Submission Control No: 234104
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_Sandoz Cinacalcet _
_Page 2 of 26 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
...................................................... 3
SUMMARY PRODUCT INFORMATION
.....................................................................
3
INDICATIONS AND CLINICAL USE
..........................................................................
3
CONTRAINDICATIONS
...............................................................................................
4
WARNINGS AND PRECAUTIONS
..............................................................................
4
ADVERSE REACTIONS
...............................................................................................
8
DRUG INTERACTIONS
.............................................................................................
11
DOSAGE AND ADMINISTRATION
..........................................................................
12
OVERDOSAGE
...........................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
......................................................... 14
STORAGE AND STABILITY
.....................................................................................
15
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................... 15
PART II: SCIENTIFIC INFORMATION
...........................................................................
16
PHARMACEUTICAL INFORMATION
......................................................................
16
CLINICAL TRIALS
.....................................................................................................
17
DETAILED PHARMACOLOGY
...........................................