SANDOZ CINACALCET TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

CINACALCET (CINACALCET HYDROCHLORIDE)

Boleh didapati daripada:

SANDOZ CANADA INCORPORATED

Kod ATC:

H05BX01

INN (Nama Antarabangsa):

CINACALCET

Dos:

90MG

Borang farmaseutikal:

TABLET

Komposisi:

CINACALCET (CINACALCET HYDROCHLORIDE) 90MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

30

Jenis preskripsi:

Prescription

Kawasan terapeutik:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Ringkasan produk:

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

Status kebenaran:

CANCELLED PRE MARKET

Tarikh kebenaran:

2021-04-21

Ciri produk

_ _
_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
_ _
_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
...........................................