SANDOZ CINACALCET TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

CINACALCET (CINACALCET HYDROCHLORIDE)

Pieejams no:

SANDOZ CANADA INCORPORATED

ATĶ kods:

H05BX01

SNN (starptautisko nepatentēto nosaukumu):

CINACALCET

Deva:

90MG

Zāļu forma:

TABLET

Kompozīcija:

CINACALCET (CINACALCET HYDROCHLORIDE) 90MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

30

Receptes veids:

Prescription

Ārstniecības joma:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Produktu pārskats:

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

Autorizācija statuss:

CANCELLED PRE MARKET

Autorizācija datums:

2021-04-21

Produkta apraksts

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