NTP-CANDESARTAN TABLET
Valsts: Kanāda
Valoda: angļu
Klimata pārmaiņas: Health Canada
Produkta apraksts
(SPC)
19-07-2013
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Aktīvā sastāvdaļa:
CANDESARTAN CILEXETIL
Pieejams no:
TEVA CANADA LIMITED
ATĶ kods:
C09CA06
SNN (starptautisko nepatentēto nosaukumu):
CANDESARTAN
Deva:
8MG
Zāļu forma:
TABLET
Kompozīcija:
CANDESARTAN CILEXETIL 8MG
Ievadīšanas:
ORAL
Vienības iepakojumā:
30/100
Receptes veids:
Prescription
Ārstniecības joma:
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Produktu pārskats:
Active ingredient group (AIG) number: 0135220002; AHFS:
Autorizācija statuss:
CANCELLED PRE MARKET
Autorizācija datums:
2015-08-06
Produkta apraksts
PRODUCT MONOGRAPH
PR
NTP-CANDESARTAN
(Candesartan cilexetil)
8 mg, 16 mg, 32 mg Tablets
Angiotensin II AT
1
Receptor Blocker
Teva Canada Ltd.
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Control No. 165862
Date of Preparation:
July 12, 2013
2
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
.....................................................................................
6
DRUG INTERACTIONS
...................................................................................
10
DOSAGE AND ADMINISTRATION
.............................................................. 11
OVERDOSAGE
..................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
........................................... 14
STORAGE AND
STABILITY...........................................................................
16
DOSAGE FORMS, COMPOSITION AND PACKAGING ........................... 16
PART II:
SCIENTIFIC INFORMATION
........................................................................
17
CLINICAL TRIALS
...........................................................................................
18
DETAILED PHARMACOLOGY
.....................................................................
20
TOXICOLOGY
..................................................................................................
21
REFERENCES
....................................................................................................
24
PART III
CONSUMER INFORMATION
........................................................................
26
3
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