TEVA-CANDESARTAN TABLET

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Nunua Sasa

Tabia za bidhaa Tabia za bidhaa (SPC)
09-05-2016

Viambatanisho vya kazi:

CANDESARTAN CILEXETIL

Inapatikana kutoka:

TEVA CANADA LIMITED

ATC kanuni:

C09CA06

INN (Jina la Kimataifa):

CANDESARTAN

Kipimo:

8MG

Dawa fomu:

TABLET

Tungo:

CANDESARTAN CILEXETIL 8MG

Njia ya uendeshaji:

ORAL

Vitengo katika mfuko:

30/100

Dawa ya aina:

Prescription

Eneo la matibabu:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Bidhaa muhtasari:

Active ingredient group (AIG) number: 0135220002; AHFS:

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2012-02-10

Tabia za bidhaa

                                PRODUCT MONOGRAPH
PR
TEVA-CANDESARTAN
Candesartan cilexetil Tablets
8 mg, 16 mg, and 32 mg
Angiotensin II AT
1
Receptor Blocker
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Control No. 194121
Date of Revision:
May 2, 2016
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
.......................................................................................
8
DRUG INTERACTIONS
.....................................................................................
13
DOSAGE AND ADMINISTRATION
................................................................. 15
OVERDOSAGE
...................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
............................................... 18
STORAGE AND STABILITY
.............................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................ 20
PART II: SCIENTIFIC INFORMATION
....................................................................................
22
PHARMACEUTICAL INFORMATION
............................................................. 22
CLINICAL TRIALS
.............................................................................................
23
DETAILED PHARMACOLOGY
........................................................................
26
TOXICOLOGY
....................................................................................................
26
REFERENCES
.......................................................
                                
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