TARO-CANDESARTAN TABLET

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Nunua Sasa

Shusha Tabia za bidhaa (SPC)
05-03-2020

Viambatanisho vya kazi:

CANDESARTAN CILEXETIL

Inapatikana kutoka:

SUN PHARMA CANADA INC

ATC kanuni:

C09CA06

INN (Jina la Kimataifa):

CANDESARTAN

Kipimo:

32MG

Dawa fomu:

TABLET

Tungo:

CANDESARTAN CILEXETIL 32MG

Njia ya uendeshaji:

ORAL

Vitengo katika mfuko:

30

Dawa ya aina:

Prescription

Eneo la matibabu:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Bidhaa muhtasari:

Active ingredient group (AIG) number: 0135220004; AHFS:

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2020-03-04

Tabia za bidhaa

                                _ _
_PR_
_TARO-CANDESARTAN (CANDESARTAN CILEXETIL) TABLETS_
_ _
_Page 1 of 39_
PRODUCT MONOGRAPH
PR
TARO–CANDESARTAN
candesartan cilexetil tablets
4 mg, 8 mg, 16 mg and 32 mg
Angiotensin II AT
1
Receptor Blocker
Sun Pharma Canada Inc.
126 East Drive
Brampton, Ontario
L6T 1C1
Date of Revision:
March 2, 2020
Submission Control Number: 236155
_ _
_PR_
_TARO-CANDESARTAN (CANDESARTAN CILEXETIL) TABLETS_
_ _
_Page 2 of 39_
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
..................................................................................................15
DOSAGE AND ADMINISTRATION
..............................................................................19
OVERDOSAGE
................................................................................................................21
ACTION AND CLINICAL PHARMACOLOGY
............................................................22
STORAGE AND STABILITY
..........................................................................................24
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................24
PART II: SCIENTIFIC INFORMATION
....................................................................................26
PHARMACEUTICAL INFORMATION
..........................................................................26
CLINICAL TRIALS
......................................................
                                
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