Q-CANDESARTAN TABLET

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Nunua Sasa

Shusha Tabia za bidhaa (SPC)
19-06-2015

Viambatanisho vya kazi:

CANDESARTAN CILEXETIL

Inapatikana kutoka:

QD PHARMACEUTICALS ULC

ATC kanuni:

C09CA06

INN (Jina la Kimataifa):

CANDESARTAN

Kipimo:

16MG

Dawa fomu:

TABLET

Tungo:

CANDESARTAN CILEXETIL 16MG

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: 0135220003; AHFS:

Idhini hali ya:

CANCELLED PRE MARKET

Idhini ya tarehe:

2015-08-21

Tabia za bidhaa

                                _Q-CANDESARTAN Product Monograph_
_Page 1 of 38 _
PRODUCT MONOGRAPH
PR
Q-CANDESARTAN
(candesartan cilexetil tablets)
4 mg, 8 mg, 16 mg and 32 mg
Angiotensin II AT
1
Receptor Blocker
QD Pharmaceuticals ULC
85 Advance Road
Toronto, ON
M8Z 2S6
Submission Control Number: 184370
Date of Revision:
May 20, 2015
_Q-CANDESARTAN Product Monograph_
_Page 2 of 38 _
TABLE OF CONTENTS
PART 1: HEALTH PROFESSIONAL INFORMATION .................................................... 3
SUMMARY PRODUCT INFORMATION
.............................................................................
3
INDICATIONS AND CLINICAL USE
...................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
4
WARNINGS AND PRECAUTIONS
.......................................................................................
4
ADVERSE REACTIONS
..........................................................................................................
8
DRUG INTERACTIONS
.........................................................................................................
14
DOSAGE AND ADMINISTRATION
....................................................................................
17
OVERDOSAGE
.........................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
.....................................................................
20
STORAGE AND STABILITY
................................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................. 23
PART II: SCIENTIFIC INFORMATION .............................................................................
24
PHARMACEUTICAL INFORMATION
...............................................................................
24
CLINICAL TRIALS
..................................................
                                
                                Soma hati kamili
                                
                            

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Tabia za bidhaa Tabia za bidhaa Kifaransa 20-05-2015

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