CANDESARTAN TABLET
Pajjiż: Kanada
Lingwa: Ingliż
Sors: Health Canada
Karatteristiċi tal-prodott
(SPC)
02-12-2016
Xi dokumenti għal dan il-prodott mhumiex disponibbli bħalissa, tista 'tibgħat talba lis-servizz tal-konsumatur tagħna u aħna ninnotifikawkom malli nkunu nistgħu niksbuhom.
Ibgħat talba.
Ibgħat talba.
Ingredjent attiv:
CANDESARTAN CILEXETIL
Disponibbli minn:
SIVEM PHARMACEUTICALS ULC
Kodiċi ATC:
C09CA06
INN (Isem Internazzjonali):
CANDESARTAN
Dożaġġ:
4MG
Għamla farmaċewtika:
TABLET
Kompożizzjoni:
CANDESARTAN CILEXETIL 4MG
Rotta amministrattiva:
ORAL
Unitajiet fil-pakkett:
30/100
Tip ta 'preskrizzjoni:
Prescription
Żona terapewtika:
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Sommarju tal-prodott:
Active ingredient group (AIG) number: 0135220001; AHFS:
L-istatus ta 'awtorizzazzjoni:
CANCELLED POST MARKET
Data ta 'l-awtorizzazzjoni:
2016-05-17
Karatteristiċi tal-prodott
_ _
_CANDESARTAN _
_Page 1 of 35_
PRODUCT MONOGRAPH
PR
CANDESARTAN
Candesartan Cilexetil Tablets
4 mg, 8 mg and 16 mg
Professed Standard
Angiotensin II AT
1
Receptor Blocker
Sivem Pharmaceuticals ULC
Date of Revision:
4705 Dobrin Street
December 02, 2016
Saint-Laurent, QC, Canada
H4R 2P7
www.sivem.ca
Submission Control No: 200116
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_CANDESARTAN _
_Page 2 of 35_
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
........................................................................................................................................
12
DOSAGE
AND
ADMINISTRATION
....................................................................................................................
14
OVERDOSAGE
......................................................................................................................................................
17
ACTION
AND
CLINICAL
PHARMACOLOGY
...................................................................................................
17
STORAGE
AND
STABILITY
................................................................................................................................
19
DOSAGE
FORMS,
COMPOSI
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