CANDESARTAN TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

CANDESARTAN CILEXETIL

Dostopno od:

RANBAXY PHARMACEUTICALS CANADA INC.

Koda artikla:

C09CA06

INN (mednarodno ime):

CANDESARTAN

Odmerek:

4MG

Farmacevtska oblika:

TABLET

Sestava:

CANDESARTAN CILEXETIL 4MG

Pot uporabe:

ORAL

Enote v paketu:

100

Tip zastaranja:

Prescription

Terapevtsko območje:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Povzetek izdelek:

Active ingredient group (AIG) number: 0135220001; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2013-08-21

Lastnosti izdelka

_ _
_CANDESARTAN (CANDESARTAN CILEXETIL) TABLETS_
_ _
_Page 1 of 28_
PRODUCT MONOGRAPH
PR
CANDESARTAN
candesartan cilexetil tablets
4 mg, 8 mg, 16 mg, and 32 mg
Angiotensin II AT
1
Receptor Blocker
Ranbaxy Pharmaceuticals Canada Inc.,
2680 Matheson Blvd. E., Suite 200
Mississauga, Ontario L4W 0A5
Submission Control No: 166986
DATE OF PREPARATION:
August 15, 2013
_ _
_CANDESARTAN (CANDESARTAN CILEXETIL) TABLETS_
_ _
_Page 2 of 28_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................6
DRUG INTERACTIONS
..................................................................................................10
DOSAGE AND ADMINISTRATION
..............................................................................13
OVERDOSAGE
................................................................................................................14
ACTION AND CLINICAL PHARMACOLOGY
............................................................14
STORAGE AND STABILITY
..........................................................................................16
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................17
PART II: SCIENTIFIC INFORMATION
...............................................................................18
PHARMACEUTICAL INFORMATION
..........................................................................18
CLINICAL TRIALS
.....................................................