CANDESARTAN TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

CANDESARTAN CILEXETIL

Διαθέσιμο από:

RANBAXY PHARMACEUTICALS CANADA INC.

Φαρμακολογική κατηγορία (ATC):

C09CA06

INN (Διεθνής Όνομα):

CANDESARTAN

Δοσολογία:

16MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

CANDESARTAN CILEXETIL 16MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

100

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0135220003; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2013-08-21

Αρχείο Π.Χ.Π.

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_CANDESARTAN (CANDESARTAN CILEXETIL) TABLETS_
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_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_
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_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
.....................................................