THELIN TABLET
Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
Tabia za bidhaa
(SPC)
13-05-2010
Hati zingine za bidhaa hii hazipatikani kwa sasa, unaweza kutuma ombi kwa huduma ya wateja wetu na tutakuarifu mara tu tutakapopata.
Tuma ombi.
Tuma ombi.
Viambatanisho vya kazi:
SITAXSENTAN SODIUM
Inapatikana kutoka:
PFIZER CANADA ULC
ATC kanuni:
C02KX03
INN (Jina la Kimataifa):
SITAXENTAN
Kipimo:
100MG
Dawa fomu:
TABLET
Tungo:
SITAXSENTAN SODIUM 100MG
Njia ya uendeshaji:
ORAL
Vitengo katika mfuko:
28
Dawa ya aina:
Prescription
Eneo la matibabu:
MISCELLANEOUS VASODILATATING AGENTS
Bidhaa muhtasari:
Active ingredient group (AIG) number: 0152215001; AHFS:
Idhini hali ya:
CANCELLED POST MARKET
Idhini ya tarehe:
2011-04-30
Tabia za bidhaa
_ _
_ _
_PR_
_THELIN_
_® _
_(sitaxsentan sodium tablets) Product Monograph _
_Page 1 of 28_
PRODUCT MONOGRAPH
PR
THELIN
®
(sitaxsentan sodium tablets)
100 mg
Endothelin receptor antagonist
® Registered trademark of Encysive Pharmaceuticals Inc.
Pfizer Canada Inc.
17 300 Trans-Canada Highway
Kirkland, Quebec H9J 2M5
Date of preparation:
April 26, 2010
Submission Control Number: 134705
_ _
_ _
_PR_
_THELIN_
_® _
_(sitaxsentan sodium tablets) Product Monograph _
_Page 2 of 28_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION................................................... 3
SUMMARY OF PRODUCT INFORMATION
............................................................. 3
INDICATIONS AND CLINICAL
USE.........................................................................
3
CONTRAINDICATIONS
..............................................................................................
3
DOSAGE AND
ADMINISTRATION.........................................................................
13
OVERDOSAGE:
..........................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
....................................................... 15
STORAGE AND
STABILITY.....................................................................................
16
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................ 16
PART II: SCIENTIFIC
INFORMATION........................................................................
18
PHARMACEUTICAL
INFORMATION.....................................................................
18
CLINICAL
TRIALS.....................................................................................................
19
DETAILED
PHARMACOLOGY................................................................................
21
TOXICOLOGY
............................................................................................................
24
REFERENCES
.................................................................
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