ZONTIVITY TABLET
Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
Tabia za bidhaa
(SPC)
27-10-2022
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:
VORAPAXAR SULFATE
Inapatikana kutoka:
XSPIRE PHARMA, LLC
ATC kanuni:
B01AC26
INN (Jina la Kimataifa):
VORAPAXAR
Kipimo:
2.5MG
Dawa fomu:
TABLET
Tungo:
VORAPAXAR SULFATE 2.5MG
Njia ya uendeshaji:
ORAL
Vitengo katika mfuko:
100
Dawa ya aina:
Prescription
Eneo la matibabu:
PLATELET AGGREGATION INHIBITORS
Bidhaa muhtasari:
Active ingredient group (AIG) number: 0158150001; AHFS:
Idhini hali ya:
APPROVED
Idhini ya tarehe:
2016-11-16
Tabia za bidhaa
_ZONTIVITY™ (vorapaxar sulfate tablets) _
_Page 1 of 31_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
ZONTIVITY
™
Vorapaxar Sulfate Tablets
2.5 mg tablets
Platelet Aggregation Inhibitor
Xspire Pharma, LLC
119 Marketridge Drive, Suite D
Ridgeland, Mississippi
39157 United States
Imported By:
Regulatory Solutions Inc.
21 Parr Blvd., Unit 12
Caledon, Ontario
L7E 4G3
Date of Preparation:
OCT 27, 2022
Submission Control No.: 267772
_ZONTIVITY™ (vorapaxar sulfate tablets) _
_Page 2 of 31_
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
....................................................................................................7
DRUG INTERACTIONS
..................................................................................................11
DOSAGE AND ADMINISTRATION
..............................................................................13
OVERDOSAGE
................................................................................................................14
ACTION AND CLINICAL PHARMACOLOGY
............................................................14
STORAGE AND STABILITY
..........................................................................................16
SPECIAL HANDLING INSTRUCTIONS
.......................................................................16
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................17
PART II: SCIENTIFIC INFORMATION
.............................................................................
Soma hati kamili
