APO-DARIFENACIN TABLET (EXTENDED-RELEASE)
Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
Tabia za bidhaa
(SPC)
25-08-2016
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:
DARIFENACIN (DARIFENACIN HYDROBROMIDE)
Inapatikana kutoka:
APOTEX INC
ATC kanuni:
G04BD10
INN (Jina la Kimataifa):
DARIFENACIN
Kipimo:
7.5MG
Dawa fomu:
TABLET (EXTENDED-RELEASE)
Tungo:
DARIFENACIN (DARIFENACIN HYDROBROMIDE) 7.5MG
Njia ya uendeshaji:
ORAL
Vitengo katika mfuko:
30/100
Dawa ya aina:
Prescription
Eneo la matibabu:
Antimuscarinics
Bidhaa muhtasari:
Active ingredient group (AIG) number: 0151554001; AHFS:
Idhini hali ya:
APPROVED
Idhini ya tarehe:
2016-08-23
Tabia za bidhaa
_APO-DARIFENACIN Product Monograph_
Page 1 of 26
PRODUCT MONOGRAPH
PR
APO-DARIFENACIN
DARIFENACIN EXTENDED RELEASE TABLETS
7.5 MG AND 15 MG DARIFENACIN (AS DARIFENACIN HYDROBROMIDE)
Muscarinic M3 selective receptor antagonist
APOTEX INC. DATE OF PREPARATION:
150 SIGNET DRIVE FEBRUARY 23, 2016
TORONTO, ONTARIO
M9L 1T9
CONTROL NUMBER: 170837
_APO-DARIFENACIN Product Monograph_
Page 2 of 26
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
......................................................................................................
5
DRUG INTERACTIONS
.......................................................................................................
8
DOSAGE AND ADMINISTRATION
......................................................................................
9
OVERDOSAGE
...................................................................................................................10
ACTION AND CLINICAL PHARMACOLOGY
......................................................................10
STORAGE AND
STABILITY................................................................................................13
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................................13
PART II: SCIENTIFIC INFORMATION
....................................................................................14
PHARMACEUTICAL INFORMATION
..................................................................................14
CLINICAL TRIALS
.......
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