APO-DARIFENACIN TABLET (EXTENDED-RELEASE)
Land: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
25-08-2016
Sum skjöl fyrir þessa vöru eru ekki tiltæk eins og er, þú getur sent beiðni til þjónustu við viðskiptavini okkar og við munum láta þig vita um leið og við getum fengið þau.
Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
DARIFENACIN (DARIFENACIN HYDROBROMIDE)
Fáanlegur frá:
APOTEX INC
ATC númer:
G04BD10
INN (Alþjóðlegt nafn):
DARIFENACIN
Skammtar:
15MG
Lyfjaform:
TABLET (EXTENDED-RELEASE)
Samsetning:
DARIFENACIN (DARIFENACIN HYDROBROMIDE) 15MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
30/100
Gerð lyfseðils:
Prescription
Lækningarsvæði:
Antimuscarinics
Vörulýsing:
Active ingredient group (AIG) number: 0151554002; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2016-08-23
Vara einkenni
_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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