APO-DABIGATRAN CAPSULE
Country: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
18-07-2022
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:
DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE)
Fáanlegur frá:
APOTEX INC
ATC númer:
B01AE07
INN (Alþjóðlegt nafn):
DABIGATRAN ETEXILATE
Skammtar:
110MG
Lyfjaform:
CAPSULE
Samsetning:
DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE MESILATE) 110MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
60
Gerð lyfseðils:
Prescription
Lækningarsvæði:
DIRECT THROMBIN INHIBITORS
Vörulýsing:
Active ingredient group (AIG) number: 0152467002; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2018-02-19
Vara einkenni
PRODUCT MONOGRAPH
PR
APO-DABIGATRAN
DABIGATRAN ETEXILATE CAPSULES
75 MG, 110 MG AND 150 MG
DABIGATRAN ETEXILATE (AS DABIGATRAN ETEXILATE MESYLATE)
ANTICOAGULANT
APOTEX INC DATE OF REVISION:
150 SIGNET DRIVE
July 18, 2022
TORONTO, ONTARIO
M9L 1T9
CONTROL NUMBER: 258873
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT
INFORMATION.................................................................................3
INDICATIONS AND CLINICAL USE
......................................................................................3
CONTRAINDICATIONS
..........................................................................................................4
WARNINGS AND
PRECAUTIONS..........................................................................................4
ADVERSE REACTIONS
........................................................................................................
12
DRUG INTERACTIONS
.........................................................................................................
23
DOSAGE AND ADMINISTRATION
......................................................................................
31
OVERDOSAGE
......................................................................................................................
36
ACTION AND CLINICAL PHARMACOLOGY
.....................................................................
37
STORAGE AND STABILITY
.................................................................................................
43
SPECIAL HANDLING
INSTRUCTIONS................................................................................
43
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................................... 43
PART II: SCIENTIFIC
INFORMATION...............................................................................45
PHARMACEUTICAL INFORMATION
..................................................................................
4
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