MINT-FINASTERIDE TABLET
Land: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
24-04-2023
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:
FINASTERIDE
Fáanlegur frá:
MINT PHARMACEUTICALS INC
ATC númer:
D11AX10
INN (Alþjóðlegt nafn):
FINASTERIDE
Skammtar:
1MG
Lyfjaform:
TABLET
Samsetning:
FINASTERIDE 1MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
100
Gerð lyfseðils:
Prescription
Vörulýsing:
Active ingredient group (AIG) number: 0124110002; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2023-04-26
Vara einkenni
_Product-Monograph MINT-FINASTERIDE _
_Page 1 of 23 _
PRODUCT MONOGRAPH
PR
MINT-FINASTERIDE
Finasteride tablets, USP
Film-coated Tablets 1 mg
Type II 5α-reductase inhibitor
Submission Control No.: 263828
Mint Pharmaceuticals Inc.
6575 Davand Drive
Mississauga, Ontario
L5T 2M3
Date of Preparation:
April 24, 2023
_Product-Monograph MINT-FINASTERIDE _
_Page 2 of 23 _
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
.....................................................................................7
DOSAGE AND ADMINISTRATION
.................................................................7
OVERDOSAGE
...................................................................................................8
ACTION AND CLINICAL PHARMACOLOGY
...............................................8
STORAGE AND STABILITY
............................................................................9
SPECIAL HANDLING INSTRUCTIONS
..........................................................9
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................9
PART II: SCIENTIFIC INFORMATION
.................................................................10
PHARMACEUTICAL INFORMATION
..........................................................10
CLINICAL TRIALS
...........................................................................................10
DETAILED PHARMACOLOGY
......................................................................12
TOXICOLOGY
....................................
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