MINT-BETAHISTINE TABLET
Land: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
17-05-2023
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:
BETAHISTINE HYDROCHLORIDE
Fáanlegur frá:
MINT PHARMACEUTICALS INC
ATC númer:
N07CA01
INN (Alþjóðlegt nafn):
BETAHISTINE
Skammtar:
24MG
Lyfjaform:
TABLET
Samsetning:
BETAHISTINE HYDROCHLORIDE 24MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
15G/50G
Gerð lyfseðils:
Prescription
Vörulýsing:
Active ingredient group (AIG) number: 0103555004; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2023-06-01
Vara einkenni
PRODUCT MONOGRAPH
PR
MINT-BETAHISTINE
Betahistine Dihydrochloride Tablets
(8 mg, 16 mg and 24 mg)
Manufacture’s Standard
Anti-vertigo Agent
Mint Pharmaceuticals Inc.
6575 Davand Drive
Mississauga, Ontario
L5T 2M3
Date of Preparation:
May 17, 2023
Submission Control No: 257693
_MINT-BETAHISTINE Product Monograph _
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_Page 2 of 20 _
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
......................................................................................................
6
DOSAGE AND ADMINISTRATION
..................................................................................
7
OVERDOSAGE
....................................................................................................................
8
ACTION AND CLINICAL PHARMACOLOGY
................................................................ 8
STORAGE AND STABILITY
...........................................................................................
10
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................... 11
PART II: SCIENTIFIC INFORMATION
...............................................................................
12
PHARMACEUTICAL INFORMATION
...........................................................................
12
CLINICAL TRIALS
............................................................................................
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