M-BETAHISTINE TABLET
Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
Tabia za bidhaa
(SPC)
25-08-2021
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:
BETAHISTINE HYDROCHLORIDE
Inapatikana kutoka:
MANTRA PHARMA INC
ATC kanuni:
N07CA01
INN (Jina la Kimataifa):
BETAHISTINE
Kipimo:
8MG
Dawa fomu:
TABLET
Tungo:
BETAHISTINE HYDROCHLORIDE 8MG
Njia ya uendeshaji:
ORAL
Vitengo katika mfuko:
15G/50G
Dawa ya aina:
Prescription
Eneo la matibabu:
MISCELLANEOUS THERAPEUTIC AGENTS
Bidhaa muhtasari:
Active ingredient group (AIG) number: 0103555002; AHFS:
Idhini hali ya:
APPROVED
Idhini ya tarehe:
2021-08-30
Tabia za bidhaa
_M-Betahistine Product Monograph_
Page 1 of 20
PRODUCT MONOGRAPH
PR
M-BETAHISTINE
BETAHISTINE DIHYDROCHLORIDE TABLETS BP
8 MG, 16 MG AND 24 MG
ANTI-VERTIGO AGENT
MANTRA PHARMA INC.
9150 Boulevard Leduc, Suite 201
Brossard, QC, Canada
J4Y 0E3
DATE OF PREPARATION:
August 25, 2021
SUBMISSION CONTROL NO: 254780
_M-Betahistine Product Monograph_
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
.............................................................................
11
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................ 11
PART II: SCIENTIFIC INFORMATION
................................................................. 12
PHARMACEUTICAL INFORMATION
............................................................. 12
CLINICAL TRIALS
.............................................................................................
13
DETAILED PHARMACOLOGY
........................................................................
13
TOXICOLOGY
............................................................................................
Soma hati kamili
