MINT-OLANZAPINE TABLET
Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
Tabia za bidhaa
(SPC)
20-06-2017
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:
OLANZAPINE
Inapatikana kutoka:
MINT PHARMACEUTICALS INC
ATC kanuni:
N05AH03
INN (Jina la Kimataifa):
OLANZAPINE
Kipimo:
15MG
Dawa fomu:
TABLET
Tungo:
OLANZAPINE 15MG
Njia ya uendeshaji:
ORAL
Vitengo katika mfuko:
15G/50G
Dawa ya aina:
Prescription
Eneo la matibabu:
ATYPICAL ANTIPSYCHOTICS
Bidhaa muhtasari:
Active ingredient group (AIG) number: 0128783005; AHFS:
Idhini hali ya:
APPROVED
Idhini ya tarehe:
2013-09-04
Tabia za bidhaa
PRODUCT MONOGRAPH
Pr
MINT-OLANZAPINE
Olanzapine Tablets
2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg
House Standard
Antipsychotic Agent
Mint Pharmaceuticals Inc.
Date of Revision:
1093 Meyerside Drive, Unit 1
13 June 2017
Mississauga, Ontario
L5T 1J6 SUBMISSION CONTROL NO: 206312
Page 2 of 63
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
..............................................................................................................
13
DRUG INTERACTIONS
..............................................................................................................
30
DOSAGE AND ADMINISTRATION
..........................................................................................
31
OVERDOSAGE
............................................................................................................................
33
ACTION AND CLINICAL PHARMACOLOGY
........................................................................
34
STORAGE AND STABILITY
......................................................................................................
36
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................................... 36
PART II: SCIENTIFIC INFORMATION
...................................................................................
38
PHARMACEUTICAL INFORMATION
......................................................................................
38
CLINICAL TRIALS
...............................
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