MINT-OLANZAPINE TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

OLANZAPINE

Dostopno od:

MINT PHARMACEUTICALS INC

Koda artikla:

N05AH03

INN (mednarodno ime):

OLANZAPINE

Odmerek:

5MG

Farmacevtska oblika:

TABLET

Sestava:

OLANZAPINE 5MG

Pot uporabe:

ORAL

Enote v paketu:

15G/50G

Tip zastaranja:

Prescription

Terapevtsko območje:

ATYPICAL ANTIPSYCHOTICS

Povzetek izdelek:

Active ingredient group (AIG) number: 0128783003; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2013-09-04

Lastnosti izdelka

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
...............................