ZYPREXA TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

OLANZAPINE

Διαθέσιμο από:

ELI LILLY CANADA INC

Φαρμακολογική κατηγορία (ATC):

N05AH03

INN (Διεθνής Όνομα):

OLANZAPINE

Δοσολογία:

5MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

OLANZAPINE 5MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

7/100

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

ATYPICAL ANTIPSYCHOTICS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

1996-10-28

Αρχείο Π.Χ.Π.

_ _
ZYPREXA
®
Product Monograph
Page 1 of 74
PRODUCT MONOGRAPH
Pr
ZYPREXA
®
(olanzapine) Tablets
2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg
Pr
ZYPREXA
® ZYDIS
®
(olanzapine) Orally Disintegrating Tablets
5 mg, 10 mg, 15 mg, 20 mg
Pr
ZYPREXA
® INTRAMUSCULAR
(olanzapine tartrate for injection)
10 mg olanzapine/vial
Antipsychotic Agent
©
Eli Lilly Canada Inc.
3650 Danforth Avenue
Toronto, Ontario
M1N 2E8
1-888-545-5972
www.lilly.ca
Date of Revision:
January 29, 2020
Submission Control No: 232853
ZYPREXA is a trademark of Eli Lilly and Company
ZYDIS is a trademark owned by R.P. Scherer Technologies, Inc., a
Catalent Pharma Solutions Company
_ _
ZYPREXA
®
Product Monograph
Page 2 of 74
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
.............................................................................
3
INDICATIONS AND CLINICAL USE
...................................................................................
3
CONTRAINDICATIONS
........................................................................................................
4
WARNINGS AND PRECAUTIONS
.......................................................................................
5
ADVERSE REACTIONS
......................................................................................................
14
DRUG INTERACTIONS
.......................................................................................................
32
DOSAGE AND ADMINISTRATION
...................................................................................
34
OVERDOSAGE
.....................................................................................................................
37
ACTION AND CLINICAL PHARMACOLOGY
................................................................. 38
STORAGE AND STABILITY
...............................................................................................
40
DOSAGE FORMS, COMPOSITION AND PACKAGING
..............