ZYM-MIRTAZAPINE TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

MIRTAZAPINE

Διαθέσιμο από:

ZYMCAN PHARMACEUTICALS INC

Φαρμακολογική κατηγορία (ATC):

N06AX11

INN (Διεθνής Όνομα):

MIRTAZAPINE

Δοσολογία:

15MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

MIRTAZAPINE 15MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

100/500

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

MISCELLANEOUS ANTIDEPRESSANTS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0143928001; AHFS:

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2014-06-16

Αρχείο Π.Χ.Π.

PRODUCT MONOGRAPH
PR
ZYM-MIRTAZAPINE
(Mirtazapine Tablets)
15 mg and 30 mg
ANTI-DEPRESSANT
ZYMCAN PHARMACEUTICALS
6111 Royalmount Ave., Suite 100
DATE OF REVISION:
Montréal, Québec
November 18, 2011
H4P 2T4
CONTROL NO. 150994
_Zym-MIRTAZAPINE Product Monograph _
_Page 2 of 39_
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
10
DRUG INTERACTIONS
15
DOSAGE AND ADMINISTRATION
18
OVERDOSAGE
20
ACTION AND CLINICAL PHARMACOLOGY
21
STORAGE AND STABILITY
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
24
PART II: SCIENTIFIC INFORMATION
25
PHARMACEUTICAL INFORMATION
25
DETAILED PHARMACOLOGY
27
TOXICOLOGY
30
REFERENCES
34
PART III: CONSUMER INFORMATION
36
_Zym-MIRTAZAPINE Product Monograph _
_Page 3 of 39_
PR
ZYM-MIRTAZAPINE
(Mirtazapine tablets)
PART I: HEALTH PROFESSIONAL INFORMATION
SUMMARY PRODUCT INFORMATION
ROUTE OF
ADMINISTRATION
DOSAGE FORM/
STRENGTH
CLINICALLY RELEVANT NONMEDICINAL
INGREDIENTS
oral
Tablet,15 and
30 mg
Lactose.
_For a complete listing see Dosage Forms, _
_Composition and Packaging section._
INDICATIONS AND CLINICAL USE
ADULTS
Zym-MIRTAZAPINE (mirtazapine) is indicated for the symptomatic relief
of depressive illness.
LONG-TERM USE OF MIRTAZAPINE
The efficacy of mirtazapine in maintaining a response in patients with
major depressive disorder for
up to 40 weeks following 8 - 12 weeks of initial open-label treatment
was demonstrated in a placebo-
controlled trial. Nevertheless, the physician who elects to use
Zym-MIRTAZAPINE for extended
periods should periodically evaluate the long-term response of the
individual patient to the drug.
GERIATRICS (> 65 YEARS OF AGE):
Evidence from clinical trials and experience suggests that use in
geriatric populations may be
associated with differences in safety or effectiveness. A brief
discussion can be found in the
appropriate sections [see WARNINGS AND
PRECAUTIONS-Neurological-Somnolence; Special
Populations-Geriatrics (> 65 years