SYNAREL METERED-DOSE AEROSOL

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

NAFARELIN (NAFARELIN ACETATE)

Διαθέσιμο από:

PFIZER CANADA ULC

Φαρμακολογική κατηγορία (ATC):

H01CA02

INN (Διεθνής Όνομα):

NAFARELIN

Δοσολογία:

200MCG

Φαρμακοτεχνική μορφή:

METERED-DOSE AEROSOL

Σύνθεση:

NAFARELIN (NAFARELIN ACETATE) 200MCG

Οδός χορήγησης:

NASAL

Μονάδες σε πακέτο:

8 ML

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

GONADOTROPINS AND ANTIGONADOTROPINS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0133344002; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2003-10-06

Αρχείο Π.Χ.Π.

1
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
SYNAREL
™
(nafarelin acetate nasal solution)
2 mg/mL nasal solution
(as nafarelin base)
Gonadotropin releasing hormone (GnRH) analogue
Pfizer Canada Inc.
DATE OF REVISION:
17,300 Trans-Canada Highway
19 January 2016
Kirkland, Quebec
H9J 2M5
Submission Control No. 187533
TM G.D. Searle & Co.
Pfizer Canada Inc, Licensee

Pfizer Canada Inc. 2016
2
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
....................................................................................................6
DRUG INTERACTIONS
..................................................................................................10
DOSAGE AND ADMINISTRATION
..............................................................................11
OVERDOSAGE
................................................................................................................11
ACTION AND CLINICAL PHARMACOLOGY
............................................................12
STORAGE AND STABILITY
..........................................................................................18
SPECIAL HANDLING INSTRUCTIONS
.......................................................................19
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................22
PART II: SCIENTIFIC INFORMATION
...............................................................................23
PHARMACEUTICAL INFORMATION
............................................................