SYNAREL METERED-DOSE AEROSOL
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
21-01-2016
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Active ingredient:
NAFARELIN (NAFARELIN ACETATE)
Available from:
PFIZER CANADA ULC
ATC code:
H01CA02
INN (International Name):
NAFARELIN
Dosage:
200MCG
Pharmaceutical form:
METERED-DOSE AEROSOL
Composition:
NAFARELIN (NAFARELIN ACETATE) 200MCG
Administration route:
NASAL
Units in package:
8 ML
Prescription type:
Prescription
Therapeutic area:
GONADOTROPINS AND ANTIGONADOTROPINS
Product summary:
Active ingredient group (AIG) number: 0133344002; AHFS:
Authorization status:
APPROVED
Authorization date:
2003-10-06
Summary of Product characteristics
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
............................................................
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