SYNAREL METERED-DOSE AEROSOL

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

NAFARELIN (NAFARELIN ACETATE)

Tersedia dari:

PFIZER CANADA ULC

Kode ATC:

H01CA02

INN (Nama Internasional):

NAFARELIN

Dosis:

200MCG

Bentuk farmasi:

METERED-DOSE AEROSOL

Komposisi:

NAFARELIN (NAFARELIN ACETATE) 200MCG

Rute administrasi :

NASAL

Unit dalam paket:

8 ML

Jenis Resep:

Prescription

Area terapi:

GONADOTROPINS AND ANTIGONADOTROPINS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2003-10-06

Karakteristik produk

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