SYNAREL METERED-DOSE AEROSOL

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

NAFARELIN (NAFARELIN ACETATE)

Предлага се от:

PFIZER CANADA ULC

АТС код:

H01CA02

INN (Международно Name):

NAFARELIN

дозиране:

200MCG

Лекарствена форма:

METERED-DOSE AEROSOL

Композиция:

NAFARELIN (NAFARELIN ACETATE) 200MCG

Начин на приложение:

NASAL

Броя в опаковка:

8 ML

Вид предписание :

Prescription

Терапевтична област:

GONADOTROPINS AND ANTIGONADOTROPINS

Каталог на резюме:

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

Статус Оторизация:

APPROVED

Дата Оторизация:

2003-10-06

Данни за продукта

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