CLIMARA PRO PATCH

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

ESTRADIOL; LEVONORGESTREL

Dostupné s:

BAYER INC

ATC kód:

G03FA11

INN (Mezinárodní Name):

LEVONORGESTREL AND ESTROGEN

Dávkování:

45MCG; 15MCG

Léková forma:

PATCH

Složení:

ESTRADIOL 45MCG; LEVONORGESTREL 15MCG

Podání:

TRANSDERMAL

Jednotky v balení:

4

Druh předpisu:

Prescription

Terapeutické oblasti:

ESTROGENS

Přehled produktů:

Active ingredient group (AIG) number: 0250024002; AHFS:

Stav Autorizace:

CANCELLED POST MARKET

Datum autorizace:

2017-11-30

Charakteristika produktu

_ _
_CLIMARA PRO Product Monograph _
_ Page 1 of 40 _
PRODUCT MONOGRAPH
PR
CLIMARA PRO
®
(Estradiol-17β and Levonorgestrel) Transdermal System
45/15 µg/day
Estrogen + Progestin
Bayer Inc.
Date of Revision:
2920 Matheson Boulevard East
Mississauga, Ontario
L4W 5R6
www.bayer.ca
March 16, 2016
Submission Control No.: 190081
© 2016, Bayer Inc.
® TM see www.bayer.ca/tm-mc
_ _
_CLIMARA PRO Product Monograph _
_ Page 2 of 40 _
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
.........................................................................................................
11
DRUG INTERACTIONS
.........................................................................................................
12
DOSAGE AND ADMINISTRATION
.....................................................................................
14
OVERDOSAGE
........................................................................................................................
15
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
16
STORAGE AND STABILITY
.................................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 20
PART II : SCIENTIFIC INFORMATION
..............................................................................
21
PHARMACEUTICAL INFORMATION
.........................................................