EVRA TRANSDERMAL PATCH

Země: Malajsie

Jazyk: angličtina

Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktivní složka:

NORELGESTROMIN; Ethinyl Estradiol

Dostupné s:

JOHNSON & JOHNSON SDN BHD

INN (Mezinárodní Name):

NORELGESTROMIN; Ethinyl Estradiol

Jednotky v balení:

9Pieces Pieces; 3Pieces Pieces; 18Pieces Pieces

Výrobce:

LTS LOHMANN THERAPIE-SYSTEM AG

Informace pro uživatele

EVRA
® TRANSDERMAL PATCH
Norelgestromin/ ethinyl estradiol (6mg/ 600mcg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What EVRA
®
_ _
is used for
2.
How EVRA
®
works
3.
Before you use EVRA
®
4.
How to use EVRA
®
5.
While you are using it
6.
Side effects
7.
Storage and disposal of EVRA
®
8.
Product description
9.
Manufacturer and product
registration holder
10.
Date of revision
WHAT EVRA
®
IS USED FOR
EVRA
®
contains two types of sex
hormones, a progestogen called
norelgestromin and an oestrogen called
ethinyl estradiol.
Because it contains two hormones,
EVRA
®
is called a ‘combined hormonal
contraceptive’.
It is used to prevent pregnancy. EVRA
®
is intended for women of fertile age. The
safety and efficacy has been established
in women aged 18 to 45 years.
HOW EVRA
®
WORKS
EVRA
®
prevents pregnancy by
delivering continuous levels of hormones
(progestin and estrogen, respectively)
into the bloodstream through the skin.
Following this process, EVRA
®
works
the same way that pills do: by preventing
ovulation. This means that the ovary
does not release an egg to be fertilized. It
also thickens the cervical mucus, which
makes it more difficult for sperm to enter
the uterus, and it changes the
endometrium, which is the mucus
membrane that lines the uterus, to reduce
the chance of implantation.
BEFORE YOU USE EVRA
®
-
_When you must not use it _
•
If you are allergic to norelgestromin,
ethinyl estradiol or any of the other
ingredients of this medicine.
•
If you have ever had a blood clot in
the blood vessels.
•
If you have ever had a heart attack
or a type of chest pain called
‘angina’.
•
If you have ever had a stroke or
signs which may lead to stroke.
•
If you have bad headaches with
neurological symptoms such as
changes in vision or numbness in
any part of your body (migraine with
focal aura).
•
If you have persistent high blood
pressure (160/100 mm Hg or above).
•
If you have heart disease.
•
If you have diabetes with damaged
blood vessels.
•
I

Charakteristika produktu

1
PRODUCT NAME
EVRA ® Transdermal Patch.
DOSAGE FORMS AND STRENGTHS
EVRA is a thin, matrix -type transdermal patch consisting of three layers:
The backing layer is composed of a beige flexible film consisting of a low -density pigmented
polyethylene outer layer and a polyester inner layer. It provides structural support and protects the
middle adhesive layer from the environment.
The middle layer contains polyisobutylene/polybutene adhesive, crospovidone, non- woven
polyester fabric and lauryl lactate as inactive components. The active components in this layer are
the hormones, norelgestromin (NGMN) and ethinyl estradiol (EE).
The third layer is the release liner , which protects the adhesive layer during storage and is removed
just prior to application. It is a transparent polyethylene terephthalate (PET) film with a
polydimethylsiloxane coating on the side that is in contact with the middle adhesive layer.
EVRA (manufactured by LTS Lohmann Therapie-Systeme AG) is a transdermal patch con taining
6 mg NGMN and 600 mic rograms EE.
Each EVRA transdermal patch has a contact surface area of 20 cm
2 and is designed to provide
continuous delivery of NGMN and EE into the bloodstream over a seven- day duration of wear.
(s ee Pharmacokinetic Properties )
For excipients , see List of Excipients .
CLINICAL INFORMATION
Therapeutic Indications
Female Contraception .
EVRA is intended for women of fertile age. The safety and efficacy has been established in women
aged 18 to 45 years.
Dosage and Administration
EVRA should be applied to clean, dry, hairless, intact healthy skin on the buttock, abdomen, upper
outer arm or upper torso, in a place where it will not be rubbed by tight clothing. EVRA should
not be placed on the breasts or on skin that is red, irritated or cut. Each consecutive E VRA patch
should be applied to a different place on the skin to help avoid potential irritation, although they
may be kept within the same anatomic site.
The patch should be pressed down fir mly until the edges stick well.
To prevent interfer