EVOREL SEQUI

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

ESTRADIOL AS HEMIHYDRATE; ESTRADIOL AS HEMIHYDRATE; NORETHISTERONE ACETATE

Tilgjengelig fra:

J-C HEALTH CARE LTD

ATC-kode:

G03CA53

Legemiddelform:

PATCHES

Sammensetning:

ESTRADIOL AS HEMIHYDRATE 3.2 MG; NORETHISTERONE ACETATE 11.2 MG; ESTRADIOL AS HEMIHYDRATE 3.2 MG

Administreringsrute:

TRANSDERMAL

Resept typen:

Required

Produsert av:

JANSSEN PHARMACEUTICA N.V.,BELGIUM

Terapeutisk gruppe:

ESTRADIOL, COMBINATIONS

Terapeutisk område:

ESTRADIOL, COMBINATIONS

Indikasjoner:

Hormone replacement therapy for the relief of menopausal symptoms.

Autorisasjon dato:

2011-01-31

Informasjon til brukeren

יווקס
®
לרווא
Evorel
®
Sequi
PATIENT PACKAGE INSERT IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) - 1986
THE DISPENSING OF THIS MEDICINE
REQUIRES A DOCTOR’S PRESCRIPTION
READ THIS PACKAGE INSERT CAREFULLY IN ITS ENTIRETY
BEFORE USING THIS MEDICINE
THE FORMAT OF THIS LEAFLET WAS DETERMINED BY THE
MINISTRY OF HEALTH AND ITS CONTENT
WAS CHECKED AND APPROVED
EVOREL
® SEQUI
TRANSDERMAL PATCH
COMPOSITION:
Each EVOREL SEQUI package contains two types of
patches: Evorel 50 and Evorel Conti.
Each Evorel 50 patch contains:
Estradiol hemihydrate 3.2 mg
and releases 50 mcg estradiol per day.
Each Evorel Conti patch contains:
Estradiol hemihydrate
3.2 mg
Norethisterone acetate 11.2 mg
and releases 50 mcg estradiol
and 170 mcg norethisterone acetate per day.
Inactive ingredients:
Adhesive: acrylate-vinylacetate copolymer (Duro-Tak);
Guar gum; Backing film: polyethylene terephthalate foil;
Release liner: siliconized polyethylene terephthalate
foil (is removed before application)
THERAPEUTIC GROUP:
Estradiol - estrogens.
Norethisterone acetate - progestogens.
THERAPEUTIC ACTIVITY:
Hormone replacement therapy for symptoms
associated with hormonal deficiency in menopause.
WHEN SHOULD THE PREPARATION NOT BE
USED?
Do not use this medicine if you are pregnant or
breastfeeding.
Do not use this medicine if there is a known sensitivity
to any of its ingredients.
This medicine is not to be used in cases of breast
cancer, malignant tumor of the uterus, other
estrogen-dependent tumors, or if you have suffered
from these diseases in the past.
Severe liver disease or history of liver disease.
Unexplained vaginal bleeding.
If you are suffering, or have suffered in the past,
from arterial blood clots that can lead, for example,
to a heart attack.
If you are suffering, or have suffered in the past,
from blood clots (thrombosis), pulmonary embolism
or phlebitis (active thromboembolic disorder or
thrombophlebitis).
If you are suffering from porphyria.
DO NOT TAKE THIS MEDICINE WITHOUT CONSULTING A
DOCTOR BEFORE S

Preparatomtale

Evorel sequi_PI _JULY_2011_Final
Page 1 of 22
ע עבקנ הז ןולע טמרופ
"
רשואו קדבנ ונכותו תואירבה דרשמ י
)
AUG 2011
(
1.
NAME OF THE MEDICINAL PRODUCT
Trademark:
EVOREL
®
SEQUI
Transdermal patches
International non-proprietary names:
estradiol
norethisterone acetate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
EVOREL
®
SEQUI is a transdermal therapy comprising
4 EVOREL
®
50 TDSs, each containing:
3.1 mg estradiol formulated as 3.2 mg of estradiol hemihydrate
4 EVOREL
®
CONTI TDSs, each containing:
3.1 mg estradiol formulated as 3.2 mg of estradiol hemihydrate
9.82 mg norethisterone formulated as 11.2 mg of norethisterone acetate
For excipients, see Section 6.1
Evorel sequi_PI _JULY_2011_Final
Page 2 of 22
3.
PHARMACEUTICAL FORM
EVOREL ® SEQUI is a combination of a estradiol matrix type
transdermal
patch and a estradiol/norethisterone acetate matrix type transdermal
patch
(sequential regimen).
EVOREL
®
SEQUI is composed of EVOREL
®
50 and EVOREL
®
CONTI.
Both EVOREL
®
50 and EVOREL
®
CONTI are a Transdermal Delivery
System (TDS) or transdermal patch, composed of a flat two-layer
laminate
which is 0.1 mm in thickness. The first layer is a flexible,
translucent and
nearly colorless backing film. The second layer is a monolayer
adhesive film
(matrix) composed of acrylic adhesive and guar gum and contains the
hormones. This system is protected by a polyester foil release liner,
which is
affixed to the adhesive matrix and is removed prior to application of
the
patch to the skin. The polyester foil is coated with silicone on both
sides.
The release liner has an S-shaped opening to facilitate its removal
prior to
use. Each TDS is enclosed in a protective, hermetically-sealed sachet.
EVOREL
®
CONTI has a surface area of 16 sq cm and contains 3.2 mg of
estradiol
hemihydrate
corresponding
to
a
nominal
release
of
50
μ
g
of
estradiol per 24 hours, and 11.2 mg of norethisterone acetate
corresponding
to a nominal release of 170
μ
g of norethisterone acetate per 24 hours. Each