EVRA

Pays: Israël

Langue: anglais

Source: Ministry of Health

Ingrédients actifs:

ETHINYLESTRADIOL; NORELGESTROMIN

Disponible depuis:

TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD

Code ATC:

G03AA13

forme pharmaceutique:

PATCHES

Composition:

NORELGESTROMIN 6 MG; ETHINYLESTRADIOL 0.6 MG

Mode d'administration:

TRANSDERMAL

Type d'ordonnance:

Required

Fabriqué par:

GEDEON RICHTER PLC, HUNGARY

Groupe thérapeutique:

NORELGESTROMIN AND ESTROGEN

Domaine thérapeutique:

NORELGESTROMIN AND ESTROGEN

indications thérapeutiques:

Female contraception. Evra is intended for women of fertile age.

Date de l'autorisation:

2014-01-31

Notice patient

SWITCHING FROM A PROGESTOGEN-ONLY PILL, AN IMPLANT OR A CONTRACEPTIVE
INJECTION TO EVRA:
∙ You may start using EVRA any day after stopping the
progestogen-only pill or on the day of removal of the
implant or on the day you are supposed to inject the contraceptive
preparation.
∙ Put on the patch the first day after stopping the progestogen-only
pill, the day of removing the implant or when
you were supposed to inject the contraceptive preparation.
∙ Use a non-hormonal contraceptive until Day 8, on which you change
a patch.
AFTER A MISCARRIAGE OR ABORTION BEFORE 20 WEEKS OF PREGNANCY
∙ Please consult the doctor.
∙ You may start treatment with EVRA right away.
If one or more days have elapsed since your miscarriage or abortion
until you start using EVRA, consult the
doctor about temporarily using a non-hormonal contraceptive.
AFTER MISCARRIAGE OR ABORTION AFTER 20 WEEKS OF PREGNANCY
∙ Please consult the doctor.
You may start using EVRA on Day 21 following the miscarriage or
abortion, or on the first day of your next period,
whichever comes first.
AFTER DELIVERY
∙ Please consult the doctor.
∙ If you have had a baby and are not breastfeeding, EVRA can only be
used after 4 weeks from the delivery have
passed.
∙ If you start using EVRA more than 4 weeks after delivery, please
use another non-hormonal contraceptive in
addition to EVRA for the first 7 days.
If you have had sex since the delivery, please wait for your first
period or see your doctor to make sure you are
not pregnant before you start using EVRA.
IF YOU ARE BREASTFEEDING
∙ Please consult the doctor.
∙ Do not use this preparation if you are breastfeeding or are
planning to breastfeed )see also section 2 - “Pregnancy
and breastfeeding”).
Important information to follow when using the patch:
∙ Change the EVRA patch on the same day of the week, since the patch
is designed to work over 7 days.
∙ Do not stop using the EVRA patch and remove it for more than 7
days in a row )in the week without a
patch).
∙ Always put on only one patch

Résumé des caractéristiques du produit

1
1.
NAME OF THE MEDICINAL PRODUCT
EVRA transdermal patch
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 20 cm
2
transdermal patch contains 6 mg norelgestromin (NGMN) and 600
micrograms
ethinyl estradiol (EE).
Each transdermal patch releases an average of 203 micrograms of NGMN
and 33.9 micrograms
of EE per 24 hours. Medicinal product exposure is more appropriately
characterised by the
pharmacokinetic profile (see section 5.2).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Transdermal patch.
Thin, matrix-type transdermal patch consisting of three layers.
The outside of the backing layer is beige matte color
4.
CLINICAL PARTICULARS
4.1
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.
The decision to prescribe EVRA should take into consideration the
individual woman’s current
risk factors, particularly those for venous thromboembolism (VTE), and
how the risk of VTE
with EVRA compares with other CHCs (see sections 4.3 and 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
To achieve maximum contraceptive effectiveness, patients must be
advised to use EVRA
exactly as directed. For initiation instructions see ‘How to start
EVRA’ below.
Only one transdermal patch is to be worn at a time.
Each used transdermal patch is removed and immediately replaced with a
new one on the same
day of the week (Change Day) on Day 8 and Day 15 of the cycle.
Transdermal patch changes
may occur at any time on the scheduled Change Day. The fourth week is
transdermal patch-free
starting on Day 22.
A new contraceptive cycle begins on the next day following transdermal
patch-free week; the
next EVRA transdermal patch should be applied even if there has been
no withdrawal
bleeding or if withdrawal bleeding has not yet stopped.
Under no circumstances should there be more than a 7-day transdermal
patch-free interval between
dosing cycles. If there are more than 7 transdermal patch-free days,
th