البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
ETHINYLESTRADIOL; NORELGESTROMIN
TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD
G03AA13
PATCHES
NORELGESTROMIN 6 MG; ETHINYLESTRADIOL 0.6 MG
TRANSDERMAL
Required
GEDEON RICHTER PLC, HUNGARY
NORELGESTROMIN AND ESTROGEN
NORELGESTROMIN AND ESTROGEN
Female contraception. Evra is intended for women of fertile age.
2014-01-31
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 اقرأ الوثيقة كاملة
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 اقرأ الوثيقة كاملة