देश: मलेशिया
भाषा: अंग्रेज़ी
स्रोत: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
NORELGESTROMIN; Ethinyl Estradiol
ABBOTT LABORATORIES (M) SDN. BHD.
NORELGESTROMIN; Ethinyl Estradiol
9Pieces Pieces; 3Pieces Pieces; 18Pieces Pieces
LTS LOHMANN THERAPIE-SYSTEM AG
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 पूरा दस्तावेज़ पढ़ें
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 containing 6 mg NGMN and 600 micrograms 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. (see _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 EVRA 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 firmly until the edges stick well. To prevent inte पूरा दस्तावेज़ पढ़ें