국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
Estradiol valerate; Medroxyprogesterone acetate
Orion Corporation
G03FA; G03FA12
Estradiol valerate; Medroxyprogesterone acetate
2 mg/5 milligram(s)
Tablet
Product subject to prescription which may not be renewed (A)
Progestogens and estrogens, fixed combinations; medroxyprogesterone and estrogen
Not marketed
2000-07-21
PACKAGE LEAFLET: INFORMATION FOR THE USER INDIVINA 1 MG/2.5 MG TABLETS INDIVINA 1 MG/5 MG TABLETS INDIVINA 2 MG/5 MG TABLETS estradiol/medroxyprogesterone READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Indivina is and what it is used for 2. What you need to know before you take Indivina 3. How to take Indivina 4. Possible side effects 5. How to store Indivina 6. Contents of the pack and other information 1. WHAT INDIVINA IS AND WHAT IT IS USED FOR Indivina is a Hormone Replacement Therapy (HRT). It contains two types of female hormones, an oestrogen and progestogen. Indivina is used in menopausal women with at least three years since their last natural period. Indivina is used for: RELIEF OF SYMPTOMS OCCURRING AFTER MENOPAUSE During the menopause, the amount of the oestrogen produced by a woman's body drops. This can cause symptoms such as hot face, neck and chest ("hot flushes"). Indivina alleviates these symptoms after menopause. You will only be prescribed Indivina if your symptoms seriously hinder your daily life. PREVENTION OF OSTEOPOROSIS After the menopause some women may develop fragile bones (osteoporosis). You should discuss all available options with your doctor. If you are at an increased risk of fractures due to osteoporosis and other medicines are not suitable for you, you can use Indivina to prevent osteoporosis after menopause. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE INDIVINA MEDICAL HISTORY AND REGULAR CHECK-UPS The use of HRT carries risks which need to be considered 전체 문서 읽기
Health Products Regulatory Authority 08 November 2023 CRN00DQL0 Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Indivina 2 mg/5 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One Indivina 2 mg/5 mg tablet contains: Estradiol valerate 2 mg Medroxyprogesterone acetate 5 mg Excipient with known effect 75.5 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White, round, bevelled-edge, diameter 7 mm, flat tablets with a code on one side with 2+5 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hormone replacement therapy (HRT) for estrogen deficiency symptoms in women with an intact uterus more than three years after menopause_._ Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis. (See also sections 4.4 and 5.1) The experience of treating women older than 65 years is limited. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Indivina is a continuous combined HRT regimen in which estrogen and progestagen are given every day without interruption. Posology One tablet each day orally without a tablet-free interval. Tablet should be taken approximately at the same time of the day. Treatment is recommended to be initiated with Indivina 1 mg/2.5 mg tablet. Depending on the clinical response to treatment, the dosage can then be adjusted to individual needs. Medroxyprogesterone acetate (MPA) 2.5 mg is usually sufficient to prevent breakthrough bleeding. If breakthrough bleeding occurs and persists, and endometrial abnormality has been ruled out, the dose can be increased to 5 mg (Indivina 1mg/5 mg tablet). If 1 mg of estradiol valerate (E 2 V) is not sufficient to alleviate oestrogen deficiency symptoms, the dose can be increased to 2 mg (Indivina 2 mg/5 mg tablet). In women with amenorrhea and not taking HRT or women who switch from another continuous combined HRT product, treatment with I 전체 문서 읽기