국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
Progesterone
Gedeon Richter Plc
G03DA; G03DA04
Progesterone
400 milligram(s)
Pessary
Pregnen (4) derivatives; progesterone
Not marketed
2017-03-31
1 PACKAGE LEAFLET: INFORMATION FOR THE USER PROGESTERONE 400 MG PESSARIES Progesterone READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Progesterone is and what it is used for 2. What you need to know before you use Progesterone 3. How to use Progesterone 4. Possible side effects 5. How to store Progesterone 6. Contents of the pack and other information 1. WHAT PROGESTERONE IS AND WHAT IT IS USED FOR Progesterone contains progesterone which is a natural, female sex hormone, produced in the body. Progesterone is for women who need extra progesterone while undergoing treatment in an Assisted Reproductive Technology (ART) programme. Progesterone acts on the lining of the womb and it helps you to become and to stay pregnant when you are treated for infertility. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE PROGESTERONE DO NOT USE PROGESTERONE: - if you are allergic to progesterone or any of the other ingredients of this medicine (listed in section 6), - have unusual vaginal bleeding that has not been evaluated by the doctor, - have known or suspected tumour that is hormone sensitive, - have porphyria disorders (a group of inherited or acquired disorders of certain enzymes), - have or have had blood clots in the legs, lungs, eyes or elsewhere in the body, - currently have or have had severe liver problems, - have a miscarriage and your physician suspects some tissue is still in the uterus or pregnancy outside of the womb. WARNINGS AND PRECAUTIONS Take special care and tell your doctor straight 전체 문서 읽기
Health Products Regulatory Authority 04 October 2021 CRN00C7LQ Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Progesterone 400 mg pessaries 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each pessary contains 400 mg progesterone For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Pessary Off-white, approximately 10mm x 30mm, torpedo shaped pessary. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Progesterone is indicated for luteal phase support as part of an Assisted Reproductive Technology (ART) treatment for women. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults_ One 400 mg pessary administered vaginally twice a day starting at oocyte retrieval. If pregnancy has been confirmed, the administration of Progesterone should be continued for 38 days from the start of therapy. _Paediatric population_ There is no relevant use of Progesterone in the paediatric population. _Elderly_ No clinical data have been collected in patients over age 65. _Use in special populations_ There is no experience with use of Progesterone in patients with impaired liver or renal function. Method of administration For vaginal insertion. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Undiagnosed vaginal bleeding. Known or suspected progesterone sensitive malignant tumours. Porphyria. Known missed abortion or ectopic pregnancy. Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events. Severe hepatic dysfunction or disease. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Progesterone should be discontinued if any of the following conditions are suspected: Health Products Regulatory Authority 04 October 2021 CRN00C7LQ Page 2 of 5 myocardial infarction, cerebrovascular disorders, arterial or venous thromboembolism (venous thromboembolism or pulmonary embolism), thrombophlebitis or retinal thrombosis. Although risk of thromboembolism has been associated with estrogens, a link with 전체 문서 읽기