국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
Nafarelin
Pfizer Healthcare Ireland
H01CA; H01CA02
Nafarelin
200 Mcg/Dose
Nasal spray, solution
Product subject to prescription which may not be renewed (A)
Gonadotropin-releasing hormones; nafarelin
Marketed
1997-03-07
Component Code Version/Proof Project Number Date: KALAMAZOO Time: PAR Number GS SKU/FERT Additional Info/Comments Component Type Site/CMO Market Layout Size Description 15:34 30 Nov 2022 PAA201687 Print Colors 01 18088 PAR-2022-0009476 J. Wood F063508807 N/A Leaflet Kalamazoo Ireland SYNAREL/NAFARELIN ACETATE:NON-STERILE LIQUID:SPRAY, NASAL:BOTTLE, PLASTIC (SPRAY):2MG/8ML(1x1x8ML) DWG-102692-00 15” x 9” (3” x 1.5” folded) Non-Print Colors Dieline Black SYNAREL ® NASAL SPRAY SOLUTION NAFARELIN PACKAGE LEAFLET: INFORMATION FOR THE USER _Synarel_ ® _200 micrograms / dose_ _Nasal Spray Solution_ nafarelin 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, 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 Synarel is and what it is used for 2. What you need to know before you use Synarel 3. How to use Synarel 4. Possible side effects 5. How to store Synarel 6. Contents of the pack and other information IMPORTANT THINGS THAT YOU SHOULD KNOW ABOUT YOUR MEDICINE: • Synarel is for the treatment of endometriosis, uterine fibroids, or as part of a supervised fertility programme and is for use by women only. • You should use Synarel regularly as instructed by your doctor or nurse, in order for it to be effective. • Most people do not have serious problems when using Synarel but side effects can occur – see Section 4 for details. • Taking other medicines may sometimes cause problems. Check with your doctor or pharmacist before taking this or any other medicines. Please read the rest of this leaflet. It includes other important infor 전체 문서 읽기
Health Products Regulatory Authority 21 November 2022 CRN009Z7Z Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Synarel 200 micrograms/dose Nasal Spray Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Solution containing 2mg/ml of nafarelin (as acetate) supplied in bottles fitted with a metered spray pump that delivers 200 micrograms of nafarelin base per spray. This medicine contains 0.01 mg benzalkonium chloride in each spray (0.1 mL per spray) which is equivalent to 0.1 mg/mL. For full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Nasal spray, solution A clear, colourless to slightly yellow, aqueous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Synarel is indicated for the hormonal management of endometriosis, including pain relief and reduction of endometriotic lesions. Synarel may also be used in the hormonal management of symptomatic uterine fibroids prior to a planned myomectomy or hysterectomy, including the relief of clinical symptoms and the reduction of uterine and fibroid volume. Synarel may be used in controlled ovarian stimulation programmes prior to _in vitro_ fertilisation, under the supervision of an infertility specialist. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Synarel is for administration by the intranasal route only _Endometriosis and uterine fibroids:_ Treatment should be started between days 2 and 4 of the menstrual cycle. The recommended daily dose of Synarel is 200mcg taken twice daily (400mcg/day) as one spray to one nostril in the morning and one spray into the other nostril in the evening. The recommended duration of therapy is six months for the management of endometriosis and three months for the management of uterine fibroids. _Controlled ovarian stimulation prior to in vitro fertilisation:_ In the use of Synarel associated with controlled ovarian stimulation prior to _in vitro_ fertilisation, the long protocol should be employed, whereby Synarelis continued through a period of transient gonadotrophin stimulation lastin 전체 문서 읽기