国家: 台湾
语言: 中文
来源: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)
PEMIROLAST POTASSIUM
台灣參天製藥股份有限公司 台北市中山區松江路126號9樓之1 (86383884)
S01GX
點眼液劑
主成分 () ; PEMIROLAST POTASSIUM (9200042710) MG
塑膠瓶裝
製 劑
須由醫師處方使用
SANTEN PHARMACEUTICAL CO. LTD.(NOTO PLANT) 2-14, SHIKINAMI, HODATSUSHIMIZU-CHO, HAKUI-GUN, ISHIKAWA,JAPAN JP
Other antiallergics
過敏性結膜炎。
有效日期: 2027/08/19; 英文品名: ALEGYSAL OPHTHALMIC SOLUTION
2002-08-19
参天製薬 アレギサール点眼液(台湾)ロール添付文書〈09〉1ページ(16/08/09)209.55×297 2° コン キンアカ 大光印刷株式会社 752401 参天製薬 アレギサール点眼液(台湾)ロール添付文書〈09〉2ページ(16/08/09)209.55×297 1° コン 大光印刷株式会社 752401 1 Anti-allergy Eye Drops Alegysal ® ophthalmic solution Pemirolast potassium ophthalmic solution DOH Import No. 023521 DESCRIPTION Product Name Alegysal ophthalmic solution Active Ingredient Pemirolast potassium Content (per 1 mL) 1mg Additives Benzalkonium chloride, concentrated glycerin, dibasic sodium phosphate hydrate, and sodium dihydrogen phosphate dihydrate, purified water pH 7.5~8.5 Osmolar ratio 0.7~0.9 Description Clear, colorless, sterile, aqueous ophthalmic solution INDICATION ALLERGIC CONJUNCTIVITIS CATEGORY This drug must be prescribed by a physician ADMINISTRATION AND DOSAGE Usually 1 drop a time, twice a day (in the morning and evening) PRECAUTIONS 1. ADVERSE REACTIONS UPON APPROVAL Adverse drug reactions were reported in 16 (2.50%) of 639 patients in clinical studies in Japan. The major adverse drug reactions were blepharitis in 4 patients (0.63%), eye irritation in 4 patients (0.63%), and conjunctival hyperaemia in 3 patients (0.47%). POST MARKETING STUDY (AT THE END OF REEXAMINATION) Adverse drug reactions were reported in 43 (1.01%) of 4255 patients in post marketing studies in Japan. The major adverse drug reactions were eye irritation in 16 patients (0.38%), blepharitis in 9 patients (0.21%), eyelid itching in 5 patients (0.12%), eye discharge in 5 patients (0.12%), and conjunctival hyperaemia in 5 patients (0.12%). If an adverse reaction is observed, appropriate measures including discontinuing administration should be taken. Incidence Type 5% > 0.1% <0.1% Hypersensitivity Blepharitis Eyelid dermatitis Ophthalmic Conjunctival hyperaemia, irritation, eye discharge, itching Conjunctivitis 2. USE DURING PREGNANCY, DELIVERY OR LACTATION This product 阅读完整的文件