Information on Bronuck
What is this medicine? This is a non-steroidal anti-inflammatory drug (NSAID). The eye drops are used to treat pain and swelling after eye surgery. This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine? They need to know if you have any of these conditions: •asthma •bleeding problems •diabetes •dry eye syndrome, other eye problems, or recent eye surgery •wear soft contact lenses •an unusual or allergic reaction to bromfenac, aspirin, other NSAIDS, sulfites, other medicines, foods, dyes or preservatives •pregnant or trying to get pregnant •breast-feeding
How should I use this medicine? This medicine is only for use in the eye. Do not take by mouth. Follow the directions on the prescription label. Remove contact lenses before use. Wash hands before and after use. Tilt your head back slightly and pull your lower eyelid down with your index finger to form a pouch. Try not to touch the tip of the dropper to your eye, fingertips, or any other surface. Squeeze the prescribed number of drops into the pouch. Close the eye gently to spread the drops. Your vision may blur for a few minutes. Use your doses at regular intervals. Do not use your medicine more often than directed. Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed. Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.
What may interact with this medicine? •agents that may increase bleeding time such as warfarin or other blood thinners •corticosteroid eye drops or ointments Do not use any other eye products without asking your doctor or health care professional. This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine? Tell your doctor or health care professional if your eye symptoms do not get better within 2 to 3 days. Do not use for longer than directed by your doctor or health care professional. Unless your doctor or health care professional gives you other instructions, you should not wear contact lenses while you are using this medicine.
What side effects may I notice from receiving this medicine? Side effects that you should report to your doctor or health care professional as soon as possible: •allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue •bleeding in the white part of your eye •breathing problems •sores in the eye or eye irritation that gets worse Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome): •burning or stinging after instilling the drops •dry, red, or itchy eyes
Where should I keep my medicine? Keep out of the reach of children. Store at room temperature between 15 and 25 degrees C (59 and 77 degrees F). Throw away any unused medicine after the expiration date on the label.
注册证号: H20090843 注册证号备注: 原注册证号: 产品名称(中文): 溴芬酸钠水合物滴眼液 产品名称(英文) : Bromfenac Sodium Hydrate Ophthalmic Solution 商品名(中文): 普罗纳克 商品名(英文): BRONUCK 剂型(中文): 滴眼剂 规格(中文): 0.1% 注册证号备注: 包装规格(中文): 5ml/支/盒 生产厂商(中文): 千寿制药株式会社 福崎工厂 生产厂商(英文): Senju Pharmaceutical Co., Ltd. Fukusaki Plant 厂商地址(中文): 厂商地址(英文): 767-7,Aza Kazukanounonishi, Saiji,Fukusakicho, Kanzaki-gun, Hyogo-ken, Japan 厂商国家(中文): 日本 厂商国家(英文): Japan 分包装批准文号: 发证日期: 2009-09-29 有效期截止日: 2014-09-28 分包装企业名称: 分包装企业地址: 分包装文号批准日期: 分包装文号有效期截止日: 产品类别: 化学药品 药品本位码: 86979077000094 药品本位码备注: 公司名称(中文): 千寿制药株式会社 公司名称(英文): Senju Pharmaceutical Co.,Ltd. 地址(中文): 地址(英文): 5-8,Hiranomachi 2-chome,Chuo-ku,Osaka,Japan 国家(中文): 日本 国家(英文): Japan
中文名称:溴芬酸钠 化学名: [2-氨基-3-(4-溴苯甲酰基)苯基]乙酸钠 英文名称:Bromfenac sodium Sodium [2-amino-3-(4-bromobenzoyl)phenyl]acetate 2-Amino-3-(4-bromobenzoyl)phenylacetic acid sodium salt 分子式:C15H11BrNNaO3 分子量: 356.15
溴芬酸钠及溴芬酸钠水合物滴眼液
溴芬酸钠是2-氨基-3-苯甲酰基苯乙酸类衍生物之一,结构与酮洛芬和双氯芬酸类似,能抑制环氧合酶介导的前列腺素类炎症介质的合成,是最有效的环氧合酶抑制剂,具有强力消炎镇痛作用,作用强度是其它的非甾体抗炎药(NSAIDs)的10倍。用于外眼部及前眼部的炎症性疾病的对症治疗:眼睑炎、结膜炎、强膜炎(包括上强膜炎)、术后炎症等。 溴芬酸钠滴眼液由日本Senju公司开发,于2000年在日本上市,商品名商品名ブロナック点眼液(BRONUCK OPHTHALMIC SOLUTION),以商品名XibromTM于2005年3月初在美国上市。非甾体类抗炎药是眼科常用药物,也是眼科手术的常规用药,用于抗炎镇痛。根据IMS Health积累的处方资料,美国每年治疗眼科炎症的局部用非甾体类抗炎药物的处方量约为5.4百万张,在美国眼科抗炎市场约为每年2.5亿美元。 目前临床上常用的非甾体类抗炎滴眼液有1%吲哚美辛、0.1%双氯芬酸、0.03%氟比洛芬、1%舒洛芬、0.5%酮洛芬滴眼液等,使用方法都是4次/日。与它们相比,溴芬酸钠滴眼液具有优越的效力:其环氧合酶抑制作用强度是其它的非甾体抗炎药的10倍;且其一日2次的用药方案,相比其它非甾体抗炎药滴眼液一日四次的给药方式,使用方便,病人的依从性高;临床研究表明溴芬酸钠滴眼液具有很好的耐受性,对眼内压无影响,眼部副作用发生率低。
ブロナック点眼液0.1%
組成
成分・含量(1mL中)
ブロムフェナクナトリウム水和物 1mg
添加物
ホウ酸、ホウ砂、乾燥亜硫酸ナトリウム、エデト酸ナトリウム水和物、ポビドン、ポリソルベート80、ベンザルコニウム塩化物、水酸化ナトリウム
性状
剤形
水性点眼剤
色
黄色澄明
一般名
ブロムフェナクナトリウム水和物 (Bromfenac Sodium Hydrate)〔JAN〕
化学名
sodium 2-amino-3-(4-bromobenzoyl)phenylacetate sesquihydrate
分子式
C15H11BrNNaO3・11/2H2O
分子量
性状
*ブロムフェナクナトリウム水和物は、黄色~橙色の結晶性の粉末で、においはない。 水に溶けやすく、メタノールにやや溶けやすく、エタノール(99.5)に溶けにくく、アセトニトリル又はジエチルエーテルにほとんど溶けない。
包装
5mL×10
5mL×50
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