Description
Product Overview / 商品概要
Benoxil Ophthalmic Solution 0.4% (ベノキシール点眼液0.4%)
Generic: Oxybuprocaine Hydrochloride / オキシブプロカイン塩酸塩
Therapeutic Category: Ophthalmic Topical Anesthetic / 眼科用表面麻酔剤
Manufactured by: Santen Pharmaceutical Co., Ltd. / 参天製薬株式会社
Composition & Specification / 組成・規格
Active Ingredient: Oxybuprocaine Hydrochloride 4mg per 1mL / 1mL中 オキシブプロカイン塩酸塩 4mg
Additives: Sodium chloride, Polyvinyl alcohol (partially hydrolyzed), Benzalkonium chloride, Sodium edetate hydrate, pH adjuster / 塩化ナトリウム、ポリビニルアルコール（部分けん化物）、ベンザルコニウム塩化物、エデト酸ナトリウム水和物、pH調節剤
Appearance: Colorless to slightly yellowish-brown clear sterile aqueous ophthalmic solution; pH 4.0–5.0; osmotic pressure ratio 0.9–1.1
外観: 無色～わずかに黄かっ色澄明、無菌水性点眼剤、pH 4.0～5.0、浸透圧比 0.9～1.1
Indications / 効能効果
EN: Topical anesthesia in ophthalmology
JA: 眼科領域における表面麻酔
Dosage and Administration / 用法用量
EN: Usually, instill 1 to 4 drops into the eye for adults. Adjust dose as appropriate based on age and individual patient condition.
JA: 通常成人では1～4滴を点眼する。なお、年令、体質により適宜増減する。
Contraindications / 禁忌
EN: Patients with a history of hypersensitivity to any component of this product or to benzoate ester (excluding cocaine) local anesthetics
JA: 本剤の成分又は安息香酸エステル（コカインを除く）系局所麻酔剤に対し過敏症の既往歴のある患者
Regulatory Information / 規制情報
Approval No.: 21400AMZ00511
Sales Started: July 1966 / 1966年7月
Classification Code: 871313
Storage: Store at room temperature / 室温保存
Shelf Life: 3 years / 3年
Packaging / 包装
Main Package (for sale): 5mL x 10 bottles / 5mL×10本
Other Available Packages (by special order): Plastic ophthalmic container 5mL x 10 bottles, 10mL
Full product insert (添付文書) is attached as a downloadable PDF. For detailed precautions, drug interactions, and safety information, please refer to the official package insert.
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