Description
Product Overview / 商品概要
Rebamipide Ophthalmic Suspension UD 2% (ムコスタ点眼液UD2%)
Generic: Rebamipide / レバミピド
Therapeutic Category: Dry Eye Treatment (Mucin Production Promoter) / ドライアイ治療剤（ムチン産生促進剤）
Manufactured by: Otsuka Pharmaceutical Co., Ltd. / 大塚製薬株式会社
Composition & Specification / 組成・規格
Active Ingredient: Rebamipide 20mg per 1mL / 1mL中 レバミピド20mg
Additives: Polyvinyl alcohol (partially saponified), Sodium citrate hydrate, Sodium chloride [isotonicity agent], Potassium chloride [isotonicity agent], Hydrochloric acid [pH adjuster], Sodium hydroxide [pH adjuster], Purified water / ポリビニルアルコール（部分けん化物）、クエン酸ナトリウム水和物、塩化ナトリウム［等張化剤］、塩化カリウム［等張化剤］、塩酸［pH調整剤］、水酸化ナトリウム［pH調整剤］、精製水
Appearance: White sterile aqueous suspension eye drops, pH 5.5-6.5, Osmotic pressure ratio 0.9-1.1 (compared to physiological saline)
外観: 白色の無菌水性懸濁点眼剤、pH 5.5～6.5、浸透圧比 0.9～1.1（生理食塩液に対する比）
Indications / 効能効果
EN: Dry eye
JA: ドライアイ
Dosage and Administration / 用法用量
EN: Usually, instill 1 drop at a time, 4 times daily.
JA: 通常、1回1滴、1日4回点眼する。
Contraindications / 禁忌
EN: Patients with a history of hypersensitivity to any component of this drug
JA: 本剤の成分に対し過敏症の既往歴のある患者
Regulatory Information / 規制情報
Approval No.: 22300AMX01213
Sales Started: January 2012 / 2012年1月
Classification Code: 871319
Storage: Store at room temperature with the dropper tip facing upward. After opening the aluminum pouch, store protected from light. / 室温保存、点眼口を上向きにして保管すること。アルミピロー開封後は遮光して保存すること。
Shelf Life: 36 months / 36箇月
Packaging / 包装
Main Package (for sale): 0.35mL x 112 units (28 units x 4) / 0.35mL×112本（28本×4）
Other Available Packages (by special order): Plastic eye drop container: 0.35mL x 112 units (28 units x 4)
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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