Description
Product Overview / 商品概要
Tacrolimus Hydrate Ophthalmic Suspension 0.1% (タリムス点眼液0.1%)
Generic: Tacrolimus Hydrate / タクロリムス水和物
Therapeutic Category: Vernal Keratoconjunctivitis Treatment / 春季カタル治療剤
Manufactured by: Senju Pharmaceutical Co., Ltd. / 千寿製薬株式会社
Composition & Specification / 組成・規格
Active Ingredient: Tacrolimus Hydrate 1.02mg (as Tacrolimus 1mg) per 1mL / 1mL中 タクロリムス水和物 1.02mg（タクロリムスとして 1 mg）
Additives: Polyvinyl alcohol (partially saponified), Sodium hydrogen phosphate hydrate, Sodium dihydrogen phosphate hydrate, Benzalkonium chloride, Tonicity agent, pH adjuster / ポリビニルアルコール（部分けん化物）、リン酸水素ナトリウム水和物、リン酸二水素ナトリウム水和物、ベンザルコニウム塩化物、等張化剤、pH調節剤
Appearance: White sterile aqueous ophthalmic suspension, pH 4.3-5.5, Osmotic pressure ratio to physiological saline: 0.9-1.1
外観: 白色の無菌水性懸濁性点眼剤、pH 4.3～5.5、生理食塩液に対する比：0.9～1.1
Indications / 効能効果
EN: Vernal keratoconjunctivitis (when antiallergic agents are insufficiently effective)
JA: 春季カタル（抗アレルギー剤が効果不十分な場合）
Dosage and Administration / 用法用量
EN: Shake well before use, then instill 1 drop at a time, twice daily.
JA: 用時よく振り混ぜたのち、通常、1回1滴を1日2回点眼する。
Contraindications / 禁忌
EN: Patients with a history of hypersensitivity to any component of this product, Patients with ocular infections
JA: 本剤の成分に対し過敏症の既往歴のある患者、眼感染症のある患者
Regulatory Information / 規制情報
Approval No.: 22000AMX00017
Sales Started: May 2008 / 2008年5月
Classification Code: 871319
Storage: Store at room temperature / 室温保存
Shelf Life: 3 years / 3年
Packaging / 包装
Main Package (for sale): 5mL x 1 bottle / 5mL×1
Other Available Packages (by special order): Plastic ophthalmic container 5mL x 1
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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