Neostigmine Methylsulfate / Inorganic Salts Ophthalmic Solution 5mL x 10 bottles (Miopin® / ミオピン点眼液)

Description

Product Overview / 商品概要

Miopin Ophthalmic Solution 5mL x 10 bottles (ミオピン点眼液)
Generic: Neostigmine Methylsulfate / Inorganic Salts Ophthalmic Solution / ネオスチグミンメチル硫酸塩・無機塩類配合点眼液
Therapeutic Category: Accommodation-Improving Ophthalmic Agent / 調節機能改善点眼剤
Manufactured by: Santen Pharmaceutical Co., Ltd. / 参天製薬株式会社

Composition & Specification / 組成・規格

Active Ingredient: Neostigmine Methylsulfate 0.05mg / Calcium Chloride Hydrate 0.3mg / Sodium Chloride 6.5mg / Sodium Bicarbonate 0.03mg / Potassium L-Aspartate 3.5mg per 1mL / 1mL中 ネオスチグミンメチル硫酸塩0.05mg／塩化カルシウム水和物0.3mg／塩化ナトリウム6.5mg／炭酸水素ナトリウム0.03mg／L-アスパラギン酸カリウム3.5mg
Additives: Benzalkonium Chloride, Polyvinyl Alcohol (Partially Hydrolyzed), pH Adjusting Agent / ベンザルコニウム塩化物、ポリビニルアルコール（部分けん化物）、pH調節剤
Appearance: Colorless, clear, sterile aqueous ophthalmic solution. pH 5.2–6.2, Osmotic pressure ratio 0.9–1.1
外観: 無色澄明、無菌水性点眼剤。pH 5.2～6.2、浸透圧比 0.9～1.1

Indications / 効能効果

EN: Improvement of accommodative function
JA: 調節機能の改善

Dosage and Administration / 用法用量

EN: Usually, instill 2–3 drops at a time, 4 times daily. Dosage may be adjusted according to symptoms.
JA: 通常、1回2～3滴を1日4回点眼する。なお、症状により適宜増減する。

Contraindications / 禁忌

EN: Patients with angle-closure glaucoma or those predisposed to elevated intraocular pressure such as narrow anterior chamber angle or shallow anterior chamber (risk of triggering acute angle-closure glaucoma attack)
JA: 閉塞隅角緑内障の患者及び狭隅角や前房が浅いなどの眼圧上昇の素因のある患者（急性閉塞隅角緑内障の発作を起こすおそれがある）

Regulatory Information / 規制情報

Approval No.: 21900AMX00024
Sales Started: October 1967 / 1967年10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 10 bottles / 5mL×10本
Other Available Packages (by special order): Plastic ophthalmic containers, 5mL x 10 bottles

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.