GLA-ALPHA Combination Ophthalmic Solution (GLA-ALPHA® / グラアルファ配合点眼液)

Description

Product Overview / 商品概要

GLA-ALPHA Combination Ophthalmic Solution (グラアルファ配合点眼液)
Generic: Ripasudil Hydrochloride Hydrate / Brimonidine Tartrate Ophthalmic Solution / リパスジル塩酸塩水和物・ブリモニジン酒石酸塩配合点眼液
Therapeutic Category: Rho Kinase Inhibitor / Alpha-2 Agonist Combination – Antiglaucoma Agent / Rhoキナーゼ阻害薬/α2作動薬配合剤－緑内障・高眼圧症治療剤
Manufactured by: Kowa Co., Ltd. / 興和株式会社

Composition & Specification / 組成・規格

Active Ingredient: Ripasudil Hydrochloride Hydrate 4.896mg (as Ripasudil 4.0mg) and Brimonidine Tartrate 1.0mg per 1mL / 1mL中 リパスジル塩酸塩水和物 4.896mg（リパスジルとして4.0mg）、ブリモニジン酒石酸塩 1.0mg
Additives: Sodium dihydrogen phosphate, Sodium chloride, Sodium hydroxide, Concentrated benzalkonium chloride solution 50 / リン酸二水素Na、塩化Na、水酸化Na、濃ベンザルコニウム塩化物液50
Appearance: Slightly yellowish-green, clear solution (sterile aqueous ophthalmic solution). pH 6.0–7.0, Osmotic pressure ratio approximately 1 (relative to physiological saline)
外観: 微黄緑色澄明の液（無菌水性点眼剤）である。pH 6.0～7.0、浸透圧比 約1（生理食塩液に対する比）

Indications / 効能効果

EN: Glaucoma and ocular hypertension in cases where other antiglaucoma medications have proven insufficiently effective
JA: 次の疾患で、他の緑内障治療薬が効果不十分な場合：緑内障、高眼圧症

Dosage and Administration / 用法用量

EN: Instill 1 drop into the affected eye(s) twice daily.
JA: 1回1滴、1日2回点眼する。

Contraindications / 禁忌

EN: Patients with a history of hypersensitivity to any component of this product / Low birth weight infants, neonates, infants, or children under 2 years of age
JA: 本剤の成分に対し過敏症の既往歴のある患者／低出生体重児、新生児、乳児又は2歳未満の幼児

Regulatory Information / 規制情報

Approval No.: 30400AMX00417
Sales Started: December 2022 / 2022年12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 5 bottles / 5mL×5本
Other Available Packages (by special order): Plastic eye drop bottle: 5mL x 5 bottles, 5mL x 10 bottles, 5mL x 30 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.