Brimonidine Tartrate / Brinzolamide Combination Ophthalmic Suspension (Ailamide® / アイラミド配合懸濁性点眼液)

Description

Product Overview / 商品概要

Ailamide Combination Ophthalmic Suspension (アイラミド配合懸濁性点眼液)
Generic: Brimonidine Tartrate / Brinzolamide Combination Ophthalmic Suspension / ブリモニジン酒石酸塩・ブリンゾラミド配合懸濁性点眼液
Therapeutic Category: Alpha-2 Agonist / Carbonic Anhydrase Inhibitor Combination Agent for Glaucoma and Ocular Hypertension / α2作動薬／炭酸脱水酵素阻害薬配合剤　緑内障・高眼圧症治療剤
Manufactured by: Senju Pharmaceutical Co., Ltd. / 千寿製薬株式会社

Composition & Specification / 組成・規格

Active Ingredient: Brimonidine Tartrate 1mg and Brinzolamide 10mg per 1mL / 1mL中 ブリモニジン酒石酸塩 1mg、ブリンゾラミド 10mg
Additives: Tyloxapol, Concentrated glycerin, Boric acid, Carboxy vinyl polymer, Edetate sodium hydrate, Benzalkonium chloride, Tonicity agent, pH adjusting agent / チロキサポール、濃グリセリン、ホウ酸、カルボキシビニルポリマー、エデト酸ナトリウム水和物、ベンザルコニウム塩化物、等張化剤、pH調節剤
Appearance: Sterile aqueous ophthalmic suspension, white to slightly yellowish-white upon shaking. pH: 6.3–6.8, osmolarity ratio to saline: 0.9–1.2
外観: 振り混ぜるとき、白色～微黄白色の無菌水性懸濁点眼剤。pH: 6.3～6.8、生理食塩液に対する比: 0.9～1.2

Indications / 効能効果

EN: Glaucoma and ocular hypertension in cases where other glaucoma medications are inadequate
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 twice daily.
JA: 1回1滴、1日2回点眼する。

Contraindications / 禁忌

EN: 1. Patients with a history of hypersensitivity to any component of this product. 2. Low birth weight infants, neonates, infants, or children under 2 years of age. 3. Patients with severe renal impairment.
JA: 1. 本剤の成分に対し過敏症の既往歴のある患者。2. 低出生体重児、新生児、乳児又は2歳未満の幼児。3. 重篤な腎障害のある患者。

Regulatory Information / 規制情報

Approval No.: 30200AMX00436
Sales Started: June 2020 / 2020年6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 / 5mL×5
Other Available Packages (by special order): Plastic ophthalmic container 5mL x 5, 5mL x 10

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.