Description
Product Overview / 商品概要
Kremezin Tablets 500mg (クレメジン速崩錠500mg)
Generic: Spherical Adsorptive Carbon / 球形吸着炭
Therapeutic Category: Chronic Renal Failure Agent / 慢性腎不全用剤
Manufactured by: Kureha Corporation / 株式会社クレハ
Composition & Specification / 組成・規格
Active Ingredient: Kremezin (spherical adsorptive carbon derived from petroleum hydrocarbons, processed by high-temperature oxidation and reduction) 500mg per tablet / 1錠中に、クレメジン原体（石油系炭化水素由来の球形微粒多孔質炭素を高温にて酸化及び還元処理して得た球形吸着炭）を500mg含有
Additives: Pullulan, Sodium lauryl sulfate / プルラン、ラウリル硫酸ナトリウム
Appearance: Black tablet. Diameter: 15mm, Thickness: 7.4mm, Weight: 540mg. Identification code: KRH103 (printed on SP packaging)
外観: 黒色の錠剤。直径15mm、厚さ7.4mm、重さ540mg。識別コード: KRH103（SP包装に表示）
Indications / 効能効果
EN: Improvement of uremic symptoms and delay of dialysis initiation in the following disease: Chronic renal failure (progressive)
JA: 下記の疾患における尿毒症症状の改善及び透析導入の遅延 慢性腎不全（進行性）
Dosage and Administration / 用法用量
EN: Usually, administer orally to adults at a dose of 6g per day of Kremezin as active substance, divided into 3 doses.
JA: 通常、成人にクレメジン原体として1日6gを3回に分割し、経口投与する。
Contraindications / 禁忌
EN: Patients with gastrointestinal obstruction [may impair excretion].
JA: 消化管に通過障害を有する患者［排泄に支障をきたすおそれがある。］
Regulatory Information / 規制情報
Approval No.: 22900AMX00641
Sales Started: December 2017 / 2017年12月
Classification Code: 873929
Storage: Store at room temperature / 室温保存
Shelf Life: 3 years / 3年
Packaging / 包装
Main Package (for sale): 336 tablets [4 tablets x 84] / 336錠［4錠×84］
Other Available Packages (by special order): 336 tablets [4 tablets x 84]
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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