英文药名:HYALUTOWA INJECTION(Purified Sodium Hyaluronate)
中文药名:透明质酸钠注射剂
生产厂家:东和制药
ヒアルトーワ関節注25mg
治疗类别名称 关节功能改善剂 欧文商標名 HYALUTOWA INTRA-ARTICULAR INJECTION 25mg 構造式:
由鸡冠的或从微生物获得糖胺D-葡糖醛酸和N-乙酰-D-葡糖胺二糖单元的钠盐。 一般名:精製ヒアルロン酸ナトリウム(Purified Sodium Hyaluronate) 分子式:(C14H20NNaO11)n 分子量:平均分子量50万~120万 性 状: 白色粉末,它是谷物或纤维的质量。微溶于水,并在乙醇(99.5)几乎不溶。它是吸湿性的。 操作注意事项 1.注意 由于这种药物使用的是单点切割安瓿,即尼基折叠在安瓿头部●标记的相反方向朝上。 2.稳定性测试 使用结果的最终包装产品(40℃,相对湿度75%,6个月)的加速试验,Hiarutowa关节注25MG据推测在市场流通的正常过程中稳定的三岁以下。 适应病症 膝关节骨性关节炎,肩周炎 在类风湿关节炎膝关节疼痛(以下(1)至(4)满足所有条件) 1)如果用抗风湿药等的全身治疗的疾病为膝关节疼痛甚至能够控制 2)如果全身的炎性疾病是小于或等于10毫克/分升的CRP值 3)如轻度膝关节的症状中度 4)如果膝关节的拉森X射线分类GradeIII从GradeI 用法用量 膝关节骨性关节炎,肩周炎 成人,每一个位置注射2.5毫升(1安瓿,25毫克1次透明质酸钠)。根据由症状给药次数给药。 类风湿关节炎的膝盖关节疼痛 成人:每一个位置注射2.5毫升(1安瓿,25毫克1次透明质酸钠)每周在连续五Kaihiza关节间隙。 药效药理 1. 药效学试验 增加联合行动的范围和疼痛抑制作用 Hiarutowa联合注25毫克,并在公兔实验模型骨关节炎标准制定(10只动物每组)(注射剂,为0.1mL/kg)的增加膝关节的运动范围的动作,而雄性大鼠实验性关节痛模型(在每组10只小鼠)注25毫克和标准制剂(注射剂,Hiarutowa关节进行比较的疼痛抑制为0.05mL的动作)。 这种药物和标准制剂,都表现出了关节弯曲改善操作和关节疼痛抑制作用,一个被判定为生物等效。 2.作用机制 以促进伤口愈合,促进角膜上皮,保水作用。另外,通过如涂布,关节软骨表面保护作用,结果在缓解和关节范围疼痛的运动的改进。 包装规格 注射(安瓿) 25毫克:2.5毫升×10管
制造厂商 东和制药有限公司 注:以上中文资料仅供参考,使用以原处方为准! HYALUTOWA INTRA-ARTICULAR INJECTION 25mg(ヒアルトーワ関節注25mg) Brand name : HYALUTOWA INTRA-ARTICULAR INJECTION 25mg Active ingredient: Purified sodium hyaluronate Dosage form: injection Print on wrapping: Effects of this medicine This medicine suppresses pain and inflammation of knee and shoulder, and improves the movement. It is usually used to treat osteoarthritis of the knee, frozen shoulder and knee pain of rheumatoid arthritis. Before using this medicine, be sure to tell your doctor and pharmacist •If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines. If you have: liver disorder or previously experienced liver disorder, skin disease on injection site. •If you are pregnant or breastfeeding. •If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.) Dosing schedule (How to take this medicine) •Your dosing schedule prescribed by your doctor is <<to be written by a healthcare professional>> •For osteoarthritis of the knee and frozen shoulder: In general, for adults, inject into a joint cavity of knee or a joint of shoulder once a week for five consecutive times. For rheumatoid arthritis: In general, for adults, inject into a joint cavity of knee once a week for five consecutive times. •The treatment period with this medicine depends on your symptoms or response to this medicine. Precautions while taking this medicine • Possible adverse reactions to this medicine The most commonly reported adverse reactions include pain, swelling or edema of knee on injection site, rash such as hives, itch, edema (edema of face/eyelid, etc) and facial redness. If any of these symptoms occur, consult with your doctor or pharmacist. The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately. •dizziness, facial pallor, loss of consciousness [shock] The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above. Storage conditions and other information •Keep at rest if you have joint pain after injection. •Keep the injection site clean as much as possible. TOWA PHARMACEUTICAL CO., LTD.Injection Revised: 12/2015 The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment. http://www.info.pmda.go.jp/go/pack/3999408A1252_1_04/
|