简介:
部份中文透明质酸钠处方资料(仅供参考)
商品名:ADANT
英文名:Purified Sodium Hyaluronate
中文名:透明质酸钠
生产商:明治制果制药社
アダントディスポ関節注25mg
药用类别名称
关节机能改善剂
批准日期:2008年6月
欧文商標名
ADANT DISPO INTRA-ARTICULAR INJECTION 25mg
性 状
精製ヒアルロン酸ナトリウムは白色の粉末、粒又は繊維状の塊である。
本品は水にやや溶けにくく、エタノール(99.5)にほとんど溶けない。
本品は吸湿性である。
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
構造式
操作注意事项
稳定性测试
由于使用最终包装产品(40°c, 75% 相对湿度, 6个月)加速测试, 因此假定ADADDISPO 联合说明25mg 在正常市场流通下稳定3年。
药用药理学
关节软骨表面的涂层和保护作用, 改善软骨组织的抑制作用, 改善关节关节的运动范围, 具有关节疼痛的抑制作用。
(1) 对关节软骨的影响
1) 通过正常的兔膝关节腔给药, 观察软骨表面的吸收。 此外, 在人骨关节炎膝关节骨关节炎软骨 (体外) 中, 软骨分布随时间的推移从软骨表面扩散到整个层, 软骨的分布与蛋白聚糖的丢失部位一致。
2) 抑制牛关节软骨细胞蛋白多糖的释放 (体外)。
3) 在骨关节炎模型和固定膝关节收缩模型中, 采用兔关节腔给药, 抑制软骨变性。
(2) 改善关节运动范围的作用
在使用家兔固定膝关节收缩模型中, 通过关节腔给药改善运动范围。
(3) 止痛作用
对尿酸晶体引起的膝关节疼痛, 使用犬观察到的抑制作用。
适应症
膝关节骨关节炎、肩周周性关节炎
类风湿关节炎膝关节疼痛 (仅当满足以下所有标准(1)至(4)时)
(1) 即使全身疾病是通过抗风湿药物等治疗控制的, 也有膝关节疼痛。
(2) 如果全身炎症症状小于10mg/dL作为CRP值
(3) 如果膝关节症状为轻度至中度
(4) 如果膝关节的大x线分类是从三级
用法与用量
膝关节骨关节炎, 肩周周性关节炎:
通常情况下, 成人一旦一个注射器在一个连续的五个膝关节腔或肩关节(肩关节腔, 肩无菌滑液毛囊或二头肌腱长肌腱)每周, 剂量的数量取决于症状适当增加或减少。
类风湿关节炎膝关节疼痛:
通常情况下, 成人一次 2.5mL 连续在膝关节腔中连续服用五次。
包装
1% 2.5毫升 (套件产品) 10注射器
制造和销售来源
明治制果制药社
注:以上中文不够完整,使用者以原处方资料为准。
完整说明附件:http://www.info.pmda.go.jp/go/pack/3999408G1301_1_07/

制造厂商
明治制果制药社
ADANT DISPO INTRA-ARTICULAR INJECTION 25mg(アダントディスポ関節注25mg)
Brand name : ADANT DISPO 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 joint, and improves the movements.
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 or have previously experienced liver disorder.
If you have 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>>
•Osteoarthritis of the knee and frozen shoulder: In general, inject into a joint cavity of knee or a joint of shoulder once a week for five consecutive times.
Rheumatoid arthritis: In general, 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 injection site pain, injection site swelling, edema of knee on injection site, rash such as hives, itching, 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.
Meiji Seika Pharma Co., Ltd.Injection
Published: 2/2015
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.kegg.jp/medicus-bin/japic_med?japic_code=00055086
http://www.kegg.jp/medicus-bin/japic_med_product?id=00055062-001
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