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Somatuline 60mg(醋酸兰瑞肽注射器,ソマチュリン皮下注)
药店国别  
产地国家 日本 
处 方 药: 是 
所属类别 60毫克/注射器 
包装规格 60毫克/注射器 
计价单位: 注射器 
生产厂家中文参考译名:
帝人制药
生产厂家英文名:
Teijin Pharma
该药品相关信息网址1:
http://www.info.pmda.go.jp/go/pack/2499413G1025_1_03/
该药品相关信息网址2:
该药品相关信息网址3:
原产地英文商品名:
Somatuline for s.c. Injection(ソマチュリン皮下注)60mg/Syringe
原产地英文药品名:
Lanreotide Acetate
中文参考商品译名:
Somatuline注射器(ソマチュリン皮下注)60毫克/注射器
中文参考药品译名:
醋酸兰瑞肽
曾用名:
简介:

 

  

部份中文醋酸兰瑞肽处方资料(仅供参考)
英文名:Lanreotide Acetate
商品名:Somatuline for s.c. Injection
中文名:醋酸兰瑞肽
生产商:日本帝人制药
药效分类名
持久性徐放性制剂
商標名
Somatuline 60mg for s.c. Injection
Somatuline 90mg for s.c. Injection
Somatuline 120mg for s.c. Injection
一般名
ランレオチド酢酸塩(Lanreotide Acetate)
化学名
3-(2-Naphthyl)-D-alanyl-L-cysteinyl-L-tyrosyl-D-tryptophyl-L-lysyl-L-valyl-L-cysteinyl-L-threoninamide cyclic(2→7)-disulfide acetate
化学構造式
分子式
C54H69N11O10S2・xC2H4O2(x:1.0~2.0)
分子量
1096.32(遊離塩基として)
性状
本品是白色的粉末。本品容易溶于二甲基苯甲氧苯及乙醇(99.5),甲醇稍容易溶解,不易溶于水。
处理上的注意
1.用冰箱(2 ~ 8折),按照终结者包装的状态保存。
2.因为本剂已经被杀菌了,所以在使用前不要打开包装。另外,取出之后要迅速使用。
3.碾压包装的开封或破损的情况下,或者紫罗兰有裂痕、破损等异常时不要使用。
4.不要落下或冲击。有破损以及故障的原因。
批准条件
*在制订医药品风险管理计划后,适当实施。
药效药理
1.作用机制
已知的是,somethistin在垂体前叶中,主要通过与2型(hsst2)和5型(hsst5)的组合来抑制生长激素的分泌。苏玛托斯坦的类似体的拉奥里德(醋酸盐)对于hsst2和hsst5展示了较高的结合亲和性。
2.血清生长激素(gh)浓度下降作用
在小白鼠中,用拉奥列多(醋酸盐)单次皮下注射使得血清gh的浓度降低了。
3. *肿瘤抑制作用
在人类胰腺癌由来的mia paca -2细胞株和结肠、直肠癌产生的colo320dm细胞股进行皮肤移植的裸体鼠中,莱奥奇德(乙酸盐)表现出了抑制肿瘤生长的作用。
适应症
适用于肢端肥大症:外科手术和/或放射治疗之后生长激素分泌异常时;类癌临床症状的治疗:试验性注射之后。
用法与用量
1.脑下垂体型巨人症
通常,成人每4周注射90毫克蜂后,3个月注射一次浓部皮下。此后,每隔4周根据患者的病态服用60毫克、90毫克或120毫克药物。
2.消化管神经内分泌肿瘤
通常,成人每4周注射一次120毫克的兰利欧丁岛,并在皮下注射一次。
包装
皮下注
60mg:1支
90mg:1支
120mg:1支
制造商(进口商)
帝人制药公司
商標
ソマチュリン/Somatuline is the registered trademark of Ipsen Pharma, Paris, France.
注:以上中文资料不够完整,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/2499413G1025_1_04/

On July 3, 2017, "soma Turin subcutaneous injection 120mg" acquires additional approval and efficacy for pancreatic and gastrointestinal neuroendocrine tumors
Teijin funma Co., Ltd. opens in a new window (head office: Chiyoda ward, Tokyo, President: akihisa nabeshima) is an acromegaly and pituitary giant disease agent introduced from Ibsen Corporation (France, Paris, Euronext: IPN, ADR: ipsy). Today we have received additional approval for the efficacy and efficacy of pancreatic and gastrointestinal neuroendocrine tumors inTurin.
Pancreatic and gastrointestinal neuroendocrine tumors
(1) neuroendocrine tumor is a malignant tumor arising from secretory neuroendocrine cells. Net that occurs in the digestive tract such as pancreas, intestinum tenue and rectum may cause symptoms such as hypoglycemia, peptic ulcer and severe diarrhoea.
(2) the rate of a new outbreak of the Japanese for a year is approximately 1.3 per cent of the total number of pancreas per 1 00000 people and the net is about 3.5. It is a relatively rare disease, however, the number of patients is increasing year by year, and the treatment significance is increasing.
Background
(1) the treatment of pancreatic and gastrointestinal net is the first choice of tumor resection. However, if the operation is difficult or the tumor remains after surgery, medication is needed.
(2) somatostatin analog drug * 1 is the first choice for drug therapy of pancreatic and gastrointestinal tract. However, in Japan, there is no somatostatin analog drug which can be used for the pancreas net with the antitumor effect, and only one drug is used for the gastrointestinal tract net, and the choice of the drug is limited.
(3) based on the results of the second phase clinical trial carried out by Ibsen Corporation in 14 countries in Europe, and the second phase clinical trial after 2013 conducted by Teijin funma in Japan, we applied an additional effect and effect.
(4) by the additional approval of this effect and effect, "soma Turin subcutaneous injection 120mg" becomes the somatostatin analog preparation for the first pancreatic net in Japan.
Somatostatin analogue preparation
A similar compound of somatostatin having the effect of suppressing the secretion of endocrine hormone.
2. Clainet test
A placebo-controlled trial of Ibsen, which validates the efficacy and safety of lanletide acetate, for pancreatic and gastrointestinal net with unresectable or distant metastasis.
Future development
(1) Ipsen continues efforts to provide treatment options to patients all over the world suffering from the symptoms of the net, with the additional approval of the efficacy and efficacy of this drug in Japan.
(2) Teijin Pharma will focus on new drug discovery and contribute to the improvement of quality of life of patients.
* soma Turin "clainet" is a registered trademark of Ipsen Corporation.
Product summary
Soma Turin, 60mg of subcutaneous injection, soma Turin
Lanletide acetate
Agent type release releasing agent (needle loaded prefilled syringe preparation)
Efficacy and effect
Improvement of growth hormone, IGF-I (somatomedin C) secretion excess state and symptoms in the following diseases
Acromegaly and pituitary giant
Pancreatic and gastrointestinal neuroendocrine tumors
Dosage and dosage
Normally, adults are injected 90 mg of oral luretide into 3months a week. Thereafter, 60 mg, 90 mg or 120 mg is administered every 4 weeks according to the disease state of the patient.
Typically, adults are implanted with 120 mg of lanletide for 4 weeks each.
* this time the bold letter was added.
Efficacy of pancreatic and gastrointestinal neuroendocrine tumors
"Soma Turin subcutaneous injection 120mg" is approved only. 

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