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注射用基因重组人生长激素Genotropin(somatropin [rDNA origin] for injection)

2012-09-28 11:16:50 作者：新特药房来源：中国新特药网天津分站浏览次数：258 文字大小：【大】【中】【小】

简介： 药品信息:About GENOTROPINGENOTROPIN® (somatropin [rDNA origin] for injection) is a growth hormone treatment. It is an exact copy of the natural growth hormone made by the body. There ...

关键字：注射用基因重组人生长激素健豪宁

药品信息:
About GENOTROPIN
GENOTROPIN® (somatropin [rDNA origin] for injection) is a growth hormone treatment. It is an exact copy of the natural growth hormone made by the body. There is one difference. GENOTROPIN is man-made. It has been proven to be safe and effective. It has been used to treat over 62,000 children and 12,000 adults for over 20 years in more than 60 countries. GENOTROPIN has been approved by the FDA to treat growth failure in:

Children with growth hormone deficiency (GHD)
Children born small for gestational age (SGA)
Children with Prader-Willi syndrome (PWS)
Girls with Turner syndrome (TS)
Other causes of short height should be ruled out.

Adults with growth hormone deficiency (aGHD)
GENOTROPIN is also the only growth hormone in the U.S. that is approved by the FDA for growth failure in children born small for gestational age (SGA) and for growth failure due to Prader-Willi syndrome (PWS).

With GENOTROPIN, you or your child will receive growth hormone treatment with long-term experience. GENOTROPIN also offers personalized services through the Pfizer Bridge Program®. It comes in a wide range of devices to fit your lifestyle.
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欧盟批准生长激素GENOTROPIN用于儿童生长障碍

7月3日，辉瑞公司宣布，欧盟药事评审委员会(EMEA)已批准来源于rDNA的生长激素注射液Genotropin?用于那些小于孕龄期出生(SGA)，到四岁或更大时生长发育迟缓的矮小儿童的生长障碍的治疗。这一批准适用于欧盟15个成员国。

FDA于2001年7月批准了Genotropin?用于出生时不足孕龄(SGA)，到两岁时生长无法跟上正常儿童的矮小儿生长障碍的长期治疗。不适用于其他原因引起的儿童身材矮小。FDA批准Genotropin为罕见病用药，这使它成为目前在美国唯一被批准用于此类病症的生长激素，推荐剂量为0.48mg/kg体重/周。

用Genotropin对273名SGA儿童所做的临床试验中，最常见的不良反应包括，一过性高血糖，一名患儿出现良性颅内压升高，两名儿童出现中枢性性早熟，两名出现下颚突出，几个患儿出现已有的脊柱侧凸加重，注射部位反应，色素沉着痣的自限性生长。
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重组人生长激素、人生长激素、健高灵、Recombinant Somatropin、Humatrope、Genotropin

药理作用: 为经重组DNA技术从大肠埃希菌中合成。

剂型剂量: 注射剂：4IU、12IU。

作用用途: 用于各种原因引起的生长激素缺乏性侏儒症包括垂体及下丘脑病变所致侏儒症。

用法用量: 皮下注射。小儿剂量：垂体侏儒症：每周0.5~0.7IU/kg，分6~7次，每日1次，晚间注射，直至达成人身高水平或至骨骺闭合。

不良反应: 鼻炎、发热、头痛、咳嗽、注射部位肿痛，偶有皮肤反应；亦可引起甲状腺功能低下。

禁用或慎用: 颅内进行性病变，恶性肿瘤患者忌用；糖尿病者慎用。

注意事项:
1、用缓慢旋转动作协助溶解，不可振摇，因可致活性减低。
2、治疗6个月后身高增长未超过2.5cm者，应查找原因。
3、用于继发于抗肿瘤治疗的生长激素缺乏患者，应注意肿瘤复发征象。
4、定期监测血糖、尿糖、糖耐受试验、甲状腺功能、肝功能等。
5、糖皮质激素可抑制本品促生长效能。
6、蛋白同化类固醇、雄激素、雌激素、甲状腺素与本品同用时，均有加速骨骺提前闭合的危险。
7、避光保存，4IU/支稀释后置冰箱24小时内、12IU/支稀释后置冰箱3周内有效。
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基因重组人生长激素

[药品名] 基因重组人生长激素

[英文名] Recombinant SomatroPin

[别名] 健高灵，Humatrpe，Genotropin，Norditropin，DNA—rhGH。

[作用与用途]

本品具有与人体生长激素同等的作用，即能促进骨骼、内脏和全身生长，促进蛋白质合成，影响脂肪和矿物质代谢，在人体生长发育中起着关键性作用。皮下注射约80％被吸收，5小时后达高峰血浓度，t1/2约4小时。主要用于内源性脑垂体生长激素分泌不足而引起的生长障碍、躯体矮小的侏儒症、短小病患儿。此外，尚可用于治疗烧伤、骨折、创伤、出血性溃疡、组织坏死、肌肉萎缩症、骨质疏松等疾病。

[用法与用量]
本品给药剂量个体差异很大，采用肌内注射或皮下注射，一般用量为每周0．5—0．7单位／kg或每周12单位／m2，分6—7次给药。

[注意事项]

偶可引进皮肤过敏、注射部位发红和皮下脂肪萎缩、氨基转移酶升高、呕吐及腹痛等。

1．肿瘤患者、糖尿病患者、颅内进行性损伤者禁用。
2，对脑肿瘤的垂体抹儒病者、心脏或肾脏病者、孕妇和哺乳妇女等慎用。
3．使用前，需对脑垂体功能作详细检查，准确诊断后才能应用。
4．应临用时配制，用注射用水溶解，轻轻摇动，切勿振荡，以免变性。

[贮藏] 2℃-8℃保存。有效期为1．5年。

[制剂] 注射用基因重组人生长激素：每瓶4单位；12单位。
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肾上腺皮质激素及促肾上腺皮质激素

肾上腺皮质分泌有多种激素，在化学构造上都属于甾醇类，为环戊烷多氢菲的衍生物。其构造上的共同点是：在C3上有酮基，C4或C5之间为双键，在C17上有还原性的酮醇基侧链。

肾上腺皮质分泌的激素根据其生理功能可分为三类：

1．糖皮质素类在C11上有氧原子，包括皮质酮、可的松和氢化可的松等。它们对糖的代谢作用强而对钠及钾的作用相对地较弱。由肾上腺皮质束状带细胞所合成和分泌。
2．盐皮质素类在C11上无氧原子，包括11-去氧皮质酮及17-羟基11-去氧皮质酮。它们对于矿物质的代谢特别是促进钠的潴留及钾的排泄的作用很强。醛固酮在C11上虽有氧，但因在体内呈半缩醛式，氧原了被包围在内酯环中，故不呈糖皮质素类作用而呈现较强的盐皮质素类的作用。
盐皮质激素都是由肾上腺皮质的球状带分泌。
3．氮皮质素类包括雄激素(如去氢异雄酮)和雌激素(黄体酮、雌二醉)。性激素不仅由性腺分泌，肾上腺皮质的网状带亦为其制造场所。但雌激素主要由卵巢分泌，皮质分泌的量极少；而雄激素则皮质分泌的量较大(特别是女性体内的雄激素几全部由此处产生)。
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健豪宁genotropin

健豪宁（注射用重组人生长激素）适用于生长激素分泌不足、或相关性腺发育不全、或特纳氏综合症所引起的生长发育障碍；青春期前慢性肾功能不全儿童的生长发育障碍；成人明显的生长激素不足替代疗法。
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Important Safety Information
Indications
GENOTROPIN® (somatropin [rDNA origin] for injection) is prescribed for the treatment of growth failure in:

children who do not make enough growth hormone on their own. This condition is called growth hormone deficiency (GHD).
children who are born smaller than most babies born after the same number of weeks of pregnancy. Some of these babies may not show catch-up growth by age 2. This condition is called small for gestational age (SGA).
children with a genetic condition called Prader-Willi syndrome (PWS). Growth hormone is not right for all children with PWS. Check with your doctor.
girls with a genetic condition called Turner syndrome (TS). Growth hormone should be used to treat TS only in girls who are still growing.
Other causes of short height should be ruled out.
In adults, GENOTROPIN is prescribed for growth hormone deficiency (GHD) that started either in childhood or as an adult. Your doctor should do tests to be sure you have GHD, as appropriate.
Contraindications
Growth hormone should not be used to increase height in children after the growth plates have closed.
Growth hormone should not be used in patients with diabetes who have certain types of eye problems called diabetic retinopathy.
Growth hormone should not be used in patients with cancer or who are being treated for cancer. Growth hormone deficiency can be caused by brain tumors. So, the presence of these brain tumors should be ruled out before treatment is started. Growth hormone should not be used if it is shown that a previous brain tumor has come back or is getting larger.
Growth hormone should not be used in patients who are critically ill because of surgery, trauma, or respiratory failure.
Growth hormone should not be used in children with Prader-Willi syndrome who are very overweight or have severe breathing problems.
Other Safety Information
The dose of diabetes medicines may need to be adjusted during growth hormone treatment. Patients should be watched carefully if growth hormone is given along with glucocorticoid therapy and/or other drugs that are processed by the body in the same way.
Treatment with growth hormone may increase the risk of a new tumor, particularly certain benign brain tumors, in childhood cancer survivors. This risk may be higher in patients who were treated with cranial radiation.
A small number of patients treated with growth hormone have had increased pressure in the brain. This can cause headaches and problems with vision. Treatment should be stopped and reassessed in these patients. Patients with Turner syndrome, Prader-Willi syndrome, and chronic renal insufficiency may be at higher risk of developing increased pressure in the brain.
Thyroid function should be checked regularly during growth hormone therapy. Thyroid hormone replacement therapy should be started or adjusted if needed.
Patients treated with growth hormone should be checked regularly if they are receiving standard hormone replacement therapy to treat a lack of more than one hormone.
In children experiencing rapid growth, curvature of the spine may develop or worsen. This is also called scoliosis.
In children experiencing rapid growth, limping, or hip or knee pain may occur.
GENOTROPIN should only be used during pregnancy if clearly needed. It should be used with caution in nursing mothers because it is not known whether growth hormone is present in human milk.
Terms of Use Agreement
The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a health care provider. All decisions regarding patient care must be made with a health care provider, considering the unique characteristics of the patient.
The product information provided in this site is intended only for residents of the United States. The products discussed herein may have different product labeling in different countries.
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注：以下产品不同规格和不同价格，购买时请以电话咨询为准！

原产地英文商品名:
Genotropin -0.2MGx7Cartridges/Box
原产地英文药品名:
somatropin [rDNA origin] for injection
原产地英文化合物名称:
Recombinant Human Growth Hormone
中文参考商品译名:
健豪宁 7支x0.2毫克/盒
中文参考药品译名:
注射用基因重组人类生长激素
中文参考化合物名称:
基因重组人类生长激素
生产厂家中文参考译名:
Pfizer Inc.
生产厂家英文名:
美国辉瑞

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原产地英文商品名:
Genotropin -0.8MGx7Cartridges/Box
原产地英文药品名:
somatropin [rDNA origin] for injection
原产地英文化合物名称:
Recombinant Human Growth Hormone
中文参考商品译名:
健豪宁 7支x0.8毫克/盒
中文参考药品译名:
注射用基因重组人类生长激素
中文参考化合物名称:
基因重组人类生长激素
生产厂家中文参考译名:
Pfizer Inc.
生产厂家英文名:
美国辉瑞

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原产地英文商品名:
Genotropin -0.6MGx7Cartridges/Box
原产地英文药品名:
somatropin [rDNA origin] for injection
原产地英文化合物名称:
Recombinant Human Growth Hormone
中文参考商品译名:
健豪宁 7支x0.6毫克/盒
中文参考药品译名:
注射用基因重组人类生长激素
中文参考化合物名称:
基因重组人类生长激素
生产厂家中文参考译名:
Pfizer Inc.
生产厂家英文名:
美国辉瑞

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原产地英文商品名:
Genotropin -1MGx7Cartridges/Box
原产地英文药品名:
somatropin [rDNA origin] for injection
原产地英文化合物名称:
Recombinant Human Growth Hormone
中文参考商品译名:
健豪宁 7支x1毫克/盒
中文参考药品译名:
注射用基因重组人类生长激素
中文参考化合物名称:
基因重组人类生长激素
生产厂家中文参考译名:
Pfizer Inc.
生产厂家英文名:
美国辉瑞

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原产地英文商品名:
Genotropin -0.4MGx7Cartridges/Box
原产地英文药品名:
somatropin [rDNA origin] for injection
原产地英文化合物名称:
Recombinant Human Growth Hormone
中文参考商品译名:
健豪宁 7支x0.4毫克/盒
中文参考药品译名:
注射用基因重组人类生长激素
中文参考化合物名称:
基因重组人类生长激素
生产厂家中文参考译名:
Pfizer Inc.
生产厂家英文名:
美国辉瑞