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当前位置:药品说明书与价格首页 >> 矮身材增高专科 >> 矮身材增高药物 >> 基因重组人生长激素(健高灵Norditropin)

基因重组人生长激素(健高灵Norditropin)

2010-04-23 16:48:10  作者:新特药房  来源:互联网  浏览次数:1080  文字大小:【】【】【
简介: Information on Norditropin DRUG DESCRIPTION Norditropin is a registered trademark of Novo Nordisk Health Care AG for somatropin, a polypeptide hormone of recombina ...

 Information on Norditropin

DRUG DESCRIPTION

 

Norditropin is a registered trademark of Novo Nordisk Health Care AG for somatropin, a polypeptide hormone of recombinant DNA origin. The hormone is synthesized by a special strain of E. coli bacteria that has been modified by the addition of a plasmid which carries the gene for human growth hormone. Norditropin contains the identical sequence of 191 amino acids constituting the naturally occurring pituitary human growth hormone with a molecular weight of about 22,000 Daltons.Norditropin cartridges are supplied as sterile solutions for subcutaneous injection in ready-to-administer cartridges or prefilled pens with a volume of 1.5 mL.

INDICATIONS


Pediatric Patients
Norditropin is indicated for the long-term treatment of children with growth failure due to
inadequate secretion of endogenous growth hormone.
Adult Patients
Norditropin cartridges [somatropin (rDNA origin) injection] is indicated for replacement of
endogenous growth hormone in adults with growth hormone deficiency who meet either of the following two criteria.
Adult Onset: Patients who have growth hormone deficiency, either alone or associated with
multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma.
Childhood Onset: Patients who were growth hormone deficient during childhood as a result of
congenital, genetic, acquired, or idiopathic causes.
In general, confirmation of the diagnosis of adult growth hormone deficiency in both groups
usually requires an appropriate growth hormone stimulation test. However, confirmatory growth hormone stimulation testing may not be required in patients with congenital/genetic growth hormone deficiency or multiple pituitary hormone deficiencies due to organic disease.

Stability And Storage


Norditropin® cartridges (somatropin [rDNA origin] injection) 5 mg/1.5 mL, 10 mg/1.5 mL, and 15
mg/1.5 mL:
Non-injected/unused Norditropin cartridges must be stored at 2-8°C/36-46°F (refrigerator). Do
not freeze. Avoid direct light.
Norditropin cartridges retain their biological potency until the date of expiry indicated on the
label.
15 mg/1.5 mL (green) cartridges:
After a Norditropin 15 mg/1.5 mL cartridge has been inserted into the NordiPen 15 injector, it
must be stored in the pen in the refrigerator (2-8°C/36-46°F) and used within 4 weeks. Discard unused portion after 4 weeks.

SIDE EFFECTS


Sudden death in pediatric patients with Prader-Willi syndrome with risk factors including severe
obesity, history of upper airway obstruction or sleep apnea and unidentified respiratory infection ;Intracranial tumors, in particular meningiomas, in teenagers/young adults treated with radiation to the head as children for a first neoplasm and somatropin ;Glucose intolerance including impaired glucose tolerance/impaired fasting glucose as well as overt diabetes mellitus ;Intracranial hypertension ;Significant diabetic retinopathy;Slipped capital femoral epiphysis in pediatric patients.


中文 Norditropin 处方信息(仅供参考)
  

 

[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。
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分。                                                                                                                   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)。

 Norditropin ( Somatropin) 4 IU

Product name: Norditropin

Contents: Is available in 4 IU vials.

Delivery: 1 vial (4 IU + Water for injections)

Manufacturer:
NOVONORDISK

Active Substances: biosynthetic human growth hormone (somatropin)

Norditropin is the fastest way to introduce the human growth hormone into the body. Norditropin is manufactured by Novo Nordisk .

• Norditropin is a FDA approved HGH therapy.

• Norditropin contains biosynthetic human growth hormone (somatropin),which is identical to the growth hormone produced in the human body. Other ingredients are: Mannitol, Histidine, Poloxamer 188, Phenol and Water for injections. 1 mg of somatropin corresponds to 3 IU of somatropin.

Norditropin HGH Benefits :

• It increase muscle strength ( 88%) and muscle size ( 81%)

• It reduces body fat ( 72%)

• It improves exercise tolerance ( 81%) and exercise endurance

• It improves skin texture (71%) and skin elasticity ( 71%)

• It improves on wrinkle disappearance (51%)

• It improves new hair growth - (38%)

• It improves healing capacity- (71%)

• It improves back flexibility (53%)

• It improves resistance to common illness- (73%)

• It improves sexual performance- (75%)

• It regulates menstrual cycle- (38 %)

• It improves on hot flashes- (58%)

• It improves energy levels- 84%

• It improves emotional stability-67%

• It improves memory- 62%

What is Human Growth Hormone?
• Human Growth Hormone (HGH) is the most abundant hormone produced by the pituitary gland (pituitary is one of the endocrine glands). The pituitary gland is located in the center of the brain.

• HGH is also a very complex hormone. It is made up of 191 amino acids . In fact, it is the largest protein created by the pituitary gland.

• HGH secretion reaches its peak in the body during adolescence. This makes sense because HGH helps stimulate our body to grow.

• But, HGH secretion does not stop after adolescence. Our body continue to produce HGH usually in short bursts during deep sleep.

What role does HGH play in the body?
HGH is responsible for everything, which goes on in our body. This is why, HGH is often called the "fountain of youth". Human Growth Hormone ( HGH) plays a significant role in:

Conversion of body fat to muscle mass
Growth of all tissues
Energy level
Tissue repair
Whole body healing
Cell replacement
Bone strength
Brain function
Sexual function
Organ health and integrity
Enzyme production
Integrity of hair, nails, skin and vital organs
High HGH levels are what makes you feel young again.

Does our body always produce HGH?
Our body must always produce HGH or we would not be able to function. However, as we age, our body produces less and less HGH. By age 60 we will probably have lost 75% of the HGH that our body produced.

At 20 years old we produce an average 500 micrograms/day of HGH.
At 40 years old we produce an average 200 micrograms/day of HGH .
At 80 years old we produce an average 25 micrograms/day of HGH.
How can we maintain high HGH levels as we age?
As we age, our HGH levels decline to a fraction of the levels of our youth. Many in modern medicine believe that supplementing our diets with HGH is an effective way to avoid the diseases and conditions associated with aging and improve vitality and appearance. HGH supplements increase the body's natural production of Human Growth Hormone to maximize health and fitness without the use of prescription drugs.

Aging pituitary glands are capable of producing as much HGH as young pituitary glands, if it is adequately stimulated. This shows that the somatotrophe cell, the cell in the pituitary gland that releases HGH, does not "lose power" as we age.

Today, HGH is made in the laboratory by genetic engineering methods, generating an identical protein to the one made naturally in the human body. For this reason, allergic reactions to the drug are rare, and it is extremely safe for human use. For instance, a daily injection of this GH leads to an overall increase of growth hormone in the body. The injections are similar to that of insulin-very small needles deliver HGH subcutaneously (under the skin). Most people find it easy to do and even less painful than a pinprick.

What effect does an increase in HGH have on the body?
While numerous studies have been done on the effects of HGH injections, the most ground breaking study was done by Dr. Rudman and published in the New England Journal of Medicine on July 5, 1990 . The journal reported the following list of benefits of HGH injections :

8.8% increase in muscle mass on average after six months, without exercise
14.4% loss of fat on average after six months, without dieting
Higher energy levels
Enhanced sexual performance
Regrowth of heart, liver, spleen, kidneys and other organs that shrink with age
Greater cardiac output
Superior immune function
Increased exercise performance
Better kidney function
Lowered blood pressure
Improved cholesterol profile, with higher HDL and lower LDL
Stronger bones
Faster wound healing
Younger, tighter, thicker skin
Hair regrowth
Wrinkle removal
Elimination of cellulite
Sharper vision
Mood elevation
Increased memory retention
Improved sleep
What kind of HGH supplements are available ?
The HGH supplements available do not use prescription HGH, but rather fall into two general categories, homeopathic HGH and HGH releasers

Homeopathic HGH supplements use small amounts of actual synthetic human growth hormone to spur the body's natural production of its own human growth hormone. These products tend to have the best results of the non-prescription products. The Food and Drug Administration closely regulates the amount of homeopathic human growth hormone that can be included without a prescription. Any company claiming to have comparable levels of HGH as found in a prescription injection are either misleading the consumer or violating federal law.
Releaser HGH products are essentially amino acid "multi- vitamins". They typically contain L- group amino acids such as valine and glutamine that are the building blocks for human growth hormone. While these ingredients are essential components of actual human growth hormone, they still need to undergo a chemical change to produce true HGH. Many of the less- expensive pill supplements touted as "HGH" today are simple amino acid releaser products.
A few products on the market today include ingredients to raise the body's level of Insulin-like Growth factor (IGF-1). Many people in the modern medical field believe that increasing IGF-1 levels in the body is the most effective way to raise secretion of human growth hormone by the pituitary gland. Higher quality supplements often combine such growth factors with homeopathic HGH or HGH releasers to maximize results."

美国FDA批准诺和诺德注射用重组人生长激素用于小于胎龄儿

     由先天疾病引起的儿童身高达不到正常水平如今有了新的治疗选择——美国FDA近日批准了诺和诺德公司的注射用重组人生长激素(somatropin [rDNA origin] injection,诺展,Norditropin)用于2~4岁无追赶生长的小于胎龄儿身材矮小症。

  FDA(此次批准本品用于小于胎龄儿是基于一项在小于胎龄儿中进行的为期13年的临床研究所提供的资料。研究显示,生长至成人高度的儿童中有63%达到同龄人的正常范围。

  有关专家指出,生长激素疗法是目前惟一可用于小于胎龄儿增加身高的疗法。

  如今,本品的适应证包括:努南综合征(假特纳综合征,Noonan syndrome)所致儿童身材矮小症;特纳综合征(Turner Syndrome)所致儿童身材矮小症;内源性生长激素分泌不足所致儿童生长不足;以及到2岁时无追赶生长的小于胎龄儿的身材矮小症。此外,本品还可以在一定条件下作为内源性生长激素的替代疗法用于治疗成人生长激素缺乏。

 

责任编辑:admin


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