基因重组人生长激素(健高灵Norditropin  NordiFlex)

药品名称：重组人生长激素 
英文药名：  Recombinant Human Somatropin 
其他名称：  DNA-rhGH、rhGH、基因重组人生长激素、重组体人生长激素、第三代人促生长激素(Humatrope)、健高灵(Genotropin)、健高宁(Genotropin)、金磊生长素、优猛茁(Humatrope)。   
临床应用：  用于治疗垂体性侏儒症。 

【药理与适用症】: 基因重组人生长激素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。
【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。
【用法与用量】: 基因重组人生长激素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。
【贮藏】: 2℃-8℃保存。有效期为1．5年。
【包装】: 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)。

Information on Norditropin NordiFlex

Norditropin NordiFlex is a disposable, premixed, prefilled pen that makes taking growth hormone simple. Unlike other growth hormone delivery pens, Norditropin NordiFlex is prefilled and remixed. This means you don't have to load the growth hormone from cartridges.  Users of Norditropin NordiFlex have access to NordiCare patient support, which can help you with Norditropin NordiFlex insurance issues you may have.Norditropin NordiFlex offers multiple doses which means you can use the pen several times before the medicine runs out.
Norditropin NordiFlex is available in 5 mg, 10 mg, and 15 mg delivery pens.Norditropin NordiFlex uses NovoFine needles* which have an ultra-sharp, low-angle point designed to help increase injection comfort. They are electropolished for smoothness and coated with silicone to reduce friction. Less friction may also mean less pain.
Norditropin NordiFlex 5 mg and 10 mg delivery pens are the only prefilled, multi-dose, disposable growth hormone pens that, after initial use, can be stored at up to 77°F for use within 3 weeks.
Norditropin NordiFlex is easy to learn Your doctor will also give you a Norditropin Starter Kit that has some things to help you to get started.

Storage flexibility
Norditropin NordiFlex is approved for use with NovoFine Autocover needle. The retracting cover hides the needle during the injection for patients with injection anxiety. The cover locks over the needle after the injection to help prevent needle-stick injuries.
All Norditropin products must be refrigerated prior to use. Do not freeze. After initial use, Norditropin NordiFlex 5 mg and 10 mg pens can either be stored outside of the refrigerator (at up to 77°F) for use within 3 weeks, or in the refrigerator (between 36°F and 46°F) for use within 4 weeks. These storage flexibility guidelines also apply to Norditropin? cartridge 5 mg.
Norditropin NordiFlex 15 mg pen must always be refrigerated (between 36°F and 46°F)—both prior to and after the initial injection—for use within 4 weeks. These guidelines for continuous refrigerated storage also apply to Norditropin? cartridge 15 mg.

Norditropin Indications and Usage
Norditropin (somatropin [rDNA origin] injection) is used to treat children with growth failure caused by very low or no production of growth hormone. It is also used to treat children who have short stature associated with Noonan syndrome and Turner syndrome, for treatment of children with short stature born small for gestational age with no catch-up growth by age 2-4 years, and to treat adults who do not make enough growth hormone.

Important Safety Information
Remember, your doctor is the main source of information about you and your health. Please consult your doctor if you have any questions about your health or your medication.
Do not use Norditropin if you have any of the following conditions: an allergy to phenol or any other ingredients in the medicine; active cancer or other forms of tumor; severe diabetic eye disease; acute critical illness due to certain types of heart or abdomen surgery, trauma, or acute respiratory failure.
Children should not use somatropin if they have any of the following conditions: closed epiphyses (closed bone growth plates), Prader-Willi syndrome with severe obesity, upper airway obstruction or sleep apnea, or Prader-Willi syndrome with significant respiratory impairment.

Be sure to tell your doctor if you have diabetes mellitus; have had cancer or other forms of tumor; are pregnant, planning to be pregnant or are breastfeeding.
Be sure to tell your doctor about all medications you are taking especially if they are: a glucocorticoid medication such as hydrocortisone or cortisone acetate, thyroid hormone, insulin and/or oral diabetes medicines, drugs metabolized by the liver (for example, corticosteroids, sex steroids, anticonvulsants, cyclosporine), or oral estrogen replacement.
Adult height can be influenced if you are on Norditropin? for growth failure and at the same time using glucocorticoids or thyroid hormone.
If you are treated with insulin and/or oral diabetes medicines, the dose of your insulin/oral diabetes medicines may need to be adjusted.

Side effects are usually mild and temporary. Side effects may include headaches, muscle pain, joint stiffness, weakness, high blood sugar (hyperglycemia), sugar in your urine (glucosuria), swollen hands and feet due to fluid retention, and redness and itching in the area you inject.
If you have any of these symptoms, discuss them with your doctor.
If you have headaches, eyesight problems, nausea and/or vomiting, these may be symptoms of raised pressure in the brain. Contact your doctor right away.
In very rare cases children treated with somatropin have experienced pain in the hip or knee or a limp. These symptoms may be caused by a slippage of the growth plate in the hip (slipped capital femoral epiphysis).
Scoliosis (curvature of the spine) can occur in children who experience rapid growth. Because growth hormone increases growth rate, children should be monitored for progression of scoliosis.
Thyroid function tests should be performed periodically.
Skin lesions should be checked carefully for any unusual changes.
Somatropin treatment can increase the chances of developing middle ear infections in patients with Turner syndrome.
Congenital heart disease is a common finding in Noonan syndrome and patients should be closely monitored.
Talk to your doctor if you think you have any of these conditions.

Do not shake Norditropin NordiFlex vigorously at any time. It should be handled with care.

Note: Norditropin NordiFlex 10mg is pictured.

Preparing Norditropin NordiFlex® for injection

A.
Pull off the pen cap.

B.
Remove the protective tab from a NovoFine needle (8mm 30 G or smaller) and screw the needle tightly onto Norditropin NordiFlex. Pull off the outer and inner needle caps. Put the outer needle cap aside to be used after the injection.

C.
Make an airshot before you make your first injection as follows:
Small amounts of air may collect in the needle and cartridge during normal use. To avoid injection of air and ensure proper dosing:

For Norditropin NordiFlex 5mg: dial 0.05mg
For Norditropin NordiFlex 10mg: dial 0.1mg
For Norditropin NordiFlex 15mg: dial 0.15mg

D.
Hold Norditropin NordiFlex with the needle pointing upwards and tap the cartridge gently with your finger a few times.

E.
Holding Norditropin NordiFlex with the needle upwards, press the push button all the way in.
A drop of growth hormone should appear at the needle tip. If not, repeat the procedure no more than 6 times.

If a drop of growth hormone still does not appear, the device is faulty, and must not be used.

Do not use Norditropin NordiFlex if the growth hormone solution in the pre-filled pen does not appear water-clear and colourless. Check this by turning the pen upside down once or twice.

Dialing the dose

F.
Check that the dose selector is set at 0.0. Dial the number of mg that needs to be injected.
The dose can be corrected up or down by turning the dose selector in either direction. When dialing back, be careful not to press the push button as growth hormone will come out. You cannot set a dose larger than the number of mg left in the cartridge.

Making the injection

G.
Use the injection technique recommended by your health care professional. Insert the needle under the skin. Deliver the dose by pressing the push button all the way in. Be careful only to press the push button when injecting.
After the injection the needle should remain under the skin for at least 6 seconds. Keep the push button fully depressed until the needle is withdrawn from the skin. This will ensure that the full dose has been delivered.

Removing the needle

H.
Replace the outer needle cap and unscrew the needle. Dispose of it carefully.

It is important that a new needle is used for each injection. Health care professionals, relatives and other carers should follow general precautionary measures for removal and disposal of needles to eliminate the risk of unintended needle penetration.

When Norditropin NordiFlex is empty, dispose of it carefully without the needle attached.

Maintenance

Your Norditropin NordiFlex is designed to work accurately and safely. Norditropin NordiFlex should be handled with care. Avoid situations where Norditropin NordiFlex might be damaged.
Protect Norditropin NordiFlex from dust, dirt and direct sunlight.

You can clean the exterior of your Norditropin NordiFlex by wiping it with cotton wool moistened with alcohol.

Do not soak Norditropin NordiFlex in alcohol, or wash or lubricate it as this may damage the mechanism.

原产地英文商品名:	NORDITROPIN NORDIFLEX 30 MG/3MLS PEN 1 X 3ML 3 Pen Injecter
原产地英文药品名:	SOMATROPIN RECOMBINANT
中文参考商品译名:	诺德人体生长激素 30毫克/3毫升/支，3支/盒
中文参考药品译名:	基因重组人生长激素
曾用名:	健高灵
临床试验期:	完成
中文适应病症参考翻译1:	儿童因内源性生长激素分泌不足导致的生长障碍
中文适应病症参考翻译2:	特纳综合征
生产厂家中文参考译名:	诺和诺德制药公司
生产厂家英文名:	NOVO NORDISK INC