部分中文 Norditropin NordiFlex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。 Norditropin NordiFlex® 5mg, 10mg and 15mg Ingredients The Norditropin® in Norditropin NordiFlex® contains the active ingredient biosynthetic human growth hormone, which is called somatropin (rbe). It is identical to the growth hormone produced in the human body. The abbreviation 'rbe' indicates the method of genetic engineering used to manufacture the growth hormone. Other ingredients in Norditropin NordiFlex® are: mannitol, histidine, poloxamer, phenol, and water for injections. The quantity of each ingredient is on the label of the box. 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 http://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=9176 诺和诺德公司日前宣布，Norditropin（生长激素[rDNA来源]注射剂）获得美国食品和药物管理局FDA批准Noonan综合征的儿童身材矮小治疗。 Noonan综合征的定义是一种常染色体显性遗传综合征通常由身材矮小，先天性心脏缺陷，和独特的面部特征的特点。这种疾病的出现，可以包括hypertelorism（广泛眼睛），向下斜着眼睛，颈蹼，和其他条件，包括先天性心脏病，在受影响的人的一半。Noonan综合征的儿童80％患有显著身材矮小。 诺和诺德公司总裁马丁说：“当你看到一个孩子Noonan综合征，它可能并不总是显而易见的肉眼，但与条件相关的并发症是相当严重的，可能会影响身体发育和其他系统” “有几个治疗方案可帮助身体发育，并批准标志着一个令人振奋的进步为这难得的条件儿童。” 努南综合征被列为与一个人口不到20万的一个罕见的情况。为了鼓励治疗罕见疾病的发展 - 否则，可能无法在商业上可行的发展 - 在FDA指定“孤儿药”称号的人数超过20万患者的药物治疗。 Norditropin已收到孤儿药治疗身材矮小与Noonan综合征相关。 关于Noonan综合征 Noonan综合征的患病率尚未确定准确日期，但大多数作者报告说，在1000 - 2500名活产婴儿，影响男性和女性同样。根据美国人口，患病率的范围可能从125000到30万活产婴儿。然而，胎儿的损失可以发生在Noonan综合征，使无序的实际发病率可能高于其患病率。 临床特点及并发症 *独特的面部特征，如广泛间隔的眼睛，三角脸，低设置的耳朵和短蹼颈身材矮小（高达80％的个人） *先天性心脏缺陷的异常胸部（缩水胸骨或凹胸） *男性的睾丸未降（超过50％） *出血性疾病，容易瘀伤，尤其是第十一因子（凝血因子）缺乏症（这会导致血友病C） *与婴儿喂养困难，包括贫穷的乳猪和断奶;频繁或有力的呕吐也可能会出现 *常见的眼部问题，包括近远视和斜视​​听觉中耳感染所引起的问题 *在早期发展 *淋巴系统问题肌张力差，如淋巴水肿 有没有具体的药物治疗目前，Noonan综合征的治疗，其临床特点及并发症的重点。 “Noonan综合征是一种异质性的遗传性疾病的临床特点变化很大，身材矮小，这可能是严重的，是最常见的特点之一，可能有助于治疗与Norditropin与Noonan综合征的儿童改善最有关的物理特性之一艾丽西亚罗马诺，医学博士，儿科内分泌专家，纽约医学院，说：“条件。 Norditropin（R）（生长激素[rDNA来源]注射液）是治疗儿童身材矮小与Noonan综合征，治疗儿童生长失败，因内源性生长激素分泌不足，在成人内源性生长激素的替代相关表示生长激素缺乏症（GHD），满足以下两个条件之一： 1）成人发病：GHD，单独或与多种激素缺乏症（垂体功能低下）相关的垂体疾病，下丘脑疾病，手术，放射治疗，或外伤患者; 2）儿童期起病：谁是生长激素缺乏童年时为先天性，遗传或特发性的原因而的患者。在一般情况下，确认两组GHD成人的诊断通常需要一个适当的生长激素刺激试验。 生长激素不应该用于促进增长，在封闭的骨骺或活跃增生或重度非增生性糖尿病视网膜病变患者的儿科患者。 Norditropin不应该使用生长激素或任何辅料过敏的患者。 生长激素不应使用或应停止任何积极恶性肿瘤的证据。预先存在的恶性肿瘤患者，应密切留意任何进展或复发。 ------------------------------------------------- 注：以下产品不同规格和不同价格，购买咨询为准！ ------------------------------------------------- 原产地英文商品名: NORDITROPIN NORDIFLEX 30 MG/3MLS/PEN 3PenS/BOX 原产地英文药品名: SOMATROPIN RECOMBINANT 中文参考商品译名: 诺德欣NORDIFLEX 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 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 -------------------------------------------------- 原产地英文商品名: NORDITROPIN NORDIFLX 10 MG/1.5ML/PEN/BOX 原产地英文药品名: SOMATROPIN RECOMBINANT 中文参考商品译名: 诺德欣NORDIFLX 10毫克/1.5毫升/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 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 ------------------------------------------------------ 原产地英文商品名: NORDITROPIN 15MG/1.5ML/PEN/BOX 原产地英文药品名: SOMATROPIN RECOMBINANT 中文参考商品译名: 诺德欣 15毫克/1.5毫升/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 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 -------------------------------------------------------- 原产地英文商品名: NORDITROPIN NORDIFLEX 5 MG/1.5ML/PEN/BOX 原产地英文药品名: SOMATROPIN RECOMBINANT 中文参考商品译名: 诺德欣NORDIFLEX 5毫克/1.5毫升/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 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