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NORDITROPIN S Injection(重组生长激素注射液)

2016-04-06 05:19:55  作者:新特药房  来源:互联网  浏览次数:6  文字大小:【】【】【
简介:英文药名: NORDITROPIN S(somatropin[genetical recombination]) 中文药名: 重组生长激素注射液 生产厂家: 诺和诺德 ノルディトロピンS注10mg 商標名 NORDITROPIN S 1. 一般名ソマトロピン(遺伝子組換え ...

英文药名: NORDITROPIN S(somatropin[genetical recombination])

中文药名: 重组生长激素注射液

生产厂家: 诺和诺德

ノルディトロピンS注10mg

商標名
NORDITROPIN S
1. 一般名
ソマトロピン(遺伝子組換え)[命名法:JAN]
somatropin(genetical recombination)[命名法:JAN]
2. 化学名
ヒト成長ホルモン(遺伝子組換え)
Growth Hormone Human(genetical recombination)
3. 分子式
C990H1528N262O300S7
4. 分子量
22,125
5. 構造式
191個のアミノ酸からなるペプチド
6. 性状
本品是一种白色粉末
适应症:
生长激素分泌不足
Norditropin是重组人生长激素显示为:
儿科:
由于生长激素缺乏症(GHD),与努南综合征相关身材矮小,和特纳综合征相关身材矮小儿童生长障碍的治疗
成人:
成人无论是成人发病或儿童期发病生长激素缺乏症的治疗
药效药理
1. 身体成長促进作用
体重增加由于切除垂体的大鼠中,在每个测试中,其中研究了胫骨生长和软骨生长,显示了身体生长促进活性与已经从脑垂体提取的人生长激素制剂的几乎相同。
2,生长调节素Ç增强作用
它是显著增加在血液中的生长调节素C水平已经在健康的成年人中观察到。
包装规格
S注射剂:10mg:1盒


制造厂商
诺和诺德
NORDITROPIN S 10mg for injection [for adult growth hormone deficiency/for short stature due to growth hormone deficiency, etc.](ノルディトロピンS注10mg[用于成人生长激素缺乏症/生长激素缺乏性侏儒症等])
Brand name : NORDITROPIN S 10mg for injection [for short stature due to growth hormone deficiency, etc.]
 Active ingredient: Somatropin (genetical recombination)
 Dosage form: clear and colorless injectable solution, (cap) blue
 Print on wrapping: 
Effects of this medicine
This medicine contains growth hormone, a kind of anterior pituitary hormones and shows growth promoting effect on the body.
It is usually used to treat short stature due to growth hormone deficiency/Turner's syndrome/chondrodystrophia/SGA(small-for-gestational age) without closure of epiphyseal lines.
Before using this medicine, be sure to tell your doctor and pharmacist
•If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
If you have diabetes or malignant tumor.
•If you are pregnant, possibly pregnant or breastfeeding.
•If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)
Dosing schedule (How to take this medicine)
•Your dosing schedule prescribed by your doctor is <<to be written by a healthcare professional>>
•For treatment of short stature due to growth hormone deficiency without closure of epiphyseal lines: In general, inject 0.175 mg/kg of the body weight a week in 6 to 7 divided doses subcutaneously.
For treatment of short stature due to Turner's syndrome or chondrodystrophia without closure of epiphyseal lines: In general, inject 0.35 mg/kg of the body weight a week in 6 to 7 divided doses subcutaneously.
For treatment of short stature born SGA without closure of epiphyseal lines: In general, inject 0.23 mg/kg of the body weight a week in 6 to 7 divided doses subcutaneously. If the dose seems to be insufficient, it is increased up to 0.47 mg/kg of the body weight a week in 6 to 7 divided doses subcutaneously. In any cases, inject the medicine with special pen-shaped injector. This product contains 10 mg of the active ingredient in a cartridge (1.5 mL). Strictly follow the instructions.
•Inject the medicine with special pen-shaped injector (NordiPen 10) and JIS (Japan Industrial Standard) A type special needles adapting to JIS T 3226-2 (Pen Needles, etc.).
•Do not inject to the same site repeatedly in short time. Change the injection site broadly in the body in an orderly manner such as upper arms, thighs, abdomen, buttocks, etc.
•If you miss a dose, skip the missed dose and continue your regular dosing schedule. Missing 1 to 2 doses may not be a problem. You should never inject two doses at one time.
•If you accidentally inject more than your prescribed dose, consult with your doctor or pharmacist.
•Do not stop injecting this medicine unless your doctor instructs you to do so.
Precautions while taking this medicine
• Possible adverse reactions to this medicine
The most commonly reported adverse reactions include rash (hives, erythema, etc.), itch, redness in injection site, growing pain such as joint pain or pain in lower limbs and pain in limbs. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
•both knees are apart when standing erect  [worsening of bowlegs]
•muscle spasmodically contracting  [convulsion]
•sweating, weight loss, increase of pulse  [hyperthyroidism]
•apparent swelling of whole body, decrease of urine output, breathing difficulty  [nephrotic syndrome]
•dry mouth, excess intake of fluid, fatigability  [diabetes]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.
Storage conditions and other information
•Keep out the reach of children. Store away from direct sunlight. Keep in the refrigerator (at 2 to 8 ℃) avoiding freezing. Use within 35 days after starting use.
•Discard the remainder. Do not store them.
Novo Nordisk Pharma Ltd.Self-injection
Revised: 12/2014
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.
http://www.info.pmda.go.jp/go/pack/2412402A2029_1_04/

责任编辑:admin


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