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Product name:genuine taitropin

Recombinant Human Growth Hormone for Injection

Recombinant human growth

Hormone (rHGH) clinical trial report

According to the Ministry of health of the State Drug Administration [97] Shen body forty-first new biological observation of human body for approval, Anhui Anke biotechnology Limited by Share Ltd to develop and produce the rHGH clinical treatment test.Effect of 1, Anhui Anke biotechnology Limited by Share Ltd development of rHGH treatment of GHD production and precise, has obvious role in promoting growth of height, height growth rate of patients after treatment significantly increased.2, Anhui Anke biotechnology Limited by Share Ltd developed the production of the rHGH and IGF-1 increased significantly, the vast majority of subjects after administration of IGF-1 were significantly increased, indicating that rHGH function is realized by IGF-1.Patients were not found after bone age increased significantly, suggesting that the drug had no obvious acceleration effect on skeletal maturity.3, after the 16 subjects appear laboratory hypothyroidism data, need to thyroid replacement therapy, and consistent with those reported abroad.4, the drug side effects, good safety, after injection of local swelling, pain, local skin rashes, itchy, were mild, without any treatment, alleviate by oneself.To sum up, Anhui Anke biotechnology limited liability company development and production of rHGH is a safe and effective drug.

[] development and production unit

Anhui Anke biotechnology Limited by Share Ltd

[] the test designer

The First Affiliated Hospital of Nanjing Medical University, Pan Huiru Chen Jiawei

[] responsible for unit test

Subordinate clinical pharmacology base of the First Affiliated Hospital of Nanjing Medical University

[] clinical test units

The First Affiliated Hospital of Nanjing Medical University, Tongji Hospital of Shanghai Ruijin Hospital affiliated to Beijing Children’s Hospital of Capital Medical University Shanghai Xinhua Hospital, Shanghai Children’s Hospital affiliated Tongji Medical University

Instructions for use

[] the preservation conditions of 2 – 8 centigrade to avoid light preservation.

[duration] two years.

[approval] the country medicine accurate S19990022 the country medicine accurate S19990021 the country medicine accurate S20063010 the country medicine accurate S20093035 the country medicine accurate S20093034 the country medicine accurate S20093033

Name of a commodity.

Official name: the use of recombinant human growth hormone injection

English Name: Recombinant Human Growth Hormone (rHGH) commodity name: An Sumeng

[main ingredients] the recombinant human growth hormone (rHGH), consisting of 191 amino acids, the molecular weight of 22KD, equivalent to the natural human growth hormone.

[character] white loose body, adding water for injection solution, solution was clear, transparent, no visible insoluble.

[] because of the role and use for the treatment of endogenous growth hormone deficiency in children caused by slow growth, as well as on Turner’s syndrome, chronic renal failure caused by short stature, congenital cartilage dysplasia (ACH), burn, negative nitrogen balance after trauma operation and has obvious therapeutic effect.

[usage and dosage] dose it differs from man to man.Subcutaneous injection of the recommended dose per kilogram of body weight per day 0.1 international units, in nightly subcutaneous injection, injection site should be changed every day to prevent adipose tissue atrophy, or as directed by a physician.Before use, 1 ml of water for injection along the bottle wall slowly adding freeze-dried rHGH, all dissolved slightly turn to.This product is dissolved to be clear and transparent, if appear turbid or insoluble particles do not use.Dissolve this product not acuteness oscillation.