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英文说明书/中文说明书

英文说明书
【Genheal】 Somatropin(Recombinant Human Growth Hormone)
4IU Lyophilized Powder For Injection (Subcutaneous use only)
【Description】 Somatropin(Genheal) is a recombinant human growth hormone(rhGH) for injection. It is a white lyophilized powder consisting of the identical sequence of human growth hormone. The molecular formula is C990H1528N262O300S7 and the molecular weight of about 22,125 Daltons.
【Formulation】 Each vial 4IU contains
Somatropin (Recombinant Human Growth Hormone) ……………… 4 IU (1.6 mg)
Glycine……………… 2 mg
Mannitol ……………… 22 mg
【Pharmacology】 * Stimulate epiphyseal cartilage cell division and proliferation, stimulate cartilage matrix cell growth, stimulate osteoblast division and proliferation, accelerate linear growth and widen bone.
* Increase cellular protein synthesis all over the body, correct the negative nitrogen balance after wound caused by surgery etc., and correct hypoproteinemia caused severe infection, cirrhosis, etc.
* Stimulate synthesis of immune globulin, stimulate the proliferation of lymphoid tissue, macrophage and lymphocyte, increase the ability of anti-infection.
* Stimulate collagen somatic cell in the burn wound and operative incision to synthesized fibrocytes, stimulate macrophage division and proliferation, increase the wound healing; promote synthesis of proteins of cardiac muscle, increase myocardial contractility, decrease myocardial oxygen consumption.
* Adjust fat metabolism, decrease level of Serum cholesterol and low density lipoprotein.
* Supplement the deficiency or lack of growth hormone, adjust adult fat metabolism, bone metabolism and heart and kidney function.
【Pharmacokinetics】 * GH is usually absorbed slowly, peak of blood plasma GH concentration are usually reached 3-5 hours after injection, and elimination half-life is generally 2-3 hours. GH is metabolized through liver and kidney, and speed is faster in adult than in children. There is very few GH without Metabolism extracted in the urine.
* GH has a high affinity for GH binding protein (hGHbp) in the blood, and the binding produces a complex that extends the half-life of GH in the serum. The time of injection does not influence the concentration of GH in the serum. However in the normal status, peak concentration of GH usually occurs with slow wave sleep. So it is generally injected in the night before sleep.
* Abdominal subcutaneous injection brings higher serum concentration than other injection site, but the IGF-1 concentration is the same.
【Indications and usage】 * For the treatment of patients who have growth failure caused by lack of adequate endogenous growth hormone secretion.
* Long term treatment of growth failure associated with chronic renal insufficiency up to the time of renal transplant and patients suffering from Turner's syndrome.
【Dosage and administration】 * The recommended dosage is 0.1IU/kg of body weight once daily. It is usually given in the evening before sleep. The injection site should change regularly to prevent lipoatrophy, or directed by physician.
* Slowly dissolve the lyophilized powder with 1ml of water for injection by gently turning the vial upside down several times. Avoid having bubble during the dissolution. DO NOT SHAKE VIAL. DO NOT SHAKE THE VIAL! Before and after reconstitution, refrigerate at temperatures between 2-8 ℃. Do no freeze. Protect from light. Dispose used needles and syringes in a puncture-proof hard plastic or glass container.
【Adverse reactions】 * Growth hormone can raise transient hyperglycemia, usually it returns to normal as medication extends or stops. Side effects occur in about 1% short stature children in clinical trial. And transient reaction (such as pain, numbness, redness and swelling, etc.) and symptoms of fluid retention (Peripheral oedema or myalgia) in injection site is common. These side effects occur earlier, and incidence rate decreases as medication extends, rarely influence daily life.
* Recombinant human growth hormone might cause antibody generation in a few patients. Antibody binding capacity is low, and there is no specific clinical significance. If expected growth effect is not reached, there might be antibody generation. When binding capacity was greater than 2 mg/mL, interference with the growth response was observed.
【Contraindications】 Patients with symptoms of tumor progression should use with caution.
【Warnings and precautions】 * Should be used to patients with clear diagnosis and supervised by a physician.
* Diabetic might need to adjust dosage of anti-diabetic medicine.
* For patients with growth hormone deficiency caused by brain tumor or patients with encephalic disease history, the progression of potential disease or recurrence of the tumor should be closely monitored.
* Simultaneous use of cortical hormone can inhibit the effect of growth hormone. So patients with ACTH deficiency should adjust the dosage of cortical hormone properly to avoid the inhibition to growth hormone.
* Hypothyroidism might occur in a few patients during growth hormone treatment. Correction should be made to avoid the influence on efficacy of growth hormone. Therefore, patients treated with somatropin should have periodic thyroid function tests and supplement of thyroxine should be given if necessary.
* Femur head Epiphyseal plate slip is likely to occur in patients with incretion disease (including growth hormone deficiency), evaluation should be taken if lameness occurs during treatment of growth hormone.
* Sometimes grow hormone might cause hypoglycemia. Therefore, impaired glucose tolerance of patients should be observed.
* Over dosage is prohibited. Short-term over dosage could lead initially to hypoglycemia and subsequently to hyperglycemia. Long-term over dosage could result in signs and symptoms of gigantism and/or acromegaly consistent with the known effects of excess human growth hormone.
* Injection site should be change regularly to avoid lipoatrophy.
* The product should be used with caution in athletes.
【Pregnancy and Lactation】 Use of the product in this population is not recommended.
【Pediatrics】 No obvious difference of growth hormone on pharmacology, pharmacology, and pharmacokinetics occurs on children compared with adult, and can be safely used based on body weight.
【Elderly】 No obvious difference of growth hormone on pharmacology, pharmacology, and pharmacokinetics occurs on elderly compared with adult, and can be safely used.
【Drug interactions】 * Concomitant glucocorticoid therapy may inhibit the growth promoting effects of growth hormone. Therefore, the dosage of glucocorticoid is usually not more than equivalent to 10-15mg hydrocortisone/square meter body surface area during growth hormone treatment.
* Simultaneous use of non-androgen steroid can increase growth speed further.
* Growth hormone has no incompatibility with other drug according to current data and report.
【Over dosage】 No acute over dosage cases were reported. However, over dosage can lead to adverse reactions. Short-term over dosage could lead initially to hypoglycemia and subsequently to hyperglycemia. Long-term over dosage could result in signs and symptoms of gigantism and/or acromegaly.
【Storage】 Store at temperature between 2-8℃, protect from light. Can be stored for 72 hours after dissolution in refrigerator at 2-8℃.
【Package】 * Neutral borosilicate glass injection bottles, brominated butyl rubber plug for freeze-dried sterile powder for injection and plastic-aluminum combined caps for antibiotic bottle.
* 1 vial/ box
【Shelf life】 24 month
【Manufacturer】 Shanghai United Cell Biotechnology Co., Ltd.
No. 1150 Guiqiao Road, Jinqiao, Pudong, Shanghai 201206, P. R. China
Tel: 021-50318800 Fax: 021-58340157
Website: www.unitedbiotech.com.cn
【Importer】

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