Recombinant human growth hormone for injection

1. Human growth hormone (hGH) is a peptide hormone composed of 191 amino acids, secreted by growth hormone (GH) secreting cells containing eosinophilic granules in the anterior pituitary gland. This product is a recombinant human growth hormone (rhGH) produced by gene recombinant Escherichia coli secretory expression technology, and its amino acid content and sequence are exactly the same as human growth hormone. This product is synthesized in Escherichia coli (E.Coli). The synthesis is carried out through prehormone. The prehormone is composed of growth hormone naturally present in bacteria and connected to a signal peptide. The prehormone splits in the bacterial cell wall, releasing the final product that is exactly the same as natural growth hormone into the periplasmic space, and then only destroys the outer cell wall for collection, while the inner cell wall remains intact to ensure that very little bacterial protein contaminates the final product. 2. Secretory gene recombinant human growth hormone (rhGH) has the same effect as endogenous growth hormone in the human body, stimulating the differentiation and proliferation of epiphyseal chondrocytes, stimulating the growth of cartilage matrix cells, stimulating the differentiation and proliferation of osteoblasts, causing accelerated linear growth and widening of bones. Promote systemic protein synthesis, correct the negative nitrogen balance after surgery and other traumas, correct hypoproteinemia caused by severe infection and cirrhosis; stimulate immunoglobulin synthesis, stimulate the proliferation of lymphoid tissue, macrophages and lymphocytes, and enhance anti-infection ability; stimulate the collagen cells in burn wounds and surgical incisions to synthesize fibroblasts, and macrophage division and proliferation, accelerate wound healing, promote myocardial protein synthesis, increase myocardial contractility, reduce myocardial oxygen consumption, regulate fat metabolism, and reduce serum cholesterol and low-density lipoprotein levels; supplement the insufficiency or deficiency of growth hormone, and regulate fat metabolism, bone metabolism, and cardiorenal function in adults.

Recombinant human growth hormone and excipients.

It is used for growth hormone deficiency in children and adults, Turner's syndrome, growth failure caused by chronic renal failure in children, hypermetabolic state (negative nitrogen balance) after surgery and trauma, burns, and sepsis.

1. The dosage for promoting growth in children varies from person to person. The recommended dosage is 0.10.15 IU/kg body weight/day, once a day, subcutaneous injection, and the course of treatment is 3 months to 3 years, or as directed by a doctor. 2. The recommended dosage for the treatment of severe burns is 0.20.4 IU/kg body weight/day, once a day, subcutaneous injection. The course of treatment is generally about 2 weeks. 3. The dosage for adult replacement therapy must be adjusted according to the individual. It is usually recommended to start with a low dose, such as 0.5 units (0.17 mg) per day or a large amount of 0.02 units/kg body weight/day, which is equivalent to 0.007 mg/kg body weight/day; after one or two months of treatment, the dose can be gradually adjusted to 0.04 units/kg body weight/day, which is equivalent to 0.013 mg/kg body weight/day. The level of insulin-like growth factor I (IGFI) in serum can be used as a reference for dosage. The dosage decreases with age.

1. Growth hormone can cause transient hyperglycemia, which usually returns to normal with prolonged medication or after discontinuation of the medication. 2. In clinical trials, 1% of children with short stature had side effects, common of which were transient local reactions at the injection site (pain, numbness, redness and swelling, etc.) and symptoms of fluid retention (peripheral edema, joint pain or myalgia). These side effects occur early, and the incidence decreases with prolonged medication, and rarely affect daily activities. 3. Long-term injection of recombinant human growth hormone causes antibody production in a small number of patients. The antibody binding capacity is low and has no definite clinical significance. However, if the expected growth effect is not achieved, antibodies may be produced. If the antibody binding capacity exceeds 2 mg/L, it may affect the efficacy.

1. It is contraindicated for growth promotion after the epiphysis has completely closed; 2. It is contraindicated for critically ill patients with severe systemic infection during the acute shock period.

Precautions for children: There is no significant difference between children and adults in the pharmacology, toxicology and pharmacokinetics of growth hormone, and it can be used safely according to body weight. Precautions for pregnancy and lactation: It is not suitable for use. Precautions for the elderly: There is no systematic clinical research on the use of growth hormone in the elderly.

Concurrent use of glucocorticoids may inhibit the hormone response, so the dosage of glucocorticoids in growth hormone therapy should not exceed 1015 mg of hydrocortisone/m2 of body surface area. Concurrent use of non-androgenic steroids can further increase growth rate.

Store and transport at 2~8℃ away from light. It can be stored at room temperature for 7 days. The dissolved solution can be refrigerated at 2~8℃ for 72 hours.

1.0 mg (2.5 IU)

24 months