[ Drug Name ]
Generic name: Recombinant human growth hormone for injection
[ Pharmacology and Toxicology ]
It stimulates the differentiation and proliferation of epiphyseal chondrocytes, stimulates the growth of cartilage stromal cells, stimulates the differentiation and proliferation of osteoblasts, and causes linear growth acceleration and bone widening; promotes the synthesis of protein throughout the body, corrects the negative nitrogen balance after surgery and other traumas, and corrects hypoproteinemia caused by severe infections and cirrhosis; Stimulates immunoglobulin synthesis, stimulates lymphoid tissue, proliferation of macrophages and lymphocytes, and enhances anti-infection ability;
Stimulates the synthesis of fibroblasts from collagen cells in burn wounds and surgical incisions, and the division and proliferation of macrophages to accelerate wound healing; promotes myocardial protein synthesis, increases myocardial contractility, reduces myocardial oxygen consumption, regulates fat metabolism, and reduces serum cholesterol and low-density lipoprotein levels; supplements growth hormone deficiency or lack, and regulates fat metabolism, bone metabolism, and cardiac and renal functions in adults.
[Pharmacokinetics]
As reported in the literature, both subcutaneous or intramuscular administration are equally effective, with subcutaneous injection usually resulting in higher serum GH concentrations than intramuscular injection, but the resulting IGF-1 concentrations are consistent. GH absorption is usually slow, with plasma GH concentrations usually peaking 3 to 5 hours after administration; clearance half-life is generally 2 to 3 hours, and GH is cleared through the liver and kidneys, and is faster in adults than in GH is cleared by the liver and kidneys and is faster in adults than in children, and the direct elimination of unmetabolized GH from the urine is extremely small.
[Indications]
For the treatment of children with endogenous growth hormone deficiency, chronic renal failure and Turner’s syndrome, and severe burns.
[ Dosage ]
Before use, slowly add 1ml of lyophilized rhGH along the wall of the bottle with water for injection and shake it slightly to dissolve it all, do not shake it vigorously.
The recommended dose for promoting growth in children varies from person to person, the recommended dose is 0.1~0.15IU/kg body weight/day, injected subcutaneously once a day for a period of 3 months to 3 years, or as prescribed by the doctor.
The recommended dose for the treatment of severe burns is 0.2~0.4IU/kg body weight/day, injected subcutaneously once a day, and the course of treatment is usually about 2 weeks.
[Adverse reactions]
Growth hormone can cause transient hyperglycemia, which usually returns to normal with prolonged use or after discontinuation of the drug.
In clinical trials, about 1% of children with short stature had side effects. Local transient reactions (pain, numbness, redness, swelling, etc.) and fluid retention (peripheral edema, arthralgia, or myalgia) at the injection site were common, but the incidence of these side effects occurred early and decreased with the duration of administration.
Long-term injections of recombinant human growth hormone cause antibody production in a small number of patients, with low antibody binding and no definite clinical significance. However, if the expected growth effect is not achieved, antibody production may occur and antibody binding above 2 mg/L may affect the efficacy.
[ Contraindicated ]
1. Contraindicated in children with closed epiphyses.
2. Contraindicated in patients with symptoms of tumor progression.
3. Contraindicated in critically ill patients with severe systemic infections during the period of acute shock of the organism.
[Caution]
1.Under the guidance of a physician for patients with a clear diagnosis.
2.Diabetic patients may need to adjust the dose of anti-diabetic drugs.
3.Patients with growth hormone deficiency caused by brain tumors or patients with a history of intracranial injuries must be closely monitored for the possibility of progression or recurrence of underlying disease.
4. The simultaneous use of corticosteroids can inhibit the growth-promoting effect of growth hormone, so patients suffering from ACTH deficiency should adjust their corticosteroid dosage appropriately to avoid its inhibitory effect on growth hormone.
5.A few patients may have hypothyroidism during growth hormone treatment, which should be corrected in time to avoid affecting the efficacy of growth hormone, so patients should have regular thyroid function checks and be given thyroxine supplements when necessary.
6. Patients suffering from endocrine disorders (including growth hormone deficiency) may be prone to slippage of the epiphyseal plate of the femoral head, and attention should be paid to the evaluation of lameness if it occurs during the treatment period of growth hormone.
7. Sometimes growth hormone can lead to excessive insulin status, so attention must be paid to whether the patient has a reduced glucose tolerance.
8. Do not overdose. One injection of too much growth hormone can lead to hypoglycemia followed by hyperglycemia. Long-term overdose may lead to signs and symptoms of acromegaly and other reactions related to growth hormone overdose.
9. The injection site should be frequently changed to prevent fat atrophy.
[For Pregnant and Lactating Women]
Not suitable for use.
[ Use in Children ]
There are no significant differences in the pharmacology and pharmacokinetics of growth hormone between children and adults, and it can be used safely according to body weight.
[For Elderly Patients]
The pharmacology and pharmacokinetics of growth hormone in the elderly are not significantly different from those in adults and can be used safely.
[Drug Interactions]
Concomitant use of glucocorticoids may inhibit the hormonal response, so the amount of glucocorticoids used in growth hormone therapy should not exceed 10-15 mg of hydrocortisone/m2 of body surface area.
Concomitant use of non-androgenic steroids may further enhance growth rate.
[Overdose]
No cases of acute overdose have been reported. However, exceeding the recommended dose can cause side effects, with overdose starting with hypoglycemia followed by hyperglycemia and long-term overdose leading to signs and symptoms of acromegaly.
[Specification]
2 IU/stick, 2.5 IU/stick, 4 IU/stick, 4.5 IU/stick, 6 IU/stick, 10 IU/stick, 16 IU/stick
[Storage]
Store at 2~8℃ away from light, the dissolved solution can be refrigerated at 2~8℃ for 48 hours.