DOSAGE AND HOW TO USE
Before administration, add 1 ml of water for injection to the rhGH freeze-dried powder bottle, and allow the solvent to slowly slide along the side of the bottle. Shake the bottle with a gentle rotational movement until the contents dissolve completely. Do not shake vigorously. The administration dose must be individual for each patient. To stimulate growth in children, the recommended dose is 0.1 – 0.15 IU / kg / day, once a day, by subcutaneous injection. The treatment period is 3 months to 3 years. Or follow the doctor’s prescription. For patients with severe burns, a daily dose of 0.2-0.4 IU / kg as a subcutaneous injection is recommended. The treatment period is approximately 2 weeks. The dose may require an individual adjustment for human replacement therapy. Generally, the dose is a small dose, for example 0.5 IU (0.17 mg) / day or up to 0.02 IU / kg / day, is equal to 0.007 / mg / kg / day; After 1-2 months of treatment, the dose can be gradually increased to 0.04 IU / kg / day, it is equal to 0.013 mg / kg / day. The daily dose should be graduated according to the determination of Insulin-I Growth Factor (IGF-I) in serum. The dose may be decreased with increasing age.
THERAPEUTIC INDICATIONS
Pediatric growth retardation due to inadequate secretion of endogenous growth hormone. Severe burns Growth hormone deficiency (GHD) due to a disease of the hypothalamus – pituitary gland, or as diagnosed by 2 independent tests of growth hormone
CONTRAINDICATIONS
It should not be used to stimulate growth in children with closed epiphyses. It should not be used in patients with severe generalized infections that are in acute shock.
ADVERSE REACTIONS; COLLATERAL DAMAGE
It can cause temporary hyperglycemia, which will return to its normal value with continued use or when discontinuing use. In clinical studies with short children, side effects could be observed in approximately 1% of the subjects. The most common effects are a local temporary response at the injection site (such as pain, numbness, redness and swelling and etc.) and fluid retention symptoms (such as peripheral edema, arthralgia and myalgia). These side effects have an early onset after starting therapy, but with a reduction in the incidence and frequency over time that rarely influence daily activities. During long-term treatment with SOMATROPIN a few patients may develop antibodies to the protein. The affinity of the antibody is usually low, and has no exact clinical importance. However, if you do not observe the expected growth effect, there is a possibility that the formation of an antibody is taking place in the body. If the affinity exceeds 2 mg / L, it can interfere with the treatment.
PRECAUTIONS AND WARNINGS
SOMATROPIN therapy should be prescribed directly by a qualified doctor. In patients with diabetes mellitus, the dose of insulin may need adjustment by the doctor before starting treatment with SOMATROPIN. A simultaneous glucocorticoid therapy will inhibit the growth stimulation effect of MATROPIN. Patients with ACTH deficiency should adjust the glucocorticoid replacement dose carefully to avoid an inhibitory effect on growth (see DRUG INTERACTIONS) Hypothyroidism can be developed during SOMATROPIN therapy in a very small number of patients, which must be corrected promptly to avoid compromising the curative effect of SOMATROPIN. Therefore, thyroid function should be monitored periodically during SOMATROPIN administration, and a thyroid hormone replacement should be initiated, if necessary. A slip of the femoral epiphysis can occur in patients with endocrine disorders (including GHD). The evaluation should be done carefully if a limp occurs during treatment with SOMATROPIN. Sometimes SOMATROPIN can reduce insulin sensitivity. Patients should be carefully monitored to verify that there is no glucose intolerance. An insulin treatment may be necessary if BG exceeds 10 mmol / L during treatment. If BG cannot be controlled with an insulin dose that exceeds 150 IU / day, discontinue SOMATROPIN treatment. The injection site should vary to prevent lipoatrophy. It should be administered with caution to athletes. SOMATROPIN should not be used in patients with known hypersensitivity to tetracycline. It should not be used in pregnant or breastfeeding women.
INTERACTION WITH DRUGS
A simultaneous glucocorticoid therapy can inhibit the effect of hGH. Generally, the dose of glucocorticoid should not exceed 10-15 mg CORT / m2 of surface area. The growth percentage can be increased with the combination with other non-androgenic steroids.
MEDICATION FOR CHILDREN
There is no significant difference in the pharmacology and pharmacokinetics of SOMATROPIN between children and adults. Administer SOMATROPIN according to body weight.
MEDICATION FOR PATIENTS OF THE THIRD AGE
There are no clinical reports in the population of elderly patients.
FARMACOCINÉTICA
It has been reported in the literature that the therapeutic effects are the same for subcutaneous and intramuscular administration. Generally, subcutaneous administration causes a higher concentration of growth hormone than intramuscular administration, but IGF-I concentrations are the same with these two administration procedures. Generally, the absorption of growth hormone is slow. The concentration of growth hormone in plasma reaches the peak 3-5 hours after administration; Usually the elimination half-life is 2-3 hours. Growth hormone is eliminated through the liver and kidney, and the process in adults is faster than in children. The non-metabolized growth hormone removed directly through the urine is very low. Almost all of the growth hormone in the bloodstream binds to the high affinity growth hormone (hGHBP) binding protein, which increases the half-life of serum growth hormone. The application of the injection at different times does not influence the concentration of serum growth hormone.
OVERDOSE
There are no reports of an acute overdose. An overdose could initially lead to hypoglycemia and then hyperglycemia. A long-term overdose may result in symptoms of acromegaly, consistent with the known effects of excessive GH. Resort to Medical Emergencies in the toxicology section.
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