Description

LANDERTROPIN

Growth Hormone Landertropin 100ui

Somatropin 3.70mg

Powder for injectable solution

Intramuscular (IM) and Subcutaneous (SC) routes.

FORMULA

Each vial contains

Somatropin.3.70 mg (equivalent to rhGH 10 IU)

PRESENTATION FORM: box with 10 transparent vials of 1 mL.

THERAPEUTIC INDICATIONS:

• Pediatric growth retardation due to inadequate secretion of endogenous growth hormone.
• severe burns
• Growth hormone deficiency (GHD) due to disease of the hypothalamus – pituitary gland, or as diagnosed by 2 independent growth hormone tests

CONTRAINDICATIONS:

• Growth Hormone Landertropin 100ui should not be used to stimulate growth in children with closed epiphyses.
• LANDERTROPIN is not intended for use in patients with severe systemic infections who are in acute shock.

ADVERSE REACTIONS, SIDE EFFECTS:

• Growth Hormone Landertropin 100ui can cause temporary hyperglycemia, which will return to its normal value with continued use or when use is discontinued.
• In clinical studies with children of short stature, side effects could be observed in approximately 1% of subjects. The most common effects are a temporary local response at the injection site (such as pain, numbness, redness and swelling and etc.) and symptoms of fluid retention (such as peripheral edema, arthralgia and myalgia).These side effects have an early onset after initiation of therapy, but with a reduction in incidence and frequency over time, rarely influencing daily activities.
• During long-term treatment with Growth Hormone Landertropin 100ui a few patients may develop antibodies to the protein. The affinity of the antibody is usually low, and is not of exact clinical importance. However, if you do not see 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 may interfere with treatment.

PRECAUTIONS AND WARNINGS:

• Growth Hormone Landertropin 100ui therapy must be prescribed directly by a qualified physician.
• In patients with diabetes mellitus, the insulin dose may need to be adjusted by the physician before starting LANDERTROPIN treatment.
• Simultaneous glucocorticoid therapy will inhibit the growth-promoting effect of LANDERTROPIN. Patients with ACTH deficiency should have their glucocorticoid replacement dose adjusted carefully to avoid an inhibitory effect on growth (see DRUG INTERACTIONS).
• Hypothyroidism may develop during LANDERTROPIN therapy in a very small number of patients, which must be corrected promptly to avoid compromising the curative effect of LANDERTROPIN. Therefore, thyroid function should be monitored periodically during administration of LANDERTROPIN, and thyroid hormone replacement should be initiated, if necessary.
• A slipped capital femoral epiphysis can occur in patients with endocrine disorders (including GHD). Evaluation should be made carefully if lameness develops during treatment with LANDERTROPIN.
• LANDERTROPIN can sometimes reduce sensitivity to insulin.Patients should be carefully monitored for glucose intolerance.
• Insulin treatment may be necessary if BG exceeds 10 mmol/L during treatment. If BG cannot be controlled with an insulin dose exceeding 150 IU/day, discontinue treatment with Growth Hormone Landertropin 100 IU.
• The injection site must vary to prevent lipoatrophy.
• It should be administered with caution to athletes.
• LANDERTROPIN should not be used in patients with known hypersensitivity to tetracycline.
• It should not be used in pregnant or nursing women.

MEDICATION FOR CHILDREN

• There is no significant difference in the pharmacology and pharmacokinetics of LANDERTROPIN between children and adults. Administer Growth Hormone Landertropin 100ui according to body weight.

MEDICATION FOR ELDERLY PATIENTS

• There are no clinical reports in the elderly patient population.

MECHANISM OF ACTION

• hGH is secreted by the anterior lobe of the pituitary. It is a peptide hormone with 191 amino acids. LANDERTROPIN is a rhGH produced by recombinant DNA technology in E. coli with secretion expression. The content and sequence of LANDERTROPIN are completely identical to that of hGH. LANDERTROPIN is synthesized in E. coli as a prehormone. The prehormone is composed of growth hormone with a signal peptide originally derived from bacteria. The prehormone is cleaved in the cytosol of bacteria, and then the final product, similar to native growth hormone, is released into the periplasmic space. The product is then collected through lysis of the outer membrane, which leaves the inner membrane intact, thereby ensuring no contamination by other bacterial proteins.
• The effect of rhGH secretion expression is the same as that of exogenous growth hormone in the human body.LANDERTROPIN stimulates osteoepiphyseal cell cartilage to differentiate and propagate, stimulates cartilage cell growth, stimulates osteoblast to differentiate and regenerate, causes linear growth acceleration and bone enlargement. LANDERTROPIN stimulates protein synthesis throughout the body, corrects the condition of negative nitrogen balance after surgery and other injuries, corrects hypoproteinemia initiated by severe infections and liver cirrhosis. LANDERTROPIN stimulates the synthesis of immune globulin, stimulates the generation of lymphoid tissue, macrophages and homeocytes, increases anti-infection capacity.

LANDERTROPIN stimulates the synthesis of collagen cells to fibrocytes in burn wounds and operative incisions, stimulates the differentiation and generation of macrophages, accelerates wound healing. LANDERTROPIN stimulates cardiac muscle protein synthesis, increases cardiac muscle contraction force, decreases myocardial oxygen consumption, regulates fat metabolism, lowers serum cholesterol and low-density lipoprotein levels. Growth Hormone Landertropin 100ui supplements growth hormone insufficiency and deficiency, adjusts fat metabolism, bone metabolism, heart and kidney function.

PHARMACOKINETICS

• 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 growth hormone concentration than intramuscular administration, but IGF-I concentrations are the same with these two methods of administration. 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. Unmetabolized growth hormone eliminated directly through the urine is very little.
• Almost all growth hormone in the bloodstream binds to high-affinity growth hormone-binding protein (hGHBP), which increases the half-life of growth hormone in serum. The application of the injection at different times does not influence the concentration of growth hormone in serum.

DOSAGE AND METHOD OF USE:

• Prior to administration, add 1 mL of water for injection to the vial of rhGH lyophilized powder, allowing the solvent to slowly run down the side of the vial. Shake the bottle with a gentle rotary motion until the content is completely dissolved. Do not shake vigorously.
• The administration dose must be individual for each patient. For growth promotion in children, the recommended dose is 0.1 – 0.15 IU/kg/day, once daily, by subcutaneous injection. The treatment period is from 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 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, equals 0.007/mg/kg/day, after 1 -2 months of treatment, the dose can be gradually increased to 0.04 IU/kg/day, equal to 0.013 mg/kg/day. The daily dose should be graduated according to the determination of the Insulin-like Growth Factor-I (IGF-I) in serum.The dose can be decreased with increasing age.

INTERACTION WITH MEDICINES:

• Simultaneous glucocorticoid therapy can inhibit the effect of hGH. Generally, the glucocorticoid dose should not exceed 10-15 mg CORT/m2 of surface area. The percentage of growth can be increased with the combination with other non-androgen steroids.

OVERDOSE (SIGNS, SYMPTOMS, BEHAVIOR AND TREATMENT):

• There are no reports of an acute overdose. An overdose could initially lead to hypoglycaemia and then to hyperglycaemia. Long-term overdose can result in symptoms of acromegaly, consistent with the known effects of excessive GH.
• Go to Medical Emergencies in the toxicology section (Manuel Gianni). Phone: 220-418.

Keep at a temperature between 2-8ºC, in a dry place and out of the reach of children. protect from light

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