Box with 10 1ml transparent vials
- Pediatric growth retardation due to inadequate secretion of endogenous growth hormone.
- Severe burns
- Deficiency of growth hormone (GHD) due to disease of the hypothalamic – pituitary gland, or as diagnosed according to two separate tests of growth hormone.
- LANDERTROPIN should not be used to stimulate growth in children with closed epiphyses.
- LANDERTROPIN should not be used in patients with severe generalized infections who are in acute shock.
ADVERSE REACTIONS: SIDE EFFECTS
- LANDERTROPIN can cause temporary hyperglycemia, returning to normal with continued use or discontinunig the drug.
- In clinical trials with short stature children, side effects could be observed in approximately 1% of the subjects. The most common side effects were temporal response at the site of injection (such as pain, numbness, redness and swelling, etc.) and symptoms of water retention (such as peripheral oedema, arthralgia and myalgia). These side effects appear on an early stage after starting therapy, but with a reduction in the incidence and frequency over time that rarely influence daily activities.
- During long term treatment with LANDERTROPIN a few patients can develop antibodies to the protein. The affinity of the antibody is usually low, and has no exact clinical significance. However, if you do not notice the expected growth effect, there is the possibility that the formation of an antibody is taking place in the body. If the affinity exceedes 2 mg/L it can interfere with the treatment.
CAUTIONS AND WARNINGS:
- LANDERTROPIN therapy must be prescribed directly by a qualified physician.
- In patients with diabetes mellitus, insulin doses might need to be adjusted by the physician before treatment with LANDERTROPIN is started.
- Simultaneous therapy with glucocorticoids inhibits the effect of growth stimulation of LANDERTROPIN. Patients with ACTH deficiency should adjust their dose of glucocorticoids replacement carefully to avoid an inhibitory effect on growth (see DRUG INTERACTIONS).
- Hypothyroidism can be developed during therapy with LANDERTROPIN in a very reduced number of patients, this must be corrected promptly to avoid compromising the curative effect of LANDERTROPIN. Therefore, thyroid function should be checked periodically during administration of LANDERTROPIN, and, a replacement of thyroid hormone should be started, if necessary.
- A slide of femoral epiphysis may occur in patients with endocrine disorders (including GHD). Evaluation should be made carefully if lameness occurs during treatment with LANDERTROPIN.
- Occasionally, LANDERTROPIN can reduce sensitivity to insulin. Patients should be monitored carefully for glucose intolerance.
- An insulin treatment may be necessary if BG exceedes 10 mmol/L during treatment. If BG cannot be controlled with a dose of insulin that exceedes 150 IU/day, withdraw treatment with LANDERTROPIN.
- The injection site should be changed 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 breastfeeding women.
- There is no significant difference in pharmacology and pharmacokinetics of LANDERTROPIN among children and adults. Administer LANDERTROPIN according to body weight.
USE IN ELDERLY PATIENTS
- There are no clinical reports in the elderly patients population.
MECHANISM OF ACTION
- hGH is secreted by the anterior lobe of the pituitary. It is a peptide hormone with 191 aminoacids. LANDERTROPIN is a rhGH produced by recombinant DNA technology in E. coli with secretory expression. Content and sequence of LANDERTROPIN are completely identical to the ones of hGH. LANDERTROPIN is synthesized in E. coli as a prehormone. The prehormone comprises the growth hormone with a signal peptide originally derived from the bacterium. The pre-hormone is divided into the cytosol of the bacterium, and then the final product, similar to the native growth hormone, is liberated into the periplasmic space. The product is then collected by lysis of the outer membrane, leaving the inner membrane intact, and through this ensures no contamination by other proteins of the bacterium.
- The effect of the expression of the secretion rhGH is the same as that of the exogenous growth hormone in human body. LANDERTROPIN stimulates cartilage cells of epiphyseal osto to differentiate and spread; stimulates growth of cartilage cells; stimulates osteoblasts to differentiate and regenerate; accelerates linear growth and enlargement of the bones. LANDERTROPIN stimulates the synthesis of proteins in the whole body; corrects the condition of a negative nitrogen balance after surgery and other injuries; corrects hypoproteinemia initiated by severe infections and cirrhosis. LANDERTROPIN stimulates the synthesis of immune globulin; stimulates generation of lymphoid, macrophage and homozygous tissue; increases anti-infectious capability
LANDERTROPIN stimulates the synthesis of collagen cells to fibrocytes in burn wounds and surgery incisions; stimulates the differentiation and generation of macrophages; accelerates wound healing. LANDERTROPIN stimulates protein synthesis in heart muscle; increases the strength of heart muscle contraction; decreases miocardial oxygen consumption; regulates the metabolism of fat; reduces cholesterol levels and plasma levels of low-density lipoprotein. LANDERTROPIN supplements the insufficiency and defficiency of the growth hormone; adjusts fat metabolism, bone metabolism, renal and cardiac function.
- It has been reported that therapeutic effects are the same for subcutaneous as for intramuscular administration. Generally, subcutaneous administration causes a higher concentration of the growth hormone than intramuscular administration, but IGF-I concentrations are the same for both administration procedures. Generally, the absorption of growth hormone is slow. Peak serum concentration of growth hormone is attained 3-5 hours after administration; usually the elimination half-life is 2-3 hours. Growth hormone is eliminated through liver and kidney, and the process is faster in adults compared to children. Unmetabolized growth hormone eliminated through urine is scarce.
- Almost all growth hormone in the bloodstream binds to the binding protein of growth of high affinity (hGHBP), which increases the serum half-life of the growth hormone. Injection application at different times does not influence serum concentration of the growth hormone.
DOSAGE AND USAGE:
- Before administration add 1 ml of water for injection to the vial with lyophilized powder rhGH, allowing the solvent to slowly slide down the side of the vial. Shake the vial gently until the content is completely dissolved. Do not shake vigorously.
- Administration dose should be individualized for each patient. To stimulate growth in children, the recommended dose is 0,1 – 0,15 IU/kg/day, once a day, via subcutaneous injection. The treatment period is three months to three years. Or follow the doctor’s prescription.
- A daily dose of 0,2-0,4 IU/kg subcutaneously is recommended for patients with severe burns. The treatment period is approximately two weeks.
- Dosage may need individualized ajustments for human replacement therapy. Generally, the dose is a small dose, e.g. 0,5 IU (0,17 mg)/day or up to 0,02 IU/kg/day, equivalent to 0,007/mg/kg/day; after 1-2 months of treatment, doses can be increased gradually to 0,04 IU/kg/day, equivalent to 0,013 mg/kg/day. Daily doses must be titrated according to the serum determination of the Growth Factor Insulin-I type (IGF-I). Doses can be decreased with increasing age.
- Concomitant therapy with glucocorticoids can inhibit the effect of hGH. Generally, the glucocorticoid dose should not exceed 10-15 mg CORT/m3 of surface area. The growth rate can be increased with the combination with other non-steroidal androgen.
OVERDOSE (SIGNS, SYMPTOMS, BEHAVIOR AND TREATMENT):
- There have been no reports of acute overdose. An overdose can lead initially to hypoglycemia and then to hyperglycemia. A long term overdose can result in acromegaly, consistent with the known effects of excessive GH.
- Resort to the Medical Emergency Center (Centro de Emergencias Médicas), Toxicology Department (Manuel Gianni). Phone: 220-418.
Keep at a temperature of 2-8ºC, in a dry place and out of reach of children. Protect from light.
MADE IN PARAGUAY
Manufactured by GeneScience Pharmaceuticals Co., Ltd.
Yueda Street 1718, Changchun High-Tech Development Zone, Changchun, China
P.O. Box: 130012
- Phone: 86-431-85195060
- Fax: 86-431-85186819
- Web page: www.gensci-china.com
- Technical Director: Duan Chengcai License Nr. 9.801.006
A Division of FARMACO S.A.
Technical Director: María Mercedes B. de Zárate – License Nr. 1186