Somabiotech Somatropin KiroBiotech Kirotropin HGH Peptide Manufacturer

What's KiroBiotech KIROTROPIN HGH Recombinant Human Growth Hormone for Injection?

【NAME OF THE MEDICINAL PRODUCTS】

Generic Name:Recombinant t Human Growth Hormone for Injection.

Brand Name: KiroBiotech KIROTROPIN HGH

【INGREDIENTS】

1.Recombinant human growth hormone and excipients.

2.Molecular Formula: C990H1528N262O300S7

3.Molecular Weight : 22125D

4.Origin of the Active Ingredient : KIROTROPIN HGH is a recombinant human growth hormone (rhGH) produced by gene recombinant E.coli secretion expression technology, It’s precursor synthesized in E.coli including gene of human growth hormone(hGH) was secreted to periplasmic space of the cell guided under signal peptide. The signal peptide was removed and polypeptide molecule is folded exactly to growth hormone (GH) molecule. KIROTROPIN HGH has 191 amino acid residues and a molecular weight of 22125 daltons. It’s amino acid content,structure and sequence are identical to those of hGH.

【CHARACTERS】

.White lyophilized powder

【INDICATIONS】

1. Pediatric growth retardation due to inadequate secretion of endogenous GH.

2. Sever burns.

3. Growth hormone deficiency (GHD) due to diseases of hypothalamus-pituitary gland. Or as diagnosed by 2 independent GH stimulation tests.

【DOSAGE AND ADMINISTRATION】

1. Before administration, add 1ml of WFI to the rhGH vial of lyophilized, and make the solvent run slowly down the side of the vial. Swirl the vial with a gentle rotary motion until contents are dissolved completely . Do not shake vigorously.

2. The dose of administration should be individual for each patients. For growth-promotion purpose in Children, the recommended dose is 0.1-0.15 IU/kg/day, once per day, subcutaneous injection. The period of the treatment is from 3 months to 3 years. Or follow your physician’s prescription.

3. For sever burn patients, a daily dose of 0.2-0.4 IU/kg/day, once per day, subcutaneous injections is recommended.The periods of treatment is about 2 weeks.

4. The dose might require adjustment individually for human replacement therapy. Generally the dose is from small dose,e.g. 0.5iu(0.17mg)/day or up to 0.02iu/kg/day, it is equal to 0.007mg/kg/day. The daily dose should be modulate according to the determination of Insulin-like Growth Factor-1(IGF-1) in serum. The dose may decrease with age increasing.

【ADVERSE REACTIONS】

1.KIROTROPIN HGH may cause temporary hyperglycaemia, which will usually return to normal after continual uses, or stop using.

2.In clinical trials in children with short stature, side effects have been noted in approximately 1% of the subject. The most common effects are temporary local response at injection sites( such as pain,numbness, redness and swelling and etc.) and symptoms of fluid retention (such as periphery oedema, arthralgia and myosalgia) ,these side effects hav an daily onset .

3.During long-term KIROTROPIN HGH treatment a few patients may develop antibodies to the protein, The affinity of the antibody is usually low. And its has no exact clinical significance .However, if the expected growth effect is not abserved, there is a possibility that formation of the antibody taking place in the body. If the affinity exceeds 2mg/L,it might interfere with the treatment.

【CONTRAINDICATIONS】

1.KIROTROPIN HGH should not be used for growth promotion in children with closed epiphyses.

2.KIROTROPIN HGH should not be use in patients with severe generalized infections who are in acute shocks.

【WARMINGS AND PRECAUTIONS】

1.Diagnosis confirmation is required before initiation of the treatment, Therapy with KIROTROPIN HGH should be prescribed directly by qualified physicians.

2.In diabetes mellitus patients. The dosage of insulin might require adjustment by physician before KIROTROPIN HGH treatment.

3.Simultaneous glucocorticoid therapy will inhibit the growth-promoting effect of KIROTROPIN HGH. Patients with ACTH efficiency should have their glucocorticoid-replacement dose carefully adjusted to avoid an inhibitory effect in growth (see DRUG INTERACTIONS).

4.Hypothyroidism may develop during KIROTROPIN HGH therapy in very few patients, which should be corrected promptly to avoid the compromised curative effect of KIROTROPIN HGH, Therefore thyroid function should be monitored periodically during KIROTROPIN HGH administration and thyroid hormone replacement should be initiated if necessary.

5.Slipped capital femoral epiphysis may occur in patients with endocrine disorders (including GHD ) . Evaluation should be made carefully if limp energes during KIROTROPIN HGH treatment.

6.Sometimes KIROTROPIN HGH may rduce insulin sensitivity, Patients should be monitored closely for evidence of glucose intolerance.

7.Insulin treatment might be needed if BG exceed 10mmol/L during treatment. If BG cannot be controlled with a dose of insulin exceeding 1501IU/day, stop KIROTROPIN HGH treatment.

8.The injection site should be varied to prevent lipoatrophy.

【MEDICATION FOR WOMEN IN PREGNACY AND LACTATION 】

.It should not be used for women in pregnancy and lactation.

【MEDICATION FOR CHILDREN】

.There is no significant difference in KIROTROPIN HGH’s pharmacology and pharmacokinetices between children and adults. Admimister KIROTROPIN HGH safely according to weights.

【MEDICATION FOR ELDERS 】

.There is no clinical report in senior population.

【DRUG INTERACTIONS】

Simultaneous glucocorticoid therapy might inhibit the effect of hGH, Generally, the dose of glucocoricoid are not exceed 10-15mg CORT/m2 of surface areas. Growth rate can be increased by the combination with other non-randrogen steroids.

【OVER DOSAGE】

. There is no report on acute overdose. Overdose could lead to initially, hypoglycemia and subsequently hyperglycemia. Long-term overdose could result in symptoms of acromegaly. consist with the know effects of excessive GH.

【PHARMACOLOGY】

1.hGH was secreted by anterior lob of the pituitary ,It is a peptide hormone with 191 amino acids. KIROTROPIN HGH is a rhGH produced by recombinant DNA technology in E. Coil with secretion expression . The content and sequence of KIROTROPIN HGH are completely identical with thosed of gHG . KIROTROPIN HGH is synthesized in E. Coil as a prehormone. The prehormone is composed of Gh with signal petpide derived originally from the bacterium. The prehormone splits in the cytosol of bacterium , and then the finished product, similar to the native GH, is released to periplasmic space. The products is then collected though lysis of the outer membrane, which leaves inner membrane, which leave inner membrane intact ,and thus guarantees almost no contamination from other bacteria proteins.

2. The effect of the secretion expression rhGH is the same as that of the endogenous GH in human body, KIROTROPIN HGH stimulates cartilage cells of osteoepiphysis to differentiate and propagate; it stimulates stroma cells of the cartilage to grow; its stimulate osteoblast to differentiate and regenerate; it causes acceleration of linear growth and ossature widening . KIROTROPIN HGH promotes whole-body synthesis of proteins; it corrects the condition of negative nitrogen balance after operation and other wounds ; it corrects hypoproteinemia initiated by severe infection and hepatic cirrhosis. KIROTROPIN HGH stimulates the synthesis of immune globulin ; its stimulate the synthesis from collagen cells to fibrocytes in burn wounding and operative incisions; it stimulates differentiation and generation of macrophage; it accelerates wound healing .KIROTROPIN HGH promotes the synthesis of protein of cardac muscle; it increase the contraction force of cardiac muscle; it decrease myocardial consumption of oxygen; it regulates fat metabolism, it decrease levels of cholesterol and low density lipoprotein in serum .KIROTROPIN HGH complements the insufficient and deficiency of GH; it adjusts fat metabolism, bone metabolism, cardiac and renal function.

【PHARMACOKINETICS】

1. It has been reported in literature that the therapeutic effects are the same for both subcutaneous and instramuscular administrations. Usually subcutaneous administration causes higher concentration of GH than intramuscular administration but the concentration of IGH-1 are the same with these two approaches of administration .Generally, the absorption of GH is slow. The concentration of GH in plasma reaches the peak after 3-5 hours of administration; usually elimination half-time metabolized GH is eliminated directly through urine is very little.

2. Almost all GH in the blood circulation is bond to the high affinity GH binding protein (hGHBP) ,which increase the half life of GH in serum. Different injection time dose not influence the concentration of GH in serum.

【SHELFLIFE】

24 MONTHS

【STORAGE】

.Store and transport at 2-8 Celsius.