Follow us :

product introduce of hgh

time2013/06/27

Package insert

【NAME OF THE MEDICINAL PRODUCT】

1.    Generic Name: Recombinant Human Growth Hormone for Injection

2.    Enlish Name: JINTROPIN

【INGREDIENTS】

1.    Recombinant human growth hormone and excipients

2.    Molecular Formula: C990H1528N262O300S7, protein with 191 aminal acid residues

3.    Molecular Weight:22125D

4.    Origin of the Active Ingredient: Jintropin is a recombinant human grouth hormone(rhGH) produced by  gene recombination E. coli secretion expression technology. Its precursor synthesized in E.coli including gene of human growth hormone(hGH) was secreted to perplasmis space of the cell guided under signal peptide. The signal peptide was removed and polypeptide molecule is folded exactly to growth hormone(GH) molecule.

5.    Jintropin has 191 amino acid residues and a molecular weight of 22125 daltons. Its amino acid content, structure and sequence are identical to those of hGH.

【CHARACTERS】

White lyophilized powder.

【INDICATIONS】

Symptom due to inadequate secretion of endogenous GH.

【SPECIFICATION】

2.5iu/0.85mg/1.0ml/vial

4.0iu/1.33mg/1.0ml/vial

4.5iu/1.7mg/1.0ml/vial

10iu/3.7mg/1.0ml/vial

12iu/4.0mg/1.0ml/vial

Test of content and purity: SDS-PAGE

【DASAGE AND ADMINISTRATION】

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

2.    The dosage should be individual for each person. The recommended dose is 0.1-0.15iu/kg/day, once per day, subcutaneous injection. The peroid of treatment is 3 months. Or follow your physicians prescription.

3.    The dose might require adjustment individually for human replacement.  Generally the dose is from samll dose, e.g., 0.5iu(0.17mg)/day or up to 0.02iu/kg/day, it is equal to 0.007mg/kg/day; after 1-2 months treatment, the dose might be modulated gradully to 0.04iu/kg/day, it is equal to 0.013mg/kg/day. The daily dose should then be modulatd according to the determination of Insulin-like Growth Factor-I(IGF-1) in serum.

【ADVERSE REACTIONS】

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

2.    In clinical trials, side effects have been noted approximately 17% of the subjects. 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 have an early onset after initiation of therapy, but with a reduction in incidence and prevalence over time, if it happens the erythema, can use the hot towel hot compress to relieve symptoms, which rarely influence daily activities.

3.    During the long-term Jintropin treament a few patients may develop antibodies to the protein. The affinity of the antibody is exceeds 2mg/L, it might interfere with the treament.

Notice

1.    If use steril water that contains acetic acid or excess preservatives, the occurrence of side effects will increase.

2.    The absorption of the products will be influenced if the peptides is not fully dissolved, thus will not only influence the GH level in serum, but cause tissue atrophy of the administrated place. So sterile water specialized for peptide is recommended.

3.    If not be stocked correctly (mentioned in below)the side effect rate will also increase, so the products should be kept strictly confirm to this instruction.

4.    The injection side should be varied to prevent lipoatrophy.

5.    The

Crowd that should be careful or can’t use

1.    Diabetes mellitus patients, patients with ATCH deficiency, patients who have hypothyroidism and patients with endocrine disorders, should be prescribed directly by qualified physicians.

2.    It should not be used in patients with a known hypersensitivity to tetracycline.

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

4.    It should not be used in patients with severe generalized infection who are in acute shocks

5.    The syringe, the injection water and injection site must be guaranteed sterilized or it will cause red spot.

Drug interactions

Simultaneous glucocorticoid therapy might inhibit the effect of HGH. And growth rate can be increased by combination by other non-androgen steroid

Pharmacology

The effect of the secretion expression rhgh is the same as that of the endogenous GH in human body. It stimulates cartilages cells of osteoepiphysis differentiate and propagate and promotes whole-body synthesis of the protein; stimulates muscle cell synthesis of the protein and help muscle grow and then increase physical strength; stimulates the synthesis of immune globulin thus enhance the body ability of anti-infection; stimulates the synthesis of collagenous fiber in collagen cells thus increase skin elasticity; excite the growth of hair follicle cells thus improve hair quality; regulate fat metabolism, decrease body fat serum cholesterol and low density lipoprotein; stimulates the synthesis of protein active factors, thus improve physique and antiage.

Pharmacokinetics

1.    it has been reported in literature that the therapeutic effects are the same for both subcutaneously and intramuscularly administrations. Usually subcutaneously administration cause higher concentration of GH than intramuscularly administration, but the concentrations of IGF-1 are the same with these two approaches of administration. Generally, the absorption of GH is slow. The concentration in plasma reaches the peak after 3 to 5 hours of administration; usually elimination half-time is 20 minutes. GH is eliminated through liver and kidney, and the process in adult is faster than that in children. Non-metabolized GH eliminated directly through urine is very little.

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

3.    After the administration of HGH, the GH in blood level has big individual difference, so blood test cannot act as the indicator of rhGH metabolism.

storage

Store and transport at 2℃ to 8℃, protect from light.

packaging

Glass vial,10vial/pack, 25 vials/pack

Shelf life

24 months at 2℃ to 8℃

Compendial specification

CP2010