Recombinant Human Growth Hormone for Injection
[NAME OF THE MEDICINAL PRODUCT]
¡ô Generic Name: Recombinant Human Growth Hormone
¡ô Trade Name: Nomatropin
¡ô Recombinant Human Growth Hormone and excipients.
¡ô Molecular Formula: C H N O S7with 191 amino acides residues.
¡ô Molecular Weight: 22125D
¡ô Origin of the Active Ingredient: Nomatropin is a Recombinants Human Growth Hormone. Nomatropin is produced by recombinant DNA technology in
E.coli secretion expression system. Nomatropin has the same amino acid
sequence with 191 residues as the native human growth hormone produced in
the human body.
¡ô White Lyophilized powder.
¡ô Growth failure of children due to endogenous growth hormone de?ciency
¡ô In adults with growth hormone deciency, Nomatropin reduces fat mass,
increases muscle mass and improves energy, vitality and subjective well-
being. In patients suffering from severe burns, AIDS associated muscle
wasting, or undergoing major operations. Nomatropin promotes wound healing,
attenuates the protein-catabolic response and improves whole-body nitrogen
condition after operation.
[DOSAGE AND ADMINISTRATION]
¡ô Before administration, add 1ml of sterile water for injection to the rhGH
vial of Lyophilized powder along the wall slowly, Shake it gently lo fully
dissolve the powder to get claried solution. DO NOT shake violently.
¡ô For anti-aging, general health & healing, fat mobilization, a dose of 2-3
IU's per day will be sufcient for the majority. A dose of 1.5 to 2.0 IU's
is considered to be a fun replacement dose for those in their middle-age
¡ô For gaining lean muscle and substantially improving body composition, a
dose of 4-8 IU's per day will be necessary. Most people will respond very
well at a dose of 4-5 IU's per day. For maximum benet in this regard, the
addition of Testosterone, Insulin, and low-dose t3 would be something lo
seriously consider. More on this in our comparative cycle guide of
¡ô The recommended dosage for injection is 0.1-0.1
5IU/kg/day, inject before Sleeping daily at the same time and the injection
site should be changes equently to prevent lipoatrophy at the site, or
follow the physician's advice.
¡ô Growth hormone may induce transient hyperglycosemia, which usually recover to normal level over time or after drug discontinuation. ? About 1%
children with microsomia in the clinical trial presented side effects.Which usually presented transient reactions at the injection site (pain,tingling numbness, red swelling, etc.)and the symptoms of uid retention (peripheral edema, arthralgia or myalgia). These side effects usually appear at early stage and the incidence rate decreases over time which rarely affects daily activities. ? Long-term injection of recombinant human growth hormone results in antibody production in minority people, however, the afnity of the antibody is low without exact clinical signicance. The antibody may be induced if the anticipant effect of growth is not achieved, which may affect the efcacy if the afnity is over 2 mg/L.
¡ô Children with closure of epiphysis are forbidden.
¡ô Patients with the progressive symptoms of tumor are forbidden
¡ô Critical ill patients in acute shock stage of serious systdematic infection are, forbidden.
[WARNINGS AND PRECAUTIONS]
¡ô rhGH therapy should be conducted on exactly diagnosed GHD patients under advice of experienced doctor.
¡ô For diabetes patients, dosage of anti-glucourea drugs should be adjusted during rhGH therapy.
¡ô For patients whose GHD were caused by encephaloma or encephalic wound, the progress and relapse possibility of potential diseases should be closely monitored.
¡ô For ACTH deciency patients, dosage of ATCH should be adjusted Because the growth improvement effect of rhGH could be inhibited by simultaneous using of ACTH.
¡ô Thyroid gland function should be tested regularly because elinieal Hypothyroidism may occur to some patients during rhGH therapy. For those hypothyroid thyroid supplementation is necessary for ensuring the Therapeutic effects of rHGH.
¡ô Careful consideration should be taken if claudicating occurred during rhGH therapy because the patients who suffered from endocrine system disease (including GHD1 have such a tendency that their epiphysis plates of femur are relatively easy to separate.
¡ô Growth hormone may lead to over insulin state. Attention should be paid to if lower glucose intolerance appeared.
¡ô Do not take over-dose of rhGH, one time over-dose rhGH administration Can lead to high blood sugar. Long-term over-does rhGH administration can lead to acromegaly.
¡ô Injection site should Often variation in case lipoatrophy.
¡ô Athletes should administer the drug with caution.
[ USAGE IN PREGNANCY AND LACTATION]
¡ô It is not suitable to use.
[ DRUG INTERACTIONS ]
¡ôConcurrent administration of glucocorticoid may inhibit the response of the hormone, therefore, the dosage of glucocorticoid is usually not over the equivalent dosage of 10-15 mg hydrocortisone/square meter body surface area.
¡ô Concurrent administration of non-androgen steroid may further promote the growth rate.
[ WARNINGS AND PRECAUTIONS ]
¡ô rhGH exerts the same actions of endogenous human growth hormone. It can stimulate proliferation and differentiation of epiphysis chondrocyte, stimulate growth of cartilage matrix cells, stimulate proliferation and differentiation of osteoblast; thus accelerate the liner growth rate and improve epiphysis width. rhGH can promote protein synthesis in whole body; reverse the negative nitrogen equilibrium caused by wound and surgery; correct the hypoproteinemia due to severe infection or hepatocirrhosis: stimulate synthesis of immune globin and proliferation of lymph adenoid, macrophage and lymphocyte, thus enhance the ability of infection resistance; stimulate proliferation of collagenocyte, broblast and macrophage in sites of burn and surgery, thus accelerate wound healing; promote synthesis of cardiocytes, thus improve cardiac contractility and reduce cardiac oxygen consumption; regulate lipometabolism , thus Clearance of GH is via liver and kidney, the half-life of clearance is about 2-3 hours.
Uncatabolized CH excreted in urea is almost immeasurable. All of the GH in circulation system exists as a complex form with GH binding proteins that make the half-life of GH prolonged.
¡ô Keep at 2-8C in the refrigerator, away from light.
¡ô Before reconstitution:
¡ôIf refrigerated between 2-8C it's good until expiration date.
¡ô At room temperature (under 37C) it's good for over 30 days.
¡ô After reconstitution:
¡ôUse Bacteriostatic W ater to reconstitute and keep in 2-8C. It will be good for 20 days.
¡ô Use Sterile W ater to reconstitute and keep in 2-8C. It will be good for 72 hours.
¡ô 10 x 10 IU/Vial, 10 x 2ml/Amp Bacteriostatic Water
[ SHELF LIFE ]
¡ô 3 years.
[ EXECUTIVE STANDARD ]
¡ô World health Organization GMP Standard.