Introduce:
Recombinant Human Growth Hormone for Injection
【NAME OF THE MEDICINAL PRODUCT】
Generic Name: Recombinant Human Growth Hormone
Trade Name: KIGTROPIN
【INGREDIENTS】
Recombinant Human Growth Hormone and excipients.
Molecular Formula：C990H1528N262O300S7 with 191 amino acids residues.
Molecular Weight：22125D
Origin of the Active Ingredient: KIGTROPIN is a Recombinants Human Growth Hormone.
KIGTROPIN is produced by recombinant DNA technology in E.coli secretion expression system.
KIGTROPIN has the same amino acid sequence with 191 residues as the native human growth hormone produced in the human body.
【CHARACTERS】
White Lyophilized powder.
【INDICATION】
Growth failure of children due to endogenous growth hormone deficiency (GHD).
In adults with growth hormone deficiency，KIGTROPIN 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，KIGTROPIN promotes wound healing，attenuates the protein-catabolic response and improves whole-body nitrogen condition after operation.
【SPECIFICATIONS】
10IU/3.7mg/1.0ml/vial
【DOSAGE AND ADMINISTRATION】
Before administration, add 1ml of sterile water for injection to the rhGH vial of Lyophilized powder along the wall slowly. Shake it gently to fully dissolve the powder to get clarified solution. DO NOT shake violently.
For anti-aging, general health & healing, fat mobilization, a dose of 2-3 IU’s per day will be sufficient for the majority. A dose of 1.5 to 2.0 IU’s is considered to be a full replacement dose for those in their middle-age and beyond.
For gaining lean muscle and substantially improving body composition, a dose of 4-8 IUs per day will be necessary. Most people will respond very well at a dose of 4-5 IU’s per day. For maximum benefit in this regard, the addition of Testosterone, Insulin, and low-dose t3 would be something to seriously consider. More on this in our comparative cycle guide of HGH/Insulin/IGF.
The recommended dosage for injection is 0.1-0.15IU/kg/day, inject before sleeping daily at the same time and the injectionsite should be changes frequently to prevent lipoatrophy at the site, or follow the physician’s advice.
【ADVERSE REACTIONS】
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 fluid 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 affinity of the antibody is low without exact clinical significance. The antibody may be induced if the anticipant effect of growth is not achieved, which may affect the efficacy if the affinity is over 2 mg/L.
【CONTRAINDICATIONS】
Children with closure of epiphysis are forbidden.
Patients with the progressive symptoms of tumor are forbidden.
Critical ill patients in acute shock stage of serious systematic infection are forbidden.
【WARNINGS AND PRECAUTIONS】
rhGH therapy should be conducted on exactly diagnosed GHD patients under advice of experienced doctor.
For diabetes patients, dosage of anti-glucourea drugs should be adjusted during rhGH therapy.
For patients whose GHD were caused by encephaloma or encephalic wound, the progress and relapse possibility of potential diseases should be closely monitored.
For ACTH deficiency patients, dosage of ATCH should be adjusted because the growth improvement effect of rhGH could be inhibited by simultaneous using of ACTH.
Thyroid gland function should be tested regularly because clinical hypothyroidism may occur to some patients during rhGH therapy. For those hypothyroid, thyroid supplementation is necessary for ensuring the therapeutic effects of rhGH.
Careful consideration should be taken if claudicating occurred during rhGH therapy because the patients who suffered from endocrine system disease (including GHD) have such a tendency that their epiphysis plates of femur are relatively easy to separate.
Growth hormone may lead to over insulin state. Attention should be paid to if lower glucose intolerance appeared.
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.
Injection site should often variation in case lipoatrophy.
Athletes should administer the drug with caution.
【USAGE IN PREGNANCY AND LACTATION】
It is not suitable to use.
【DRUG INTERACTIONS】
Concurrent 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.
Concurrent administration of non-androgen steroid may further promote the growth rate.
【PHARMACOLOGY AND TOXICOLOGY】
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, fibroblast 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 depress serum cholesterol and low density lipoprotein’s level; complement insufficiency or deficiency of growth hormone, regulate adult’s lipometabolism, osteometabolism, heart and kidney function.
【PHARMACOKINETICS】
It is reported that the equal pharmacological effect could be achieved via subcutaneous (sc) or intramuscular (IM) administration. Even though sc may lead a higher concentration of GH in plasma, IM could also yield the same IGF-l level. The absorption of GH is the relatively slow, max often occurs at 3-5 hours after injection. Clearance of GH is via liver and kidney, the half-life of clearance is about 2-3 hours. Uncatabolized GH 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.
【STORAGE】
Keep at 2~8oC in the refrigerator，away from light.
Before reconstitution:
–If refrigerated between 2-8oC, it’s good until expiration date.
–At room temperature (under 37oC) it’s good for over 30 days.
After reconstitution:
–Use Bacteriostatic Water to reconstitute and keep in 2~8oC, it will be good for 20 days.
–Use Sterile Water to reconstitute and keep in 2~8oC. it will be good for 72 hours.
【PACKAGE】
Tube-shaped antibiotics glass bottle, 10 bottles/inner box.
【SHELF LIFE】
Two years.
【EXECUTIVE STANDARD】
Pharmacopoeia of People’s Republic of China 2005 Edition 2
Specification: 10iu/vial 10vial/kit
Introduce:
IGtropin IGF-1 Long R3
Long R3 IGF-1 ACTIVE INGREDIENT
Long R3 IGF-1 is an 83 amino acid analog of IGF-1 comprising the complete human IGF-1 sequence with the substation of an Arg(R) for the Glu(E) at position three, hence R3 ,and a 13 amino acid extension peptide at the N terminus. This analog of IGF-1 has been produced with the purpose of increasing the biological activity of the IGF peptide. Long R3 IGF-1 is significantly more potent than IGF-1.The enhanced potency is due to the decreased binding of Long R3 IGF-1 to all known IGF binding proteins. These binding proteins normally inhibit the biological actions of IGF’s.
【BIOLOGICAL EFFECTS】
During puberty, IGF is the most responsible for the natural muscle growth that occurs during these few years .there are many different things that IGF does in the human body; among the effects the most positive are increased amino acid transport to cells, increased glucose transport, increased protein synthesis, decreased protein degradation and increased RNA synthesis. When IGF is active, it behaves differently in different types of tissues. in muscle cells ,proteins and associated cell components are stimulated.
Protein synthesis is increased along with amino acid absorption. as a source of energy,IGF mobilizes fat for use as energy in adipose tissue. In lean tissue, IGF prevents insulin form transporting glucose across cell membranes. as a result, the cells have to switch to burning off fat as a source of energy. IGF also mimic’s insulin in the human body .it makes muscles more sensitive to insulin’s effects, so if you are a person that currently uses insulin, you can lower your dosage by a decent margin to achieve the same effects and as mentioned IGF will keep the insulin from making you fat. perhaps the most interesting and potent effect IGF has on the human body is its ability to cause hyperplasia, which is an actual splitting of cells .Hypertrophy is what occurs during weight training, it is simply an increase in the size of muscle cells. See, after puberty you have a set number of muscle cells, and all you are able to do is to increase the size of these muscle cells, you don’t actually gain more. But, with IGF use you are able to cause this hyperplasia which actually increases the number of muscle cells present in the tissue, and through weight training you are able to mature these new cells, in other words make them grow and become stronger. So in a way IGF can actually change your genetic differentiates the number of types of cells present .at a genetic level it has the potential to alter an individual’s capacity to build superior muscle density and size.
【HOW TO USE】
The most effective length for a cycle of IGF is 50days on and 20-40days off .
Take dosages ranging from 60mcg up to 120mcg per day in divided doses .one injection in the morning and again at bed time. Never exceed 120mcg in one day .
Dissolve each vial by 1ml of water for injection that comes with it. Inject twice daily.
Do not use Insulin for the nighttime injection of IGF1.by taking insulin in the morning you prolong the IGF1’s half life to 12 hours and then take a 6 hour injection, you should be fine.
【SIDE EFFECTS】
The drug used in larger quantity around the 100mcg+range will cause headaches, occasional nausea and can contribute to low blood sugar of hypoglycemia in some users.
【INDICATION】
Growth failure of children due to endogenous growth hormone deficiency (GHD).
In adults with growth hormone deficiency，KIGTROPIN 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，KIGTROPIN promotes wound healing，attenuates the protein-catabolic response and improves whole-body nitrogen condition after operation.
【HOW SUPPLIED AND STORAGE】
IGtropin IGF-1 is supplied in a box of 10vials of lyophilized powder for injections. each vial contains 100mcg and 1.0mg of Long R3 IGF-1.Shelf life for 24months.
Store at 2-8℃,After Dissolve, keep at 2-8℃ and it is stable within 72 hours.
Specification: 100mcg/vial 10vial/kit
Specification: 30iu/vial 1vial/kit
Introduce:
Recombinant Human Growth Hormone for Injection
【NAME OF THE MEDICINAL PRODUCT】
Generic Name: Recombinant Human Growth Hormone
Trade Name: KIGTROPIN
【INGREDIENTS】
Recombinant Human Growth Hormone and excipients.
Molecular Formula：C990H1528N262O300S7 with 191 amino acids residues.
Molecular Weight：22125D
Origin of the Active Ingredient: KIGTROPIN is a Recombinants Human Growth Hormone.
KIGTROPIN is produced by recombinant DNA technology in E.coli secretion expression system.
KIGTROPIN has the same amino acid sequence with 191 residues as the native human growth hormone produced in the human body.
【CHARACTERS】
White Lyophilized powder.
【INDICATION】
Growth failure of children due to endogenous growth hormone deficiency (GHD).
In adults with growth hormone deficiency，KIGTROPIN 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，KIGTROPIN promotes wound healing，attenuates the protein-catabolic response and improves whole-body nitrogen condition after operation.
【SPECIFICATIONS】
10IU/3.7mg/1.0ml/vial
【DOSAGE AND ADMINISTRATION】
Before administration, add 1ml of sterile water for injection to the rhGH vial of Lyophilized powder along the wall slowly. Shake it gently to fully dissolve the powder to get clarified solution. DO NOT shake violently.
For anti-aging, general health & healing, fat mobilization, a dose of 2-3 IU’s per day will be sufficient for the majority. A dose of 1.5 to 2.0 IU’s is considered to be a full replacement dose for those in their middle-age and beyond.
For gaining lean muscle and substantially improving body composition, a dose of 4-8 IUs per day will be necessary. Most people will respond very well at a dose of 4-5 IU’s per day. For maximum benefit in this regard, the addition of Testosterone, Insulin, and low-dose t3 would be something to seriously consider. More on this in our comparative cycle guide of HGH/Insulin/IGF.
The recommended dosage for injection is 0.1-0.15IU/kg/day, inject before sleeping daily at the same time and the injectionsite should be changes frequently to prevent lipoatrophy at the site, or follow the physician’s advice.
【ADVERSE REACTIONS】
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 fluid 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 affinity of the antibody is low without exact clinical significance. The antibody may be induced if the anticipant effect of growth is not achieved, which may affect the efficacy if the affinity is over 2 mg/L.
【CONTRAINDICATIONS】
Children with closure of epiphysis are forbidden.
Patients with the progressive symptoms of tumor are forbidden.
Critical ill patients in acute shock stage of serious systematic infection are forbidden.
【WARNINGS AND PRECAUTIONS】
rhGH therapy should be conducted on exactly diagnosed GHD patients under advice of experienced doctor.
For diabetes patients, dosage of anti-glucourea drugs should be adjusted during rhGH therapy.
For patients whose GHD were caused by encephaloma or encephalic wound, the progress and relapse possibility of potential diseases should be closely monitored.
For ACTH deficiency patients, dosage of ATCH should be adjusted because the growth improvement effect of rhGH could be inhibited by simultaneous using of ACTH.
Thyroid gland function should be tested regularly because clinical hypothyroidism may occur to some patients during rhGH therapy. For those hypothyroid, thyroid supplementation is necessary for ensuring the therapeutic effects of rhGH.
Careful consideration should be taken if claudicating occurred during rhGH therapy because the patients who suffered from endocrine system disease (including GHD) have such a tendency that their epiphysis plates of femur are relatively easy to separate.
Growth hormone may lead to over insulin state. Attention should be paid to if lower glucose intolerance appeared.
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.
Injection site should often variation in case lipoatrophy.
Athletes should administer the drug with caution.
【USAGE IN PREGNANCY AND LACTATION】
It is not suitable to use.
【DRUG INTERACTIONS】
Concurrent 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.
Concurrent administration of non-androgen steroid may further promote the growth rate.
【PHARMACOLOGY AND TOXICOLOGY】
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, fibroblast 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 depress serum cholesterol and low density lipoprotein’s level; complement insufficiency or deficiency of growth hormone, regulate adult’s lipometabolism, osteometabolism, heart and kidney function.
【PHARMACOKINETICS】
It is reported that the equal pharmacological effect could be achieved via subcutaneous (sc) or intramuscular (IM) administration. Even though sc may lead a higher concentration of GH in plasma, IM could also yield the same IGF-l level. The absorption of GH is the relatively slow, max often occurs at 3-5 hours after injection. Clearance of GH is via liver and kidney, the half-life of clearance is about 2-3 hours. Uncatabolized GH 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.
【STORAGE】
Keep at 2~8oC in the refrigerator，away from light.
Before reconstitution:
–If refrigerated between 2-8oC, it’s good until expiration date.
–At room temperature (under 37oC) it’s good for over 30 days.
After reconstitution:
–Use Bacteriostatic Water to reconstitute and keep in 2~8oC, it will be good for 20 days.
–Use Sterile Water to reconstitute and keep in 2~8oC. it will be good for 72 hours.
【PACKAGE】
Tube-shaped antibiotics glass bottle, 10 bottles/inner box.
【SHELF LIFE】
Two years.
【EXECUTIVE STANDARD】
Pharmacopoeia of People’s Republic of China 2005 Edition 2
Specification: 20iu/vial 20vial/kit