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INSTRUCTION OF KIGTROPIN

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 li 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.

[SPECIFICATION]

4.0IU/1.33mg/1.0ml/ vial

10IU/3.7mg/10.0ml/ vial

20IU/7.4mg/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, fat mobilization, a dose of 2-3 IUs per day will be sufficient for the majority a dose of 1.5 to 2.0 IUs  is considered to be 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 IUS 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 0.1-0.5IU/kg/day, inject before sleeping daily at the same time and the injection site should be changes frequently to prevent lipoatrophy at the site, or follow the physician’s advice.

[ADVERSE REACTIONS]

Growth hormone may induce transient hyperglycemia, 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 2mg/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 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 hypoglycemia 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 claudication 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 –dose 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 cholecterol and low density lipoprotein’s level; complement insufficiency or deficiency of growth hormone, regulate adult’s lipometabolism, bone metabolism,, 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-1 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 2~8℃ in the refrigerator, away from light.

Before reconstitution:

-If refrigerated between 2~8℃, it’s good until expiration date.

-At room temperature (under 37℃) it’s good for over 30 days

After reconstitution:

-Use bacteriostatic water to reconstitute and keep in 2~8℃, it will be good for 20 days.

-Use sterile water to reconstitute and keep in 2~8℃ it will be good for 72 hours.

[PACKAGE]

Antibiotics glass bottle, 10 vials/box.

[SHELF LIFE]

Two years

[EXECUTIVE STANDARD]

Fulfill with EP2005 specifications