Human Growth Hormone (sHGH)

Composition: One vial contains Powder for injection of EC-Tropin (rDNA origin) 10IU and other ingredients: Mannitol, sodium phosphate (monobasis-sodium phosphate and biradical-sodium phosphate).

Recombinant Human Growth Hormone (rDNA origin)

Presentation: 2cc vials, 10iu per vial. 10 vials in box. Box protected with hologram. Comes without solvent.

PHARMACEUTICAL FORM: Powder for injection is prepared with water solution for subcutaneous (s.c.) administration.

STORAGE: Before the drug is reconstituted (the powder mixed with the liquid), you can store EC-Tropin at room temperature (77oF For less) for up to three months. Keep it in the carton to protect it from light. You should make the injection of EC-Tropin right after you have reconstituted it. If that is not possible, you can keep EC-Tropin in the refrigerator (in the carton) for up to 48 hours after reconstitution. Do not freeze. If you do not use EC-Tropin within 48 hours after reconstitution, throw it away.

PHARMACO-THERAPEUTIC GROUP: Human Growth Hormone, hGH (r DNA origin). EC-Tropin stimulates linear growth and increases growth rate in children who lack adequate endogenous growth hormone. In adults with growth hormone deficiency, EC-Tropin reduces fat mass, increases muscle mass and improves energy, vitality and subjective well-being. EC-Tropin promotes the patients who suffering from severe burns, AIDS associated muscle wasting, or undergoing major operations, wound healing, attenuates the protein-catabolic response and improves whole body nitrogen condition after operation.

INTRODUCTION: EC-Tropin is produced by gene recombination DNA technology. It contains high purity human growth hormone (hGH) consisting of 191 amino acid ingredients. Amino acid series of the EC-Tropin are equivalent to the human growth hormone (hGH) secreted by human hypophysis. Its biological titer has been determined by cell proliferation tests. EC-Tropin is an asepsis and freeze-dried powder. It can be used in subcutaneous injection diluted with water. After dilution, this substance is close to liquid state.

DOSAGE AND ADMINISTRATION: The dosage is individual, based on body weight or body surfaces area and should be determined by your physician. Growth inhibition due to insufficient secretion of growth hormone in children: Generally a dose of 0.5-0.7 IU/kg/wk or 14-20 IU/m2/wk is recommended. Even higher doses have been used. Gonadal digenesis (Turner's syndrome): A dose of 1.0 IU/kg/wk or 28 IU/m2/wk is recommended. Chronic renal insufficiency: A dose of 30IU/m2/wk (approximately 1.0 IU/kg/wk) is recommended. Higher doses can be needed if growth velocity is too slow. A dose needs to be corrected after six months of treatment. Growth hormone deficiency in adults: An initial dose for about four weeks of 0.125 IU/kg/wk, is recommended. The daily dose should be modulated according to the patients' side effects as well as determination of Insulin like Growth Factor-1(IGF-1) in serum as guidance. The week dosage should be divided into 7 s.c. injections. The injection site should be changed to prevent lipoathrophy. If treatment has been forgotten one day do not take double doses the next day but continue the treatment according to the directions. For severe burns or multiple injuries, it is recommended an initial dose of 10IU/day followed by 16IU/day after patients' blood glucose level is stabilized. Typical treatment starts in 6 days after burns or injuries and treatment lasts for about 15-20 days. For major operations, 10IU/day for a period of 10 days is recommended, typical treatment starts in 2-3 days after operations. For topical application to wound or ulcer surface, a dose of 0.2IU/cm2 is recommended three times a day. Duration of the treatment depends on the healing time.

INSTRUCTIONS FOR USE/HANDLING: Vials: Add solvent to vial with powder for injection. Gently dissolve the drug with a slow, swirling motion. Do not shake vigorously, which might cause denaturation of the active ingredient. Injection: Wipe the selected injection site with alcohol swab. Injection angel should be 45~90 degree. Slowly inject the injection.