Dinatrope-HGH 10 IU x 25 vials
Human Growth Hormone, hGH (r DNA origin)
COMPOSITION:
One vial contains Powder for injection of Dynatrope (r DNA origin) 10IU and other ingredients: 18mg Mannitol, 3.0mg sodium phosphate (0.36 monobasis-sodium phosphate and 2.64 mg biradical-sodium phosphate).
PHARMACEUTICAL FORM:
Powder for injection is prepared with water solution for subcutaneous (s.c.) administration.
PHARMACO-THERAPEUTIC GROUP:
Human Growth Hormone, hGH (r DNA origin).
HGH stimulates linear growth and increases growth rate in children who lack adequate endogenous growth hormone. In adults with growth hormone deficiency, Dinatrope-HGH reduces fat mass, increases muscle mass and improves energy, vitality and subjective well-being. Dinatrope-HGH 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:
Dinatrope-HGH 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 Dynatrope are equivalent to the human growth hormone (hGH) secreted by human hypophysis. Its biological titer has been determined by cell proliferation tests.
Dinatrope-HGH 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.
INDICATIONS:
Growth inhibition due to insufficient secretion of growth hormone or associated with gonadal digenesis or Turner's syndrome which is a chromosome aberration.
Growth inhibition in prepubertal children with chronic renal insufficiency.
Replacement therapy in adults with pronounced growth hormone deficiency. Improve wound healing and attenuate catabolic responses in severe burns, sepsis, multiple trauma, major operations, acute pancreatitis and intestinal fistula.
Topical application to improve wound healing in acute wound or chronic ulcer, such as burns, diabetic foot ulcer, chronic venous ulcer and requital ulcer.
CONTRAINDICATIONS:
Dinatrope-HGH should not be used when there is any evidence of activity of a tumor. Intracranial lesions must be inactive and antitumour therapy completed prior to starting therapy.
DYNATROPE is used for acceleration of growth in children with closed epiphyses.
WARNINGS AND PRECAUTIONS:
The diagnosis should be confirmed before the treatment starts. Therapy with Dynatrope should be directed by suitably qualified physicians. In diabetes mellitus, the dose of insulin might repuire adjustment by your physician before HGH treatment starts. Experience in adult GHD patients above 60 years is lacking. Experience with prolonged treatment in adults is limited.
In chronic renal insufficiency the renal function should be investigated before the treatment starts. The treatment should be discontinued after renal transplantation.
If you become pregnant while you are taking Dynatrope, you are recommended to stop the treatment and discuss this with your doctor.
You are recommended not to take Dynatrope while you are chest-feeding because somatropin might pass into your milk.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:
The ability to react is not influenced by HGH.
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.
OVERDOSAGE:
No overdose or intoxication is known.
If you inject too much growth hormone, contact your doctor.
ADVERSE REACTIONS:
The following side effects are usually mild and temporary:
headaches, muscle pain, joint stiffness, weakness, high blood sugar (hyperglycemia), sugar in your urine (glucosuria), swollen hands and feet due to fluid retention, redness and itching in the area you inject. If you experience any of these symptoms, you may need to reduce your dose. Discuss this with your doctor.
In rare cases you may develop antibodies to growth hormone or suffer raised pressure within the brain. If you get headaches, eyesight problems, feel sick or vomit, contact your doctor as these complaints could be signs of raised pressure within your brain.
Be sure to tell your doctor if you have any other side effects not mentioned here.
Special warnings
In very rare cases children treated with somatropin have experienced pain in the hip or knee or a limp. These symptoms may be caused by slipped capital femoral epiphysis (the end of the bone slips from the cartilage).
Scoliosis (curvature of the spine) can occur in children who experience rapid growth. Patients should be monitored for progression of scoliosis because growth hormone increases growth rate. Patients should have periodic thyroid function tests.
The following tumors have been reported in patients treated with somatropin: Leukemia in children, relapse of brain tumors in children and adults. However, there is no evidence that somatropin is responsible for causing these diseases. Talk to your doctor if you think you have any of these conditions.
INCOMPATIBILITIES:
Incompatibilities have not been reported for combined use of HGH with other medicines or medical solution.
STORAGE:
Before the drug is reconstituted (the powder mixed with the liquid), you can store HGH at room temperature (77°F For less) for up to three months. Keep it in the carton to protect it from light. You should make the injection of HGH right after you have reconstituted it. If that is not possible, you can keep DYNATROPE in the refrigerator (in the carton) for up to 24 hours after reconstitution. Do not freeze. If you do not use DYNATROPE within 24 hours after reconstitution, throw it away.
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.
EXPIRY:
3 (three) years.
WEBSITE:
http://www.development-labs.com/
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