White lyophilized powder
4 IU (1,33 mg) and 10 IU (3,33 mg)
- 5 vials with lyophilized powder (5 ampoules with water for injection, 5 syringes)
- 10 vials with lyophilized powder (10 ampoules with water for injection)
- 20 vials with lyophilized powder (without ampoules)
- 50 vials with lyophilized powder (50 ampoules with water for injection)
Human Growth Hormone, hGH (rDNA origin). JINTROPIN stimulates linear growth and increases growth rate in children who lack adequate endogenous growth hormone. In adults with growth hormone deficiency, JINTROPIN 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, JINTROPIN promotes wound healing, attenuates the protein-catabolic response and improves whole-body nitrogen condition after operation.
Growth disturbance due to insufficient secretion of growth hormone or associated with gonadal dysgenesis or Turner's syndrome which is a chromosome aberration. Growth disturbance in prepubertal children with chronic renal insufficiency. Replacement therapy in adults with pronounced growth hormone deficiency. Promote wound healing and attenuate catabolic responses in severe burns, sepsis, multiple trauma, major operations, acute pancreatitis and intestinal fistula. Topical application to promote wound healing in acute wound or chronic ulcer, such as burns, diabetic foot ulcer, chronic venous ulcer and decubital ulcer.
JINTROPIN 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. JINTROPIN should not be used for growth promotion in children with closed epiphyses.
WARNINGS AND PRECAUTIONS
The diagnosis should be confirmed before treatment starts. Therapy with Jintropin should be directed by suitably qualified physicians. In diabetes mellitus, the dose of insulin might repuire adjustment by your physician before JINTROPIN 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 start of the treatment. The treatment should be discontinued after renal transplantation.
PREGNANCY AND LACTATION
No clinical experience of the use in pregnant women is available. Treatment with JINTROPIN should be interrupted if pregnancy occurs. Information is lacking whether peptide hormones pass over into the breast milk but absorption in the gastro-intestinal tract of the infant of intact protein is extremely unlikely.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
The ability to react is not influenced by JINTROPIN.
DOSAGE AND ADMINISTRATION
The dosage is individual, based on body weight or body surfaces area and should be determined by your physician. Growth disturbance 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 dysgenesis (Turner's syndrome): A dose of 1.0 IU/kg/wk or 28 IU/kg/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 correction can be needed 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 then be modulated according to the side effects of the patients as well as determination of Insulin like Growth Factor-1(IGF-1) in serum as guidance. The weekly dose should be divided into 7 s.c. injections. The injection site should be varied 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 length is 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 at three times a day .Length of treatment depends on healing time .
No overdose or intoxication is known. If an overdose of JINTROPIN has been injected contact should be taken with your physician.
Side effects have been noted in approximately 10% (most common local skin reactions )of the patients participating in clinical trials in children with short stature. In clinical trials in adults side effects have been noted in approximately 30 to 40% of the patients, primarily related to symptoms of fluid retention (oedema).These events have an early onset after initiation of therapy, but with a reduction in incidence and prevalence over time and rarely influencing daily activities. JINTROPIN has given rise to the formation of antibodies in very few patients. This has no influence on the treatment result. It has been reported that patients may develop hypothyroidism during treatment with JINTROPIN which should be considered by your physician. If nausea and/or vomiting, severe and recurrent headache especially in combination with visual problems occur take contact with your physician.
Incompatibilities have not been reported for combined use of JINTROPIN with other medica-ments or medical solution.