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7.CONTRAINDICATIONS

JINTROPIN should not be used when there is any evidence of activity of brain 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.

8.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 require 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.

9.INTERACTIONS WITH OTHER MEDICAMENTS AND OTHER FORMS OF INTERACTION
See under 8.

10.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.

11.EFFECTS ON ABILITY TO DRIVE AND USE MACHINES 

The ability to react is not influenced by Jintropin.

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12.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/m2/wk is recommended. Chronic renal insufficiency: A dose of 30IU/m2/wk (approximately 1 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-l (IGF-I) 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 8IU/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, 12IU/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. More on Jintropin HGH Growth Hormone