1. NAME OF THE MEDICINAL PRODUCT JINTROPIN (Recombinant human growth hormone (rDNA origin) for injection). Powder for injection 10 IU.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION OF ACTIVE INGREDIENT Powder for injection substance 4 IU or 10 IU One vial contains Powder for injection of (rDNA origin) 10 IU.

3. PHARMACEUTICAL FORM Powder for injection prepared with supplied solvent, with or without preservative, for subcutaneous (s.c.) administration.

4. PHARMACO-THERAPEUTIC GROUP 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 economy after operation.

5. HOLDER OF THE AUTHORIZATION JINTROPIN is manufactured by GeneScience Pharmaceuticals Co., LTD, Changchun, China. It is the largest biotech company in China and further information can be obtained from the local GeneScience offices in the different Member States.

6. THERAPEUTIC INDICATIONS Growth disturbance due to insufficient secretion of growth hormone or associated with gonadal dysgenesis or Turners 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.

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.

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.

13. OVERDOSAGE No overdose or intoxication is known. If an overdose of JINTROPIN has been injected contact should be taken with your physician.

14. ADVERSE REACTIONS - 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.

15. INCOMPATIBILITIES Incompatibilities have not been reported for combined use of JINTROPIN with other medicaments or medical solution.

16. SHELF LIFE The powder for injection is assigned a shelf life of 24 months when stored cold at +2 to +8°. Storage for one month can take place in room temperature. Reconstituted JINTROPIN with preservative may be stored cold at +2 to +8° for 2 weeks protected from light.

17. SPECIAL PRECAUTIONS FOR STORAGE Frozen powder should not be used. Store cold at +2 to +8°.

18. 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, or the active ingredient might denature.

Jintropin is the most popular rHGH sold in China. According to IMS, an internationally recognized marketing firm, jintropin is the absolute market leader in China with just over 75% market share. Jintropin and Lily's Humatrope use secretion technology which produces a 191 amino acid sequence growth hormone, with much less E.coli protein contamination and no side effects associated with injection, such as red painful welts. This technology also has the advantage that growth hormone produced using secretion technology is very stable; it remains stable at 37C (98F degrees) for over 30 days (45C degrees for over a week). While growth hormone with 192 amino acid sequence is stable at room temperature for only a few days.

Jintropin Indications

Lowered blood pressure Improved cholesterol profile Supplement stronger bones Younger, tighter, thicker skin Hair re growth Wrinkle removal Increased muscle mass Reduced body fat Higher energy levels Increased exercise performance Re-generation of major organs that shrink with age Greater cardiac output Superior immune function Enhanced human sexual performance

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 economy after operation. Bodybuilders use JINTROPIN because it promotes growth of new muscle cells and uses body's own fat as energy source.