Sinobioway Group Co., Ltd.

[Drug name]

Generic name: Recombinant human growth hormone for injection

[Product advantage]

1.Natural: 191 amini acid which the sequence is identical with growth hormone secreted by human pituitary.

2. High purity:99.9%, nearly no rhGH dimer;

3. High Specific Activity:>3IU/mg;

4. High Safety and effective: Launched since 2005,benefits over 15,000 patiens;

[Indication]

Children with growth failure due to endogenous growth hormone deficiency (GHD)

[U.S.FDA Approved indication]

1. Children growth hormone deficiency (1985);

2. Renal deficiency (1993);

3. HIV-associated failure syndrome (1996);

4. Turner’s syndrome (1996);

5. Adult growth hormone deficiency (1997);

6. Prader-Willi syndrome (2000);

7. Small gestational age (2001);

8. Idiopathic short stature (2003);

9. SHOX deficiency (2006);

10. Noonan’s syndrome (2008);

[Off-label use]

1. Anti-aging;

2. Assisted reproduction;

3. Osteoporosis;

4. others.

[Dosage & Administration]

The lyophilized rhGH is dissolved in the attached 1 ml sterilizing water for injection. Shake slightly to dissolve the powder. The solution should be clear liquid. Do not use the product if the solution is muddy or has particles. Avoid violent oscillation.

The dose is different from person to person. The recommended dose for subcutaneous injections is 0.1IU/kg/d. The subcutaneous injection should be administered at bedtime daily, or as directed by the doctor's advice. The injection site should be changed frequently to avoid injection site fat atrophy.

[Adversion reactions]

Growth hormone can cause the transient hyperglycemia, which usually returns normal after the extended treatment or treatment termination. Clinical trials showed side effects in 1% of children with short stature. The most common adverse reactions are injection site reactions (e.g. pain, numbness, redness, and swelling) and fluid retention (e.g. peripheral edema, arthralgia, or myalgia). These side effects occur in the earlier stage of the treatment and rarely influence the daily activities. The frequency of side effects reduces over time.

Injecting the recombinant human growth hormone for a long time will form antibodies in a minority of patients but the antibody binding force is low, indicating no exact clinical significance. Antibodies may be produced if the expected growth effect is not achieved. If the antibody binding force is more than 2 mg/L, it may affect the efficacy of the treatment.

[Contraindication]

1.  The drug should not be used in pediatric patients with closed epiphyses.

2. The drug should not be used in patients with symptoms of tumor progression.

3. The drug should not be used in critical patients with severe systematic inflammation during the acute shock period.