Somatropin. 3.3mg/ml solution; 1.5ml cartridge corresponding to 5mg (15 units; produced by recombinant DNA technology in Escherichia coli): Cartridge for injection (subcutaneous).

Ind; C/I; S/E; Cautions: See above under the text of somatropin.

Dosage & admin: Dose should be personalized for each individual. The subcutaneous injection site should be varied to prevent lipoatrophy. Dosages are given as below: Children:

Growth hormone deficiency (GHD)- 0.025 - 0.035mg/kg/day, higher doses can be used. Turner syndrome (TS)- 0.045 - 0.050mg/kg/day. Short stature associated with chronic renal insufficiency (CRI)- 0.045 - 0.050mg/kg/day; higher doses may be needed if growth velocity is too low; a dose correction may be needed after 6 months of treatment.

Small for gestational age (SGA)- 0.035mg/kg/ day until final height is reached.

Prader-Willi syndrome (PWS)- 0.035mg/kg/day; daily doses of 2.7mg should not be exceeded. Adults:

Growth hormone deficiency (GHD)- start with low dose, 0.15 - 0.3mg/day; the dose should be gradually increased as determined by the IGF- I concentration; clinical response and side effects may guide dose titration; women may require higher dose than men.

Before administration, dissolve the sterile powder in the solvent and prepare a solution for subcutaneous injection.

1.5ml (5mg or 15 units) cartridge x 5's pack:

45000.0      MRP