Saizen solution for injection 5.83mg/ml (6mg in 1.03ml)

INJECTION, SOLUTION

**Posology and method of administration** Saizen® 5.83mg/ml and Saizen® 8mg/ml are intended for multiple dose use. Saizen® dosage should be individualised for each patient based on body surface area (BSA) or on body weight (BW). It is recommended that Saizen® be administered at bedtime according to the following dosage: **Growth failure due to inadequate endogenous growth hormone secretion:** 0.7–1.0 mg/m2 body surface area (BSA) per day or 0.025–0.035 mg/kg body weight (BW) per day by subcutaneous administration. **Growth failure in girls due to gonadal dysgenesis (Turner Syndrome):** 1.4 mg/m2 body surface area (BSA) per day or 0.045–0.050 mg/kg body weight (BW) per day by subcutaneous administration. Concomitant therapy with non-androgenic anabolic steroids in patients with Turner Syndrome can enhance the growth response. **Growth failure in short children born small for gestational age (SGA):** The recommended daily dose is 0.035 mg/kg body weight (or 1 mg/m2/day, equal to 0.1 international units/kg/day or 3 international units/m2/day) per day, by subcutaneous administration. Duration of treatment Treatment should be discontinued when the patient has reached a satisfactory adult height, or the epiphyses are fused. For growth disturbance in short children born SGA, treatment is usually recommended until final height is reached. Treatment should be discontinued after the first year if height velocity SDS is below +1. Treatment should be discontinued when final height is reached (defined as height velocity < 2 cm/year), and if confirmation is required if bone age is > 14 years (girls) or > 16 years (boys), corresponding to closure of the epiphyseal growth plates. **Growth failure in prepubertal children due to chronic renal failure (CRF):** 1.4 mg/m2 body surface area per day, approximately equal to 0.045–0.050 mg/kg body weight per day by subcutaneous administration. **Growth disturbance due to idiopathic short stature (ISS):** 0.067 mg/kg body weight per day, is injected 6 times subcutaneously per week (0.40 mg/kg/week). **Growth Hormone Deficiency in adults:** At the start of somatropin therapy, low doses of 0.15–0.3mg are recommended, given as a daily subcutaneous injection. The dose should be adjusted stepwise, controlled by Insulin-like Growth Factor 1 (IGF-1) values. The recommended final GH dose seldom exceeds 1.0mg/day. In general the lowest efficacious dose should be administered. Women may require higher doses than men, with men showing an increasing IGF-1 sensitivity over time. This means that there is a risk that women, especially those on oral oestrogen replacement are under-treated while men are over-treated. In older or overweight patients, lower doses may be necessary. **Method of administration** For administration of the solution for injection of Saizen® follow the instructions given in the package leaflet and in the instruction manual provided with the Easypod® auto-injector or aluetta pen injector.