SEIZEN Click.Easy

− Growth failure in girls with gonadal dysgenesis (Turner Syndrome), confirmed by chromosomal analysis.

− Growth failure in prepubertal children due to chronic renal failure (CRF).

− Growth disturbance (current height SDS <-2.5 and parental adjusted height SDS <-1) in short children born small for gestational age (SGA) with a birth weight and/or length below -2 SD, who failed to show catch-up growth (HV SDS <0 during the last year) by 4 years of age or later.

Saizen 8 mg click.easy, is 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:

Children and adolescents:

− 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 prepubertal children due to chronic renal failure (CRF):

1.4 mg/m² body surface area (BSA), approximately equal to 0.045-0.050 mg/kg body weight (BW), per day by subcutaneous administration.

− 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 IU kg/day or 3 IU m²/day) per day, by subcutaneous administration.

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.

Adults:

− Growth Hormone Deficiency in adults

At the start of somatropin therapy, low doses of 0.15-0.3 mg 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 1.0 mg/day. In general the lowest efficacious dose should be administered. In older or overweight patients, lower doses may be necessary.

For administration of the reconstituted solution for injection of Saizen 8 mg click.easy follow the instructions given in the package leaflet and in the instruction manual provided with the selected auto-injector: one.click auto-injector, cool.click needle-free auto-injectors or easypod auto-injector.

Intended users of easypod are primarily children starting from the age of 7 up to adults. Use of the devices by children should always be made under adult's supervision.