Saizen Dosage/Direction for Use

Saizen is intended for multiple dose use in an individual patient.
Saizen dosage should be individualised for each patient based on body surface area (BSA) or on body weight (BW).
Posology: 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 per day or 0.025-0.035 mg/kg body weight (BW) per day by subcutaneous administration or intramuscular administration (for Powder for injection 3.33 mg vial).
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 U/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 growth hormone dose seldom exceeds 1.0 mg/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.
Patients with renal or hepatic impairment: Currently available data are described in Pharmacology: Pharmacokinetics under Actions but no recommendation on a posology can be made.
Powder for injection 3.33 mg vial: Benzyl alcohol as a preservative in bacteriostatic sodium chloride solution may cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old and must not be given to premature babies or neonates. Saizen may be reconstituted with Sodium Chloride Injection BP or Sterile Water for Injections for immediate use when administering to children under 3 years of age.
Method of administration: Solution for injection: 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 selected injector: cool.click needle-free auto-injectors, easypod auto-injector or aluetta pen 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.
For instructions for handling please see Special precautions for disposal and other handling under Cautions for Usage.
Powder for injection 3.33 mg vial: The powder for solution for injection should be used with the enclosed solvent for parenteral use. The reconstituted solution for injection should be clear with no particles. For instructions for preparation, please see Instructions for use/handling under Cautions for Usage.
Powder for injection 8 mg click.easy vial: 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.
The powder for solution for injection must be reconstituted with the enclosed bacteriostatic solvent (0.3% (w/v) metacresol solution in water for injections) for parenteral use, using the click.easy reconstitution device. For instructions for preparation please see Instructions for use/handling under Cautions for Usage.