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SAIZEN is a human growth hormone produced by recombinant DNA technology. SAIZEN has 191 amino acid residues and a molecular weight of 22,125 daltons. Its amino acid sequence and structure are identical to the dominant form of human pituitary growth hormone. SAIZEN is produced by a mammalian cell line (mouse C127) that has been modified by the addition of the human growth hormone gene.
SAIZEN is a sterile, non pyrogenic, white, lyophilized powder intended for subcutaneous injection after reconstitution with Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol). The reconstituted solution has a pH of 6.5 to 8.5. RELATED PRODUCTS
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Dosage/Direction for Use
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. MORE ON HGH
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.
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.