Somatonorm post-marketing surveillance study (UK and Ireland, 1986-1987): a preliminary report.
A PMS study in the UK and Ireland recruited 581 children, mainly with GH deficiency, for treatment with Somatonorm and observation for 1 year; only 1 child proved totally non-evaluable. The mean dose prescribed was 0.41 IU/kg/week, with 56% of children receiving below the recommended dose. Underdosing was reflected particularly by the low growth rates of pubertal children. Somatonorm was safe, with a low incidence of reported events, of which lipoatrophy (in 6 cases) was the most common. Antibody assays were seldom requested and always negative.
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Medical Department, KabiVitrum Ltd, Uxbridge, Middlesex, UK.
D000293:Adolescent; D000328:Adult; D001827:Body Height / Q000187:drug effects; D002648:Child; D002675:Child, Preschool; D005260:Female; D006130:Growth Disorders / Q000188:drug therapy*; D013006:Growth Hormone / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000172:deficiency / Q000627:therapeutic use; D019382:Human Growth Hormone; D006801:Humans; D007223:Infant; D008060:Lipodystrophy / Q000139:chemically induced; D008297:Male; D011627:Puberty
D019382:Human Growth Hormone; D013006:Growth Hormone