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Humatrope Summary of Product Characteristics (SmPC)
clinical trials with growth hormone deficient patients, approximately
2% of the patients developed antibodies to growth hormone. In trials
in Turner syndrome, where higher doses were used, up to 8% of
patients developed antibodies to growth hormone. The binding capacity
of these antibodies was low and growth rate was not affected
adversely. Testing for antibodies to growth hormone should be carried
out in any patient who fails to respond to therapy.
mild and transient oedema was observed early during the course of
has been reported in a small number of children who have been treated
with growth hormone. However, there is no evidence that leukaemia
incidence is increased in growth hormone recipients without
patients with adult onset growth hormone deficiency, oedema, muscle
pain and joint pain and disorder, were reported early in therapy and
tended to be transient.
patients treated with growth hormone, following diagnosis of growth
hormone deficiency in childhood, reported side-effects less
frequently than those with adult onset growth hormone deficiency.
Summary of Product Characteristics.
Date of Last Review:February 01, 2019
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