Known hypersensitivity to somatropin or to 1 of the inactive ingredients of Saizen, or to the components of the solvent. Presence of an active tumour and/or active intracranial lesions or evidence of progression or recurrence of an underlying intracranial lesion, critically ill patients with complications following open-heart or abdominal operations, presence of multiple trauma or acute respiratory insufficiency; proliferative or pre-proliferative diabetic retinopathy.
As a growth hormone deficiency can, in rare cases, be an early sign of the presence of a cerebral tumour, tumours of this type must be excluded before the start of the treatment. Any already existing tumour should be inactive and its treatment should be stopped before starting the treatment with Saizen. Saizen is ineffective in children whose epiphyses are closed.
For Saizen 8 mg: Patients with acute critical illness suffering complications following open heart surgery, abdominal surgery, multiple accidental trauma, acute respiratory failure or similar conditions should not be treated with Somatropin. Regarding patients undergoing Somatropin therapy and becoming critically ill (see Precautions).
Use in pregnancy & lactation: There are no controlled studies available on the use of Saizen in animals or in pregnant women. Saizen must not be administered during pregnancy (see Precautions), as it is not yet known what the effect of an increase in the concentration of growth hormone on specific stages of embryogenesis or fetal growth may be.
Consequently, pregnancy must be excluded throughout the whole period of the treatment with Saizen and the patients must be informed of the possible non-hormonal methods of contraception. In the event of a pregnancy occurring, the treatment must be stopped. If the treatment with Saizen is continued in girls after the 1st menstruation, a non-hormonal method of contraception must be envisaged.
There is no indication that hGH passes into the mother's milk. It is not known if exogenous peptide hormones are excreted into breast milk but absorption of intact protein from the gastrointestinal tract of the infant is unlikely. However, as a precaution, weaning is indicated before Saizen is administered.
For Saizen 8 mg: It is not known if exogenous peptide hormones are excreted into breast milk but absorption of intact protein from the gastrointestinal tract of the infant is unlikely.