Saizen Use In Pregnancy & Lactation

Pregnancy: Solution for injection: From the reproductive studies performed in animals with somatropin containing products, there is no evidence of an increased risk of adverse reactions for the embryo or foetus. There are no data from the use of somatropin during pregnancy in animals (see Pharmacology: Toxicology: Preclinical safety data under Actions). Therefore, somatropin containing products are not recommended during pregnancy and in woman of childbearing potential not using contraception.
Powder for injection 3.33 mg vial/Powder for injection 8 mg click.easy vial: Animal studies are insufficient and/or animal data is not available with regard to effects on pregnancy, embryofoetal development, parturition or postnatal development (see Pharmacology: Toxicology: Preclinical safety data under Actions). No clinical data on exposed pregnancies are available. Therefore, somatropin containing products are not recommended during pregnancy and in woman of childbearing potential not using contraception.
Breastfeeding: There have been no clinical studies conducted with somatropin in breast-feeding women. It is not known whether somatropin is excreted in human milk. Therefore caution should be exercised when somatropin is administered to breast-feeding women.
Fertility: Non-clinical toxicity studies showed that recombinant human growth hormone did not induce adverse effects on male and female fertility (see Pharmacology: Toxicology: Preclinical safety data under Actions).