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Pregnancy: There is a limited amount of data from the use of empagliflozin and linagliptin in pregnant women. Nonclinical studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is recommended to avoid the use of Empagliflozin + Linagliptin (GLYXAMBI) during pregnancy unless clearly needed.
Lactation: No data in humans are available on excretion of empagliflozin and linagliptin into milk.
Available nonclinical data in animals have shown excretion of empagliflozin and linagliptin in milk. A risk to human newborns/infants cannot be excluded. It is recommended to discontinue breast feeding during treatment with Empagliflozin + Linagliptin (GLYXAMBI).
Fertility: No studies on the effect on human fertility have been conducted for Empagliflozin + Linagliptin (GLYXAMBI) or with the individual components.
Nonclinical studies of empagliflozin alone and of linagliptin alone do not indicate direct or indirect harmful effects with respect to fertility.
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