Description

Pregnant Women: There are insufficient data on the use of indacaterol, glycopyrronium and mometasone furoate in pregnant women to inform a drug-associated risk. Indacaterol and glycopyrronium were not teratogenic in rats and rabbits following subcutaneous or inhalation administration respectively. In animal reproduction studies with pregnant mice, rats and rabbits, mometasone furoate caused increased fetal malformations and decreased fetal survival and growth. This should only be used during pregnancy if the expected benefit to the patient justifies the potential risk to the fetus. Breast-feeding: There is no information available on the presence of indacaterol, glycopyrronium or mometasone in human milk, on the effects on a breastfed child, or on the effects on milk production. Other inhaled corticosteroids, similar to mometasone furoate, are transferred into human milk. Indacaterol, glycopyrronium and mometasone furoate have been detected in the milk of lactating rats. Glycopyrronium reached up to 10-fold higher concentrations in the milk of lactating rats than in the blood of the dam after intravenous administration.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.