To meet basal to moderately increased requirements of trace elements in intravenous nutrition

Concentrate for solution for infusion

When infused intravenously, the trace elements in Addaven are handled in a similar way to trace elements from an oral diet. Copper and manganese are normally excreted via the bile, whereas selenium, zinc and chromium (especially in patients receiving intravenous nutrition) are mainly excreted via the urine. The main route of molybdenum excretion is the urine, although small amounts are excreted inthe bile. Iron is eliminated in small amounts by superficial loss and desquamation of gut cells. Premenopausal women can lose 30-150 mg of iron in the monthly blood loss.

-Conditions with total biliary obstruction - Wilson’s disease, hemochromatosis - Children less than 15 kg body weight

Animal reproduction studies or clinical investigations during pregnancy have not been carriedout with Addaven. However, the requirements of trace elements in a pregnant woman areslightly increased compared to non-pregnant women. No adverse events are to be expected when Addaven is administered during pregnancy.

The active substances in Addaven are secreted in human milk and effects have been shown inbreastfed newborns/infants of treated women. These effects are desirable and anticipated.

No adverse effects related to the trace elements in Addaven, following intravenous administration according to recommendations, have been reported.

Adults: The recommended daily dosage of Addaven in adult patients with basal to moderately increased requirements is 10 ml (one ampoule).

Children ?15 kg: 0.1 ml Addaven is given per kg body weight and day.

Addaven should be used with caution in patients with liver dysfunction. Liver dysfunction, including impaired biliary excretion, may interfere with excretion of trace elements from Addaven, leading to a risk of accumulation. In patients with renal or hepatic impairments, or mild cholestasis the dose should be adapted.

Shelf life of the medicinal product as packed for sale：3 years Shelf life after mixing： Chemical and physical in-use stability after dilution has been demonstrated for 24 hours at 25°C. From a microbiological point of view, the product should be used immediately. If notused immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C, unless mixing has taken place in controlled and validated aseptic conditions.