Summary of Product Characteristics (SmPC) - Addaven concentrate for solution for infusion
1 NAME OF THE MEDICINAL PRODUCT
Addaven concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ampoule of 10 ml contains:
Chromic chloride hexahydrate 53.3 microgram
Copper chloride dihydrate 1.02 milligram
Ferric chloride hexahydrate 5.40 milligram
Manganese chloride tetrahydrate 198 microgram
Potassium iodide 166 microgram
Sodium fluoride 2.10 milligram
Sodium molybdate dihydrate 48.5 microgram
Sodium selenite 173 microgram
Zinc chloride 10.5 milligram
The active ingredients in 10 ml of Addaven correspond to:
Cr3+ 0.2 μmol 10 μg
Cu 2+ 6 μmol 380 μg
Fe3+ 20 μmol 1.1 mg
Mn 2+ 1 μmol 55 μg
I- 1 μmol 130 μg
F- 50 μmol 950 μg
Mo6+ 0.2 μmol 19 μg (as Mo6+)
Se4+ 1 μmol 79 μg (as Se4+)
Zn 2+ 77 μmol 5 mg
The content of sodium and potassium in 10 ml corresponds to
Sodium 1.2 mg 52 μmol
Potassium 39 μg 1 μmol
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear solution, almost colourless.
- Osmolality: approx. 3100 mosm/kg water
- pH: 2.5
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
To meet basal to moderately increased requirements of trace elements in intravenous nutrition.
4.2 Posology and method of administration
Posology
Adults: The recommended daily dosage of Addaven in adult patients with basal to moderately increased requirements is 10 ml (one ampoule).
Children: Addaven is not recommended for use in children weighing under 40 kg body weight. The trace element Peditrace should be used.
Method of administration
Addaven must not be given undiluted.
For instructions on dilution of the medicinal product before administration, see section 6.6.
4.3 Contraindications
- Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
Addaven should be used with caution in patients with impaired biliary (copper, manganese) and/or renal function (zinc, selenium, chromium, molybdenum, iodine, fluoride) due to a decrease in excretion which may lead to accumulation.
Addaven should also be used with caution in patients with biochemical or clinical evidence of liver dysfunction (especially cholestasis).
Individual requirements of trace elements should be considered as some patients may require separate supplementation.
If the treatment is continued for more than 4 weeks, checking of manganese levels in blood is required.
4.5 Interaction with other medicinal products and other forms of interaction
No interactions with other drugs have been observed.
4.6 Fertility, pregnancy and lactation
Pregnancy
Animal reproduction studies or clinical investigations during pregnancy have not been carried out with Addaven. However, the requirements of trace elements in a pregnant woman are slightly increased compared to non-pregnant women.
No adverse events are to be expected when Addaven is administered during pregnancy.
Breast-feeding
The active substances in Addaven are secreted in human milk and effects have been shown in breastfed newborns/infants of treated women. These effects are desirable and anticipated.
Fertility
There are no data on fertility effects of chromic chloride, copper chloride, ferric chloride, manganese chloride, potassium iodide, sodium fluoride , sodium molybdate, sodium selenite and zinc chloride available.
4.7 Effects on ability to drive and use machines
Addaven has no or negligible influence on the ability to drive and use machines.
4.8 Undesirable effects
No adverse effects related to the trace elements in Addaven have been reported.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
In patients with impaired renal or biliary function, there is an increased risk for accumulation of trace elements. In case of a chronic overload of iron there is a risk of haemosiderosis, which in severe and rare cases can be treated by venesection.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Electrolytes in combination with other drugs, ATC code: B05X A31
Addaven is a mixture of trace elements in amounts normally absorbed from the oral diet and should have no pharmacodynamic effect besides maintaining or repleting the nutritional status.
5.2 Pharmacokinetic properties
When infused intravenously, the trace elements in Addaven are handled in a similar way to trace elements from an oral diet. Individual trace elements will be taken up by tissues to different extents, depending on the requirements within each tissue to maintain or restore the concentration of each element for the metabolic requirements of that tissue.
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 in the 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.
5.3 Preclinical safety data
There are no preclinical data of relevance to the safety evaluation beyond those already included in the SmPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Xylitol
Hydrochloric acid, concentrated (for pH adjustment)
Water for injections
6.2 Incompatibilities
This medicinal product must only be mixed with other medicinal products for which compatibility has been documented, see section 6.6.
6.3 Shelf life
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 not used 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.
6.4 Special precautions for storage
No special precautions for storage.
For storage conditions after mixing of the medicinal product, see section 6.3.
6.5 Nature and contents of container
Ampoule (polypropylene) 20 x 10 ml
6.6 Special precautions for disposal and other handling
Handling
Do not use if Addaven is cloudy or contains sediment.
Compatibility
Addaven may only be added to medicinal or nutrition solutions for which compatibility has been documented. Compatibility with different products and the storage time of the different admixtures will be available upon request.
7 MARKETING AUTHORISATION HOLDER
Fresenius Kabi Limited
Cestrian Court, Eastgate Way,
Manor Park, Runcorn,
Cheshire,
WA7 1NT
UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 08828/0275
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
23/05/2025
10 DATE OF REVISION OF THE TEXT
23/05/2025