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Addaven is a medicine that contains trace elements. Trace elements are tiny amounts of chemicals that your
body needs to work normally. Addaven is given intravenously (into a vein) when you can not eat normally.
This medicine is usually used as part of a balanced intravenous diet, together with proteins, fat,
carbohydrates, salts and vitamins.
You should not receive Addaven:
- if you are allergic to any of the ingredients of this medicine (listed in section 6). If you develop a rash
or other allergic reactions (like itching, swollen lips or face, or shortness of breath), inform your
doctor immediately.
- if your bile excretion is blocked;
- if you have Wilson’s disease (a genetic disorder in which copper builds up in the body) or
hemochromatosis (accumulation of iron in the body).
Addaven must not be given to children less than 15 kg body weight.
Warnings and precautions
Talk to your doctor if you have problems with the way your liver and/or kidney work.
Your doctor may want to do regular blood tests to check your condition.
Other medicines and Addaven
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your
doctor for advice before taking this medicine.
Driving and using machines
Addaven has no effect on driving or using machines.
This medicine will be administered to you by a healthcare professional.
You will receive your medicine by infusion (IV drip), directly into a vein.
Your doctor will decide on the correct dose for you to receive.
The recommended dose for adults is 10 millilitres (ml) each day.
Addaven should be added to another solution before it is given to you.Your doctor or nurse will make sure it
is prepared correctly before you receive Addaven.
Use in children
The recommended dose for children weighing more than 15 kg is 0.1 ml per kg body weight each day.
If you receive too much Addaven
It is very unlikely that you will receive more medicine than you should as your doctor or nurse will monitor
you during the treatment. However if you think that you have received too much Addaven, inform
your doctor or nurse immediately.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
No known undesirable effects have been reported with the use of Addaven. However, if you get any side
effects, talk to your doctor or nurse.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and vial label. The expiry date
refers to the last day of that month.
Do not store above 30 °C.
Your doctor and hospital pharmacist are responsible for the correct storage, use and disposal of Addaven
infusion.
After dilution: The addition of Addaven should be performed immediately before the start of the infusion and
should be used within 24 hours. 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.
Any solution remaining after treatment should be thrown away via approved hospital procedures.
What Addaven infusion contains
- The active substances in one ampoule (10 ml) are:
Chromic chloride hexahydrate 53.3 µg
Copper chloride dihydrate 1.02 mg
Ferric chloride hexahydrate 5.40 mg
Manganese chloride tetrahydrate 198 µg
Potassium iodide 166 µg
Sodium fluoride 2.10 mg
Sodium molybdate dihydrate 48.5 µg
Sodium selenite anhydrous 173 µg
Zinc chloride 10.5 mg
- The other ingredients are: xylitol, hydrochloric acid, water for injections.
Fresenius Kabi Norge AS
NO-1753 Halden
Norway
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To meet basal to moderately increased requirements of trace elements in intravenous
nutrition.
Posology
Adults: The recommended daily dose of Addaven in adult patients with basal to moderately
increased requirements is 10 ml (one ampoule).
In patients with renal or hepatic impairments, or mild cholestasis the dose should be adapted.
Children 15 kg: 0.1 ml Addaven is given per kg body weight and day.
Method of administration
Addaven must not be given undiluted. Addaven shall be given as an intravenous infusion,
diluted in a parenteral nutrition solution/emulsion.
For instructions on dilution of the medicinal product before administration, see section 6.6.
Parenterally administered iron or iodine preparations can cause hypersensitivity reactions on
rare occasions, including serious and potentially fatal anaphylactic reactions.
Patients should be clinically observed for signs and symptoms of hypersensitivity reactions.
In case of hypersensitivity reactions, the infusion should be stopped immediately and
appropriate measures performed.
If iron is taken orally in parallel with infusion of Addaven, the total intake of iron should be
determined to ensure that there is no iron accumulation.
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.
Addaven should be used with caution in patients with impaired renal function as excretion of
some trace elements in urine may be significantly decreased.
If the treatment is continued for more than 4 weeks, checking trace element levels in plasma,
especially manganese, is required.
If an individual patient has a markedly increased requirement for any of the trace elements,
the regimen can be adjusted using separate supplements.
No interactions with other drugs have been observed.
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.
Addaven has no or negligible influence on the ability to drive and use machines.
No adverse effects related to the trace elements in Addaven, following intravenous
administration according to recommendations, 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 national
reporting system listed in Appendix V*.
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.
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.
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.
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
There are no preclinical data of relevance to the safety evaluation beyond those already
included in the SmPC.
Xylitol
Hydrochloric acid, concentrated (for pH adjustment)
Water for injections
This medicinal product must only be mixed with other medicinal products for which
compatibility has been documented.
No special precautions for storage.
For storage conditions after mixing of the medicinal product, see section 6.3.
Ampoule (polypropylene) 20 x 10 ml
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.
Disposal
Any unused medicinal product or waste material should be disposed of in accordance with
local requirements.
