TRACUTIL CONCENTRATE FOR SOLUTION FOR INFUSION

PACKAGE LEAFLET: INFORMATION FOR THE USER
B. Braun Melsungen AG · 34209 Melsungen, Germany

Tracutil Concentrate for Solution for Infusion
Electrolytes and trace elements
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor or pharmacist.
– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
– If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet
1. What Tracutil is and what it is used for
2. What you need to know before you use Tracutil
3. How to use Tracutil
4. Possible side effects
5. How to store Tracutil
6. Contents of the pack and other information

1. What Tracutil is and what it is used for
Tracutil is a concentrate which is diluted prior to use in a suitable solution
for infusion.
It is a solution for providing trace elements used during parenteral nutrition
(nutrition via a venous catheter) in adult patients.

If you have a liver or kidney disease your dose may be reduced where this
is appropriate.

Method of administration
Tracutil will be given by infusion (intravenous drip) after it has been diluted
in a suitable solution for infusion.

If you received more Tracutil than you should

Do not use Tracutil,
• If you are allergic to the active substances or any of the other ingredients
of this medicine (listed in section 6)
• If you have pronounced cholestasis (with reduced bile flux) and abnormal
liver function tests
• If you suffer from Wilson’s disease (disturbed copper elimination) or certain
types of iron storage disorders (haemosiderosis, haemochromatosis).
Tracutil must not be administered to newborn babies, infants and children.

Warnings and precautions:
Talk to your doctor before using Tracutil
• If you have impaired liver function which may impair the excretion of
manganese, copper and zinc. Your dose may have to be reduced.
• If you have impaired kidney function, because excretion of selenium,
fluoride, chromium, molybdenum and zinc may be significantly decreased.
• If you have increased thyroid activity.
• If you are hypersensitive to iodine
Various tests may be performed while you are given this medicine to ensure
that none of the elements that Tracutil contains accumulate excessively in
the body.
If you have impaired liver function or receive blood transfusions your blood
should be monitored regularly for the concentration of a specific ironstorage protein (serum ferritin levels) to prevent an iron overload.
In patients undergoing medium to prolonged Tracutil treatment zinc and
selenium deficiency may develop. Your doctor will adapt your Tracutil dose
accordingly or you will be given additional supplements.
Correcting a chromium deficiency leads to an improvement in glucose
utilisation. This must be taken into account in patients with insulindependent diabetes. Readjustment of the insulin doses may become
necessary.

Children and adolescents
This medicine must not be used in newborn babies, infants and children,
since its composition is not suitable for this age group. (see section “Do not
use Tracutil”). The use of this medicine in adolescence is not recommended.

Other medicines and Tracutil
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 or pharmacist for advice before
taking this medicine.
Pregnancy
There are no or limited amount of data from the use of this medicine in
pregnancy. Tracutil should not be given during pregnancy unless the clinical
condition of the woman requires treatment with Tracutil.
Breast-feeding
It is unknown whether the components of Tracutil are excreted in human
milk. Your doctor will therefore weigh up very carefully whether this
medicine is appropriate for you.

Driving and using machines
This medicine is normally given to immobile patients in a controlled setting.
This will exclude driving and using machines.

Lätus 443

If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.

Like all medicines, Tracutil can cause side effects, although not everybody
gets them.
If you notice any of the following side effects please tell your doctor
without delay:
Not known (frequency cannot be estimated from the available data)
Allergic (anaphylactic) reactions to iron given intravenously, with possible
fatal outcome.
Iodine may cause allergic reactions.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any side effects not listed in this leaflet. You can also report side effects
directly via the following:
United Kingdom
Yellow Card Scheme
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Tracutil
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
ampoule and carton after “EXP”. The expiry date refers to the last day of
that month.
This medicine does not require any special storage conditions.
Only to be used if the solution is clear and colourless and if the container
is undamaged.

6. Contents of the pack and other information
What Tracutil contains
The active substances are salts of trace elements:
The concentrate for solution for infusion contains:
Ferrous chloride
Zinc chloride
Manganese chloride
Cupric chloride
Chromic chloride
Sodium selenite pentahydrate
Sodium molybdate dihydrate
Potassium iodide
Sodium fluoride
Trace element content
Iron
Zinc
Manganese
Copper
Chromium
Selenium
Molybdenum
Iodine
Fluorine

Micromoles/ampoule
35
50
10
12
0.2
0.3
0.1
1.0
30

Micrograms per 1 ml
695.8
681.5
197.9
204.6
5.3
7.89
2.42
16.6
126.0
Micrograms/ampoule
2,000
3,300
550
760
10
24
10
127
570

The other ingredients are hydrochloric acid (for pH adjustment) and water
for injections.

Tracutil contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per 10 ml dose; i.e.
it is essentially ‘sodium-free’.

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This medicine will be given to you by a healthcare professional.

The recommended dose is:
Your doctor will decide on the dose that is right for you.

If the requirement is much greater (such as in patients with higher energy
requirements e.g. after serious injuries, burns or major surgery) higher
doses may also be needed.

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PACKAGE LEAFLET: I
NFORMATION FOR THE USER

Tracutil
Concentrate for Solution
for Infusion
Electrolytes and trace
elements

3. How to use Tracutil

For normal requirements adults will receive 1 ampoule Tracutil per day and
for moderately increased requirements up to 2 ampoules.

Format = 210 x 447 mm
2 Seiten

An overdose is very unlikely as the amount of trace elements contained
in Tracutil is far below values that could be toxic. Yet if an overdose is
suspected, administration of Tracutil should be discontinued. An overdose
can be confirmed by appropriate laboratory tests.

4. Possible side effects
2. What you need to know before you use Tracutil

schwarz

B|BRAUN
B. Braun Melsungen AG
34209 Melsungen
Germany

06.09.13 07:24

GB___293
293/12610276/0913
GA-GIF (L04)
Standort Berlin

Fontsize: 9,0 pt.

What Tracutil looks like and contents of the pack

Incompatibilities

Tracutil is a clear, colourless, aqueous solution.
Tracutil is supplied in 10 ml glass ampoules.
Tracutil is available in packs containing 5 or 50 glass ampoules.
Not all pack sizes may be marketed.

The product should not be added to alkaline solutions with marked buffer
capacity, e.g. sodium bicarbonate solutions.

Marketing Authorisation Holder and Manufacturer
B. Braun Melsungen AG
Carl-Braun-Straße 1
34212 Melsungen
Germany
Postal address
34209 Melsungen
Germany

The degradation of vitamin C in solutions for infusion is accelerated in the
presence of trace elements.
Tracutil should not be added directly to inorganic phosphate (additive)
solutions.
It is not possible to present complete information about incompatibilities in
this section. Please refer to the marketing authorisation holder for further
information.
This medicinal product must not be mixed with other medicinal products
except those mentioned in section 6.6 of the SmPC.

Tel.: +49 5661-71-0
Fax: +49 5661-71-4567

This medicinal product is authorised in the Member States of
the EEA under the following names:
Belgium:
Denmark:
Finland:
France:
Great Britain:
Italy:
Luxembourg:
Netherlands:
Austria:
Spain:

Do not add to fat emulsions.

Tracutil
Nutritrace
Nutritrace
Tracutil
Tracutil
Olitrace
Tracutil
Nutritrace
Tracutil
OligoPlus

This leaflet was last revised in June 2013

Method and duration of administration
Tracutil is a concentrate for solution for infusion. It should only be
administered intravenously after dilution with not less than 250 ml of a
suitable solution for infusion. Suitable carrier solutions include for example
– glucose solutions (glucose 5% w/v, 10% w/v, 20% w/v, 40% w/v, 50% w/v)
– electrolyte solutions (e.g. sodium chloride 0.9% w/v, Ringer’s solution)
A compatibility test must be performed before it is added to other infusion
solutions.
Addition to the diluent solution should be performed under strict aseptic
conditions.
The compatibility with solutions administered simultaneously via a common
inlet cannula must be ensured.
Tracutil must not be used as a diluent for other medicinal products.
The infusion of the ready-to-use mixture should not take less than 6 hours
and should be completed within 24 hours.
Administration can be continued for the duration of parenteral nutrition.

The following information is intended for healthcare
professionals only:

Notes:
Diarrhoea may lead to increased intestinal loss of zinc. The serum
concentrations must be checked in this case.
Deficiencies of individual trace elements should be corrected by specific
supplementation.

Monitoring measures

Shelf life after dilution

It is recommended to monitor the levels of trace elements included in
this medicinal product and other parameters on a regular basis during the
treatment with Tracutil.
For details please refer to section 4.4. of the Summary of Product
Characteristics.

Chemical and physical in-use stability 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 to 8 °C, unless dilution has taken place in
controlled and validated aseptic conditions.

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