Tracutil is used as part of intravenous nutrition providing a source of trace
elements for adult patients.re�

Posology
Adults
The recommended daily dose in adult patients with basal requirements is
10 ml (1 ampoule).
In patients with moderately increased requirements the daily dose may be
up to 20 ml (2 ampoules), accompanied by monitoring of the trace element
status.
In cases of significantly increased trace element requirements (such as extensive
burns, severe hypercatabolic polytraumatic patients) higher doses
may be necessary.
Paediatric population
Tracutil is contraindicated in neonates, infants and children (see section 4.3).
Tracutil is not recommended in adolescents (see section 4.4).
Renal and hepatic impairment
The doses for patients with impaired hepatic and/or renal function should
be determined individually. For these patients lower doses may be required.
Method of administration
Tracutil, which is a trace element concentrate, should only be administered
intravenously after dilution with not less than 250 ml of a suitable solution
for infusion, for example:

� glucose solutions (5% w/v or 10% w/v)
� electrolyte solutions (e.g. sodium chloride 0.9% w/v, Ringer�s solution).
Compatibility must be tested before addition to other infusion solutions.
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.
For incompatibilities and instructions for use see sections 6.2. and 6.6.
Notes:
Diarrhoea may lead to increased intestinal loss of zinc. The serum concentrations
must be checked in this case.
Deficiencies of individual trace elements must be corrected by specific supplementation.

Manganese blood levels should be regularly monitored in case of prolonged
artificial nutrition. Dose reduction may be necessary, or Tracutil infusion
should be stopped, if manganese accumulates.
Tracutil should be used with caution in case of impaired hepatic function,
which may impair the biliary elimination of manganese, copper and zinc,
leading to accumulation and overdose.
This trace element solution should be used with caution in case of impaired
renal function, as excretion of some trace elements (selenium, fluoride,
chromium, molybdenum and zinc) may be significantly decreased.
To prevent iron overload, which is a risk mainly in patients with impaired
hepatic function or those receiving blood transfusions, serum ferritin levels
should be monitored at regular intervals.
In patients undergoing medium to long-term parenteral nutrition, there is
an increased frequency of zinc and selenium deficiency. In such circumstances,
especially in the presence of hypercatabolism, e.g. after massive
trauma, major surgery, burns etc., when necessary the dose should be
adapted and an extra supply of these elements should be provided.
Tracutil should be given with caution in cases of manifest hyperthyroidism
or sensitivity to iodine if other iodine containing medicinal products (e.g.
iodine antiseptics) are administered concomitantly.
Chromium deficiency leads to a decrease in glucose tolerance, which improves
after chromium supplementation. Then in diabetic patients on insulin
medication, relative overdose of insulin and consecutive hypoglycaemia
may result. Therefore checks of the blood glucose levels are recommended.
Re-adjustment of the insulin doses may become necessary.
Paediatric population
Tracutil is not recommended in adolescents due to lack of specific studies.
This medicinal product contains less than 1 mmol sodium (23 mg) per 10 ml
dose; i.e. essentially �sodium-free�.

For information on compatibility/incompatibility see sections 6.2 and 6.6.

Pregnancy
There are no or limited amount of data from the use of Tracutil in pregnant
women. Animal studies are insufficient with respect to reproductive toxicity
(see section 5.3). Tracutil should not be used during pregnancy unless
the clinical condition of the woman requires treatment with Tracutil.
Breastfeeding
It is unknown whether the active substances/metabolites of Tracutil are
excreted in human milk.
Tracutil should not be used during lactation except after careful consideration
of its expected benefits to mother and potential risks to the child.hA

Fertility
No data available.

Not relevant.

Immune system disorder:
Not known: Anaphylactic reactions to parenterally administered iron,
with possible fatal outcome.
Iodine may cause allergic reactions.
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.
To report any side effects :
National Pharmacovigilance & Drug Safety Center (NPC)
Fax: +966-11-205-7662
Call NPC at +966-11-2038222,
Exts: 2317-2356-2353-2354-2334-2340
Toll free phone: 8002490000
E-mail: npc.drug@sfda.gov.sa
Website: www.sfda.gov.sa/npc

Overdose with Tracutil is extremely unlikely since the quantity of trace elements
per ampoule is well below known toxic levels. If overdose is suspected,
treatment with Tracutil should be discontinued. Overdose can be
confirmed by appropriate laboratory tests.

Pharmacotherapeutic group: Blood substitutes and perfusion solutions, i.v.
solution additives; ATC code: B05X
Pharmacodynamic effects
Tracutil is a balanced solution composed of all nine trace elements that are
currently considered to be essential. They are necessary to maintain the
organism�s metabolic equilibrium.
The pharmacodynamic and pharmacokinetic properties of the ingredients
resemble those of the naturally occurring substances.
During artificial nutrition, supply of trace elements is necessary since deficiencies
can generate important metabolic and clinical disturbances.
Trace elements are normally derived from a balanced diet, but the need increases
in case of hypercatabolism (e.g. due to surgery, polytrauma, burns),
insufficient supply or abnormal loss and in cases of malabsorption (short
bowel syndrome or Crohn�s disease).
The composition of Tracutil is based on present international recommendations
concerning the requirements for trace elements.xamp

Elimination
Elimination of individual trace elements takes place via different routes:
- Iron is eliminated via faeces and, to a minimal proportion, in urine.
- Zinc is predominantly excreted in the stool, and renal excretion is low.
- Manganese is predominantly excreted via the bile into the intestines and
is partially re-absorbed from the intestines (enterohepatic circulation).
The primary route of excretion is with the faeces; elimination with the
urine or via sweat is insignificant.
- The main route of elimination of copper is in the bile, while only small
amounts are excreted via the intestinal wall into the lumen or with the
urine.
- Chromium and molybdenum are primarily excreted renally, and the remainder
is eliminated via the intestines. Molybdenum is also known to be
excreted in the bile and to be recycled via the enterohepatic circulation.
- Elimination of selenium is in the faeces or the urine, depending on the
selenium status.
- Fluorine and iodine primarily undergo renal excretion.�,uA

No conventional non-clinical studies on safety pharmacology, repeated
dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction
and development have been conducted with Tracutil.
Since Tracutil is intended for replacement therapy, the risk for toxic effects
is considered to be low at normal clinical use.

Hydrochloric acid (for pH-adjustment)
Water for injectionsa($�

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

This medicinal product does not require any special storage conditions.
For storage conditions after dilution of the medicinal product, see section
6.3.

Tracutil is supplied in 10 ml type I glass ampoules.
Tracutil is available in packages containing 5 or 50 glass ampoules.
Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in
accordance with local requirements.
The product should be inspected visually for particulate matter, damage of
container or any visible signs of deterioration prior to dilution and administration.
Solutions where such defects are observed have to be discarded.
Administration should be completed within 24 hours.
Tracutil can be diluted in not less than 250 ml of 5% w/v, 10% w/v, 20%
w/v, 40% w/v or 50% w/v glucose solution or electrolyte solutions e.g.
sodium chloride 0.9% w/v or Ringer�s solution.
Addition to the diluent solution should be performed under strict aseptic
conditions.
Tracutil must not be used as a diluent for other medicinal products.
The compatibility with solutions administered simultaneously via a common
inlet cannula must be ensured.: