Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Tracutil Concentrate for Solution for Infusion
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Ferrous chloride, Zinc chloride, Manganese chloride, Cupric chloride, Chromic chloride, Sodium molybdate dihydrate, Sodium fluoride, Sodium selenite pentahydrate, Potassium iodide may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
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.
2.
What you need to know before you take it
e Tracutil
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 iodide
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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 iron-storage 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 insulin-dependent 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. Tracutil contains sodium This medicine contains less than 1 mmol sodium (23 mg) per 10 ml dose; i.e. it is essentially 'sodiumfree'.
3.
How to take it
Tracutil
This medicine will be given to you by a healthcare professional.
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The recommended dose is: Your doctor will decide on the dose that is right for you. For normal requirements adults will receive 1 ampoule Tracutil per day and for moderately increased requirements up to 2 ampoules. 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. 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 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. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4.
Possible side effects
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 it
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.
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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
Micrograms per 1 ml 695.8
Zinc chloride
681.5
Manganese chloride
197.9
Cupric chloride
204.6
Chromic chloride
5.3
Sodium selenite pentahydrate
7.89
Sodium molybdate dihydrate
2.42
Potassium iodide
16.6
Sodium fluoride
126.0
• 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/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. What Tracutil looks like and contents of the pack 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.
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Marketing Authorisation Holder and Manufacturer B. Braun Melsungen AG Carl-Braun-Straße 1 34212 Melsungen Germany Postal address 34209 Melsungen Germany 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:
Tracutil Nutritrace Nutritrace Tracutil Tracutil Olitrace Tracutil Nutritrace Tracutil OligoPlus
This leaflet was last revised in June 2013 <—————————————————————————————————————————-> The following information is intended for healthcare professionals only: Monitoring measures 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. Incompatibilities 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 of the SmPC. Method and duration of administration 6
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. 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.
Shelf life after dilution Chemical and physical in-use stability has been demonstrated for 24 hours at 25oC. From a microbiological point of view, the product should be used immediately. If not used immediately, inuse 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 8oC, unless dilution has taken place in controlled and validated aseptic conditions.
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Frequently asked questions about Tracutil Concentrate for Solution for Infusion
How do I take Tracutil Concentrate for Solution for Infusion?
Tracutil Concentrate for Solution for Infusion comes as infusion. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Tracutil Concentrate for Solution for Infusion?
The active substance in Tracutil Concentrate for Solution for Infusion is ferrous chloride, zinc chloride, manganese chloride, cupric chloride, chromic chloride, sodium molybdate dihydrate, sodium fluoride, sodium selenite pentahydrate, potassium iodide.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Tracutil Concentrate for Solution for Infusion, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Tracutil Concentrate for Solution for Infusion without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: ferrous chloride, zinc chloride, manganese chloride, cupric chloride, chromic chloride, sodium molybdate dihydrate, sodium fluoride, sodium selenite pentahydrate, potassium iodide
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Tracutil is used as part of intravenous nutrition providing a source of trace elements for adult patients.
4.2. Posology and method of administration
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.
4.3. Contraindications
- Hypersensitivity to the active substances or to any of the excipients listed in section 6.1
- Pronounced cholestasis (serum bilirubin > 140 mmol/l and elevated levels of gamma-glutamyltransferase and alkaline phosphatase)
- Wilson's disease and disturbed iron storage (i.e. haemosiderosis or haemochromatosis).
Tracutil is contraindicated in neonates, infants and children as its composition is not suitable for this age group.
4.4. Special warnings and precautions for use
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'.
4.5. Interaction with other medicinal products and other forms of interaction
For information on compatibility/incompatibility see sections 6.2 and 6.6.
4.6. Fertility, pregnancy and lactation
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.
Fertility
No data available.
4.7. Effects on ability to drive and use machines
Not relevant
4.8. Undesirable effects
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 of 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 following:
United Kingdom
Yellow Card Scheme
www.mhra.gov.uk/yellowcard
4.9. Overdose
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.
💬 Ask about this leaflet
Ask anything about Tracutil Concentrate for Solution for Infusion. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.