Olitrace

PACKAGE LEAFLET: INFORMATION FOR THE USER

Olitrace concentrate solution for infusion

Electrolytes and trace elements
Please read this leaflet carefully before using this medicine because it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:

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

1. What Olitrace is and what it is used for

Olitrace is a concentrate which, prior to use, is diluted in a compatible infusion solution.
It is a solution used to administer trace elements during parenteral nutrition (nutrition via venous catheter) in adult patients.

2. What you need to know before using Olitrace

Do not use Olitrace

• if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6).
• if you have severe cholestasis (with reduced bile flow and abnormal liver function tests)
• if you have Wilson's disease (a disorder of copper elimination) or certain iron overload disorders (hemosiderosis, hemochromatosis)

Olitrace must not be administered to neonates, infants, or children.
Warnings and precautions
Talk to your doctor before using Olitrace:

• if your liver function is impaired: this may alter the elimination of manganese, copper, and zinc. It may be necessary to reduce the dose of the medicine.
• if your kidney function is impaired: this may significantly reduce the elimination of selenium, fluoride, chromium, molybdenum, and zinc.
• if your thyroid gland is overactive
• if you are hypersensitive to iodine

While you are receiving this medicine, various tests may be performed to ensure that there is no excessive accumulation of the elements contained in Olitrace in your body.
If your liver function is impaired or if you receive blood transfusions, your blood will be monitored regularly to check the concentration of a specific iron storage protein (serum ferritin levels), to prevent iron overload.
In patients treated with Olitrace for medium to long periods, deficiency of zinc and selenium may occur. Your doctor will adjust the dose of Olitrace according to these conditions, or will administer specific supplements.
When correcting a chromium deficiency, glucose utilization improves. This should be taken into account in patients with insulin-dependent diabetes. It may be necessary to adjust insulin doses.
Children and adolescents
This medicine must not be used in neonates, infants, and children, as its composition is not suitable for these age groups (see section “Do not use Olitrace”). The use of this medicine in adolescents is not recommended.
Other medicines and Olitrace
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Data on the use of this medicine in pregnant women are lacking or limited in number.
Olitrace must not be used during pregnancy unless the woman's clinical condition requires treatment with Olitrace.
Breastfeeding
It is not known whether the components of Olitrace are excreted in breast milk. Therefore, your doctor will carefully evaluate whether this medicine is suitable for you.
Driving and using machines
This medicine is usually administered to immobile patients in a controlled environment. This rules out the possibility of driving vehicles or operating machinery.
Olitrace contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 10 ml dose, i.e. it is practically “sodium-free”.

3. How to use Olitrace

This medicine will be administered to you by healthcare personnel.
Recommended dose:
Your doctor will determine the correct dose for you.

Normally, adults receive 1 vial of Olitrace per day, or up to 2 vials per day in case of moderately increased requirements.
If requirements are much higher (in patients with high energy demands, for example in case of severe wounds, burns or major surgical procedures), higher doses may be required.
If you have liver or kidney disease, the dose may be reduced when necessary.
Method of administration
Olitrace is administered by infusion (intravenous drip) after being diluted in a compatible infusion solution.
If you have been given more Olitrace than you should have
It is extremely unlikely that an overdose will occur with Olitrace, as the amount of trace elements per vial is well below levels that could be toxic. If an overdose is suspected, administration of Olitrace should be discontinued. Any potential overdose can be confirmed by appropriate laboratory tests.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
If you notice any of the following adverse reactions, contact your doctor immediately:
Not known (frequency cannot be estimated from the available data)
Allergic (anaphylactic) reactions to intravenously administered iron, which may be fatal.
Iodine may cause allergic reactions.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store Olitrace

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial and carton after "Exp.".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Use only if the solution is clear and colourless and the container is undamaged.

6. Contents of the pack and other information

What Olitrace contains
The active substances are salts of trace elements.
The concentrate for solution for infusion contains:

The other components are hydrochloric acid (for pH adjustment) and water for injections.
Description of the appearance of Olitrace and contents of the pack
Olitrace is a clear, colourless aqueous solution.
Olitrace is supplied in 10 ml glass vials.
Olitrace is available in packs containing 5 or 50 glass vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
B. Braun Melsungen AG
Carl-Braun-Straße 1
34212 Melsungen, Germany
Address:
34209 Melsungen, Germany
tel: +49 - (0)-5661-71-0
fax: +49 - (0)-5661-71-4567

This medicinal product is authorised in the European Economic Area countries under the following
names:
Austria: Tracutil
Belgium: Tracutil
Denmark: Nutritrace
Finland: Nutritrace
France: Tracutil
Great Britain: Tracutil
Italy: Olitrace
Luxembourg: Tracutil
Netherlands: Nutritrace
Spain: OligoPlus
The following information is intended for healthcare professionals only:
Monitoring
During treatment with Olitrace, regular monitoring of the levels of trace elements contained in this medicinal product and of other parameters is recommended.
For detailed information, see section 4.4 of the Summary of Product Characteristics.
Incompatibilities
The product must not be added to alkaline solutions with high buffer capacity, e.g. sodium bicarbonate solutions.
Do not add to lipid emulsions.
The presence of trace elements accelerates the degradation of vitamin C in infusion solutions.
Olitrace must not be added directly to inorganic phosphate solutions (additives).
Complete information on incompatibilities cannot be provided in this section. For further information, contact the Marketing Authorisation Holder.
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
Olitrace is a concentrate for infusion solution. It must be administered only intravenously, diluted in not less than 250 ml of a compatible infusion solution, 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)

Before adding to other infusion solutions, compatibility must be verified.
Addition to the diluent solution must be carried out under strictly aseptic conditions.
Compatibility with solutions administered simultaneously through the same catheter must be ensured.
Olitrace must not be used as a diluent for other medicinal products.
The infusion of the ready-to-use mixture must not last less than 6 hours and must be completed within 24 hours.
Administration may continue for the entire duration of parenteral nutrition.
Notes:
Diarrhoea may lead to increased intestinal loss of zinc. In such cases, serum concentrations should be monitored.
Deficiency of individual trace elements should be corrected by specific additional supplementation.
Stability after reconstitution
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, the storage time and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at 2–8°C, unless dilution has been carried out under controlled and validated aseptic conditions.