OLITRACE 10 ML Roztwór do infuzji
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Jak stosować OLITRAKE
Treść ulotki
Olitrace concentrate for solution for infusion
Electrolytes and trace elements
Read this leaflet carefully before you use this medicine as 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 pass it on to others, even if their symptoms are the
same as yours, as it may be harmful.
If any side effects occur, including those not listed in this leaflet, tell 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 you use 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 is Olitrace and what is it used for
Olitrace is a concentrate that must be diluted in a compatible infusion solution before use.
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 you use Olitrace
Do not use Olitrace
- if you are allergic to the active ingredients or to any of the other ingredients of this medicine (listed in section 6).
- if you have pronounced cholestasis (with reduced bile flow and abnormal liver function tests)
- if you have Wilson's disease (a disorder of copper elimination) or if you have certain iron accumulation disorders (hemosiderosis, hemochromatosis)
Olitrace must not be administered to newborns, infants and 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 has increased activity
- 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 for medium and long periods with Olitrace, zinc and selenium deficiency may occur. Your
doctor will adjust the dose of Olitrace based on these conditions, or will administer appropriate
supplements.
When correcting a chromium deficiency, glucose utilization improves. This must be taken into
consideration in patients with insulin-dependent diabetes. It may be necessary to adjust doses of
insulin.
Children and adolescents
This medicine should not be used in newborns, 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 are pregnant, are planning to become pregnant, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Data relating to the use of this medicine in pregnant women are unavailable or limited.
Olitrace should not be used during pregnancy unless the woman's clinical condition makes
treatment with Olitrace necessary.
Breastfeeding
It is not known whether the components of Olitrace are excreted in breast milk. Therefore, your doctor will
carefully assess whether this medicine is suitable for you.
Driving and using machines
Usually, this medicine is administered to immobile patients in a controlled environment. This
excludes the possibility of driving vehicles and using 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 professionals.
The recommended dose is:
Your doctor will decide 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 requirement.
If the requirement is much higher (in patients with high energy needs, for example in case of
severe wounds, burns or major surgery) higher doses may be necessary.
If you have a 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 received more Olitrace than you should
It is extremely unlikely that an overdose will occur with Olitrace, as the amount of
trace elements per vial is well below the levels that could be toxic. If an overdose is suspected, the administration of Olitrace should be stopped. Any overdose can be
confirmed with appropriate laboratory tests.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any of the following side effects, contact your doctor immediately:
not known (frequency cannot be estimated based on available data)
Allergic (anaphylactic) reactions to iron administered intravenously, with possible fatal outcome.
Iodine may cause allergic reactions.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at www.agenziafarmaco.gov.it/it/responsabili
By reporting side effects 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 which is stated on the vial and the packaging box after “Exp.”. The
expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Use only if the solution is clear and colourless and the container is intact.
6. Contents of the pack and other information
What Olitrace contains
The active ingredients are trace element salts.
The concentrate for solution for infusion contains:
| micrograms in 1 ml | |
| Ferrous chloride Zinc chloride Manganese chloride Cupric chloride Chromic chloride Sodium selenite pentahydrate Sodium molybdate dihydrate Potassium iodide Sodium fluoride | 695.8 681.5 197.9 204.6 5.3 7.89 2.42 16.6 126.0 |
| Trace element content | d micromoles/vial | micrograms/vial |
| Iron Zinc Manganese Copper Chromium Selenium Molybdenum Iodine Fluorine | 35 a 50 10 n 12 0.2 a 0.3 0.1 i 1.0 30 |
|
The other components are hydrochloric acid (for pH adjustment) and water for injections.
Description of Olitrace and contents of the pack
Olitrace is a clear and 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 Member States of the European Economic Area with the following
denominations:
Tracutil
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:
Monitoring
During treatment with Olitrace, it is recommended to regularly monitor the levels of the trace elements
contained in this medicinal product and other parameters.
For detailed information, see section 4.4 of the summary of product characteristics.
Incompatibilities
The product should not be added to alkaline solutions with a high buffering 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 should not be added directly to inorganic phosphate solutions (additives).
Complete information regarding incompatibilities cannot be provided in this section. For further
information, contact the marketing authorisation holder.
This medicinal product should 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 solution for infusion. 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) Austria: Belgium:
Before adding to other infusion solutions, compatibility must be proven.
Addition to the diluent solution must be carried out under strictly aseptic conditions.
Ensure compatibility with solutions administered simultaneously via the same
cannula.
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 be continued for the entire duration of parenteral nutrition.
Notes:
Diarrhoea can lead to increased intestinal loss of zinc. In this case, serum concentrations must be
checked.
Deficiency of individual trace elements should be corrected by additional specific supplementation.
Shelf life after reconstitution
Chemical and physical stability has been demonstrated after reconstitution for a period of 24 hours at 25°C.
From a microbiological point of view, the product must be used immediately. If not used immediately, the
storage times and conditions prior to use are the responsibility of the user and should not normally exceed
24 hours at 2-8°C, unless the dilution has been carried out in controlled and validated aseptic conditions.
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- Kraj rejestracji
- Postać farmaceutycznaInfusion solution, 10 ML
- Kod ATCB05XA30
- Substancja czynna
- Wymaga receptyNie
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki OLITRAKEPostać farmaceutyczna: Concentrate for infusion solution, 290 MG/10 ML + 610 MG/10 MLSubstancja czynna: combinations of electrolytesWymaga receptyPostać farmaceutyczna: Concentrate for infusion solution, 10 MLSubstancja czynna: combinations of electrolytesProducent: MONICO S.P.A.Wymaga receptyPostać farmaceutyczna: Concentrate for infusion solution, 1 G/10 MLSubstancja czynna: calcium chlorideWymaga recepty
Odpowiedniki OLITRAKE w innych krajach
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Często zadawane pytania
OLITRAKE nie wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w OLITRAKE jest combinations of electrolytes. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
OLITRAKE jest produkowany przez B. BRAUN MELSUNGEN AG. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie OLITRAKE jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić OLITRAKE w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (combinations of electrolytes) to m.in. KALKIO E MANYESIO KLORURO BIOINDUSTRIA L.I.M., SOLUTSIONE POLISALINIKA KONKENTRATA SENTSA POTASSIO, KALKIO KLORURO BIOINDUSTRIA L.I.M.. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
