SUPPLYELT 10ML Koncentrat do roztworu do wstrzykiwań/infuzji
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Treść ulotki
- What is SUPPLYELT and what is it used for
- What you need to know before using SUPPLYELT
- How to use SUPPLYELT
- Possible side effects
- How to store SUPPLYELT
- Contents of the pack and other information
SUPPLYELT, Concentrate for solution for infusion
Read this leaflet carefully before using 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, pharmacist or nurse.
- 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 could be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet
- 1. What SUPPLYELT is and what it is used for
- 2. What you need to know before using SUPPLYELT
- 3. How to use SUPPLYELT
- 4. Possible side effects
- 5. How to store SUPPLYELT
- 6. Contents of the pack and other information
1. What is SUPPLYELT and what is it used for
SUPPLYELT is a concentrate for infusion solution.
It contains 9 essential trace elements (iron, copper, manganese, zinc, fluorine, iodine, selenium, chromium,
molybdenum).
These trace elements are considered essential because the body cannot produce them but needs them in very small quantities to function correctly.
SUPPLYELT is used to provide trace elements in adults who require parenteral nutrition (intravenous).
2. What you need to know before using SUPPLYELT
Do not use SUPPLYELT:
- If you are allergic (hypersensitive) to any of the ingredients of SUPPLYELT (see section 6 of this leaflet).
- If the levels in the blood of one of the medicinal product's components are elevated, abnormally. (If you have any doubts, consult your doctor).
- If you suffer from pronounced cholestasis (yellowing of the skin or whites of the eyes caused by liver or blood problems).
- If you have an excess of copper (Wilson's disease) or iron (hemochromatosis) in the body.
Warnings and precautions
Talk to your doctor or pharmacist before taking SUPPLYELT if
- you have kidney problems,
- you have liver problems, for example mild cholestasis (reduced liver function with yellowing of the skin or whites of the eyes)
- you receive repeated blood transfusions.
- you suffer from diabetes and are undergoing insulin therapy,
- you suffer from thyroid disorders, or if you are taking medicines containing iodine (e.g. iodine-based antiseptics).
The level of trace elements in the blood will be monitored regularly by the doctor during the
treatment, and the doctor will adjust the dosage of SUPPLYELT accordingly.
Children
SUPPLYELT should not be used in children and adolescents.
Other medicines and SUPPLYELT
Tell your doctor if you are taking, have recently taken or might take any other
medicines. In particular iron salts (oral route).
SUPPLYELT and alcohol
Not applicable
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or nurse for advice before using this medicine.
SUPPLYELT should not be used during pregnancy and breastfeeding unless your doctor considers it
absolutely necessary.
Driving and using machines
Not applicable
SUPPLYELT contains sodium
and potassium
This medicine contains less than 1 mmol of sodium (23 mg) per vial, i.e. it is practically “sodium-free”.
This medicine contains less than 1 mmol of potassium (39 mg) per vial, that is to say essentially
“potassium-free”.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
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3. How to use SUPPLYELT
SUPPLYELT is intended for use in adult patients only.
SUPPLYELT will be administered to you intravenously (into a vein) by a nurse or a doctor. Use
this medicine following the doctor's instructions exactly. If you have any doubts, ask your
doctor or pharmacist.
Instructions for diluting SUPPLYELT before administration
SUPPLYELT is not intended to be administered in its formulation as is.
SUPPLYELT must be diluted or mixed with gentle agitation during preparation under
strict aseptic conditions, before infusion.
SUPPLYELT must be diluted respecting the appropriate final osmolarity. For example:
- From 10 to 20 ml of SUPPLYELT can be diluted in at least 250 ml of Sodium Chloride 0.9% solution for infusion,
- From 10 to 20 ml of SUPPLYELT can be diluted in at least 250 ml of Glucose 5% solution for infusion. The pH after reconstitution of 20 ml of SUPPLYELT with 250 ml of sodium chloride 0.9% will be 3.3 or 3.3-3.4 with glucose 5%.
The reconstituted solution for infusion must be visually inspected before use. Only a clear
solution free of particles should be used.
Do not store partially used containers and discard all equipment after use.
Compatibility with solutions administered simultaneously via a
common inlet cannula must be ensured.
The degradation of ascorbic acid in parenteral nutrition mixtures is accelerated by trace
elements.
This medicine should not be mixed with other medicines except those mentioned in
this paragraph.
SUPPLYELT should not be used as a vehicle for other drugs.
Dosage
The doctor will determine the correct dosage for you.
The recommended daily dose is one vial (10 ml) of SUPPLYELT. The doctor may administer
up to 2 vials per day.
SUPPLYELT will be diluted before use.
Use in children
SUPPLYELT should not be used in children and adolescents.
Use a specific product to provide trace elements to children and adolescents when
parenteral nutrition (into a vein) is required.
If you use more SUPPLYELT than you should
The doctor will stop the treatment with SUPPLYELT and perform the necessary laboratory
tests in case of suspected overdose.
If you stop using SUPPLYELT
Not applicable
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor if you notice any of the following:
Frequency not known (the frequency cannot be estimated from the available data): Pain at the
application site.
Cases of hypersensitivity reactions including fatal anaphylactic reactions have been reported in
patients receiving intravenous medicines containing iron.
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system at
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting side effects you can help provide more information on the safety of
this medicine.
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5. How to store SUPPLYELT
After dilution, chemical and physical stability during use has been demonstrated for 48 h at 25°C protected from light.
From a microbiological point of view, the medicine must be used immediately after dilution. If not used immediately, the storage times during use and the conditions before use are the responsibility of the user.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is stated on the label after Expiry. The expiry date refers to the last day of that month.
Do not freeze.
Keep the container in the outer packaging to protect the medicine from light.
Do not use this medicine if you notice visible signs of deterioration.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What SUPPLYELT contains
The active ingredients are:
For 10 ml of SUPPLYELT
Zinc (Zn) 10000 µg (as Zinc gluconate)
Copper (Cu) 300 µg (as Copper gluconate)
Manganese (Mn) 55 µg (as Manganese gluconate)
Fluorine (F) 950 µg (as Sodium fluoride)
Iodine (I) 130 µg (as Potassium iodide)
Selenium (Se) 70 µg (as Sodium selenite)
Molybdenum (Mo) 20 µg (as Sodium molybdate)
Chromium (Cr) 10 µg (as Chromium chloride)
Iron (Fe) 1000 µg (as Iron gluconate)
The other components are hydrochloric acid and water for injectable preparations.
Description of the appearance of SUPPLYELT and contents of the pack
SUPPLYELT is a clear, transparent and slightly yellow concentrate for infusion solution in
a 10 ml vial.
SUPPLYELT is packaged in boxes of 10, 25 and 50 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Laboratoire Aguettant
1 rue Alexander Fleming
69007 LYON
France
Manufacturer responsible for batch release
Laboratoire AGUETTANT
Lieu-dit Chantecaille
07340 CHAMPAGNE
France
- Kraj rejestracji
- Postać farmaceutycznaConcentrate for injectable/infusion solution, 10ML
- Kod ATCB05XA31
- Substancja czynna
- Wymaga receptyNie
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki SUPPLYELTPostać farmaceutyczna: Concentrate for infusion solution, 10 MLSubstancja czynna: electrolytes in combination with other drugsProducent: LABORATOIRE AGUETTANTWymaga receptyPostać farmaceutyczna: Concentrate for infusion solution, 1 G/10 MLSubstancja czynna: calcium chlorideWymaga receptyPostać farmaceutyczna: Concentrate for injectable/infusion solution, 500 MG/10 MLSubstancja czynna: calcium chlorideWymaga recepty
Odpowiedniki SUPPLYELT w innych krajach
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Odpowiednik SUPPLYELT w Polska
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Często zadawane pytania
SUPPLYELT 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 SUPPLYELT jest electrolytes in combination with other drugs. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
SUPPLYELT jest produkowany przez LABORATOIRE AGUETTANT. 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 SUPPLYELT 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 SUPPLYELT 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 (electrolytes in combination with other drugs) to m.in. TRAKYELT, KALKIO KLORURO BIOINDUSTRIA L.I.M., KALKIO KLORURO GALENIKA SENESE. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
