AMINOVEN 5% Roztwór do infuzji
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Treść ulotki
Aminoven 5% Solution for Infusion, 10% Solution for Infusion, 15% solution for Infusion
Read this leaflet carefully before you receive 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, pharmacist or nurse.
- If any side effect occurs, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet:
- 1. What Aminoven is and what it is used for
- 2. What you need to know before you receive Aminoven
- 3. How to use Aminoven
- 4. Possible side effects
- 5. How to store Aminoven
- 6. Contents of the pack and other information
1. What is Aminoven and what is it used for
Aminoven provides nourishment directly into the bloodstream when it is not possible to eat normally. It provides amino acids, which your body will use to produce proteins (to build and repair muscles, organs and other structures of the body).
Aminoven is typically mixed in the pharmacy with lipids, carbohydrates, salts and vitamins, which together provide your complete nutritional needs.
- Aminoven 5% Solution for infusion
- Aminoven 10% Solution for infusion
- Aminoven 15% Solution for infusion
2. What you need to know before receiving Aminoven
You must not receive Aminoven if you suffer from or have suffered from the following conditions
Do not use Aminoven:
- If you have a condition in which your body has problems using proteins or amino acids
- If you have metabolic acidosis(the levels of acidity in your body fluids and tissues become too high)
- If you have reduced renal functionwithout dialysis treatment or another form of blood filtration treatment
- If you have severely reduced liver function
- If you have fluid retention
- If you suffer from shock
- If you have hypoxia(low oxygen levels)
- If you have decompensated heart failure
Aminoven 5% and 10% must not be used in children under 2 years of age.
Aminoven 15% must not be used for children.
For children under 2 years of age, amino acid preparations
specifically designed to meet their different metabolic needs must be used.
Warnings and precautions
Tell your doctor if you suffer from:
- low potassium levels(hypokalemia);
- low sodium levels(hyponatremia);
- folate deficiency;
- heart failure.
Before use, the doctor or nurse will check that the solution is free from visible particles.
Other medicines and Aminoven
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including those available without a prescription.
Pregnancy and breastfeeding
If you are pregnant, if you think you may be pregnant or if you are breastfeeding, you must tell your doctor.
The doctor will decide whether you should receive Aminoven.
Driving and using machines
The infusion of Aminoven has no effect on driving vehicles or using machines.
3. How to use Aminoven
You will receive the medication by infusion (drip).
The amount and rate of infusion depend on your needs.
The doctor will decide the correct dose you should receive.
You may be kept under observation during treatment.
If you use more Aminoven than you should
It is unlikely that you will receive more infusion than necessary, as the doctor or nurse will keep
you under observation during treatment. The effects of an overdose may include
nausea, vomiting and chills. If you experience these symptoms or believe you have received too much Aminoven
inform your doctor or nurse immediately.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Aminoven can cause side effects, although not everybody gets them.
The following side effects have been observed when the infusion was given too
quickly:
- loss of potassium or sodium from the blood
- folate deficiency.
The following side effects may occur at the injection site:
- irritation and sensitivity of the vein
- thrombosis (blood clot formation) in the vein at the injection site.
Reporting of side effects
If you get any side effects, talk to 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 Aminoven
Keep this medicine out of the reach and sight of children
The doctor or hospital pharmacist is responsible for the correct storage, use and disposal of Aminoven.
Do not freeze and always store the container in the outer packaging.
Do not use Aminoven after the expiry date which is stated on the label.
Any unused solution after treatment must be disposed of in accordance with approved hospital procedures.
6. Contents of the pack and other information
What Aminoven infusion solution contains
1000 ml of Aminoven contains the following active ingredients:
| n Active ingredients | Quantity (g) | ||
| Aminoven 5% | Aminoven 10% | Aminoven 15% | |
| e Isoleucine | 2.50 | 5.00 | 5.20 |
| Leucine | 3.70 | 7.40 | 8.90 |
| g Lysine acetate | 4.655 | 9.31 | 15.66 |
| Methionine | 2.15 | 4.30 | 3.80 |
| A Phenylalanine | 2.55 | 5.10 | 5.50 |
| Threonine | 2.20 | 4.40 | 8.60 |
| Tryptophan | 1.00 | 2.00 | 1.60 |
| Valine | 3.10 | 6.20 | 5.50 |
Aminoven 5% and Aminoven 10% also contain glacial acetic acid and water for injections
Aminoven 15% also contains glacial acetic acid, water for injections and malic acid.
Description of the appearance of Aminoven and contents of the pack
Aminoven 5% and Aminoven 10% are available in colourless glass bottles with a rubber stopper and
aluminium seal, containing 500 ml or 1000 ml of solution.
Aminoven 15% is available in colourless glass bottles with a rubber stopper and aluminium seal, containing 250 ml, 500 ml or 1000 ml of solution.
Aminoven 5% is also available in infusion bags containing 500 ml of solution.
Aminoven 10% and Aminoven 15% are available in infusion bags containing 500 ml or 1000
ml of solution.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Fresenius Kabi Italia S.r.l.
Via Camagre, 41
37063 Isola della Scala (Verona)
Italy
Manufacturer
Aminoven in glass bottles is manufactured by:
Fresenius Kabi Austria GmbH
Hafnerstrasse 36
A-8055 Graz
Austria
Aminoven in bags is manufactured by:
Fresenius Kabi AB Uppsala
Rapsgatan 7
S-75174 Uppsala Sweden
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| Arginine | 6.00 | 12.00 | 20.00 |
| Histidine | 1.50 | 3.00 | 7.30 |
| Alanine | 7.00 | 14.00 | o 25.00 |
| Glycine | 5.50 | 11.00 | 18.50 |
| Proline | 5.60 | 11.20 | c 17.00 |
| Serine | 3.25 | 6.50 | a 9.60 |
| Tyrosine | 0.20 | 0.40 | 0.40 |
| Taurine | 0.50 | 1.00 | 2.00 |
The following information is intended exclusively for healthcare professionals:
Dosage and method of administration:
The daily amino acid requirement depends on body weight and the patient's metabolic status.
The maximum daily dose varies depending on the patient's clinical condition and may also
change from day to day.
The recommended infusion time is that necessary to provide a continuous infusion for
at least 14 hours up to 24 hours, depending on the clinical situation. Bolus administration is not
recommended.
The solution is administered as long as parenteral nutrition is required.
Aminoven 5%
For administration as a continuous infusion via a peripheral or central vein.
The usual daily dose of Aminoven 5% is 16-20 ml per kg of body weight (equivalent to
0.8-1.0 g of amino acids per kg of body weight), i.e. corresponding to 1120-1400 ml of Aminoven
5% for a body weight of 70 kg.
The maximum infusion rate is 2.0 ml of Aminoven 5% per kg of body weight/hour
(equivalent to 0.1 g of amino acids per kg of body weight/hour).
Maximum daily dose for adults
20 ml of Aminoven 5% per kg of body weight/day (equivalent to 1.0 g of amino acids per kg of
body weight) i.e. corresponding to 70 g of amino acids for a body weight of 70 kg.
Suitable preparations are available for increased amino acid dosages.
Maximum daily dose for children and adolescents (2-18 years)
40 ml of Aminoven 5% per kg of body weight/day (equivalent to 2.0 g of amino acids per kg of body
weight/day), but the total daily fluid intake must be considered.
Aminoven 10%
For administration as a continuous infusion via a central vein.
The usual daily dose of Aminoven 10% is 10-20 ml per kg of body weight (equivalent to
1.0–2.0 g of amino acids per kg of body weight), i.e. corresponding to 700-1400 ml of Aminoven
10% for a body weight of 70 kg.
The maximum infusion rate is 1.0 ml of Aminoven 10% per kg of body weight/hour
(equivalent to 0.1 g of amino acids per kg of body weight/hour).
Maximum daily dose for adults, adolescents and children (from 2 years):
20 ml of Aminoven 10% per kg of body weight/day (equivalent to 2.0 g of amino acids per kg of
body weight), i.e. corresponding to 1400 ml of Aminoven 10% or 140 g of amino acids for a
body weight of 70 kg.
Aminoven 15%
For administration as a continuous infusion via a central vein.
The usual daily dose of Aminoven 15% is 6.7-13.3 ml per kg of body weight (equivalent to
1.0-2.0 g of amino acids per kg of body weight), corresponding to 470-930 ml of Aminoven 15%
for a body weight of 70 kg.
The maximum infusion rate is 0.67 ml of Aminoven 15% per kg of body weight per hour
(equivalent to 0.1 g of amino acids per kg of body weight per hour).
Maximum daily dose for adults
13.3 ml of Aminoven 15% per kg of body weight (equivalent to 2.0 g of amino acids per kg of body
weight) corresponding to 140 g of amino acids for a body weight of 70 kg.
Aminoven 15% is contraindicated in children.
Overdosage (symptoms, emergency procedures, antidotes)
As with other amino acid solutions, in case of overdosage with Aminoven or exceeding
the infusion rate, chills, vomiting, nausea and increased renal excretion of amino acids may occur. In this case the infusion must be stopped immediately. It
can be resumed at a reduced dose.
Infusion too rapid can cause fluid overload and electrolyte disturbances.
Emergency procedures should consist of general supportive measures, with
particular attention to the respiratory and cardiovascular systems. Careful biochemical monitoring may be essential and specific abnormalities should be treated appropriately.
There are no specific antidotes for overdosage.
Storage
Keep out of the reach and sight of children.
Store the container in the outer carton. Do not store above 25°C.
Do not freeze.
Use only clear solutions, free from particles and with intact containers.
Do not use Aminoven after the expiry date which is stated on the label after Expiry date. The expiry date refers to the last day of that month.
Aminoven must be used immediately after opening with a sterile transfer set. The
unused solution must be discarded.
Aminoven can be mixed aseptically with other nutrients such as e.g. lipid emulsions,
carbohydrates and electrolytes. Stability data chemical and physical for many mixtures stored at 4°C up to
9 days are available from the manufacturer on request.
From a microbiological point of view, total parenteral nutrition solutions mixed with
other compounds in non-controlled or non-validated conditions must be used immediately.
If not used immediately, the storage time for use and the conditions before
use are the responsibility of the user and normally should not exceed 24 hours between 2 and
8°C, unless the mixing has taken place under controlled and validated aseptic conditions.
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- Kraj rejestracji
- Postać farmaceutycznaInfusion solution, 5%
- Kod ATCB05BA01
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki AMINOVENPostać farmaceutyczna: Infusion solution, 500 MLSubstancja czynna: amino acidsProducent: MONICO S.P.A.Wymaga receptyPostać farmaceutyczna: Infusion solution, 4 G/100 MLSubstancja czynna: amino acidsWymaga receptyPostać farmaceutyczna: Infusion solution, 500 MLSubstancja czynna: amino acidsWymaga recepty
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Często zadawane pytania
AMINOVEN wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w AMINOVEN jest amino acids. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
AMINOVEN jest produkowany przez FRESENIUS KABI ITALIA S.R.L.. 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 AMINOVEN 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 AMINOVEN 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 (amino acids) to m.in. AMINOAKIDI A KATENA RAMIFIKATA MONIKO, AMINOAKIDI A KATENA RAMIFIKATA, AMINOAKIDI KR 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.
