Amino acids CR Bioindustria L.I.M.
ItalyTable of Contents
Package leaflet: Information for the user
L-Amino Acids, Branched Chain 4%
Equivalent medicine
Please read all of this leaflet carefully before you start 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 other people, even if their symptoms are the same as yours, as it may be harmful.
- If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
Contents of this leaflet:
- What AMINOACIDI CR Bioindustria L.I.M. is and what it is used for
- What you need to know before using AMINOACIDI CR Bioindustria L.I.M.
- How to use AMINOACIDI CR Bioindustria L.I.M.
- Possible side effects
- How to store AMINOACIDI CR Bioindustria L.I.M.
- Contents of the pack and other information
1. What AMINOACIDI CR Bioindustria L.I.M. is and what it is used for
AMINOACIDI CR Bioindustria L.I.M. contains a group of substances called amino acids, which are essential for the human body and used to nourish patients who cannot be fed orally (parenteral nutrition).
This medicine is indicated in the following conditions:
- for the treatment of patients in coma due to severe liver disease (hepatic coma grade III and IV);
- for the treatment of diseases and brain function disorders caused by severe liver damage (hepatic encephalopathy);
- as supplementation of protein substances in debilitated patients following surgical operations or various types of trauma (post-traumatic, surgical and non-surgical states);
- in the treatment of a metabolic disturbance state (hypercatabolism);
- in combination therapy for diseases and brain function disorders caused by infection (septic encephalopathy) or kidney malfunction (uremic encephalopathy).
2. What you need to know before using AMINOACIDI CR Bioindustria L.I.M.
Do not use AMINOACIDI CR Bioindustria L.I.M.
- if you are allergic to any of the ingredients of this medicine (listed in section 6);
- if you have problems metabolizing amino acids;
- if you suffer from kidney malfunction (renal insufficiency).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using AMINOACIDI CR Bioindustria L.I.M.
The solution (in bags and administration sets) must be protected from exposure to light until administration is complete. Exposure of AMINOACIDI CR Bioindustria L.I.M. to ambient light, especially after addition of trace elements and/or vitamins, may generate peroxides and other degradation products, which can be minimized by protecting from light exposure.
This medicine will be administered to you with caution in the following cases:
- if you have kidney problems (renal insufficiency, reduced renal clearance);
- if you have diabetes; in this case, care must be taken regarding the concomitant administration of sugars.
During treatment with AMINOACIDI CR Bioindustria L.I.M., it is necessary to monitor levels of mineral salts (fluid and electrolyte balance) and blood pH (acid-base balance) through specific laboratory tests, and correct any imbalances as needed by administering appropriate electrolyte solutions.
Other medicines and AMINOACIDI CR Bioindustria L.I.M.
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
No interactions with other medicines are known. However, it is advisable not to mix this medicine with other medicinal products.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before this medicine is administered to you.
There are no available data regarding the use of this medicine in pregnant or breastfeeding women. Your doctor will prescribe this medicine only if clearly needed.
Driving and using machines
There are no data available regarding the effects of this medicine on the ability to drive vehicles or operate machinery.
3. How to use AMINOACIDI CR Bioindustria L.I.M.
This medicine will be administered to you by a doctor or other trained healthcare professional. If you have any doubts, please consult your doctor, pharmacist, or nurse.
The doctor will determine the dose and duration of treatment based on your health condition.
The recommended dose is 2 vials (1000 ml) on the first day of treatment, which may be increased to 3 vials (1500 ml) starting on the second day and thereafter.
This medicine will be administered directly into a vein (slow intravenous infusion), one vial over approximately 8 hours. An adequate amount of glucose (approximately 300–400 g per 24 hours) will generally be administered concomitantly to ensure an appropriate caloric intake.
Preparation of the medicine: Use immediately after opening the container. The solution should only be used if it is perfectly clear and free from visible particles. It is intended for single, continuous administration; any unused portion must not be reused.
If crystals are observed in the neck of the vial, the vial must be warmed to 37°C until any crystals are completely dissolved before administering the solution.
The solution (in bags and administration sets) must be protected from exposure to light until administration is complete (see section 2).
If you use more AMINOACIDI CR Bioindustria L.I.M. than you should
Since this medicine will be administered by trained healthcare professionals, it is unlikely that you will receive an excessive dose. However, if you think that you have received too much AMINOACIDI CR Bioindustria L.I.M., inform your doctor or another healthcare professional immediately.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur:
- fever, chills, nausea and vomiting, especially if administered by rapid intravenous infusion (intravenous infusion);
- skin irritation (urticaria) or redness (vasodilatation), abdominal pain, involuntary muscle movements (convulsions). If you experience these symptoms, inform your doctor immediately; the doctor must discontinue administration;
- inflammation of the veins at the injection site (phlebitis and thrombophlebitis).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store AMINOACIDI CR Bioindustria L.I.M.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP.".
The expiry date refers to the last day of that month.
Protect from light.
The solution (in bags and administration sets) must be protected from exposure to light
until administration is complete (see section 2).
Do not dispose of medicines via wastewater or household waste.
Ask your pharmacist how to dispose of medicines you no longer use.
This will help protect the environment.
6. Package contents and other information
What AMINOACIDI CR Bioindustria L.I.M. contains
- The active substances are L-amino acids with branched chains. 500 ml of solution contain: 6.43 g of L-isoleucine, 7.855 g of L-leucine, 6.0 g of L-valine. The other component is: water for injections.
Description of the appearance of AMINOACIDI CR Bioindustria L.I.M. and contents of the package
500 ml vial of solution for intravenous infusion.
Marketing Authorization Holder and Manufacturer
Bioindustria Laboratorio Italiano Medicinali S.p.A.
(Bioindustria L.I.M. S.p.A.)
Via de Ambrosiis 2, 15067 Novi Ligure (AL) - Italy
Package leaflet: information for the physician
L-Amino acids with branched chains 4%
Generic medicinal product
The following information is intended exclusively for physicians or healthcare professionals
Method of administration
The solution (in bags and administration sets) must be protected from exposure to light until administration is complete.
Special warnings and precautions for use
Exposure to light of intravenous parenteral nutrition solutions, particularly after the addition of trace elements and/or vitamins, may have adverse effects on clinical outcomes in neonates due to the formation of peroxides and other degradation products. AMINOACIDI CR Bioindustria L.I.M. must be protected from ambient light until administration is complete.
Special precautions for disposal and handling
Protect from light exposure until administration is complete. Exposure of AMINOACIDI CR Bioindustria L.I.M. to ambient light, especially after addition of trace elements and/or vitamins, leads to the formation of peroxides and other degradation products, which can be minimized by protection from light.
For further information, please consult the Summary of Product Characteristics