Amino acids and Bioindustria L.I.M.

Patient Information Leaflet: Information for the User

AMINOACIDS E Bioindustria L.I.M. infusion solution

5.4% Essential L-amino acids for nephrology
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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What AMINOACIDI E Bioindustria L.I.M. is and what it is used for

AMINOACIDI E 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 by mouth (parenteral nutrition).
This medicinal product is indicated in the following cases:

• to provide the body with protein components (amino acids) in patients suffering from kidney diseases (acute and chronic renal failure) and/or undergoing mechanical blood filtration (post-dialysis period);
• to supply amino acids (amino acid supplementation) in patients with kidney problems (renal failure) following surgical intervention (post-operative period).

2. What you need to know before using AMINOACIDS E Bioindustria L.I.M.

Do not use AMINOACIDS E 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.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using AMINOACIDS E Bioindustria L.I.M.
The solution (in bags and administration sets) must be protected from exposure to light until administration is complete. Exposure of AMINOACIDS E Bioindustria L.I.M. to ambient light, especially after the addition of trace elements and/or vitamins, generates peroxides and other degradation products, which can be minimized by protecting the solution from light.
This medicine must be administered with caution if you have severe liver problems (severe hepatic insufficiency), to avoid complications due to accumulation of amino acids and ammonia in the blood (aminoacidemia and hyperammonemia).
Before treatment with AMINOACIDS E Bioindustria L.I.M., serum electrolyte levels (water and electrolyte balance) and blood pH (acid-base balance) must be checked via specific laboratory tests. If necessary, imbalances should be corrected by administering appropriate electrolyte solutions.
Furthermore, blood glucose levels (glycemia), protein levels (proteinemia), and ammonia levels (ammoniemia) should be monitored, along with blood volume (volemia), liver and kidney function, blood cell count (hematological examination), and other specific tests (CO(_2) combining capacity, and serum osmolarity including mineral salts and protein levels).
To avoid excessive increase in blood chloride levels (hyperchloremia), it is recommended to administer the daily requirement of sodium and potassium in the form of acetate salts.

Children
Extreme caution must be exercised when using this medicine in children and neonates, as it may cause increased blood ammonia levels (hyperammonemia), particularly in patients with low body weight or when high doses are administered.

Other medicines and AMINOACIDS E Bioindustria L.I.M.
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take 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 to become pregnant, or are breastfeeding, consult your doctor or pharmacist before this medicine is administered.
There are no available data on the use of this medicine in pregnant or breastfeeding women.
Your doctor will prescribe this medicine only if clearly necessary.

Driving and using machines
There are no available data regarding the effects of this medicine on the ability to drive or operate machinery.

AMINOACIDS E Bioindustria L.I.M. contains sodium metabisulfite and sodium
This medicine contains sodium metabisulfite, which may rarely cause severe hypersensitivity reactions and bronchospasm.
This medicine contains 30 mg (1.3 mmol) of sodium per 250 ml of solution.
This should be taken into consideration in patients with impaired renal function or those on a low-sodium diet.

3. How to use AMINOACIDI E Bioindustria L.I.M.

This medicine will be administered to you by a doctor or other trained healthcare professional as a slow infusion into a vein (intravenous route). If you have any doubts, consult your doctor, pharmacist, or nurse.
Your doctor will determine the dose and duration of treatment according to your medical condition.
The recommended dose is 250–500 ml per day for slow intravenous infusion directly into a vein (intravenous route).
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 and continuous administration; any remaining solution must not be reused. The solution (in bags and administration sets) must be protected from exposure to light until the end of administration (see section 2).
If you use more AMINOACIDI E Bioindustria L.I.M. than you should
Since this medicine is administered by trained healthcare professionals, it is unlikely that you will receive an excessive dose. However, if you think that you have been given too much AMINOACIDI E Bioindustria L.I.M., inform your doctor or another healthcare provider 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 everyone will experience them.
The following side effects may occur:

• fever, chills, nausea and vomiting, especially if administered as a 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 stop 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, consult your doctor or pharmacist.
You may 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 AMINOACIDS AND 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.
Keep protected 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 any medicine 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 E Bioindustria L.I.M. contains

• The active substances are L-amino acids. 250 ml of solution contain: 0.75 g of L-phenylalanine (18.16 mmol/l), 1.75 g of L-isoleucine (53.36 mmol/l), 1.25 g of L-histidine (32.22 mmol/l), 1.75 g of L-leucine (53.36 mmol/l), 2.0 g of L-lysine hydrochloride (equivalent to 1.6 g of L-lysine) (43.78 mmol/l), 1.7 g of L-methionine (45.57 mmol/l), 2.0 g of L-threonine (67.16 mmol/l), 0.5 g of L-tryptophan (9.79 mmol/l), 2.25 g of L-valine (77.82 mmol/l).
• Other components are: sodium metabisulfite 0.125 g, hydrochloric acid 37% 0.85 g and water for injections.

Description of the appearance of AMINOACIDI E Bioindustria L.I.M. and contents of the pack
250 ml vial of infusion solution.
Marketing Authorisation 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 user

AMINO ACIDS AND Bioindustria L.I.M. infusion solution

5.4% essential L-amino acids for nephrology
Equivalent medicine

The following information is intended exclusively for physicians or healthcare professionals

Route 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 parenteral nutrition solutions for intravenous use, particularly after 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 E Bioindustria L.I.M. must be protected from ambient light until administration is complete.
Special precautions for disposal and handling
Protect from exposure to light until administration is complete. Exposure of AMINOACIDI E 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 protecting the solution from light exposure.
For further information, please refer to the Summary of Product Characteristics