Package leaflet: Information for the user

AMINOACIDI SELETTIVI GALENICA SENESE 8 g/100 ml infusion solution

L-amino acids, selective
Equivalent medicine
Please read this leaflet carefully before using 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.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What AMINOACIDI SELETTIVI GALENICA SENESE is and what it is used for
What you need to know before using AMINOACIDI SELETTIVI GALENICA SENESE
How to use AMINOACIDI SELETTIVI GALENICA SENESE
Possible side effects
How to store AMINOACIDI SELETTIVI GALENICA SENESE
Contents of the pack and other information

1. What AMINOACIDI SELETTIVI GALENICA SENESE is and what it is used for

AMINOACIDI SELETTIVI GALENICA SENESE 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 medicinal product is indicated in the following cases:

for the treatment of diseases caused by severe impairment of liver function (hepatic insufficiency);
for the treatment of brain disorders caused by severe liver damage (hepatic encephalopathy);
for the treatment of patients in coma due to severe liver disease (hepatic coma).

2. What you need to know before using AMINOACIDI SELETTIVI GALENICA SENESE

Do not use AMINOACIDI SELETTIVI GALENICA SENESE

if you are allergic to any of the ingredients of this medicine (listed in section 6);
if you have severe kidney disease (severe renal failure);
if you have problems metabolizing amino acids;
if you have a severe or uncorrected imbalance of electrolytes or blood pH (severe or uncorrected electrolyte or acid-base imbalance);
if you have low circulating blood volume (hypovolemia);
If you are pregnant or breastfeeding, see the section “Pregnancy and breastfeeding”.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using AMINOACIDI SELETTIVI GALENICA SENESE.
Exposure to ambient light of parenteral nutrition solutions for intravenous use after the addition of trace elements and/or vitamins may have adverse effects on clinical outcomes in neonates and young children, due to the formation of peroxides and other degradation products. AMINOACIDI SELETTIVI GALENICA SENESE must be protected from light until completion of administration (see section 3).
This medicine must be administered with caution in the following cases:

if you have kidney problems (renal failure), as you may have specific issues related to electrolyte imbalance;
if you have lung or heart problems (cardiac failure);
if you have fluid accumulation (edema);
if you have high levels of nitrogen in the blood (hyperazotemia); this must be evaluated before starting treatment and monitored during therapy, especially in patients with kidney problems. Administration of amino acid solutions may increase blood nitrogen levels, particularly in the presence of impaired liver and kidney function or gastrointestinal bleeding;
if you have diabetes or glucose intolerance, especially if concomitant administration of glucose is required; in such cases, blood and urine glucose levels must be closely monitored;
if you have liver problems (hepatic insufficiency), to avoid complications due to accumulation of nitrogen and ammonia, which may lead to loss of consciousness and coma.

Due to its sodium content, this medicine should be administered with caution in patients with heart problems (congestive heart failure), severe kidney problems (severe renal failure), or fluid retention with sodium retention.
Due to its acetate content, this medicine should be used with caution in patients with increased blood pH (metabolic or respiratory alkalosis) or elevated acetate levels in the blood, such as in patients with liver problems (mild or moderate hepatic insufficiency).
During treatment with AMINOACIDI SELETTIVI GALENICA SENESE, the following parameters must be monitored through specific laboratory tests, and their balance restored if necessary:

levels of mineral salts (water and electrolyte balance) and blood pH (acid-base balance), correcting imbalances with appropriate corrective solutions if needed. Specific blood tests are required for:
blood nitrogen levels. In cases of elevated levels (hyperazotemia of any origin), amino acid infusions must not be administered without first evaluating the patient's total nitrogen intake, particularly in patients with impaired renal function;
blood ammonia levels. Hyperammonemia must be monitored and appropriately assessed, especially in infants;
blood glucose levels. When using high-concentration glucose solutions, blood glucose and glucose in urine must be routinely monitored. The risk of hyperglycemia must be carefully evaluated, especially in diabetic patients or in cases of impaired glucose tolerance. Furthermore, when using concentrated glucose solutions, the possibility of hyperinsulinemia following abrupt interruption of infusion must also be considered. The infusion site must also be monitored to prevent vein inflammation (phlebitis) or blood clot formation (thrombosis).

In cases of total parenteral nutrition for more than 5 days, a deficiency of essential fatty acids may occur; to prevent this, administration of lipid substances (lipid emulsions), such as those containing linoleic acid, may be beneficial.
Children
Extreme caution must be exercised when using this medicine in children, as the efficacy and safety of the medicine have not been established.
Other medicines and AMINOACIDI SELETTIVI GALENICA SENESE
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking antibiotics belonging to the tetracycline class.
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.
This medicine must not be used during pregnancy or breastfeeding unless absolutely necessary.
Driving and using machines
There are no data available regarding the effects of this medicine on the ability to drive vehicles or operate machinery.
AMINOACIDI SELETTIVI GALENICA SENESE contains sodium metabisulfite and sodium
This medicine contains sodium metabisulfite, which may rarely cause severe hypersensitivity reactions and bronchospasm.
This medicine contains 54.5 mg (2.37 mmol) of sodium per liter of solution. This should be taken into account in patients with impaired renal function or those on a low-sodium diet.

3. How to use AMINOACIDI SELETTIVI GALENICA SENESE

This medicine will be administered to you by a doctor or other specialized healthcare professional as a slow intravenous infusion (into a vein). If you have any doubts, consult your doctor, pharmacist, or nurse.
Your doctor will determine the dose and duration of treatment based on your health condition.
The recommended initial dose is 35–50 g of amino acids over 24 hours (approximately 400–600 ml). The dosage may be gradually increased up to a maximum total dose of 80–120 g of amino acids (approximately 1000–1500 ml), associated with the administration of 50–70% glucose (to ensure at least 2000 non-protein calories).
Avoid excessively rapid infusion, as this may increase the risk of adverse effects.
Parenteral nutrition must be discontinued gradually.
If other intravenous solutions (electrolytes and carbohydrates) need to be administered, it is preferable to use a separate infusion site or a side port of the infusion set, in order to avoid compatibility issues.
The solution must be used only if completely clear and free from visible particles. To minimize the risk of incompatibilities due to the addition of other prescribed substances, the solution must be carefully inspected (for cloudiness or precipitates) before administration and periodically during infusion. It is intended for single, continuous use; any remaining solution must not be reused.
Protect from exposure to light until administration is complete.
Exposure of the medicine AMINOACIDI SELETTIVI GALENICA SENESE to ambient light, especially when mixtures include trace elements and vitamins, may generate peroxides and other degradation products; these can be minimized by photoprotection (see section 2).
If you use more AMINOACIDI SELETTIVI GALENICA SENESE than you should
Since this medicine is administered by trained healthcare personnel, it is unlikely that you will receive an excessive dose. However, if you think you have been given too much AMINOACIDI SELETTIVI GALENICA SENESE, inform your doctor or another healthcare professional immediately.
Overdose of this medicine may cause changes in blood values, particularly metabolic imbalances, disturbances in mineral salts (electrolyte imbalances), and blood pH (acid-base balance); in such cases, appropriate treatment should be initiated to restore balance.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
The following adverse reactions may occur:

inflammation of the veins at the injection site and risk of blood clot formation (phlebitis and thrombophlebitis), burning and irritation (erythema);
fever, nausea, generalized erythema;
changes in blood parameters, particularly metabolic imbalances, disturbances in electrolyte levels (hydroelectrolytic), and blood pH (acid-base balance). If you experience any adverse reaction, contact your doctor immediately. The doctor must stop administration and take appropriate therapeutic countermeasures.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report adverse reactions directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store AMINOACIDI SELETTIVI GALENICA SENESE

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.
Store protected from light and at a temperature not exceeding 25°C.
The solution (in bags and in the administration set) 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 SELETTIVI GALENICA SENESE contains
The active substances are essential and non-essential amino acids.

1000 ml of solution contain 80 g of total amino acids, corresponding to: 7.5 g of L-Alanine, 6 g of L-Arginine, 1 g of L-Phenylalanine, 9 g of Glycine, 9 g of L-Isoleucine, 2.4 g of L-Histidine, 11 g of L-Leucine, 8.6 g of L-Lysine acetate (equivalent to 6.1 g of L-Lysine base), 1 g of L-Methionine, 8 g of L-Proline, 5 g of L-Serine, 4.5 g of L-Threonine, 0.76 g of L-Tryptophan, 8.4 g of L-Valine.
Each litre of solution contains 42 mEq/l of acetate, 2.37 mEq/l of sodium. pH 5.8 - 6.8. The other components are: sodium metabisulfite, edetate disodium, glacial acetic acid and water for injections.

Description of the appearance of AMINOACIDI SELETTIVI GALENICA SENESE and contents of the
package
250 ml or 500 ml glass vial containing solution for infusion.

Marketing Authorisation Holder and Manufacturer
Industria Farmaceutica Galenica Senese S.r.l., Via Cassia Nord 351 - 53014 Monteroni d’Arbia (SI).