AMINO ACIDS ESSENTIAL GALENICA SENESE

Package leaflet: Information for the user

AMINOACIDS GALENICA SENESE 5.3 g/100 ml solution for infusion

L-amino acids
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 doubts, 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 effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

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

AMINOACIDI ESSENZIALI 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 to provide protein substances to individuals affected by kidney diseases (acute and chronic renal failure) and/or undergoing mechanical blood filtration (peritoneal dialysis or haemodialysis).

2. What you must know before using AMINOACIDI ESSENZIALI GALENICA SENESE

Do not use AMINOACIDI ESSENZIALI GALENICA SENESE

• if you are allergic to the active substances or to any of the other components of this medicine (listed in section 6);
• if you have severe liver problems that may cause confusion and mental problems (hepatic encephalopathy) or are in a state of coma;
• if you have problems metabolizing amino acids;
• if you have a severe or uncorrected imbalance of mineral salts or blood pH (severe electrolyte or acid-base imbalance);
• if you have high levels of ammonia (hyperammonemia) or nitrogen in the blood;
• if you have low circulating blood volume (hypovolemia);
• if you suffer from severe liver disease (severe hepatic disease);
• if you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using AMINOACIDI ESSENZIALI 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 ESSENZIALI GALENICA SENESE must be protected from light until administration is completed (see section 3).
This medicine must be administered with caution in the following cases:

• if you suffer from kidney problems (renal failure);
• if you have lung or heart problems (cardiac failure), in order to avoid fluid accumulation (edema);
• if you have high levels of nitrogen in the blood (hyperazotemia), this should be evaluated before starting treatment and monitored during therapy, especially in people with kidney problems;
• if you suffer from diabetes or glucose intolerance, in case glucose needs to be co-administered; in this case, blood and urine glucose levels must be monitored;
• if you suffer from liver problems (hepatic insufficiency), to avoid complications due to amino acid imbalance, increased pH (metabolic alkalosis), or accumulation of nitrogen and ammonia, which may lead to loss of consciousness and coma.

Due to the presence of sodium, this medicine should be administered with caution in patients with heart problems (congestive heart failure), severe kidney problems (severe renal insufficiency), or fluid accumulation with sodium retention.
Due to the presence of acetate, this medicine should be used with caution in patients with increased pH (metabolic and 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 ESSENZIALI GALENICA SENESE, it is necessary to monitor levels of mineral salts (water and electrolyte balance) and blood pH (acid-base balance) through specific laboratory tests, and to restore balance if needed by administering corrective solutions. In case of significant deviations from normal values (such as may occur, for example, with prolonged nasogastric aspiration, vomiting, or diarrhea), appropriate therapeutic countermeasures should be taken. In addition, the infusion site should be monitored to prevent vein inflammation (phlebitis) or blood clot formation (thrombosis).
In case of kidney disease (chronic renal failure) not treated with hemodialysis or peritoneal dialysis, the product may be used only until oral protein administration becomes possible. In case of acute renal failure with adequate urine output, use should be limited to a few days, with a maximum of two weeks.
In case of total parenteral nutrition for more than 5 days, a deficiency of essential fatty acids may occur; to prevent this, administration of fat-containing substances (lipid emulsions), such as linoleic acid, may be beneficial.
Excessively rapid infusion may increase the risk of adverse effects.
Parenteral nutrition should be discontinued gradually.
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 ESSENZIALI GALENICA SENESE
Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicine.
In particular, inform your doctor if you are taking antibiotics belonging to the tetracycline class.
Tetracyclines may reduce the protein-sparing effect of amino acid solutions.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before this medicine is administered to you.
This medicine must not be used during pregnancy or breastfeeding unless strictly necessary.
Driving and using machines
There are no data available regarding the effects of this medicine on the ability to drive or operate machinery.
AMINOACIDI ESSENZIALI GALENICA SENESE contains sodium metabisulfite
This medicine contains sodium metabisulfite, which may rarely cause severe hypersensitivity reactions and bronchospasm.
This medicine contains 24.19 mg of sodium (the main component of table salt) per liter of solution. This corresponds to 1.21% of the maximum recommended daily dietary intake for an adult.

3. How to use AMINOACIDI ESSENZIALI GALENICA SENESE

This medicine will be administered to you by a doctor or other trained healthcare professional as a slow intravenous infusion, with an infusion rate not exceeding 20 drops per minute. If you have any doubts, consult your doctor, pharmacist, or nurse.
The doctor will determine the dose and duration of treatment based on your health condition and body weight.
In case of kidney disease (acute and chronic renal failure) not undergoing dialysis treatment, the recommended dose is up to 0.5 g of amino acids per kilogram of body weight per day (equivalent to 500 ml for a 70 kg patient).
In case of kidney disease (acute and chronic renal failure) undergoing hemodialysis or peritoneal dialysis, the recommended dose is up to 1 g of amino acids per kilogram of body weight per day (equivalent to 1000 ml for a 70 kg patient).
The maximum dosage is up to 1.5 g of amino acids per kilogram of body weight per day (equivalent to 1500 ml/day for a 70 kg patient).
In patients with chronic renal failure not treated with hemodialysis or peritoneal dialysis, this product may be used until oral protein administration becomes possible. In acute renal failure with adequate urine output, treatment should be limited to a few days, with a maximum duration of two weeks.
Avoid excessively rapid infusion, as it may increase the risk of adverse effects.
The solution should be used only if it is clear, colourless or slightly straw-yellow, and free from visible particles.
Protect from light exposure until administration is complete. Exposure of the medicine AMINOACIDI ESSENZIALI GALENICA SENESE to ambient light, especially when mixtures contain trace elements and vitamins, may generate peroxides and other degradation products, which can be minimized by photoprotection (see section 2).
This product is intended for single, continuous administration; any unused portion must not be reused.
If you use more AMINOACIDI ESSENZIALI GALENICA SENESE 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 been given too much AMINOACIDI ESSENZIALI GALENICA SENESE, inform your doctor or another healthcare provider immediately.
Overdose may cause blood test abnormalities, particularly metabolic, electrolyte, and blood pH (acid-base) imbalances; in such cases, appropriate treatment should be initiated to restore balance.
If you have any questions about how to use this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everybody gets them.
The following side effects may occur:

• inflammation of the veins at the injection site (phlebitis and thrombophlebitis), burning and irritation (erythema);
• fever, nausea, generalized erythema;
• changes in blood parameters, particularly metabolic, water-electrolyte and acid-base imbalances.

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 ESSENZIALI 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 pack after “Exp”.
The expiry date refers to the last day of that month.
Store in the original packaging to protect from light and at a temperature below 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 ESSENZIALI GALENICA SENESE contains

• The active substances are amino acids. 1000 ml of solution contain 53.4 g of total amino acids corresponding to: 8.8 g of L-Phenylalanine, 8.8 g of L-Leucine, 5.6 g of L-Isoleucine, 9.0 g of L-Lysine acetate (equivalent to 6.4 g of L-Lysine base), 8.8 g of L-Methionine, 4.0 g of L-Threonine, 2.0 g of L-Tryptophan, 6.4 g of L-Valine, 2.6 g of L-Histidine. Each liter of solution contains 44 mEq of acetate, 1.05 mEq of sodium and 6.54 g of total nitrogen. pH 5.8 - 6.8.
• The other components are: sodium metabisulfite, glacial acetic acid and water for injections.

Description of the appearance of AMINOACIDI ESSENZIALI GALENICA SENESE and contents of the
package
250 ml or 500 ml vial of infusion solution.
Marketing Authorization Holder and Manufacturer
Industria Farmaceutica Galenica Senese S.r.l. - Via Cassia Nord, 351 – 53014 Monteroni d’Arbia (SI).