Amino acids essential and non-essential Galenica Senese

Package leaflet: Information for the user

ESSENTIAL AND NON-ESSENTIAL AMINO ACIDS GALENICA SENESE 10 g/100 ml

infusion solution
L-Amino acids, essential and non-essential
Generic 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 they have the same symptoms as yours, because it could 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 ESSENTIAL AND NON-ESSENTIAL GALENICA SENESE is and what it is used for
2. What you need to know before using AMINOACIDS ESSENTIAL AND NON-ESSENTIAL GALENICA SENESE
3. How to use AMINOACIDS ESSENTIAL AND NON-ESSENTIAL GALENICA SENESE
4. Possible side effects
5. How to store AMINOACIDS ESSENTIAL AND NON-ESSENTIAL GALENICA SENESE
6. Contents of the pack and other information

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

AMINOACIDI ESSENZIALI E NON ESSENZIALI GALENICA SENESE contains a group of substances known as 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 all situations where supplementation with protein substances is required:

• as a supplement of protein substances in debilitated individuals before and/or after surgical procedures (pre- and post-surgery) or various types of trauma, in cases of generalized infection (sepsis), or burns;
• in the treatment of a metabolic disturbance state (hypercatabolism);
• in debilitated individuals due to prolonged malnutrition (cachectic states).

2. What you need to know before using AMINOACIDS ESSENTIAL AND NON-ESSENTIAL

GALENICA SENESE
Do not use AMINOACIDS ESSENTIAL AND NON-ESSENTIAL GALENICA SENESE

• if you are allergic to any of the ingredients of this medicine (listed in section 6);
• if you have severe kidney function problems (severe renal insufficiency);
• if you suffer from a severe liver disease that may cause confusion and mental problems (hepatic encephalopathy) or are in a coma;
• if you have problems metabolizing amino acids;
• if you have a severe or uncorrected imbalance of blood electrolytes or pH (electrolyte or acid-base imbalance);
• if you have high levels of ammonia (hyperammonemia) or other disorders characterized by reduced nitrogen utilization;
• if you have low circulating blood volume (hypovolemia);
  If you are pregnant or breastfeeding, see section “Pregnancy and breastfeeding”.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using AMINOACIDS ESSENTIAL AND NON-ESSENTIAL 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 children under 2 years of age, due to the formation of peroxides and other degradation products. AMINOACIDS ESSENTIAL AND NON-ESSENTIAL GALENICA SENESE must be protected from light until administration is complete (see section 3).
This medicine must be administered with caution in the following cases:

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

Due to its sodium content, this medicine must be administered with caution in patients with heart problems (congestive heart failure), severe kidney problems (severe renal insufficiency), or fluid retention with sodium retention.
Due to the presence of acetate, this medicine must be used with caution in patients with increased pH (metabolic or respiratory alkalosis) or elevated blood acetate levels, such as in patients with mild to moderate liver impairment (hepatic insufficiency).
During treatment with AMINOACIDS ESSENTIAL AND NON-ESSENTIAL GALENICA SENESE, it is necessary to monitor levels of electrolytes (water and electrolyte balance) and blood pH (acid-base balance) through specific laboratory tests, and correct any imbalances with appropriate corrective solutions. Specific blood tests must be performed to monitor:

• nitrogen levels in the blood. Amino acid infusions must not be administered in cases of hyperazotemia of any origin without first evaluating the patient's total nitrogen intake, particularly in patients with impaired renal function;
• ammonia levels in the blood. Hyperammonemia must be monitored and adequately assessed, especially in children;
• blood glucose levels. When using high-concentration glucose solutions, blood glucose and glucose in urine (glycosuria) must be routinely monitored. The risk of hyperglycemia must be carefully evaluated, especially in diabetics and in cases of impaired glucose tolerance. Moreover, when using concentrated glucose solutions, the possibility of hyperinsulinemia following abrupt interruption of infusion must also be considered.

In cases of kidney disease (renal insufficiency), adequate caloric intake should be provided together with minimal amounts of essential amino acids, and intake of non-essential amino acids should be reduced.
In cases of total parenteral nutrition for more than 5 days, a deficiency of essential fatty acids may occur; to prevent this, administration of fat substances (lipid emulsions), for example 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 AMINOACIDS ESSENTIAL AND NON-ESSENTIAL 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 a pregnancy, or are breastfeeding, consult your doctor or pharmacist before this medicine is administered.
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 vehicles or operate machinery.

AMINOACIDS ESSENTIAL AND NON-ESSENTIAL GALENICA SENESE contains sodium and sodium metabisulfite
This medicine contains sodium metabisulfite, which may rarely cause severe hypersensitivity reactions and bronchospasm.
This medicine contains 24.15 mg (1.05 mmol) of sodium per liter 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 ESSENZIALI E NON ESSENZIALI GALENICA SENESE

This medicine will be administered to you by a doctor or other specialized healthcare professional. If you have any doubts, consult your doctor, pharmacist, or nurse.
Protect the solution from exposure to light until the end of administration. Exposure of the medicine AMINOACIDI ESSENZIALI E NON 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).
The medicine must be administered by slow intravenous infusion at a rate of 35–45 drops per minute, corresponding to a total infusion time of 8–9 hours per liter of solution.
The doctor will determine the dose and duration of treatment based on your protein requirements, your clinical condition, body weight, and blood levels of nitrogen and minerals.
The recommended dose in adults is approximately 10–15 ml of solution per kg of body weight per day, providing a protein intake of about 1–1.5 g per kg of body weight. This dosage should be individually adjusted according to each patient's needs.
Concurrently, an adequate amount of glucose and/or fat solutions may be administered to ensure a non-protein caloric intake of at least 100–150 kcal per gram of nitrogen, along with appropriate electrolyte supplementation, if necessary.
The doctor will preferably administer the medicine through a central vein for long-term therapy. However, peripheral administration is also possible, combined with 5–10% glucose solution and/or lipid emulsions (to reduce the risk of thrombus formation), in the case of short-term treatments. Any mineral deficiencies should be corrected before starting therapy with this medicine.
Rapid infusion should be avoided, as it may increase the risk of adverse effects.
Use in children
In children up to 10 kg body weight, the recommended dose is approximately 20–30 ml of solution per kg of body weight per day, providing a protein intake of about 2–3 g per kg of body weight, divided over 24 hours.
The solution should only be used if it is perfectly clear, colorless or pale yellow, and free from visible particles. It is intended for single, continuous use; any unused portion must not be reused.
If you use more AMINOACIDI ESSENZIALI E NON ESSENZIALI 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 ESSENZIALI E NON ESSENZIALI GALENICA SENESE, inform your doctor or another healthcare professional immediately.
Overdose may cause changes in blood parameters, particularly metabolic and electrolyte (water and electrolyte) imbalances, and disturbances in blood pH (acid-base balance). In such cases, appropriate treatment should be initiated to restore balance.
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:

• inflammation of the veins at the injection site or formation of blood clots (phlebitis and thrombosis), burning and irritation (erythema);
• fever, nausea, generalized erythema;
• changes in blood test values, particularly metabolic and electrolyte imbalances, increased levels of nitrogen (azotemia), and changes in blood pH (acid-base balance);
• allergic reactions

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, speak to 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 ESSENTIAL AND NON-ESSENTIAL GALENICA SENESE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after "EXP".
The expiry date refers to the last day of that month.
Store the medicine at a temperature not exceeding 25°C and protect it from light.
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 no longer used. This will help protect the environment.

6. Package contents and other information

What AMINOACIDS ESSENTIAL AND NON-ESSENTIAL GALENICA SENESE contains

• The active substances are L-amino acids, essential and non-essential. 1000 ml of solution contain 100 g of total amino acids corresponding to:

Essential amino acids: 3 g of L-Phenylalanine, 5.5 g of L-Isoleucine, 11.8 g of L-Leucine, 21.6 g of L-
Lysine acetate (equivalent to 15.3 g of L-Lysine base), 2.8 g of L-Methionine, 5.8 g of L-Threonine, 1.7 g of L-
Tryptophan, 9.7 g of L-Valine.
Non-essential amino acids: 6.2 g of L-Alanine, 4.7 g of L-Arginine, 3.4 g of Glycine, 2.1 g of L-
Histidine, 19.9 g of L-Proline, 7.4 g of L-Serine, 0.7 g of L-Tyrosine.
Each liter of solution contains 130 mEq of acetate, 10.5 mEq of sodium and 14.5 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 AMINOACIDS ESSENTIAL AND NON-ESSENTIAL GALENICA SENESE
and contents of the pack
Glass vials of 250 ml or 500 ml of solution for infusion.
Marketing Authorization Holder and Manufacturer
Industria Farmaceutica Galenica Senese S.r.l., Via Cassia Nord 351 - 53014 Monteroni d’Arbia (SI)