Package leaflet: Information for the user

AMINOACIDS WITH BRANCHED CHAIN GALENICA SENESE 4 g/100 ml infusion solution

L-Amino acids with branched chain (leucine, isoleucine, valine)
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 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:

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

1. What AMINOACIDI A CATENA RAMIFICATA GALENICA SENESE is and what it is used for

AMINOACIDI A CATENA RAMIFICATA GALENICA SENESE contains a group of substances called
amino acids, essential for the human body and used to nourish patients who cannot be fed orally (parenteral nutrition).
This medicinal product is indicated for supplementing protein components in the management of hepatic coma (liver coma) to support recovery.

2. What you need to know before using AMINOACIDS BRANCHED CHAIN GALENICA SENESE

DO NOT use AMINOACIDS BRANCHED CHAIN 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 failure);
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 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 BRANCHED CHAIN GALENICA SENESE.
Exposure to light of intravenous parenteral nutrition solutions after mixing with 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. AMINOACIDS BRANCHED CHAIN GALENICA SENESE must be protected from light until the end 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 experience specific issues related to electrolyte imbalance;
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 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, and in case of gastrointestinal bleeding;
if you have diabetes or glucose intolerance, especially if concomitant glucose administration is required; in this case, blood and urine glucose levels must be closely monitored;
if you have liver problems (hepatic failure), to prevent complications due to accumulation of nitrogen and ammonia, which may lead to loss of consciousness and coma.

During treatment with AMINOACIDS BRANCHED CHAIN GALENICA SENESE, it is necessary to monitor blood electrolyte levels (water and electrolyte balance) and blood pH (acid-base balance) through specific laboratory tests, and, if needed, correct any imbalances by administering corrective solutions. 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 assessing the total nitrogen intake of the patient, particularly in patients with impaired kidney function;
blood ammonia levels. Hyperammonemia must be monitored and properly evaluated, especially in children;
blood glucose levels. When using high-concentration glucose solutions, blood glucose and glucose in urine must be routinely checked. The risk of hyperglycemia must be carefully assessed, especially in diabetic patients and in cases of reduced glucose tolerance. Furthermore, when using concentrated glucose solutions, the possibility of hyperinsulinemia following abrupt discontinuation of infusion should also be considered.

The infusion site must also be monitored to prevent vein inflammation (phlebitis) or blood clot formation (thrombosis).
In case of kidney disease (renal failure), adequate caloric intake should be provided together with minimal amounts of essential amino acids, and the intake of non-essential amino acids should be reduced.
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.

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 BRANCHED CHAIN 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 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 available data regarding the effects of this medicine on the ability to drive vehicles or operate machinery.

3. How to use AMINOACIDI A CATENA RAMIFICATA GALENICA SENESE

This medicine will be administered to you by a doctor or other trained healthcare professional as a slow intravenous infusion (into a vein) over a 24-hour period. If you have any doubts, consult your doctor, pharmacist, or nurse.
Your doctor will determine the dose and duration of treatment based on your medical condition.
The recommended dose is 1000 ml of solution on the first day of treatment, which will then be increased to 1500 ml from the second day onwards. Please note that the content of a 500 ml vial will be administered by slow intravenous infusion lasting approximately 8 hours.
At the same time, you will also receive an adequate amount of 50% glucose (approximately 300–400 g over 24 hours).
Avoid excessively rapid infusion, as this may increase the risk of adverse effects.
Parenteral nutrition must be discontinued gradually.
The solution should only be used if it is clear and free from visible particles. To minimize the risk of incompatibilities arising from the addition of other prescribed substances, the solution must be carefully inspected (for cloudiness or precipitates) before administration and periodically during infusion. The solution is intended for single and continuous use; any residual solution must not be reused.
Protect from exposure to light until administration is complete. Exposure of the medicine AMINOACIDI A CATENA RAMIFICATA GALENICA SENESE to ambient light, especially when mixtures contain trace elements and vitamins, may generate peroxides and other degradation products, which can be reduced by photoprotection (see section 2).
If you use more AMINOACIDI A CATENA RAMIFICATA GALENICA SENESE than you should
Since this medicine will be 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 A CATENA RAMIFICATA 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 electrolyte levels (water and electrolyte balance), and blood pH (acid-base balance). In such cases, balance should be restored with appropriate treatment.
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:

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 test values, particularly metabolic and electrolyte imbalances, increased levels of nitrogen (azotemia) and blood pH (acid-base imbalance). If you experience any side effect, consult your doctor immediately; the doctor must stop administration and take appropriate therapeutic countermeasures.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You may also report side effects directly through 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 A CATENA RAMIFICATA 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 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 you no longer use. This will help protect the environment.

6. Package contents and other information

What AMINOACIDI A CATENA RAMIFICATA GALENICA SENESE contains

The active substances are L-amino acids with branched side chains. 1000 ml of solution contain 40 g of total amino acids, consisting of: 12.5 g of L-isoleucine, 15.5 g of L-leucine, 12.0 g of L-valine. Each litre of solution contains 4.42 g of total nitrogen. pH 5.8–6.8.
The other component is: water for injections.

Description of the appearance of AMINOACIDI A CATENA RAMIFICATA GALENICA SENESE and
contents of the pack
Glass bottles of 250 ml or 500 ml of infusion solution.
Marketing Authorisation Holder and Manufacturer
Industria Farmaceutica Galenica Senese S.r.l., Via Cassia Nord 351 - 53014 Monteroni d'Arbia (SI)