Amino acids with branched chain Monico

Package leaflet: Information for the user

AMINOACIDI A CATENA RAMIFICATA MONICO

4% Amino Acid Solution
solution for infusion
L-isoleucine, L-leucine, L-valine
Equivalent medicine
Please read all of this leaflet carefully before you start 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 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 AMINOACIDI A CATENA RAMIFICATA MONICO is and what it is used for
2. What you need to know before using AMINOACIDI A CATENA RAMIFICATA MONICO
3. How to use AMINOACIDI A CATENA RAMIFICATA MONICO
4. Possible side effects
5. How to store AMINOACIDI A CATENA RAMIFICATA MONICO
6. Contents of the pack and other information

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

AMINOACIDI A CATENA RAMIFICATA MONICO 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 and disturbances of brain function caused by severe liver damage (hepatic encephalopathy);
• as a supplement to protein substances (conventional amino acid solutions) in debilitated patients following surgical procedures or various types of trauma (mechanical trauma, surgical trauma, postoperative period, septic conditions, post-traumatic stress states in cirrhotic patients).

2. What you should know before using AMINOACIDI A CATENA RAMIFICATA MONICO

Do not use AMINOACIDI A CATENA RAMIFICATA MONICO

• if you are allergic to any of the ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using AMINOACIDI A CATENA RAMIFICATA MONICO.
When used in neonates and children under 2 years of age, the solution (in bags and administration sets) must be protected from light exposure until the end of administration. Exposure of AMINOACIDI A CATENA RAMIFICATA MONICO to ambient light, especially after addition of trace elements and/or vitamins, generates peroxides and other degradation products, which can be minimized by protecting from light exposure.
This medicine must be administered with caution in patients with impaired kidney function (renal insufficiency, reduced renal clearance).
During treatment with AMINOACIDI A CATENA RAMIFICATA MONICO, specific blood tests are required to monitor kidney function, blood cell count (complete blood count), levels of minerals and proteins (serum osmolarity, electrolyte and serum protein profile), blood sugar (glycaemia), ammonia (ammoniemia, especially in the presence of kidney disease), and certain blood gases (blood gas analysis).
The infusion site should also be monitored to prevent vein inflammation (phlebitis) or blood clot formation (thrombosis). If these occur, or if fever or chills develop, administration should be stopped.
Other medicines and AMINOACIDI A CATENA RAMIFICATA MONICO
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions with other medicines are known.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
This medicine should 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.

3. How to use AMINOACIDI A CATENA RAMIFICATA MONICO

This medicine will be administered to you by a doctor or other trained healthcare professional. If you have any doubts, please consult your doctor, pharmacist, or nurse.
This medicine will be given directly into a vein (intravenous infusion), and generally, an adequate amount of glucose will also be administered concomitantly (to ensure a caloric intake of at least 20–25 kcal per kilogram of body weight per day).
When used in newborns and children under 2 years of age, the solution (in bags and administration sets) must be protected from exposure to light until the end of administration (see section 2).
Your doctor will determine the dose according to your individual needs; therefore, the dosage recommendations provided should be considered as guidance only.
For the treatment of hepatic encephalopathy, the recommended dose is generally 1–2 bottles of 500 ml (corresponding to 500–1000 ml of solution) per day, administered by direct intravenous injection (intravenous infusion).
For other indications, the recommended dose is 1–3 bottles of 250 ml (corresponding to 250–750 ml of solution) per day, in combination with other amino acid solutions.
Your doctor will preferably administer this medicine into a central vein, although peripheral administration is also possible. Daily administration is recommended unless otherwise directed by the physician; however, the most rational way to use this product is by continuous infusion over 24 hours. If used for discontinuous administration, each single 500 ml bottle must be infused over no more than 4 hours (infusion rate of 30 drops/minute).
Administration should continue as long as there is a need for nutritional or metabolic support in the patient.
Use immediately after opening the container. The solution should only be used if it is completely clear and free from visible particles. Each bottle is intended for single and continuous use only; any remaining solution must not be reused.
If amino acid crystals are observed in the neck of the bottle, the solution must be shaken vigorously and, if necessary, the bottle warmed in a water bath at 37°C until the crystals are completely dissolved, before proceeding with administration.
If you use more AMINOACIDI A CATENA RAMIFICATA MONICO 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 that you have been given too much AMINOACIDI A CATENA RAMIFICATA MONICO, inform your doctor or another healthcare professional immediately.
If the infusion is administered too rapidly or if the amount of amino acids exceeds the amount of glucose, an increase in circulating ammonia levels (hyperammonemia) may occur.
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:

• fever, chills, nausea and vomiting, especially if administered by too 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, who will stop administration and take appropriate countermeasures;
• inflammation of the veins and risk of blood clot formation (phlebitis and thrombophlebitis) at the injection site; in this case, the doctor will change the injection site.

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 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 A CATENA RAMIFICATA MONICO

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.
When used in neonates and children under 2 years of age, 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 medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What AMINOACIDI A CATENA RAMIFICATA MONICO contains

• The active substances are L-branched chain amino acids. 1000 ml of solution contain: 12.85 g of L-isoleucine, 15.70 g of L-leucine and 12.00 g of L-valine.
• The other component is water for injections.

Description of the appearance of AMINOACIDI A CATENA RAMIFICATA MONICO and contents of the pack
500 ml glass flacons of infusion solution.

Marketing Authorization Holder and Manufacturer
Monico spa
Via Ponte di Pietra 7, 30173 Venezia Mestre – Italy

The following information is intended exclusively for physicians or healthcare professionals

Method of administration
When used in neonates and children under 2 years of age, the solution (in bags and administration sets) must be protected from light exposure until the infusion is completed.

Special warnings and precautions for use
Exposure to light of parenteral nutrition solutions, particularly after the 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. When used in neonates and children under 2 years of age, AMINOACIDI A CATENA RAMIFICATA MONICO must be protected from ambient light until the completion of administration.

Special precautions for disposal and handling
When used in neonates and children under 2 years of age, protect from light exposure until administration is complete. Exposure of AMINOACIDI A CATENA RAMIFICATA MONICO to ambient light, particularly after the 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.