Patient Information Leaflet

AMINOMEL NEPHRO, infusion solution
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are similar.
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist immediately. See section 4.

Table of contents:

What AMINOMEL NEPHRO is and what it is used for
Important information before using AMINOMEL NEPHRO
How to use AMINOMEL NEPHRO
Possible side effects
How to store AMINOMEL NEPHRO
Contents of the pack and other information

1. What AMINOMEL NEPHRO is and what it is used for

AMINOMEL NEPHRO is a glucose-free amino acid solution. It is administered to the patient by intravenous infusion, a method of delivering nutrients into the body.
This medicine may be used in the following situations:

in cases of acute or chronic renal failure;
during treatments aimed at removing metabolic waste products from the body through so-called artificial filtration, used in the management of renal failure (hemodialysis, peritoneal dialysis, or hemofiltration).

As a general rule, AMINOMEL NEPHRO should always be administered together with solutions containing sugars.

2. Important information before using AMINOMEL NEPHRO

When not to use AMINOMEL NEPHRO

if the patient is allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
if the patient has unstable circulation with life-threatening risk (e.g. shock);
if oxygen delivery to the cells is insufficient; if the patient has a condition in which the lungs are filled with fluid (pulmonary edema);
the patient has a disease impairing amino acid metabolism.

Warnings and precautions
Before starting treatment with AMINOMEL NEPHRO, consult a doctor or
pharmacist.
Inform the doctor if the patient currently has or has previously had any of the following conditions:

if the patient experienced an allergic reaction during infusion. The infusion will be immediately discontinued;
if the patient has liver disease or liver failure;
if the patient has heart failure and/or adrenal gland disease; (in the above conditions, special monitoring of the patient may be required)
if the patient is undergoing hemodialysis. In such a case, the maximum infusion volume tolerated by the patient should be considered.

If the patient receives an infusion of this solution, blood and urine samples will be taken to monitor:

fluid balance in the body;
levels of chemical compounds in blood and urine (electrolyte concentrations in blood and urine);
acid-base balance (acidity of blood and urine);
blood glucose concentration;
liver and kidney function (urea concentration, creatinine concentration in blood);
complete blood count and coagulation factors, if the patient is receiving AMINOMEL NEPHRO for a prolonged period (several weeks).

During treatment, a decrease in vitamin B (thiamine) concentration, an increase in blood ammonia levels, and a condition caused by excess ammonia in the blood (hyperammonemia) may occur.
Irritation at the infusion site may also occur (see section 4).

AMINOMEL NEPHRO and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
AMINOMEL NEPHRO must not be administered together with drugs used to treat infections, antibiotics, or steroids.
AMINOMEL NEPHRO will be administered to the patient together with other medicines only after confirmation of their compatibility and stability in the prepared solution.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning a pregnancy, she should discuss this with her doctor before using this medicine.

3. How to use AMINOMEL NEPHRO

AMINOMEL NEPHRO will be administered to the patient by medical personnel. The doctor will decide the dose to be given to the patient depending on age, body weight, clinical condition (nutritional status and severity of disease), and tolerance capacity. The doctor will also decide how long the treatment should last.
AMINOMEL NEPHRO should be administered together with other solutions containing sugars to ensure adequate supply of energy, electrolytes, vitamins, and trace elements.
The patient may also receive insulin to prevent an increase in blood sugar concentration.
The patient will receive AMINOMEL NEPHRO as an intravenous infusion.
Use in children
It is recommended to use special amino acid solutions intended for children.
Administration of a higher than recommended dose of AMINOMEL NEPHRO
If the patient receives too much AMINOMEL NEPHRO and/or the infusion is administered too rapidly, the following symptoms may occur:

blood acidification causing fatigue, disorientation, lethargy, and increased respiratory rate;
increased concentration of urea and nitrogenous waste products, which may lead to more frequent urination, nausea, vomiting, and swelling of the feet and ankles;
dizziness, muscle cramps and/or twitching, weakness, and symptoms of chemical imbalances in blood and urine.

If any of these symptoms occur, inform the doctor immediately. The infusion may be stopped and the patient will receive treatment appropriate to the symptoms present.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions may be associated with the use of AMINOMEL Nephro.
The following have been reported with similar medicines, and their frequency is unknown (frequency cannot be estimated from the available data):

Severe allergic reactions, called anaphylactic or anaphylactoid reactions, which may cause: sensation of throat tightness; circulatory instability with risk of life-threatening conditions, low blood pressure; breathing difficulties, wheezing; rapid or deep breathing; insufficient oxygen delivery to cells; vomiting, nausea, tingling or numbness in the oral cavity, pain in the posterior part of the mouth; rapid heartbeat; facial flushing, pallor.
Other symptoms of allergic reaction: urticaria, headache, increased blood pressure, skin reactions, joint and muscle pain.
Excessively high blood ammonia levels.
Liver failure.
Chronic liver disease, known as cirrhosis.
Enlargement of the liver.
Fatty infiltration of the liver.
A condition in which bile cannot flow from the liver to the duodenum.
Inflammation of the gallbladder.
Presence of one or more gallstones in the gallbladder (cholelithiasis).
High levels of urea and nitrogenous waste products in the blood.
Local pain or reaction at the infusion site (irritation, swelling, increased warmth, and formation of a hard lump). Irritation, inflammation, and blood clot formation in the vein used for infusion.
Increased bilirubin levels.
Increased liver enzyme activity.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail: [email protected]
Reporting adverse reactions allows the collection of additional information on the safety of this medicine.

5. How to store AMINOMEL NEPHRO

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle. The expiry date refers to the last day of the stated month.
Store below 25°C. Keep in the original packaging to protect from light.
For single use only.
Do not use AMINOMEL NEPHRO if the container is damaged or if the solution is not clear, colourless, and free from visible particles.

6. Contents of the pack and other information

What AMINOMEL NEPHRO contains
AMINOMEL NEPHRO is a solution containing L-amino acids without carbohydrates and
electrolytes.

Active substances contained in 1000 ml of infusion solution:
L-isoleucine 6.00 g
L-leucine 6.40 g
L-lysine acetate 10.27 g (corresponding to 7.28 g of L-lysine)
L-methionine 4.59 g
L-phenylalanine 5.53 g
L-threonine 5.13 g
L-tryptophan 2.05 g
L-valine 5.13 g
L-arginine 3.02 g
L-histidine 3.88 g
L-alanine 2.59 g
L-glutamic acid 2.16 g
Glycine 1.29 g
L-proline 1.66 g
L-serine 2.59 g
Acetylcysteine 0.54 g (corresponding to 0.40 g of L-cysteine)
N-acetyl-L-tyrosine 0.37 g (corresponding to 0.30 g of L-tyrosine)
Other components:
Disodium edetate dihydrate
Acetic acid (for pH adjustment)
Water for injections

Additional information:
Theoretical osmolarity (mOsm/l): 510
pH: 5.9–6.3
Titratable acidity (mmol/l; to pH = 7.4): 15–25
Energy value (kJ/l): 930
(kcal/l): 222
Nitrogen content (g/l): 8.6

What AMINOMEL NEPHRO looks like and contents of the pack
AMINOMEL NEPHRO is a clear, almost colourless solution.
Glass bottles containing 250 ml or 500 ml of infusion solution.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Baxter Polska Sp. z o.o.
ul. Kruczkowskiego 8
00-380 Warszawa
Poland

Manufacturer
Bieffe Medital S.p.A.
Via Nuova Provinciale
23034 Grosotto
Italy

For further information, please contact the representative of the Marketing Authorisation Holder.
Baxter Polska Sp. z o.o.
ul. Kruczkowskiego 8
00-380 Warszawa
Poland
Tel.: 22 4883 777

Baxter, Aminomel – are trademarks of Baxter International Inc.

Information intended exclusively for medical professionals:

Before starting the infusion, correct conditions such as severe fluid and electrolyte imbalances, significant fluid overload, and severe metabolic disturbances.

Refeeding syndrome
Nutrition of severely malnourished patients may lead to refeeding syndrome, characterized by shifts of potassium, phosphate, and magnesium into the intracellular space due to the onset of anabolic metabolism. Thiamine deficiency and fluid retention may also occur. These complications can be prevented by careful monitoring and gradual increase of nutrient supply, avoiding excessive feeding.

If the nutrient supply does not meet the patient's requirements or if the metabolic capacity for any of the administered nutritional components is inaccurately assessed, metabolic disturbances may occur. Adverse metabolic effects may result from administering too small or too large amounts of nutrients or from an inappropriate composition of added substances relative to the individual patient's needs. The composition of the AMINOMEL NEPHRO infusion solution has been designed considering amino acid imbalances observed in patients with chronic and acute renal failure. If this product is used off-label, disturbances in amino acid balance may occur.

Instructions for handling
Parenteral medicinal products should be visually inspected before administration to ensure they contain no visible particles and that the solution has not changed color.

When administering any parenteral infusion solutions, the use of an in-line filter is recommended.

If other substances are added to AMINOMEL NEPHRO, the following steps must be taken:

Maintain aseptic technique;
Ensure stability and compatibility of components;
Mix AMINOMEL NEPHRO and added components thoroughly;
Visually inspect the solution for discoloration and presence of visible particles;
Check that the container does not leak;
Ensure appropriate storage conditions after addition of components.

Infusion administration:

Do not reconnect any infusion that has already been partially used.
To avoid air embolism, do not connect containers in series, as residual air may remain in the first container.

Incompatibilities with other drugs
Added substances may exhibit incompatibilities.
Do not add antibiotics or steroids to AMINOMEL NEPHRO.
Do not add other medicinal products or substances without prior confirmation of their compatibility and stability in the resulting mixture.
Excessive addition of calcium and phosphates increases the risk of calcium phosphate precipitation.

Aminomel nephro