Aminomel Nephro

Leaflet attached to the packaging: patient information

AMINOMEL NEPHRO, solution for infusion

Read the leaflet carefully before using the medicine, as it contains

important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is AMINOMEL NEPHRO and what is it used for
• 2. Important information before using AMINOMEL NEPHRO
• 3. How to use AMINOMEL NEPHRO
• 4. Possible side effects
• 5. How to store AMINOMEL NEPHRO
• 6. Contents of the pack and other information

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

AMINOMEL NEPHRO is a solution of amino acids without sugars. It is administered to the patient by intravenous infusion, which is a method of delivering nutrients to the body.
The medicine may be used in the following situations:

• in case of acute or chronic kidney failure;
• during treatment aimed at removing metabolic products from the body through so-called artificial filtration, which is used in the treatment of kidney failure (hemodialysis, peritoneal dialysis or hemofiltration).

As a general rule, AMINOMEL NEPHRO should always be administered together with solutions that contain sugars,
to ensure an adequate amount of energy, electrolytes, vitamins, and microelements.

2. Important information before using AMINOMEL NEPHRO

When not to use AMINOMEL NEPHRO

• if the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);
• if the patient has unstable circulation with a risk to life (e.g. shock);
• if the amount of oxygen delivered 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 that disrupts amino acid metabolism.

Warnings and precautions

Before starting treatment with AMINOMEL NEPHRO, the patient should consult a doctor or pharmacist.
The patient should inform their doctor if they have or have had any of the following conditions:

• if the patient has had an allergic reaction during infusion. The infusion will be stopped immediately;
• if the patient has liver disease or liver failure;
• if the patient has heart failure and (or) adrenal disease; (in the above conditions, special monitoring of the patient may be necessary)
• if the patient is undergoing hemodialysis. In such a case, the maximum infusion volume that the patient will tolerate should be taken into account.

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

• the amount of fluid in the body;
• the amount of chemical compounds in the blood and urine (electrolyte concentration in the blood and urine);
• acid-base balance (acidity of the blood and urine);
• blood sugar levels;
• liver and kidney function (urea and creatinine levels in the blood);
• full blood count and clotting factors, if the patient is receiving AMINOMEL NEPHRO for a long time (several weeks).

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

AMINOMEL NEPHRO and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.
AMINOMEL NEPHRO should not be administered with medicines used to treat infections, antibiotics, and steroids.
AMINOMEL NEPHRO will be administered to the patient together with other medicines only after confirming their compatibility and stability of the prepared solution.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to become pregnant, they should consult their 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 what dose will be given to the patient, depending on their age, weight, clinical condition (nutritional status and disease severity), and tolerance.
The doctor will also decide how long the medicine will be administered.
AMINOMEL NEPHRO should be administered together with other solutions that contain sugars, to ensure an adequate amount of energy, electrolytes, vitamins, and microelements.
The patient may also receive insulin to prevent an increase in blood sugar levels.
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.

Using more than the recommended dose of AMINOMEL NEPHRO

If the patient receives too much AMINOMEL NEPHRO and (or) the infusion is administered too quickly, the following symptoms may occur:

• acidosis of the blood, causing a feeling of fatigue, disorientation, lethargy, and increased respiratory rate;
• increased levels of urea and nitrogenous waste products, which may cause more frequent urination, nausea, vomiting, and swelling of the feet and ankles;
• dizziness, muscle cramps, and (or) spasms and weakness, symptoms of disturbances in the chemical composition of the blood and urine.

If any of these symptoms occur, the patient should immediately tell their doctor.
The infusion may be stopped, and the patient will receive treatment that will depend on the symptoms.
If the patient has any further doubts about the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, AMINOMEL NEPHRO can cause side effects, although not everybody gets them.
The following side effects may be related to the use of AMINOMEL NEPHRO.
They have been reported during the use of similar medicines, and their frequency is unknown (the frequency cannot be determined based on available data):

• Severe allergic reactions, called anaphylactic or pseudo-anaphylactic reactions, which can cause: a feeling of constriction in the throat; unstable circulation with a risk to life, low blood pressure; difficulty breathing, wheezing; rapid or deep breathing; insufficient oxygen supply to the cells; vomiting, nausea; tingling or numbness in the mouth, pain in the back of the mouth; rapid heartbeat; flushing of the face, pallor.
• Other symptoms of an allergic reaction: hives, headache, increased blood pressure, skin reactions, joint and muscle pain.
• Excessive ammonia levels in the blood.
• Liver failure.
• Chronic liver disease, called cirrhosis.
• Liver enlargement.
• Fatty liver.
• A condition in which bile cannot flow from the liver to the duodenum.
• Gallbladder inflammation.
• The presence of one or more stones in the gallbladder (cholecystolithiasis).
• High levels of urea and nitrogenous waste products in the blood.
• Local pain or reaction at the infusion site (irritation, swelling, increased heat, and formation of a hard lump). Irritation, inflammation, and formation of a blood clot in the vein into which the solution was infused.
• Increased bilirubin levels.
• Increased liver enzyme activity.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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:
ndl@urpl.gov.pl
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store AMINOMEL NEPHRO

The medicine should be stored 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 given month.
Store in a temperature below 25°C. Store in the original packaging to protect from light.
For single use only.
Do not use AMINOMEL NEPHRO if the container is damaged or the solution is not clear, colorless, 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 the solution for infusion: L-isoleucine L-leucine L-lysine acetate (corresponding to L-lysine L-methionine L-phenylalanine L-threonine L-tryptophan L-valine L-arginine L-histidine L-alanine L-glutamic acid Glycine L-proline L-serine Acetylcysteine (corresponding to L-cysteine N-acetyl-L-tyrosine (corresponding to L-tyrosine 6.00 g 6.40 g 10.27 g 7.28 g) 4.59 g 5.53 g 5.13 g 2.05 g 5.13 g 3.02 g 3.88 g 2.59 g 2.16 g 1.29 g 1.66 g 2.59 0.54 g 0.40 g) 0.37 g 0.30 g)
• Other ingredients:

Disodium edetate dihydrate
Acetic acid (to adjust pH)
Water for injections
Additional information:
Theoretical osmolality (mOsm/l)
510
pH
5.9-6.3
Buffering capacity (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 what the pack contains

AMINOMEL NEPHRO is a clear and practically colorless solution.
Glass bottles containing 250 ml or 500 ml of the solution for infusion.

Responsible person and manufacturer

Responsible person

Baxter Polska Sp. z o.o.
ul. Kruczkowskiego 8
00-380 Warsaw

Manufacturer

Bieffe Medital S.p.A.
Via Nuova Provinciale
23034 Grosotto
Italy
To obtain more detailed information, please contact the representative of the responsible person.
Baxter Polska Sp. z o.o.
ul. Kruczkowskiego 8
00-380 Warsaw
tel.: 22 4883 777

Date of last update of the leaflet:

Baxter, Aminomel –are trademarks of Baxter International Inc.
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Information intended only for healthcare professionals:

Before starting the infusion, it is necessary to correct conditions such as severe water-electrolyte disturbances, significant fluid overload, and severe metabolic disorders.
Refeeding syndrome
Refeeding of severely malnourished patients may cause the occurrence of refeeding syndrome, which is characterized by a shift of potassium, phosphates, and magnesium into the cells, as anabolic processes begin to predominate in the patient. Thiamine deficiency and fluid retention may also occur. These complications can be prevented by carefully monitoring and gradually increasing the supply of nutrients, avoiding overfeeding the patient.
If the supply of nutrients is not adequate to the patient's needs or the metabolic capacity of any of the administered nutrients is not accurately assessed, metabolic disorders may occur. Metabolic side effects may result from the administration of too small or too large an amount of nutrients or from an inappropriate composition of the added substances. The composition of the AMINOMEL NEPHRO solution was designed with consideration of amino acid disturbances in patients with chronic and acute kidney failure. If the product is used contrary to the indications, amino acid balance disorders may occur.
Instructions for use
Medicinal products for parenteral administration should be visually inspected before administration for the presence of visible particles and color change.
When using all solutions for parenteral administration, it is recommended to use a final filter.
If other substances are added to AMINOMEL NEPHRO, the following should be observed:

• aseptic rules should be followed;
• it should be ensured that the stability and compatibility of the components will be maintained;
• AMINOMEL NEPHRO and the added substances should be thoroughly mixed;
• the solution should be visually inspected for any change in color or the presence of visible particles;
• the container should be checked for leakage;
• proper storage conditions should be ensured after adding the substances.

Infusion administration:

• No partially used infusion should be reconnected.
• To avoid air embolism, containers should not be connected in series, as the first container may contain residual air.

Incompatibilities with other medicines
Added substances may exhibit incompatibilities.
Antibiotics or steroids should not be added to AMINOMEL NEPHRO.
No other medicinal products or substances should be added without prior confirmation of their compatibility and stability of the resulting mixture.
Excessive addition of calcium and phosphates increases the risk of calcium phosphate precipitation.