AMINOMEL 10 E Solution

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. AMINOMEL 10E, solution for infusion
3. Read carefully the contents of the leaflet before using the medicine, as it contains
   1. Table of contents of the leaflet
4. What is AMINOMEL 10E and what is it used for
5. Important information before administering AMINOMEL 10E
   1. When not to administer AMINOMEL 10E
   2. Warnings and precautions
   3. Children
   4. Elderly
   5. AMINOMEL 10E and other medicines
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
6. How to administer AMINOMEL 10E
   1. Administration of a higher dose of AMINOMEL 10E than recommended
7. Possible side effects
   1. Reporting side effects
8. How to store AMINOMEL 10E
9. Contents of the packaging and other information
   1. What AMINOMEL 10E contains
   2. AMINOMEL 10E
   3. Active substances:
   4. What AMINOMEL 10E looks like and what the packaging contains
   5. Marketing authorization holder and manufacturer
   6. Marketing authorization holder
   7. Manufacturer
   8. Date of leaflet approval:
   9. Administration and handling of the product

Leaflet attached to the packaging: information for the user

AMINOMEL 10E, solution for infusion

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

important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is AMINOMEL 10E and what is it used for
• 2. Important information before administering AMINOMEL 10E
• 3. How to administer AMINOMEL 10E
• 5. How to store AMINOMEL 10E
• 6. Contents of the packaging and other information

1. What is AMINOMEL 10E and what is it used for

AMINOMEL 10E is a sterile solution containing:
amino acids - substances used by the body to build proteins.
electrolytes - chemical compounds that ensure proper body function.
AMINOMEL 10E is used as a component of parenteral nutrition, providing the necessary components for protein synthesis:

• especially in patients after severe injuries and multiple injuries
• in acute and chronic diseases requiring parenteral nutrition
• in cases of major surgical procedures with significant protein deficiency (before, during, and after surgery).

2. Important information before administering AMINOMEL 10E

When not to administer AMINOMEL 10E

• if the patient is allergic to the active substance or any of the other components of this medicine (listed in section 6);
• if blood flow in the body is not adequate (shock);
• if the amount of oxygen delivered to the cells is insufficient (cellular hypoxia);
• if the patient has a condition where the lungs are filled with fluid (pulmonary edema);
• if the patient has high potassium levels in the blood (hyperkalemia);
• if the patient has high sodium levels in the blood (hypernatremia);
• if the patient has high magnesium levels in the blood (hypermagnesemia);
• if the patient has a problem with the use of certain amino acids (amino acid metabolism disorders);

The doctor will check the patient's condition before starting the infusion, especially if the patient has liver, kidney, heart, or circulatory problems.

Warnings and precautions

Before starting treatment with AMINOMEL 10E, consult a doctor or nurse.
If any abnormal signs or symptoms of an allergic reaction occur, such as fever, chills, rash, difficulty breathing, excessive sweating, nausea, or headache, inform the doctor or nurse: the infusion will be stopped immediately.
AMINOMEL may cause the formation of small particles in the blood. If breathing difficulties or a feeling of shortness of breath occur, inform the doctor or nurse: the infusion will be stopped immediately.
Certain medications and diseases may increase the risk of infection or sepsis (presence of bacteria in the blood). There is a particular risk of infection or sepsis if a tube is inserted into a vein (central venous catheter). The doctor will closely monitor the patient for signs of infection.
If the patient is severely malnourished and requires intravenous nutrition, it is recommended to start parenteral nutrition slowly and cautiously.

Children

AMINOMEL 10E should not be used for parenteral nutrition in children under 2 years of age, as its amino acid composition is not suitable for these patients.

Elderly

In elderly patients, AMINOMEL 10E should be administered with caution, taking into account decreased liver, kidney, and heart function, as well as other medications taken by these patients.
AMINOMEL 10E will only be used if the solution is clear, free of particles, and the container is not damaged.
The patient will undergo regular blood and urine tests during the administration of the product AMINOMEL. This will ensure that the patient is receiving the correct amounts of the solution and, if necessary, will receive additional treatment. If the product AMINOMEL is administered to a very small child, the control will be more detailed.
During treatment, the doctor will order monitoring of water and electrolyte balance and acid-base balance.
Amino acid solutions may increase the level of ammonia compounds in the blood. The doctor will perform a blood test in this direction.
The doctor will order regular monitoring of the condition of patients with:

• abnormal amino acid metabolism
• liver, kidney, heart, or circulatory problems
• liver failure, due to the risk of developing or worsening previous neurological disorders with hyperammonemia (high ammonia levels in the blood)
• kidney failure, especially in cases of concurrent hyperkalemia (high potassium levels in the blood), a risk factor for the development or worsening of metabolic acidosis or hyperazotemia (high nitrogen levels in the blood) due to impaired creatinine clearance.

It should be remembered that this solution is only one component of parenteral nutrition. If not otherwise recommended, to establish a fully balanced diet, it is necessary to provide additional energy components (taking into account individual needs for essential fatty acids), electrolytes, vitamins, and microelements.
When using solutions with high glucose concentrations, it may be necessary to administer insulin to prevent high glucose levels in the blood.
Use with caution in cases of increased serum osmolality.

AMINOMEL 10E and other medicines

Inform the doctor or nurse about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Particular caution should be exercised when administering AMINOMEL to patients treated with corticosteroids, which may increase the risk of sodium and fluid retention.
AMINOMEL contains potassium. Particular caution should be exercised when administering the product AMINOMEL to patients using diuretics, angiotensin-converting enzyme (ACE) inhibitors, or angiotensin II receptor antagonists (antihypertensive drugs) or immunosuppressive drugs.
These medications may increase potassium levels in the blood.
Caution is recommended when administering AMINOMEL to patients using thiazide diuretics or vitamin D, as these medications may increase calcium levels in the blood.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor before using this medicine. The doctor will decide whether the patient can take AMINOMEL 10E.

Driving and using machines

No studies have been conducted on the effect of the medicine on the ability to drive and use machines.

3. How to administer AMINOMEL 10E

For intravenous infusion (through a catheter in a central vein).
To cover energy needs in parenteral nutrition, amino acid solutions are usually administered in combination with carbohydrate solutions.
Dosing and intravenous infusion rate
If not otherwise recommended, the following guidelines should be followed:

It is not recommended to exceed the maximum daily fluid intake of 40 ml/kg body weight in adult patients receiving parenteral nutrition.
Use only if the solution is clear and almost colorless, and the container is not damaged.
In children, it is recommended to use solutions intended for pediatric use.
The duration of use depends on the possibility of changing to complete enteral nutrition or oral diet.
The solution is intended for single use.
AMINOMEL 10E should always be used in accordance with the doctor's recommendations. In case of doubts, consult a doctor.

Administration of a higher dose of AMINOMEL 10E than recommended

AMINOMEL will be administered by a doctor, so it is unlikely that the patient will receive too much medicine. If the patient has concerns that they have received too much medicine, they should inform their doctor or nurse.
Too high a dose or too rapid infusion may cause intolerance symptoms, such as nausea, chills, and vomiting, as well as clinically significant losses of amino acids through the kidneys. There may also be disturbances in the chemical composition of blood and urine, increased nitrogen levels, and acidosis of the blood. In such cases, the infusion should be stopped immediately, and the patient may be subject to treatment, depending on the symptoms.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
No side effects have been reported with proper use.
The following side effects have been reported during the use of products with a similar composition, with an unknown frequency of occurrence (the frequency cannot be determined based on available data).
Severe allergic reactions (hypersensitivity, anaphylactic, and anaphylactoid reactions), such as:

• unstable circulatory condition with a life-threatening condition (cyanosis, hypoxia, shock)
• stridor (laryngeal spasm)
• throat constriction
• increased respiratory rate (hyperventilation)
• vomiting, nausea
• mouth pain
• edema, flushing
• redness of the skin (flushing), pallor of the skin (pallor)
• headache
• rapid heart rate (tachycardia), palpitations
• low blood pressure (hypotension), high blood pressure (hypertension)
• increased blood flow (hyperemia)
• breathing difficulties (dyspnea)
• wheezing

urticaria or skin rash (similar to urticaria), feeling of itching (pruritus)

• hair standing on end (piloerection)
• cold sweats
• joint pain, muscle pain
• burning sensation
• chest pain, chest discomfort
• loss of energy, feeling of weakness (asthenia)
• malaise
• peripheral edema
• increased body temperature, fever, chills

Other side effects include:

• increased potassium levels in the blood (hyperkalemia)
• breathing difficulties (respiratory disorders)
• increased ammonia levels in the blood (hyperammonemia)
• liver failure, liver damage (liver cirrhosis)
• liver fibrosis
• disorders of bile excretion (cholestasis)
• fatty liver
• gallbladder edema (cholecystitis)
• formation of gallstones (cholelithiasis)
• increased nitrogen levels in the blood (azotemia)
• pain, redness, increased warmth, swelling, and induration at the infusion site, phlebitis at the infusion site, formation of blood clots at the infusion site.

Reporting side effects

If any side effects occur, consult a doctor or nurse.
This includes any side effects not listed in this leaflet.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
PL 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected]
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store AMINOMEL 10E

Store in a place invisible and inaccessible to children.
Store at a temperature below 25°C. Protect from light.
After opening the container, the solution should be used immediately.
Do not use the medicine after the expiry date stated on the label on the bottle. The expiry date refers to the last day of the given month.
Do not use if the solution is not clear, and the container is damaged.
AMINOMEL is intended for single use. Do not use a partially used solution. All unused residues should be safely disposed of after use by medical personnel.

6. Contents of the packaging and other information

What AMINOMEL 10E contains

AMINOMEL 10E contains a solution of L-amino acids (100 g/l) with electrolytes.

• The active substances of the medicine are:

1000 ml of the solution for infusion contains:

AMINOMEL 10E

Active substances:

L-isoleucine
5.85 g
L-leucine
6.24 g
L-lysine acetate
(calculated as lysine)
10.02 g
7.10 g
L-methionine
4.68 g
L-phenylalanine
5.40 g
L-threonine
5.00 g
L-tryptophan
2.00 g
L-valine
5.00 g
L-arginine
9.66 g
L-histidine
3.30 g
L-alanine
15.50 g
L-glutamic acid
5.00 g
Glycine
7.55 g
L-proline
7.50 g
L-ornithine hydrochloride
(calculated as ornithine)
2.42 g
1.90 g
L-aspartic acid
1.91 g
L-serine
4.30 g
N-acetylcysteine
(calculated as cysteine)
0.673 g
0.50 g
N-acetyl-L-tyrosine
(calculated as tyrosine)
2.00 g
1.62 g
Sodium acetate trihydrate
3.456 g
Sodium hydroxide
1.324 g
Sodium chloride
0.625 g
Potassium chloride
3.355 g
Magnesium chloride hexahydrate
1.017 g
Calcium chloride dihydrate
0.735 g
Which corresponds to the following ionic composition of electrolytes (mmol/l):

Additional information:

Other components are: water for injections, disodium edetate dihydrate, and malic acid, to adjust the pH.

What AMINOMEL 10E looks like and what the packaging contains

AMINOMEL 10E is a clear and sterile solution containing amino acids and electrolytes.
Glass bottles containing 500 ml or 1000 ml of the solution for infusion.

Marketing authorization holder and manufacturer

Marketing authorization holder

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, contact the representative of the marketing authorization holder.
Baxter Polska Sp. z o.o.
ul. Kruczkowskiego 8
00-380 Warsaw
phone: 22 4883 777

Date of leaflet approval:

Baxter, Aminomel – trademarks registered for Baxter International Inc.
Information intended exclusively for healthcare professionals:

Administration and handling of the product

Do not use if the solution is not clear, almost colorless, and the container is damaged.
After opening the container, the solution should be used immediately. Do not store it for use in the next infusion. Do not reconnect a partially used container.
When adding supplements to the container:

• aseptic conditions must be maintained.
• the stability and compatibility of the added components must be checked.
• prepare a place on the container for the injection of the supplement.
• pierce the entry and inject the supplement using a needle or transfusion set.
• mix the solution with the added component thoroughly.
• check the final solution for any change in color or visible particles.
• check for any leaks in the container
• ensure that the added components were stored according to the recommendations.

Additional components

• supplements may be incompatible with the product Aminomel.
• as with all parenteral nutrition solutions, before adding components, their compatibility with the solution should be checked. Before adding a substance or medicine, it should be evaluated whether they are soluble and/or stable in water and whether the pH range of the product Aminomel is suitable. After addition, the solution should be checked for any change in color, precipitation, formation of insoluble complexes, or crystals.
• you should familiarize yourself with the instructions for use of the added medicine and other relevant literature.
• amino acid solutions should not be mixed with other medicines due to the increased risk of infections and the possibility of incompatibility.
• supplements must be added using aseptic technique. After adding supplements, the solution should be mixed thoroughly. Do not store the solution containing supplements.
• adding too much calcium and phosphate increases the risk of forming calcium phosphate precipitates.