Aminomel 10 e: detailed information

Package leaflet: Information for the user

AMINOMEL 10E, infusion solution
Please read all of this leaflet carefully before use, as it contains important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further 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 other people, even if their symptoms are the same.
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

What AMINOMEL 10E is and what it is used for
Important information before administration of AMINOMEL 10E
How to administer AMINOMEL 10E
How to store AMINOMEL 10E
Contents of the pack and other information

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

AMINOMEL 10E is a sterile solution containing:
amino acids – substances used by the body for protein synthesis;
electrolytes – chemical compounds essential for normal body function.
AMINOMEL 10E is used as a component of parenteral nutrition, providing nutrients necessary for protein synthesis:

especially in patients after severe or multiple traumas;
in acute and chronic diseases requiring parenteral nutrition;
in major surgical procedures associated with significant protein deficit (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 to any of the other ingredients of this medicine (listed in section 6);
if blood circulation in the body is inadequate (shock);
if oxygen delivery to cells is insufficient (cellular hypoxia);
if the patient has a condition in which the lungs are filled with fluid (pulmonary edema);
if the patient has excessively high potassium levels in the blood (hyperkalemia);
if the patient has excessively high sodium levels in the blood (hypernatremia);
if the patient has excessively high magnesium levels in the blood (hypermagnesemia);
if the patient has a disorder affecting the use of certain amino acids (amino acid metabolism disorders).

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

Warnings and precautions

Before starting treatment with AMINOMEL 10E, consult with the 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 immediately: the infusion will be stopped immediately.

AMINOMEL may cause the formation of small particles in the blood. If breathing difficulties or shortness of breath occur, inform the doctor or nurse immediately: the infusion will be stopped immediately.

The use of certain medications and certain diseases may increase the risk of infection or sepsis (presence of bacteria in the blood). There is a particularly high risk of infection or sepsis if a tube (intravenous catheter) is inserted into a vein. The doctor will closely monitor the patient for signs of infection.

If the patient is severely malnourished and requires intravenous feeding, parenteral nutrition should be initiated slowly and cautiously.

Children

AMINOMEL 10E must 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 patients

AMINOMEL 10E should be administered with caution in elderly patients, taking into account reduced liver, kidney, and heart function, as well as other medications the patient may be taking.

AMINOMEL 10E will only be used if the solution is clear, free from particles, and the container is undamaged.

The patient will undergo regular blood and urine tests during administration of AMINOMEL. This will ensure the patient receives the appropriate amount of solution and, if necessary, additional treatment. If AMINOMEL is administered to a very young child, monitoring will be more intensive.

During treatment, the doctor will monitor the patient's fluid and electrolyte balance and acid-base balance.

Amino acid solutions may increase blood ammonia levels. The doctor will perform blood tests for this purpose.

The doctor will order regular monitoring of patients who have:

impaired amino acid metabolism;
liver, kidney, heart, or circulatory disorders;
liver failure, due to the risk of developing or worsening pre-existing neurological disorders with hyperammonemia (excessively high blood ammonia levels);
kidney failure, particularly if hyperkalemia (excessively high blood potassium levels) is also present, a risk factor for developing or worsening metabolic acidosis or hyperazotemia (excessively high blood nitrogen levels) due to impaired creatinine clearance.

It should be remembered that this solution is only one component of parenteral nutrition. Unless otherwise directed, a complete balanced diet requires the simultaneous provision of additional energy sources (considering individual requirements for essential fatty acids), electrolytes, vitamins, and trace elements.

When administering highly concentrated glucose solutions concurrently, insulin may be required to prevent excessively high blood glucose levels.

Use with caution in cases of elevated serum osmolarity.

Interaction of AMINOMEL 10E with other medicines

Inform the doctor or nurse about all medicines currently taken or taken recently, as well as any medicines the patient plans to take.

Particular caution is required when administering AMINOMEL to patients receiving corticosteroids, which may increase the risk of sodium and fluid retention.

AMINOMEL contains potassium. Particular caution is required when administering AMINOMEL to patients receiving diuretics, angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists (antihypertensive drugs), or immunosuppressive drugs. These drugs may increase blood potassium levels.

Caution is advised when administering AMINOMEL to patients receiving thiazide diuretics or vitamin D, as these may increase blood calcium levels.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine. The doctor will decide whether the patient may receive AMINOMEL 10E.

Driving and operating machinery

No studies on the effect of the medicine on the ability to drive vehicles or operate machinery have been conducted.

3. How to administer the medicinal product AMINOMEL 10E

For intravenous infusion (via a central venous catheter).
To meet energy requirements in parenteral nutrition, amino acid solutions are usually administered in combination with carbohydrate solutions.
Dosing and rate of intravenous infusion
Unless otherwise directed, the following guidelines should be followed in patients with normal metabolism:

AMINOMEL	10E
Maximum infusion rate: in ml/kg body weight/hour up to in g/kg body weight/hour up to drops/min. (for body weight 70 kg) approx.	1 ml 0.1 g 20
Recommended daily dose: to cover the minimal requirement of amino acids of 0.8 – 1.0 g/kg body weight: ml/kg body weight	8 – 10 ml
Maximum daily dose: in catabolic metabolic states, amino acid supply
should be increased to 2.0 g/kg body weight, taking into account maintenance of fluid balance and adequate energy supply, which corresponds to: ml/kg body weight	20 ml

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 undamaged.
In children, it is recommended to use solutions intended for pediatric use.
The duration of treatment depends on the possibility of switching to complete enteral nutrition or oral diet.
The solution is for single use only.
AMINOMEL 10E should always be used according to the doctor's instructions. In case of doubt, consult your doctor.
Administration of a higher than recommended dose of AMINOMEL 10E
AMINOMEL will be administered by a healthcare professional; therefore, it is unlikely that the patient will receive too much medication. If the patient suspects that an excessive amount has been administered, they should inform the doctor or nurse immediately.
An overdose or too rapid infusion may cause symptoms of intolerance such as nausea, chills, and vomiting, as well as clinically significant losses of amino acids through the kidneys. Disturbances in blood and urine chemistry may also occur, including increased blood nitrogen levels and blood acidity (acidosis). In such cases, the infusion should be stopped immediately, and the patient may require symptomatic treatment.
4. Possible side effects
Like all medicines, this product can cause side effects, although not everybody will experience them.
No adverse reactions have been reported with proper use.
The following adverse reactions have been reported during the use of products with similar composition, with unknown frequency (the frequency cannot be determined from available data):
Severe allergic reactions (hypersensitivity, anaphylactic and anaphylactoid reactions), such as:

Hemodynamic instability with life-threatening risk (cyanosis, hypoxia, shock)
Noisy breathing (stridor)
Throat tightness
Increased respiratory rate (hyperventilation)
Vomiting, nausea
Oral cavity pain
Swelling, hot flushes
Skin redness (erythema), skin pallor (pallor)
Headache
Increased heart rate (tachycardia), palpitations
Low blood pressure (hypotension), high blood pressure (hypertension)
Increased blood flow (hyperemia)
Breathing difficulties (dyspnea)
Wheezing

Urticaria or skin rash (urticaria-like), itching sensation (pruritus)

Hair standing on skin (piloerection)
Cold sweats
Joint pain, muscle pain
Burning sensation
Chest pain, chest discomfort
Loss of energy, feeling of weakness (asthenia)
Malaise
Limb swelling (peripheral edema)
Increased body temperature, fever, chills

Other adverse reactions include:

Increased potassium levels in blood (hyperkalemia)
Breathing difficulties (respiratory disturbances)
Increased ammonia levels in blood (hyperammonemia)
Liver failure, liver damage (hepatic cirrhosis)
Liver fibrosis
Biliary excretion disorders (cholestasis)
Fatty liver (hepatic steatosis)
Gallbladder edema (cholecystitis)
Gallstone formation (cholelithiasis)
Increased nitrogen levels in blood (azotemia)
Pain, redness, increased warmth, swelling, induration at the infusion site, phlebitis at the infusion site, blood clot formation at the infusion site.

Reporting of adverse reactions
If any adverse reactions occur, consult your doctor or nurse.
This also applies to any adverse reactions not listed in this leaflet.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL 02-222 Warszawa
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
e-mail: [email protected]
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps to gather further information on the safety of the medicinal product.

5. How to store AMINOMEL 10E

Keep out of the sight and reach of children.
Store below 25°C. Protect from light.
After opening the container, the solution should be used immediately.
Do not use this medicine after the expiry date stated on the bottle label. The expiry date refers to the last day of the specified month.
Do not use if the solution is not clear or if the container is damaged.
AMINOMEL is for single use only. Partially used solutions must not be reused. Any unused portions should be safely disposed of after use by qualified medical personnel.

6. Contents of the pack and other information

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

The active substances in the medicine are:

1000 ml of infusion solution contains:
AMINOMEL 10E
Active substances:
L-isoleucine 5.85 g
L-leucine 6.24 g
L-lysine acetate 10.02 g
(expressed as lysine) 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 2.42 g
(expressed as ornithine) 1.90 g
L-aspartic acid 1.91 g
L-serine 4.30 g
Acetylcysteine 0.673 g
(expressed as cysteine) 0.50 g
N-acetyl-L-tyrosine 2.00 g
(expressed as tyrosine) 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

Corresponding to the following electrolyte ion composition (mmol/l):

AMINOMEL	10E
Na+ K+ Ca++ Mg++ Chlorides− Octanoates− L-malates−	69 45 5 5 90 74 22

Additional information:

AMINOMEL	10E
Theoretical osmolarity (mOsm/l) pH value Titration acidity (mmol/l; to pH = 7.4) Nitrogen content (g/l) Energy value: (kJ/l) (kcal/l)	1145 6.0 – 6.3 18 – 25 15.6 1700 400

The other ingredients are: water for injections, disodium edetate dihydrate and malic acid, used for pH adjustment.
What AMINOMEL 10E looks like and what the pack contains
AMINOMEL 10E is a clear, sterile solution containing amino acids and electrolytes.
Glass bottles containing 500 ml or 1000 ml of infusion solution.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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
For more detailed information, please contact the representative of the Marketing Authorisation Holder.
Baxter Polska Sp. z o.o.
ul. Kruczkowskiego 8
00-380 Warsaw
tel.: 22 4883 777
Baxter, Aminomel – trademarks of Baxter International Inc.
Information intended exclusively for healthcare professionals:
Administration and handling of the product
Do not use if the solution is not clear and almost colourless, or if the container is damaged.
After opening, the solution should be used immediately. Do not store for later use in another infusion. Partially used containers must not be reconnected.
When adding components to the container:

Aseptic conditions must be maintained.
The stability and compatibility of added components must be verified.
Prepare an injection site on the container for the addition.
Pierce the entry port and inject the additive using a syringe or infusion set.
Mix the solution thoroughly with the added component.
Examine the final solution for any change in colour or visible particles.
Check for any container leakage.
Ensure that the components to be added have been stored according to recommendations.

Additional components

Additives may be incompatible with Aminomel.
As with all parenteral nutrition solutions, compatibility of any added components with the solution must be checked before addition. Before adding any substance or drug, assess whether it is soluble and/or stable in water and whether the pH range of Aminomel is suitable. After addition, examine the solution for any change in colour, precipitation, or formation of insoluble complexes or crystals.
Refer to the instructions for use of the added drug and other relevant literature.
Amino acid solutions should not be mixed with other drugs due to increased risk of infection and possible incompatibility.
Additives must be introduced using aseptic technique. After addition, the solution must be thoroughly mixed. Do not store the solution containing additives.
Excessive addition of calcium and phosphates increases the risk of calcium phosphate precipitation.