Aminomel 12.5 e: detailed information

Package leaflet: Information for the user

AMINOMEL 12.5E, solution for infusion
Please read all of this leaflet carefully before using this medicine, 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 ask 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 the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor or pharmacist immediately. See section 4.

Table of contents

What AMINOMEL 12.5E is and what it is used for
Important information before receiving AMINOMEL 12.5E
How to use AMINOMEL 12.5E
Possible side effects
How to store AMINOMEL 12.5E
Contents of the pack and other information

1. What AMINOMEL 12.5E is and what it is used for

AMINOMEL 12.5E is a sterile solution containing:
amino acids – substances used by the body for protein synthesis.
electrolytes – chemical compounds essential for normal body function.
AMINOMEL 12.5E is used as a component of parenteral nutrition, providing essential components for protein synthesis:

particularly in patients with severe or multiple trauma
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 12,5E

When not to administer AMINOMEL 12,5E

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 abnormally high potassium levels in the blood (hyperkalemia);
if the patient has abnormally high sodium levels in the blood (hypernatremia);
if the patient has abnormally 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 12,5E, 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 medical conditions 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 nutrition, it is recommended that parenteral nutrition be initiated slowly and cautiously.

Children

AMINOMEL 12,5E 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 12,5E 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 12,5E will only be used if the solution is clear, free from particles, and the container is undamaged.

The patient will have regular blood and urine tests performed during administration of AMINOMEL. This will ensure that the patient is receiving the appropriate dosage and, if necessary, will receive additional treatment. If AMINOMEL is administered to a very young child, monitoring will be more intensive.

During treatment, the doctor will monitor fluid and electrolyte balance and acid-base equilibrium.

Amino acid solutions may increase blood ammonia levels. The doctor will perform blood tests to monitor this.

The doctor will order regular monitoring of patients with:

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

It should be noted that this solution is only one component of parenteral nutrition. Unless otherwise directed, additional intake of energy components (including essential fatty acids according to individual requirements), electrolytes, vitamins and trace elements should be provided simultaneously to ensure a fully balanced diet.

When administering solutions with high glucose concentrations simultaneously, insulin may be required to prevent excessively high blood glucose levels.

Use with caution in cases of increased serum osmolality.

Interaction of AMINOMEL 12,5E with other medicines

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

Extreme caution should be exercised when administering AMINOMEL to patients receiving corticosteroids, which may increase the risk of sodium and fluid retention.

AMINOMEL contains potassium. Extreme caution should be exercised when administering AMINOMEL to patients receiving diuretics, angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor antagonists (antihypertensive drugs), or immunosuppressive drugs. These medications 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 or 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 12,5E.

Driving and operating machinery

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

3. How to administer the medicinal product AMINOMEL 12,5E

For intravenous infusion (via a central venous catheter).
In order 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	12.5E
Maximum infusion rate: in ml/kg body weight/hour up to in g/kg body weight/hour up to drops/min. (at body weight 70 kg) approx.	0.8 ml 0.1 g 16
Recommended daily dose: to cover the minimal requirement for amino acids of 0.8 – 1.0 g/kg body weight: ml/kg body weight	6.4 – 8 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	16 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 colourless, and the container is undamaged.
In children, solutions intended for pediatric use are recommended.
The duration of treatment depends on the possibility of switching to complete enteral or oral nutrition.
The solution is for single use only.
AMINOMEL 12,5E must always be used in accordance with the physician's instructions. In case of doubt, consult your physician.
Administration of a higher than recommended dose of AMINOMEL 12,5E
AMINOMEL will be administered by a physician; therefore, it is unlikely that the patient will receive too high a dose. If the patient suspects having received an excessive dose, they should inform the physician or nurse immediately.
An overdose or infusion administered too rapidly may cause symptoms of intolerance such as nausea, chills, and vomiting, as well as clinically significant urinary loss of amino acids. Disturbances in blood and urine chemistry may also occur, including increased blood nitrogen levels and blood acidosis. In such cases, the infusion should be immediately discontinued, and the patient may require symptomatic treatment depending on the symptoms presented.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone 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 a similar composition, with unknown frequency (frequency cannot be estimated from the 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
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 (urticaria-like), itching (pruritus)

piloerection (goosebumps)
cold sweats
joint pain, muscle pain
burning sensation
chest pain, chest discomfort
loss of energy, feeling of weakness (asthenia)
malaise
peripheral 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 (liver cirrhosis)
liver fibrosis
disturbances in bile excretion (cholestasis)
fatty liver (hepatic steatosis)
gallbladder swelling (cholecystitis)
gallstone formation (gallstones, 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 a doctor or nurse.
This includes any adverse reactions not listed in this leaflet.
Adverse reactions may be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL 02-222 Warsaw
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 provide more information on the safety of the medicine.

5. How to store AMINOMEL 12,5E

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 the medicinal product after the expiry date stated on the bottle label. The expiry date refers to the last day of the stated month.
Do not use if the solution is not clear or if the container is damaged.
AMINOMEL is for single use only. Partially used solution must not be used. Any unused portions should be safely disposed of after use by trained medical personnel.

6. Contents of the pack and other information

What Aminomel 12,5 E contains
Aminomel 12,5 E contains a solution of L-amino acids (125 g/l) with electrolytes.

Active substances of the medicinal product:

1000 ml of infusion solution contains:
AMINOMEL 12,5E
Active substances:
L-isoleucine 7.31 g
L-leucine 7.80 g
L-lysine acetate 12.53 g
(expressed as lysine) 8.88 g
L-methionine 5.85 g
L-phenylalanine 6.75 g
L-threonine 6.25 g
L-tryptophan 2.50 g
L-valine 6.25 g
L-arginine 12.08 g
L-histidine 4.13 g
L-alanine 19.38 g
L-glutamic acid 6.25 g
Glycine 9.44 g
L-proline 9.38 g
L-ornithine hydrochloride 3.02 g
(expressed as ornithine) 2.37 g
L-aspartic acid 2.39 g
L-serine 5.38 g
Acetylcysteine 0.84 g
(expressed as cysteine) 0.625 g
N-acetyl-L-tyrosine 2.50 g
(expressed as tyrosine) 2.03 g
Sodium acetate trihydrate 4.320 g
Sodium hydroxide 1.664 g
Sodium chloride 0.780 g
Potassium chloride 4.194 g
Magnesium chloride hexahydrate 1.270 g
Calcium chloride dihydrate 0.919 g
Corresponding to the following electrolyte ionic composition (mmol/l):

AMINOMEL	12.5E
Na+ K+ Ca++ Mg++ Chlorides− Octanoates− L-malate−	87 mmol/l 56.25 mmol/l 6 mmol/l 6 mmol/l 112.5 mmol/l 92.5 mmol/l 28 mmol/l

Additional information:

AMINOMEL	12.5E
Theoretical osmolarity (mOsm/l) pH value Titration acidity (mmol/l; to pH = 7.4) Nitrogen content (g/l) Energy value: (kJ/l) (kcal/l)	1430 6.0 – 6.3 22 – 30 19.5 2125 500

Other ingredients: water for injections, disodium edetate dihydrate and malic acid, to
adjust pH.
What AMINOMEL 12,5E looks like and contents of the pack
AMINOMEL 12,5E 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 further information, please contact the Marketing Authorisation Holder's representative.
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 container, the solution should be used immediately. Do not store for subsequent use in another infusion. Do not reconnect a partially used container.
When adding additives to the container:

aseptic conditions must be maintained.
the stability and compatibility of the added components must be checked.
prepare an injection site on the container for the additive.
puncture the port and inject the additive using a syringe or infusion set.
mix the solution thoroughly with the added component.
check the final solution for any change in colour or presence of visible particles.
check for any leaks in the container.
ensure that the additives have been stored according to the manufacturer's recommendations.

Additional components

additives may be incompatible with the Aminomel product.
as with all parenteral solutions, compatibility of additives with the solution must be verified before addition. Before adding any substance or medicinal product, assess whether it is soluble and/or stable in water and whether the pH range of the Aminomel product is suitable. After addition, check the solution for changes in colour, precipitation, formation of insoluble complexes or crystals.
refer to the package leaflet of the medicinal product being added and other appropriate literature.
amino acid solutions should not be mixed with other medicinal products due to increased risk of infection and possible incompatibilities.
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.