Aminomix 1 Novum

Patient Information Leaflet: User Information

Aminomix 1 Novum, Solution for Infusion

Solution of amino acids and carbohydrates with electrolytes

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, pharmacist, or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

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

1. What is Aminomix 1 Novum and what is it used for

Aminomix 1 Novum is a solution containing amino acids, carbohydrates, and electrolytes (salts).
Aminomix 1 Novum is administered by medical professionals when other methods of nutrition are insufficient, impossible, or contraindicated. The medicine is administered to the patient intravenously through a drip or using an infusion pump.

2. Important information before using Aminomix 1 Novum

Do not use Aminomix 1 Novum if:

• the patient is allergicto the active substances or to any of the other ingredients of this medicine (listed in section 6);
• the patient has a rare genetic disorderthat causes an inappropriate reaction to amino acids(inborn errors of metabolism);
• the patient is in an unstable condition, for example, shortly after severe injuries with shock, after acute heart attack, acute stroke, or when the patient has untreated diabetes, or is in an undefined coma state;
• the patient has severe liver function disorders;
• the patient has severe kidney function disorderswithout the possibility of using dialysis;
• the patient has high potassium or sodium levelsin the blood;
• the patient has high blood sugar levels(hyperglycemia) resistant to insulin;
• the patient has metabolic acidosis(disorders resulting from too high acid levels in the blood);
• the patient has too much fluid in the body(overhydration) or in the lungs(pulmonary edema);
• the patient has untreated heart failure or other untreated heart disease;
• the patient has low sodium levelsin the blood (the doctor will determine these conditions and correct the sodium deficiency before treatment).

Warnings and precautions

Tell your doctor or nurse if the patient has:

• liver or kidney disease;
• heart or lung failure;
• diabetes;
• lactic acidosis (a condition in which lactic acid accumulates in the body, leading to blood acidification);
• amino acid metabolism disorder (disorders of amino acid utilization in the body);
• adrenal insufficiency (adrenal gland disorders). During treatment, the doctor will systematically monitor the electrolyte levels in the serum, fluid balance, kidney function, and blood glucose levels.

Children and adolescents

Aminomix 1 Novum should not be used in infants and children under 2 years of age.

Aminomix 1 Novum and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medicine.
The doctor will decide whether the patient should receive Aminomix 1 Novum.

Driving and using machines

This does not apply, as the medicine is used in a hospital.

3. How to use Aminomix 1 Novum

Aminomix 1 Novum is administered into the blood through a drip or infusion pump, in a hospital, by medical professionals. The dosage is determined by the doctor individually for each patient, depending on body weight and the ability to utilize the amino acids and glucose contained in the medicine.

Using a higher dose of Aminomix 1 Novum than recommended

It is unlikely that the patient will receive too high a dose of Aminomix 1 Novum, as the medicine is administered by medical professionals.
Symptoms of overdose or infusion at a rate higher than recommended are chills, nausea, and vomiting.
If such symptoms occur or it is suspected that too high a dose of Aminomix 1 Novum has been administered, tell the doctor or nurse immediately. If these symptoms occur, the infusion should be stopped immediately or continued at a reduced rate.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Uncommon side effects (may occur in less than 1 in 100 patients):

• nausea, vomiting;
• headache;
• chills;
• fever.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. 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, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: ndl@urpl.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Aminomix 1 Novum

The doctor and pharmacist in the hospital are responsible for the proper storage, administration, and disposal of Aminomix 1 Novum.
Store in a place out of sight and reach of children.
Do not store above 25°C. Store in the outer bag.
Store the bag in the outer cardboard packaging to protect from light.
Do not use this medicine after the expiry date stated on the bag and cardboard packaging after EXP. The expiry date refers to the last day of the month stated.

6. Contents of the pack and other information

What Aminomix 1 Novum contains:

• The active substances of the medicine are:

• Other ingredients are: water for injections, sodium hydroxide (for pH adjustment), and hydrochloric acid (for pH adjustment).

What Aminomix 1 Novum looks like and what the pack contains

Aminomix 1 Novum is available in dual-chamber bags (Excel or Biofine type) containing 1000 ml, 1500 ml, or 2000 ml of solution, packed in cardboard boxes. The packaging consists of a dual-chamber inner bag placed in an outer protective bag. The inner bag is divided into two chambers separated by a seal that can be opened.
Between the inner and outer bags, there is a sachet with an oxygen-absorbing substance.
Pack sizes: 6 x 1000 ml, 4 x 1500 ml, 4 x 2000 ml.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Fresenius Kabi Deutschland GmbH
61346 Bad Homburg v.d.H.
Germany
For more detailed information, please contact the representative of the marketing authorization holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
tel. +48 22 345 67 89

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria
Aminomix 1 Novum - Infusionslösung
Belgium
Aminomix 1 Novum oplossing voor infusie
Czech Republic
Aminomix 1 Novum
Denmark
Mixamin Glucos 200 mg/ml
France
Aminomix 800 E, solution pour perfusion
Greece
Aminomix 1 Novum, solution for infusion
Netherlands
Aminomix 1 Novum, oplossing voor intraveneuze infusie
Luxembourg
Aminomix 1 Novum Infusionslösung
Norway
Mixamin Glucos 200 mg/ml
Poland
Aminomix 1 Novum
Slovakia
Aminomix 1 Novum
Slovenia
Mixamin glukoza 20 % raztopina za infundiranje
Sweden
Mixamin Glucos 200 mg/ml
Hungary
Aminomix 1 Novum oldatos infúzió
Italy
Aminomix con glucosio 20% ed elettroliti

Date of last revision of the leaflet:

Information intended for healthcare professionals only:

Special warnings and precautions for use

In the case of infusion duration less than 24 hours, the infusion rate should be increased gradually in the first hour and decreased gradually in the last hour to avoid sudden changes in blood sugar levels.
When using the medicine in children over 2 years of age, a pack size should be used that allows for the daily requirement to be met.
Aminomix 1 Novum should be used in combination with other medicines that provide additional energy, vitamins, and trace elements. To supplement deficiencies, pediatric medicines should be used.

Incompatibilities

Incompatibilities may occur when adding multivalent cations, e.g., calcium, especially in combination with heparin. Inorganic phosphates should not be added due to the possibility of precipitation of calcium and magnesium phosphate.

Method of preparation of the solution for use

The two solutions in the bag should be mixed together immediately before use.

• 1. Remove the outer bag and place the bag on a hard surface, with the ports facing away from each other.
• 2. Roll the bag starting from the top (handle) towards the ports until the seal that separates the chambers is opened. Mix thoroughly.

Use only if both the amino acid solution and the carbohydrate solution are clear, and the packaging is not damaged.
Use immediately after opening the packaging.
Any unused solution should be discarded.
To Aminomix 1 Novum, other components necessary for parenteral nutrition, such as fats, additional solutions containing electrolytes, microelements, and vitamins, can be added under aseptic conditions. Attention should be paid to proper mixing and, in particular, to pharmaceutical compatibility.
From a microbiological point of view, the medicine should be used immediately after the addition of other substances. Otherwise, the user is responsible for the storage period during use and the storage conditions before administration.
This period should not exceed 24 hours at a temperature of 4-8°C, unless the addition was made under controlled and validated aseptic conditions.
Data confirming the chemical and physical stability of many "all-in-one" mixtures stored at 4°C for up to 7 days are available upon request from the representative of the marketing authorization holder.