Aminomix 1 novum

Aminomix 1 Novum, solution for infusion
Amino acid and carbohydrate solution with electrolytes

Please read the entire package leaflet carefully before use, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• If the patient experiences any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

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

2. Important information before using Aminomix 1 Novum

Do not use Aminomix 1 Novum if:

• the patient is allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
• the patient has a rare inherited disorder causing an abnormal reaction to amino acids (inborn errors of metabolism);
• the patient is in an unstable condition, for example shortly after severe trauma with shock, after acute myocardial infarction, acute stroke, or when the patient has untreated diabetes mellitus, or is in an undefined comatose state;
• the patient has severe liver function impairment;
• the patient has severe renal function impairment without possibility of dialysis;
• the patient has elevated potassium or sodium levels in the blood;
• the patient has increased blood sugar levels (hyperglycemia) resistant to insulin;
• the patient has metabolic acidosis (disorders resulting from excessive acid levels in the blood);
• the patient has excessive fluid in the body (hypervolemia) or in the lungs (pulmonary edema);
• the patient has untreated heart failure or other untreated heart disease;
• the patient has low sodium levels in the blood (the physician will identify these conditions and correct the sodium deficiency before treatment).

Warnings and precautions
Inform the doctor or nurse if the patient has:

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

Children and adolescents
Aminomix 1 Novum must not be used in infants and children under 2 years of age.
Aminomix 1 Novum and other medicines
Inform the doctor or pharmacist about all medicines currently used or recently used by the patient, as well as any medicines the patient intends to use.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
The physician will decide whether the patient should receive Aminomix 1 Novum.
Driving and operating machinery
Not applicable, as this medicine is administered in a hospital setting.

3. How to use Aminomix 1 Novum

Aminomix 1 Novum is administered into the bloodstream via an intravenous infusion or infusion pump in a hospital setting by trained medical personnel. The dosage is determined individually by the physician for each patient, depending on body weight and the ability to utilize the amino acids and glucose contained in the medicinal product.

Administration of a higher than recommended dose of Aminomix 1 Novum
It is unlikely that a patient would receive an excessive dose of Aminomix 1 Novum, as this medicinal product is administered by trained medical personnel.
Symptoms of overdose or infusion administered at a higher rate than recommended include chills, nausea, and vomiting.
If such symptoms occur or if there is suspicion that an excessive dose of Aminomix 1 Novum has been administered, inform the doctor or nurse immediately. In the event these symptoms occur, the infusion should be stopped immediately or continued at a reduced rate.

4. Possible adverse reactions

Like all medicinal products, this medicine can cause adverse reactions, although not everyone experiences them.
Adverse reactions occurring uncommonly (may occur in not more than 1 in
100 patients):

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in the leaflet, inform your doctor, pharmacist, or nurse. 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, 02-222 Warsaw
tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, e-mail: [email protected] .
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions enables continuous monitoring of the benefit-risk balance of the medicinal product.

5. How to store Aminomix 1 Novum

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

6. Contents of the package 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 contents of the pack
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 pack consists
of an inner dual-chamber bag placed within an outer protective bag. The inner bag
is divided into two chambers separated by a breakable seal. An oxygen-absorbing
sachet is placed in the space between the inner and outer bags.
Pack sizes: 6 x 1000 ml, 4 x 1500 ml, 4 x 2000 ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Fresenius Kabi Deutschland GmbH
61346 Bad Homburg v.d.H.
Germany
For further information, contact the Marketing Authorisation Holder's representative:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
tel. +48 22 345 67 89
This medicinal product is authorised for sale in the European Economic Area countries under the following names:
Austria Aminomix 1 Novum - Infusionslösung
Belgium Aminomix 1 Novum solution for infusion
Czech Republic Aminomix 1 Novum
Denmark Mixamin Glucos 200 mg/ml
France Aminomix 800 E, solution for perfusion
Greece Aminomix 1 Novum, solution for infusion
Netherlands Aminomix 1 Novum, solution for intravenous infusion
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

Information intended exclusively for medical professionals:

Special warnings and precautions for use
When infusions last less than 24 hours, the infusion rate should be gradually increased during the first hour and gradually decreased during the last hour to avoid sudden changes in blood glucose concentration.
When using the medicinal product in children over 2 years of age, a bag size should be selected that allows for meeting daily requirements.
Aminomix 1 Novum should be used in combination with other medicinal products providing additional energy, vitamins, and trace elements. Pediatric medicinal products should be used to correct deficiencies.

Pharmaceutical incompatibilities
Incompatibilities may occur upon addition of multivalent cations, e.g., calcium, particularly in combination with heparin. Inorganic phosphates should not be added due to the risk of precipitation of calcium and magnesium phosphates.

Preparation of the solution for use
The two solutions in the bag must be mixed together immediately before use.

1. Remove the outer bag and place the inner bag on a firm surface with ports facing apart.
2. Roll the bag from the top (handle) toward the ports until the seal separating the chambers opens. Mix thoroughly.

Use only if both the amino acid solution and the carbohydrate solution are clear and the packaging is undamaged.
Use immediately after opening the packaging.
Any unused solution should be discarded.

Other components necessary for parenteral nutrition, such as lipids, additional electrolyte solutions, trace elements, and vitamins, may be added to Aminomix 1 Novum under aseptic conditions. Appropriate mixing and, in particular, pharmaceutical compatibility must be ensured.
From a microbiological point of view, the product should be used immediately after addition of other substances. Otherwise, the user is responsible for the in-use storage duration and storage conditions prior to use.
This period should not generally exceed 24 hours at 4–8°C unless the addition was performed under controlled and validated aseptic conditions.
Data confirming the chemical and physical stability of numerous "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.