Amixal

PACKAGE LEAFLET: INFORMATION FOR THE USER

Amixal 10% Infusion Solution

amino acids
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Amixal 10% is and what it is used for.
2. What you need to know before using Amixal 10%.
3. How to use Amixal 10%.
4. Possible side effects.
5. How to store Amixal 10%.
6. Contents of the pack and other information.

1. What Amixal 10% is and what it is used for

Amixal 10% is a solution administered through a small tube with a cannula inserted into a vein (intravenous infusion).
The solution contains amino acids essential for the body to grow and recover.
You will receive this medicine if you are unable to eat normally and cannot be fed either through a tube inserted into the stomach. This solution can be administered to adults, adolescents, and children over 2 years of age.

2. What you should know before using Amixal 10%

Do not use Amixal 10%

• if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
• if you have a congenital disorder of protein and amino acid metabolism;
• if you have severe (i.e. potentially life-threatening) circulatory disorder (shock);
• if you have insufficient oxygen supply (hypoxia);
• if you accumulate acidic substances in the blood (metabolic acidosis);
• if you have severe liver disease (severe hepatic insufficiency or decompensated hepatic cirrhosis with hepatic encephalopathy grade III and IV);
• if you have severe renal failure (severe renal insufficiency) that cannot be adequately treated with artificial kidney or similar therapies;
• if you have poorly controlled heart failure associated with marked impairment of blood circulation (decompensated heart failure);
• if you have fluid accumulation in the lungs (acute pulmonary edema);
• if your body's electrolyte or fluid balance is disturbed.

This solution must not be administered to neonates, infants, and children under two years of age
because the composition of the solution does not adequately meet the specific nutritional requirements
for this age group.
Warnings and precautions
Talk to your doctor or pharmacist before using Amixal 10%:

• if you have impaired protein and amino acid metabolism due to any condition not previously listed (see section "Do not use …");
• if you have mild to moderate impairment of liver function or decompensated hepatic cirrhosis with hepatic encephalopathy (grade I and II), or impaired kidney function;
• if you have impaired heart function;
• if you have excessively concentrated blood serum (high serum osmolarity).

If your body's fluid or electrolyte balance is disturbed, this condition must be corrected before you
receive this medicine. Examples of such conditions include concurrent deficiency of fluids and salts
(hypotonic dehydration), or deficiency of sodium (hyponatremia) or potassium (hypokalemia).
Before and during administration of this medicine, blood electrolyte levels, blood glucose levels, fluid balance, acid-base balance, blood proteins, and kidney and liver function will be monitored. For this purpose, blood and urine samples will be taken and analyzed.
In general, when parenteral nutrition is required, administration of Amixal 10% should be combined with non-protein energy sources (carbohydrate solutions, lipid emulsions), essential fatty acids, electrolytes, vitamins, fluids, and trace elements.
Other medicines and Amixal 10%
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
If you are pregnant, you will receive this medicine only if your doctor considers it necessary for your treatment. There are no available data on the use of this medicine in pregnant women.
Breastfeeding
At therapeutic doses of Amixal 10%, effects on neonates/infants are not expected. However, breastfeeding is not recommended in women who simultaneously require parenteral nutrition.
Driving and using machines
This medicine is generally administered to immobile patients in a controlled setting (emergency treatment, acute treatment in a hospital or day-hospital therapy unit). This excludes driving vehicles or operating machinery.

3. How to use Amixal 10%

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Dosage

Adults
Your doctor will determine the required amount of solution each day.
Generally, the dose is 10–20 ml per kg of body weight per day. The solution will be administered at a rate not exceeding 1 ml per kg of body weight per hour.

Children from 2 to 18 years
In children, the doctor will carefully adjust the dosage based on age, stage of development, and the individual child's condition.
The amounts to be administered are as follows:
from 2 to less than 3 years: 10–25 ml per kg of body weight per day;
from 3 to 18 years: 10–20 ml per kg of body weight per day.
For critically ill children, the amount administered may be higher (up to 30 ml per kg of body weight per day).
The solution will be administered at a rate not exceeding 1 ml per kg of body weight per hour.

Patients with renal or hepatic disease
If you have liver disease (mild to moderate hepatic insufficiency or decompensated hepatic cirrhosis with grade I or II hepatic encephalopathy) or kidney disease, doses will be adjusted according to individual needs.
When administered during dialysis, amino acid losses into the dialysate must be taken into account.

Duration of use
This medicine may be used for as long as parenteral nutrition is required.

Method of administration
This medicine will be administered to you through a tube inserted into a large vein (central venous infusion).

If you have received more Amixal 10% than you should
It is unlikely that this will occur, as your doctor will determine your daily doses.
However, if you receive an excessive dose or if the solution is administered too rapidly, you may experience vomiting and/or headache. Additionally, there may be too much ammonia in the blood (hyperammonaemia), and amino acids may be excreted in the urine. It is also possible to develop excess fluid in the body (hyperhydration), an imbalance of salts in the body (electrolyte imbalance), or accumulation of fluid in the lungs (pulmonary oedema). In such cases, the infusion will be stopped and resumed later at a slower infusion rate.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
These side effects are not specifically related to Amixal 10%, but may occur with any intravenous nutrition, particularly at the beginning of treatment.
The following side effects can be serious. If you experience any of these side effects,
inform your doctor immediately, who will stop administration of this medicine:
Not known (frequency cannot be estimated from the available data)

• Allergic reactions

Other side effects
Uncommon (may affect up to 1 in 100 people):

• vomiting, feeling unwell

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Amixal 10%

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label of the bottle and the outer carton.
The expiry date refers to the last day of the month.
Keep the bottle in the outer packaging to protect the medicine from light.
Do not store above 25 °C.
Storing the solution at cold temperatures below 15 °C may cause the formation of crystals, which can however be easily dissolved by moderate warming to 25 °C until complete dissolution.
Gently shake the container to ensure homogeneity.
Do not freeze.
After infusion, any remaining solution must not be retained for later use.

6. Package contents and other information

What Amixal 10% contains
The active substances are amino acids.
This medicinal product contains:
per 1 ml per 250 ml per 500 ml per 1000 ml
Isoleucine 5.00 mg 1.25 g 2.50 g 5.00 g
Leucine 8.90 mg 2.23 g 4.45 g 8.90 g
Lysine monohydrate 3.12 mg 0.78 g 1.56 g 3.12 g
(equivalent to lysine) (2.78 mg) (0.70 g) (1.39 g) (2.78 g)
Lysine acetate 5.74 mg 1.44 g 2.87 g 5.74 g
(equivalent to lysine) (4.07 mg) (1.02 g) (2.04 g) (4.07 g)
Methionine 4.40 mg 1.10 g 2.20 g 4.40 g
Phenylalanine 4.70 mg 1.18 g 2.35 g 4.70 g
Threonine 4.20 mg 1.05 g 2.10 g 4.20 g
Tryptophan 1.60 mg 0.40 g 0.80 g 1.60 g
Valine 6.20 mg 1.55 g 3.10 g 6.20 g
Arginine 11.50 mg 2.88 g 5.75 g 11.50 g
Histidine 3.00 mg 0.75 g 1.50 g 3.00 g
Alanine 10.50 mg 2.63 g 5.25 g 10.50 g
Glycine 12.00 mg 3.00 g 6.00 g 12.00 g
Aspartic acid 5.60 mg 1.40 g 2.80 g 5.60 g
Glutamic acid 7.20 mg 1.80 g 3.60 g 7.20 g
Proline 5.50 mg 1.38 g 2.75 g 5.50 g
Serine 2.30 mg 0.58 g 1.15 g 2.30 g
Tyrosine 0.40 mg 0.10 g 0.20 g 0.40 g
The other components are acetylcysteine, citric acid monohydrate (for pH adjustment), and water for
injections.

Electrolyte concentrations
acetate 28 mmol/l
citrate 1.0–2.0 mmol/l
Total amino acids 100 g/l
Total nitrogen 15.8 g/l
Energy value [kJ/L (kcal/L)] 1675 (400)
Theoretical osmolarity [mOsm/L] 864
Acidity (titration to pH 7.4) [mmol NaOH/L] approximately 20
pH 5.7–6.3

Description of the appearance of Amixal 10% and package contents
Amixal 10% is a clear, colourless to slightly straw-yellow solution, practically free from visible particles.
The product is contained in colourless glass bottles of 250 ml, 500 ml, and 1,000 ml, closed with rubber stoppers.
The 250 ml and 500 ml bottles are available in packs of 10. The 1,000 ml bottles are available in packs of 6.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
B. Braun Melsungen AG
Carl-Braun-Straße 1
34212 Melsungen
Germany
Postal address
34209 Melsungen, Germany
Tel.: +49-5661-71-0
Fax: +49-5661-71-4567

This medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland)
under the following names:
Austria, Germany Aminoplasmal B. Braun 10 % Infusionslösung
Czech Republic, Poland, Portugal, Slovakia Aminoplasmal B. Braun 10 %
Denmark Aminoplasmal
Spain Aminoplasmal B. Braun 10 % solución para perfusión
Finland Aminoplasmal 16 N/l infuusioneste, liuos
Italy Amixal
Lithuania Aminoplasmal B. Braun 10 % infuzinis tirpalas
Latvia Aminoplasmal B. Braun 10 % šķīdums infūzijām
Netherlands Aminoplasmal B. Braun 10 % E-vrij, oplossing voor infusie
Slovenia Amixal 100 mg/ml raztopina za infundiranje
United Kingdom (Northern Ireland) Aminoplasmal 10 % solution for infusion

The following information is intended exclusively for healthcare professionals:

Dosage
When a daily amino acid intake of 1.0 g per kg of body weight or more is required, particular attention must be paid to fluid intake limitations. In such situations, to avoid fluid overload, solutions with a higher amino acid content may need to be used.

Patients with renal/hepatic impairment
Dosage must be adjusted according to individual requirements in patients with mild to moderate hepatic insufficiency or decompensated liver cirrhosis with hepatic encephalopathy (grade I and II), or in patients with renal insufficiency. When administered during dialysis, amino acid losses into the dialysate must be taken into account.

Instructions for handling
Use a sterile infusion set for Amixal 10%.
When used as part of total parenteral nutrition, this medicinal product must be supplemented with other nutrients such as carbohydrates, lipids, vitamins, electrolytes, and trace elements; mixing must be performed under aseptic conditions. Mix thoroughly after adding any additives. Amixal 10% may only be mixed with other nutrients whose compatibility has been documented. Upon request, the manufacturer can provide compatibility data for various additives, as well as the corresponding shelf life of such mixtures.
Particular attention must be paid to compatibility.

• Glucose: Physicochemical stability has been demonstrated for 24 hours at room temperature with a total glucose concentration of up to 158 g/l in the mixture.
• Electrolytes: Physicochemical stability has been demonstrated for 24 hours at room temperature with total concentrations of up to 32 mmol/l sodium, 16 mmol/l potassium, and 2 mmol/l magnesium in the mixture.
• Lipids: Physicochemical stability has been demonstrated for 24 hours at room temperature with a total lipid emulsion concentration of up to 50 g/l in the mixture.
• Trace elements and vitamins: Stability has been demonstrated for 24 hours at room temperature when using commercially available multi-trace element and multivitamin products (e.g., Tracutil, Cernevit), up to the standard dosage recommended by the respective manufacturers of the micronutrients.

Special storage precautions
The solution must only be used if the container closure is intact and the solution is clear, colorless or slightly straw-colored, and practically free from visible particles.
Containers are for single use only. Dispose of the container and any unused contents after use.

Shelf life after addition of additives
Do not refrigerate.
Chemical and physical stability during use has been demonstrated for 24 hours at 25 °C. From a microbiological standpoint, unless the method used for opening and mixing ensures exclusion of microbial contamination risk, the product should be used immediately. If not used immediately, the user is responsible for the duration and conditions of storage during use.

For complete information on this medicinal product, consult the product's summary of characteristics.