AMIXAL 10% Infusion solution

Зміст інструкції

1. Amixal 10% Solution for Infusion
   1. What is amixal 10% and what is it 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

Amixal 10% Solution for Infusion

Amino acids

Read this leaflet carefully before using this medicine as 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 any side effects occur, 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 is amixal 10% and what is it used for

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

2. What you need to know before using Amixal 10%

Do not use Amixal 10%

• if you are allergic to the active ingredients or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from a congenital abnormality of protein and amino acid metabolism;
• if you have a 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 suffer from poorly controlled heart failure, associated with a marked impairment of blood circulation (decompensated heart failure);
• if you have fluid accumulation in the lungs (acute pulmonary edema);
• if you have an excess of water in the body and swelling of the limbs (hyperhydration). The doctor will also bear in mind that, in general, solutions containing amino acids should not be used:
• if you have a severe liver disease (severe hepatic insufficiency)
• if you suffer from severe kidney failure (severe renal insufficiency) that cannot be adequately treated with an artificial kidney or similar therapies

Newborns, infants and children under two years of age
This solution should not be administered to newborns, infants and children under two years of age
because the composition of the solution does not adequately meet the specific nutritional needs
for this age group.

Warnings and precautions
Talk to your doctor before you are given Amixal 10%:

• if you suffer from an impairment of protein and amino acid metabolism caused by any other condition not previously indicated (see section “Do not use …");
• if you have impaired liver or kidney function;
• if you have impaired heart function;
• if your blood serum is excessively concentrated (high serum osmolarity);

Other precautions taken by the doctor
If your fluid or electrolyte balance is disturbed, this condition must be resolved before you
receive this medicine. Examples of such a condition are a simultaneous deficiency of fluids and salts
(hypotonic dehydration) or a deficiency of sodium (hyponatremia) or potassium (hypokalemia).
Before and during the administration of this medicine, blood salt levels, blood sugar levels, fluid balance, acid-base balance, blood proteins and kidney and liver function will be monitored. To this end, blood and urine samples will be taken and both will be
analyzed.
In general, in case of parenteral nutrition, the administration of Amixal 10% should be associated with
non-protein energy sources (carbohydrate solutions, lipid emulsions), essential fatty acids,
electrolytes, vitamins, fluids and trace elements.

Other medicines and Amixal 10%
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
If you are pregnant, you will only receive this medicine if your doctor considers it necessary for your
recovery. No data are available regarding the use of this medicine in pregnant women.

Breastfeeding
At the therapeutic doses of Amixal 10%, it is believed that there are no effects on newborns/infants. However,
breastfeeding is not recommended in women who, at the same time, 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 in a day hospital department). This excludes
driving vehicles and using machinery.

3. How to use Amixal 10%

Amixal 10% is administered by healthcare professionals.
The doctor will determine the necessary amount of this medicine and for how long the medicine should be
administered to patients.
The solution will be administered through a plastic tube inserted into a vein.

Patients with kidney or liver disease
If you suffer from liver or kidney disease, the doses will be modified according to individual needs.

Duration of use
This medicine can be used for as long as intravenous nutrition is required.

If you have received more Amixal 10% than you should
It is unlikely that this will occur, because the doctor will determine your daily doses.
However, if you receive an excessive dosage or if the solution is administered at too high a rate,
you may vomit and experience chills. In addition, there may be too much ammonia in the blood (hyperammonemia) and amino
acids may be excreted in the urine. It is also possible that the fluid level in the body is
elevated (hyperhydration), that the salt balance in the body is disturbed (electrolyte imbalance) and there may be
an accumulation of water in the lungs (pulmonary edema). In this case, the infusion will be stopped and resumed
later with a lower infusion rate.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 any of these side effects occur,
inform your doctor immediately, who will stop administering this
medicine:
Not known (the frequency cannot be estimated from 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 get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist.
You can also report side effects directly through the national reporting system
at
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
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 sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bottle and carton labels.
The expiry date refers to the last day of the month.
Keep the bottle in the outer packaging to protect the medicine from light.
This medicine does not require any particular storage conditions.
Do not freeze.
After infusion, the remaining solution must not be stored for later use.

6. Contents of the pack and other information

What Amixal 10% contains
The active ingredients are amino acids.
This medicine 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 contents of the pack
The solution must only be used if the container closure is not damaged and if the solution is
clear, colourless to slightly straw-yellow, and free from 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 Member States of the European Economic Area with the following
denominations:
Austria Aminoplasmal B. Braun 10 % Infusionslösung
Belgium Aminoplasmal 16, solution for infusion
Czech Republic Aminoplasmal B. Braun 10 %
Denmark Aminoplasmal
Germany Aminoplasmal B. Braun 10 %
Estonia Aminoplasmal B. Braun 10 %
Spain Aminoplasmal B. Braun 10 % solution for perfusion
Finland Aminoplasmal 16 N/l infuusioneste, liuos
Italy Amixal 10 %, solution for infusion
Lithuania Aminoplasmal B. Braun 10 % infuzinis tirpalas
Latvia Aminoplasmal B. Braun 10 % šķīdums infūzijām
Netherlands Aminoplasmal B. Braun 10 % E-vrij, solution for infusion
Poland Aminoplasmal B. Braun 10 %
Portugal Aminoplasmal B. Braun 10 %
Slovakia Aminoplasmal B. Braun 10 %
Slovenia Amixal 100 mg/ml solution for infusion
United Kingdom B. Braun Aminoplasmal 10 % solution for infusion

The following information is intended exclusively for healthcare professionals:
Route of administration
Intravenous use.
For central venous infusion only.

Dosage
The dosage must be adjusted according to individual amino acid and fluid requirements depending on the
patient’s clinical condition (nutritional status and/or degree of nitrogen catabolism due to the underlying
disease).

Adults and adolescents aged 14 to 17 years
Daily dose:
1.0 – 2.0 g of amino acids/kg of body weight ≙ 10 – 20 ml/kg of body weight
≙ 700 – 1400 ml for a 70 kg patient
Maximum infusion rate:
0.1 g of amino acids/kg of body weight/h ≙ 1.0 ml/kg of body weight/h
≙ 1.17 ml/min for a 70 kg patient

Paediatric population

Newborns, infants and children under 2 years of age
Amixal 10% is contraindicated in newborns, infants and children under 2 years of age (see
section 4.3).

Children and adolescents from 2 to 13 years of age
The dosages for these patient groups indicated below are indicative average values. The precise dosage must be
adapted to each individual case based on age, stage of development and predominant disease.
Daily dose for children aged between 2 and 4 years:
1.5 g of amino acids/kg of body weight ≙ 15 ml/kg of body weight
Daily dose for children aged between 5 and 13 years:
1.0 g of amino acids/kg of body weight ≙ 10 ml/kg of body weight
Critically ill children: for patients in critical condition, the recommended intake of amino acids may
be higher (up to 3.0 g of amino acids/kg of body weight per day).
Maximum infusion rate:
0.1 g of amino acids/kg of body weight/h ≙ 1.0 ml/kg of body weight/h
If a quantity of amino acids of 1.0 g per kg of body weight per day or more is required, particular attention must
be paid to the limitations regarding fluid intake. In such situations, solutions with a higher amino acid content may
be used to avoid fluid overload.

Renal impairment
In patients with renal insufficiency, the doses must be carefully adjusted according to individual needs,
the severity of organ failure and the type of renal replacement therapy established
(haemodialysis, haemofiltration, etc.).

Hepatic impairment
In patients with hepatic insufficiency, the dose must be adjusted according to individual needs and the
severity of organ failure.

Instructions for handling
Use a sterile infusion set for Amixal 10%.
In the case of total parenteral nutrition, other nutrients such as
carbohydrates, lipids, vitamins, electrolytes and trace elements must be added to the medicine; mixing must be
carried out under aseptic conditions. Mix well after adding any additives. Amixal 10% may only be mixed with other
nutrients whose compatibility has been documented. The manufacturer can provide compatibility data for different
additives and their respective shelf life on request.

Special precautions for storage
The product must not be used if the solution is not clear, colourless or slightly straw-yellow or
if the bottle or stopper is damaged. Storing the solution cold, below 15 °C, may lead to the formation of crystals, which can
still be easily dissolved by gently warming to 25 °C until completely dissolved. Shake the container gently to ensure
homogeneity.
The containers are for single use only. Dispose of the container and any unused contents after
use.

Shelf life after dilution with additives
From a microbiological point of view, mixtures must be administered immediately after
preparation. If not administered immediately, the user is responsible for the storage times and conditions of the mixtures
before use, which must not exceed 24 hours
at a temperature between 2 and 8°C, unless the mixing has been carried out under controlled and validated aseptic conditions.
For complete information on this medicinal product, see the summary of product characteristics.