AMINOPLASMAL PO 12.5% SOLUTION FOR INFUSION

Introduction

Leaflet:information for theuser

Aminoplasmal PO 12.5% solution for infusion

Read the entire leaflet carefully before starting to use the medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you personally and should not be given to others, even if they have the same symptoms, as it may harm them.
  • If you consider that any of the adverse effects you are suffering from is serious or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Contents of the leaflet:

1. What Aminoplasmal PO 12.5% is and what it is used for
2. Before using Aminoplasmal PO 12.5%
3. How to use Aminoplasmal PO 12.5%
4. Possible side effects
   1. Storage of Aminoplasmal PO 12.5%
   2. Additional information

1. What Aminoplasmal PO 12.5% is and what it is used for

Aminoplasmal PO 12.5% is a nutritional supplement for intravenous administration, which contains essential substances for the body's functions.

It is used to cover the body's needs for protein and fluid after surgical interventions and traumas.

The administration of this solution should always be combined with an adequate intake of calories (glucose solutions or fat emulsions).

2. Before using Aminoplasmal PO 12.5%

Do not use Aminoplasmal PO 12.5%

• If you are allergic (hypersensitive) to any of the components of Aminoplasmal PO 12.5%.

• If you are allergic to any amino acid

Be careful with Aminoplasmal PO 12.5%

If you have:

• any congenital anomaly (problem that exists at birth) of amino acid metabolism (degradation)
• severe liver disease
• kidney function disorder with abnormal values in residual nitrogen levels
• hyperkalemia (excess potassium in the blood)
• hyperhydration (excess water in the body)
• manifest heart failure
• acidic substances accumulated in your blood (metabolic acidosis)

Aminoplasmal PO 12.5% should not be used in premature and newborn babies

The levels of fluids and electrolytes, acid balance, should be regularly checked to be correct.

Maximum duration of administration: up to 7 days, after an operation (post-operative state) or after an accident (post-traumatic state).

Your doctor should regularly check that the levels of fluids and electrolytes, blood sugar, serum proteins, acid-base balance, and liver and kidney function are correct.

Use of other medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those purchased without a prescription.

Amino acid solutions like Aminoplasmal PO 12.5% should not be used as carrier solutions for other medicines. If they are mixed with other medicines, reactions may occur that could spoil the solution.

Pregnancy and breastfeeding

Aminoplasmal PO 12.5% should not be administered during the first three months of pregnancy.

During the rest of the pregnancy, your doctor will decide, after assessing the possible benefits and risks of administering Aminoplasmal PO 12.5%, if you can take this medicine.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Not applicable

3. How to use Aminoplasmal PO 12.5% solution for infusion

Your doctor will determine the amount you need daily. The normal dose is 8-16 ml per kg of body weight and per day (1-2 g of amino acids per kg of body weight and day).

For optimal utilization of amino acids, it is recommended that 100-200 kcal per gram of nitrogen be administered simultaneously with Aminoplasmal PO 12.5%.

Follow exactly the administration instructions of Aminoplasmal PO 12.5% indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

If you use more Aminoplasmal PO 12.5% than you should

It is unlikely that this will happen since your doctor will determine your daily doses. However, if you receive an overdose or the solution is administered too quickly, you may lose some amino acids in the urine, and you may feel nausea, chills, or vomiting. These symptoms will disappear as soon as the infusion is interrupted or the speed of the infusion is reduced.

If you have used more Aminoplasmal PO 12.5% than you should, consult your doctor, pharmacist, or call the Toxicology Information Service immediately. Telephone 91-562 04 20, indicating the medicine and the amount used.

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Aminoplasmal PO 12.5% solution can cause side effects, although not everyone gets them.

The frequency of side effects is classified into the following categories:

The following side effects have been reported when administering Aminoplasmal PO 12.5% solution:

Gastrointestinal disorders

Uncommon: nausea and vomiting

General disorders and administration site conditions:

Uncommon: headache, chills, and fever.

In addition, if the administration of the solution is too rapid, losses of amino acids in the urine with the consequent imbalance in their levels may occur, apart from the adverse reactions described.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Aminoplasmal 12.5% solution for infusion

Keep out of the reach and sight of children.

No special storage conditions are required. Keep the container in the outer packaging to protect it from light. Do not freeze.

Do not use Aminoplasmal PO 12.5% after the expiration date stated on the container. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the container and any unused medicine. This will help protect the environment.

6. Additional information

Composition of Aminoplasmal PO 12.5%:

The other components are: citric acid and water for injectable preparations.

Appearance of the product and contents of the container

Aminoplasmal PO 12.5% is a clear, colorless or slightly straw-colored solution for infusion, presented in glass vials, closed with rubber stoppers.

This medicine is presented in 500 ml vials.

Marketing authorization holder and manufacturer

Marketing authorization holder:

• Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

Manufacturer:

• Braun Melsungen AG

Carl-Braun Straße, 1

34212 Melsungen

Germany

This leaflet was approved in June 2015.

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products.

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This information is intended only for healthcare professionals:

Single-use containers. Discard any unused contents after completing the infusion.

The solution should only be used if the container closure is not damaged and the solution is clear.

Use the sterile administration set for administration.

If it is necessary to add other nutrients such as carbohydrates, lipids, vitamins, and trace elements to this medicine in total parenteral nutrition, the addition should be performed under strict aseptic conditions. Mix well after adding any additive. Pay special attention to compatibility.

The disposal of unused medicine and all materials that have come into contact with it will be carried out in accordance with local regulations.