Label:information for theuser

Aminoplasmal PO 12.5% solution for perfusion

Read the entire label carefully before starting to use the medication.

-Keep this label, as you may need to refer to it again.

-If you have any questions, consult your doctor or pharmacist.

-This medication 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 experiencing is severe or if you notice any adverse effect not mentioned in this label, inform your doctor or pharmacist.

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

2.Before using Aminoplasmal PO 12.5%

3.How to use Aminoplasmal PO 12.5%

4.Possible adverse effects

1. Storage of Aminoplasmal PO 12.5%
2. Additional information

Aminoplasmal PO 12,5% is an intravenous nutritional supplement, containing essential substances for the body's functions.

It is used to meet the protein and fluid needs of the body after surgical interventions and trauma.

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

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 especially 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
• renal function alteration with abnormal levels of residual nitrogen
• hyperkalemia (excess of potassium in blood)
• hyperhydration (excess of water in the body)
• manifest heart failure
• accumulated acidic substances in your blood (metabolic acidosis)

Aminoplasmal PO 12.5% should not be used in premature and newborns

Regularly monitor that fluid and electrolyte levels, acid-base balance are correct.

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

Your doctor should regularly monitor that fluid and electrolyte levels, blood sugar, serum proteins, acid-base balance, and liver and kidney function are correct.

Use of other medications

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

Amino acid solutions like Aminoplasmal PO 12.5% should not be used as carriers for other medications. If mixed with other medications, they may cause reactions 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 evaluating the possible benefits and risks of administering Aminoplasmal PO 12.5%, whether you can take this medication.

Consult your doctor or pharmacist before using any medication.

Driving and operating machines

Not applicable

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

To optimize the use of amino acids, it is recommended that it be administered simultaneously with Aminoplasmal PO 12.5%, 100 to 200 kcal per gram of nitrogen.

Follow exactly the administration instructions for Aminoplasmal PO 12.5% indicated by your doctor. Consult your doctor or pharmacist if you have any 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 of the amino acids through urine, and you may feel nausea, chills, or vomiting. These symptoms will disappear as soon as the perfusion is interrupted or the speed of the perfusion is reduced. .

If you have used more Aminoplasmal PO 12.5% than you should, consult your doctor, pharmacist immediately, or call the Toxicological Information Service. Phone 91-562 04 20. Indicating the medication and the amount used.

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

Like all medications, Aminoplasmal PO 12.5% solution may cause adverse effects, although not everyone will experience them.

The frequency of adverse effects is classified in the following categories:

The following adverse 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.

Additionally, if the solution is administered too quickly, apart from the adverse reactions described, amino acid losses through urine may occur, resulting in a subsequent imbalance of these levels.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out of the reach and sight of children.

No special storage conditions are required..Store 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 shown on the container. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

Composition of Aminoplasmal PO 12.5%:

The remaining 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 yellowish solution for perfusion, presented in glass bottles, closed with rubber stoppers.

This medication is presented in 500 ml bottles.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

B. Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

Responsible for manufacturing:

B. Braun Melsungen AG

Carl-Braun Straße, 1

34212 Melsungen

Germany

This leaflet was approved in June 2015.

The detailed information of this medication is available on the website of the Spanish Agency for Medicines and Medical Devices.

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This information is intended solely for medical professionals or healthcare professionals:

Single-use containers. Dispose of any remaining unused content after completing the perfusion.

Only use the solution if the container closure is not damaged and the solution is clear.

Use the sterile administration set for administration.

If additional nutrients such as carbohydrates, lipids, vitamins, and oligoelements are required in parenteral nutrition, they should be added to this medication under strict aseptic conditions. Mix well after adding any additives. Pay special attention to compatibility.

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