AMINOPLASMAL PO 12.5% SOLUTION FOR INFUSION

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Aminoplasmal PO 12.5% solution for infusion

Read the entire leaflet carefully before you start using this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you personally; do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
  • If you consider any of the side effects you experience to be serious, or if you notice any side effects not listed 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 you use Aminoplasmal PO 12.5%

3. How to use Aminoplasmal PO 12.5%

4. Possible side effects

5. Storage of Aminoplasmal PO 12.5%

6. Further 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, containing essential substances for bodily functions.

It is used to meet the body's requirements for protein and fluid following surgical procedures and trauma.

Administration of this solution must always be combined with an adequate supply 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.

Take special care with Aminoplasmal PO 12.5%

If you have:

• any congenital abnormality (a condition present at birth) in the metabolism (breakdown) of amino acids
• severe liver disease
• impaired kidney function with abnormal levels of residual nitrogen
• hyperkalemia (excess potassium in the blood)
• hyperhydration (excess water in the body)
• manifest heart failure
• accumulation of acidic substances in your blood (metabolic acidosis)

Aminoplasmal PO 12.5% must not be used in premature infants and newborns.

Regular monitoring of fluid and electrolyte levels, as well as acid-base balance, must be ensured.

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

Your doctor must regularly monitor fluid and electrolyte levels, blood glucose, serum proteins, acid-base balance, and liver and kidney function.

Use of other medicines

Inform your doctor or pharmacist if you are currently using or have recently used any other medicines, including those obtained without a prescription.

Amino acid solutions such as Aminoplasmal PO 12.5% must not be used as carrier solutions for other medicines. If mixed with other medications, reactions may occur that could compromise the solution.

Pregnancy and breastfeeding

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

During the remainder of pregnancy, your doctor will decide, after assessing the potential benefits and risks of administering Aminoplasmal PO 12.5%, whether you may take this medicine.

Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

Not applicable

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

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

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

Always follow exactly the administration instructions for Aminoplasmal PO 12.5% provided by your doctor. If you have any doubts, consult your doctor or pharmacist.

If you use more Aminoplasmal PO 12.5% than you should

It is unlikely this will occur, as your doctor will determine your daily doses. However, if you receive an overdose or the solution is administered too rapidly, you may lose some amino acids through urine and may experience nausea, chills, or vomiting. These symptoms will disappear as soon as the infusion is stopped or its rate is reduced.

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

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

4. Possible adverse effects

Like all medicines, Aminoplasmal PO 12.5% solution may cause adverse effects, although not everyone experiences them.

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

The following adverse reactions have been reported with administration of 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 solution is administered too rapidly, amino acid loss in urine may occur, leading to a consequent imbalance in amino acid levels, in addition to the adverse reactions described above.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse reactions, 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 12.5% after the expiry date stated on the container. The expiry 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 medicines and packaging you no longer need. This will help protect the environment.

6. Additional Information

Composition of Aminoplasmal PO 12.5%:

The other components are: citric acid and water for injections.

Appearance of the product and contents of the container

Aminoplasmal PO 12.5% is a clear, colourless or slightly straw-coloured perfusion solution supplied in glass bottles closed with rubber stoppers.

This medicinal product is available in 500 ml bottles.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 last approved in June 2015.

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios).

This information is intended for healthcare professionals only:

Single-use containers. Discard any unused residue remaining after completion of the infusion.

The solution should only be used if the container closure is undamaged and the solution is clear.

Use a sterile administration set for administration.

If, in total parenteral nutrition, it is necessary to add other nutrients such as carbohydrates, lipids, vitamins and trace elements to this medicinal product, such additions must be made under strict aseptic conditions. Mix thoroughly after addition of any additive. Pay special attention to compatibility.

Disposal of unused medicinal product and of all materials that have been in contact with it must be carried out in accordance with local regulations.