Prospect: information for the user

Isoplasmal G solution for perfusion

Read this prospect carefully before starting to use the medication.

-Keep this prospect, as you may need to read it again.

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

-This medication has been prescribed to you and should not be given to other people, 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 prospect, inform your doctor or pharmacist.

1.What is Isoplasmal G solution for perfusion (hereinafter referred to as Isoplasmal) and for what it is used

2.Before using Isoplasmal

3.How to use Isoplasmal

4.Possible adverse effects

1. Storage of Isoplasmal
2. Additional information

Isoplasmalis a nutritional supplementthat is administered directly into a vein, which contains essential substances for the body's functions.

It is used to meet the needs of proteins, glucose, electrolytes, and fluids during periods of limited fasting.

No use Isoplasmal Isoplasmal

If you are allergic (hypersensitive) to any of the components of Isoplasmal

If you have:

• any metabolic anomaly (degradation) of amino acids
• advanced liver alterations
• alteration of kidney function (renal insufficiency) with abnormal levels of residual nitrogen
• excess of potassium in the blood (hyperkalemia)
• excess of water in the body (hyperhydration)
• alteration of heart function (manifest cardiac insufficiency)
• acidosis
• diabetes mellitus
• excess of glucose in the blood (hyperglycemia)

Isoplasmal should not be used in premature and newborns.

Be especially careful with Isoplasmal Isoplasmal

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

Ensure adequate intake of vitamins (particularly vitamin B1)

The single use of Isoplasmal can be prolonged up to 7 days. In case of prolonged nutritional alterations, the use time can be increased.

Use of other medications

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

Amino acid solutions such as Isoplasmal should not be used as carriers for other medications. If mixed with other medications, they may cause reactions that could alter the solution.

Pregnancy and breastfeeding

During pregnancy, your doctor will decide after evaluating the possible benefits and risks of administering Isoplasmal, whether you can take this medication.

Consult your doctor or pharmacist before using any medication.

This medication will always be administered by healthcare personnel.

Your doctor will determine the amount you need daily. The maximum dose is 40 ml per kg of your body weight and per day.

This medication must be administered intravenously and drop by drop.

If you use more Isoplasmal than you should

It is unlikely that this will happen since your doctor will determine your daily doses. However, if you receive more Isoplasmal than you should or if the solution is injected too quickly, you may lose some of the amino acids through your urine and may feel nausea, chills, or vomiting.These symptoms will disappear as soon as the administration is suspended or the speed is reduced.

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

Like all medications,Isoplasmalmaycauseadverse effects, although not all people will experience them.

Even in exceptional cases,and when Isoplasmalis administeredat toorapida rate, there may be losses of amino acids through the urine.

The adverse effects listed below are not due to the medication, but may occur in general when any substance used for injectable nutrition is administered, especially at the beginning.

The following adverse effects have been reported when Isoplasmalis administered:

Rare (affect between 1 and 10 of every 1,000 patients)

Gastrointestinal disorders:

nausea and vomiting.

General disorders and reactions at the site of administration:

headache, chills, and fever.

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 Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep out of reach and sight of children.

Do not store at a temperature above 25°C.

Store the bags in the outer packaging to protect them from light.

Do not use Isoplasmal after the expiration date (after CAD) that appears on the packaging. 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 packaging and medicines you no longer need. This will help protect the environment.

Composition ofIsoplasmal

The active principles are amino acids, glucose, and electrolytes.

The composition after mixing the two chambers is as follows:

From the upper chamber:

From the lower chamber:

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

Appearance of the product and contents of the packaging

Isoplasmal is a clear, colorless or slightly yellowish solution for perfusion, presented in flexible plastic bags of 1000 ml and 2000 ml. The packaging is divided into two compartments, separated by an internal seal (obturator), of 860 ml and 140 ml or 1720 ml and 280 ml.

The design of the double-chamber bag allows for the mixing of amino acids and glucose. If necessary, lipids, vitamins, oligoelements, and even more electrolytes can be added, as long as the solution does not precipitate.

Holder of the marketing authorization and responsible for manufacturing

B. Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

This prospectus was approved in February 2025.

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

---------------------------------------------------------------------------------------------------------------------------------

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

Disposable containers. Dispose of any remaining unused content after completing the perfusion.

Only use the solution if the packaging seal is not damaged and the solution is clear.

Use the sterile administration set for administration.

If, in the parenteral nutrition, it is necessary to add other nutrients such as carbohydrates, lipids, vitamins, and oligoelements to this medication, the addition should be made under strict aseptic conditions. Mix well after the inclusion of any additive. 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.

Instructions for the correct use of Isoplasmal

Preparation:

After removing the protective cover, proceed as follows: Deploy the bag and place it on a hard surface. Open the central joint by pressing with both hands on one of the chambers of the bag. The homogeneous mixture is ready for use. Remove the white capsule from the perfusion connector. Clean the connector and insert the perfusion equipment. Perfuse according to protocol.

Adding lipids:

Close the flow regulator and the air intake of the lipid transfer equipment. Disinfect the connectors and insert the needle of the transfer equipment into the lipid bottle and the connector into the addition connector located at the top of the bag. Ensure a distance of 40-60 cm (= 2-3 Medihook hangers) between the lipid bottle and the bag. Open the flow regulator and the air intake of the transfer equipment. The lipid emulsion will flow by gravity into the bag. During the transfer of lipids, no supervision is required.

Aditivos:

If necessary, additives can be incorporated directly into the bag through a syringe in the connector located at the bottom of the bag, using an aseptic procedure. For information on compatibility, consult your pharmacist or the manufacturer/distributor.

Perfusion:

Connect the perfusion equipment (without air intake) to the perfusion connector.

Mixing:

Hang the bag and mix the contents by inverting the bag 2-3 times.

The administration rate: maximum 40 drops per minute (120 ml/h).