POLIELECTROLÍTICA PLUS BRAUN MINIPLASCO CONCENTRATED SOLUTION FOR INFUSION

Introduction

Leaflet:information for the patient

Polielectrolytic Plus Braun Miniplasco concentrated solution for perfusion

Contents of the leaflet:

1. What Polielectrolytic Plus Braun Miniplasco is and what it is used for
2. What you need to know before using Polielectrolytic Plus Braun Miniplasco
3. How to use Polielectrolytic Plus Braun Miniplasco
4. Possible side effects
5. Storage of Polielectrolytic Plus Braun Miniplasco
6. Package contents and additional information

1. What Polielectrolytic Plus Braun Miniplasco is and what it is used for

Polielectrolytic Plus Braun Miniplasco is an injectable aqueous solution of electrolytes that belongs to a group of medicines called electrolyte combinations.

Polielectrolytic Plus Braun Miniplasco is used as a complement to Parenteral Nutrition (directly into a vein) solutions to facilitate the use of amino acids (a type of nutrient that is the basis of proteins) and maintain adequate levels of salts and acidic substances in the body (electrolyte and acid-base balance).

2. What you need to know before using Polielectrolytic Plus Braun Miniplasco

Do not use Polielectrolytic Plus Braun Miniplasco:

• if you are allergic to the active ingredients or to any of the other components of this medicine (listed in section 6).
• In cases where the administration of sodium, calcium, potassium, magnesium, zinc, chloride, or acetate may be harmful, such as:
• excess water in the blood (hyperhydration)
• excess sodium, potassium, calcium, or chloride in the blood
• kidney disorders
• heart disorders
• fluid accumulation (edema)
• high blood pressure (hypertension)
• eclampsia (pregnancy complication with seizures)
• anuria (absence of urine production)
• The composition of Polielectrolytic Plus Braun Miniplasco does not make its use advisable in children and adolescents.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Polielectrolytic Plus Braun Miniplasco.

Polielectrolytic Plus Braun Miniplasco is a concentrated electrolyte solution, hypertonic (7.620 mOsm/l), and must always be used diluted in Parenteral Nutrition solutions. It should not be administered directly.

Various analytical controls will be performed: water balance, acid-base balance, and blood tests (serum ionogram), and, depending on the results, other additional electrolytes may be administered separately; this is especially important in the case of phosphate, necessary for the metabolism of nutrients. In this case, phosphate is added when the polyelectrolyte solution is already dissolved to avoid possible precipitation with the calcium present in the solution.

In patients with renal or cardiovascular insufficiency, especially if they are elderly or postoperative, solutions containing more than 30 mEq of sodium and 40 mEq of potassium per liter should be administered with caution.

Due to its sodium content, it requires special caution in patients treated with corticosteroids or corticotropin (anti-inflammatory medications) or those patients with salt retention.

Potassium administration should be monitored through serial electrocardiograms, as blood potassium levels are not necessarily indicative of tissue potassium levels.

In patients receiving barbiturates, narcotics, or hypnotics (tranquilizers), doses should be adjusted, as magnesium-containing solutions potentiate the depressive effects of these medications.

Due to its magnesium, calcium, and/or potassium content, it should be administered with extreme caution in patients receiving digitalis preparations (heart medications, such as digoxin).

Since Polielectrolytic Plus Braun Miniplasco is administered in conjunction with Parenteral Nutrition solutions, precautions related to the administration of glucose, fats, and amino acids should be considered. It is necessary to regularly monitor plasma triglyceride levels, bilirubin, and transaminases if disorders of fat and glucose metabolism are suspected in cases of reduced tolerance.

Children and adolescents

The composition of Polielectrolytic Plus Braun Miniplasco does not make its use advisable in children and adolescents.

Using Polielectrolytic Plus Braun Miniplasco with other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicine or may need to take any other medicine.

No interactions have been observed between Polielectrolytic Plus Braun Miniplasco Injectable Solution and Parenteral Nutrition solutions. Interactions between electrolyte solutions and amino acid, carbohydrate, and fat solutions are only observed when electrolytes are present in concentrations much higher than those in Polielectrolytic Plus Braun Miniplasco.

It is essential to inform your doctor if you use any of the following medications:

• Corticosteroids/steroids (anti-inflammatory)
• Barbiturates, narcotics, or hypnotics (tranquilizers)
• Digitalis cardiac glycosides (digoxin, methyldigoxin)

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

If the medicine is used according to the recommendations of this leaflet and adequate control is performed, there are no specific complications related to the use of this medicine during pregnancy and breastfeeding.

Driving and using machines

Not applicable.

3. How to use Polielectrolytic Plus Braun Miniplasco

This medicine will be administered to you by healthcare personnel.

This solution should never be administered directly to the patient. It should only be used diluted (mixed) in other Parenteral Nutrition solutions (nutrition administered through a vein).

The Polielectrolytic Plus Braun Miniplasco solution should be added to the Parenteral Nutrition solution at the time of administration. The mixture can be used for a maximum of 24 hours.

Before use, shake the mixture and only use it if the emulsion is homogeneous.

The dosage will depend on the patient's condition and the values obtained in blood tests.

If you use more Polielectrolytic Plus Braun Miniplasco than you should

Due to the form of administration (diluted in parenteral nutrition mixtures), it is difficult for an overdose to occur. In the event of accidental overdose, administration will be discontinued, and symptoms will be treated.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount used.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

All components of the solution are usual constituents of the body, so the appearance of side effects is not expected.

Electrolyte levels in the blood should be monitored, as an excess or deficit of one or more ions in the solution can cause side effects:

• Excess sodium can cause edema and subsequent congestive heart failure in patients with cardiovascular insufficiency.

• Excess potassium can cause abnormal electrocardiogram, cardiac arrhythmias leading to cardiac arrest, paresthesias, and flaccid paralysis, mental confusion, and weakness. Potassium deficiency can alter neuromuscular function and cause intestinal dilation or even paralytic ileus.

• Excess magnesium can cause muscle weakness, flushing, sweating, hypotension, circulatory collapse, and depression of cardiac function and central nervous system. Magnesium deficiency can cause hyperirritability, psychotic behavior, tachycardia, hypertension, and neuromuscular dysfunction.

• Excess calcium can cause depression, headaches, somnolence, disorientation, syncope, dysphagia, hypotonia of skeletal and smooth muscles, arrhythmias, and coma. Calcium deficiency can produce neuromuscular hyperexcitability (paresthesias, cramps, tetany, and characteristic alterations of grand mal).

• Phosphorus deficiency can lead to altered tissue oxygenation and acute hemolytic anemia. In relation to calcium, excessive phosphorus intake can precipitate hypocalcemia with subsequent neuromuscular hyperexcitability.

Adverse reactions may occur due to the route of administration (infection, venous thrombosis, or phlebitis, and reactions due to extravasation).

Reporting 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 Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Polielectrolytic Plus Braun Miniplasco

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

Do not use Polielectrolytic Plus Braun Miniplasco after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.

Do not use this medicine if you observe that the solution is not transparent or contains particles at the bottom of the packaging, or if the packaging shows visible signs of deterioration.

Medicines and materials that have come into contact with them should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of packaging and medicines that are no longer needed. This will help protect the environment.

6. Package contents and additional information

Composition of Polielectrolytic Plus Braun Miniplasco

Appearance of the product and package contents

Polielectrolytic Plus Braun Miniplasco is a clear and colorless concentrated solution for perfusion, presented in polyethylene ampoules (MiniPlasco) of 20 ml in boxes of 10 and 100 ampoules.

Marketing authorization holder and manufacturer

B|BRAUN

• Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

Date of the last revision of this leaflet: April 2018.

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).

This information is intended only for healthcare professionals:

Polielectrolytic Plus Braun Miniplasco is a hypertonic solution, so it must be diluted properly before use. It should not be administered directly to the patient.

Solution for single use. Once the packaging is opened, discard the unused contents of the solution.

It should be administered diluted in a parenteral nutrition solution that will be administered intravenously, centrally or peripherally. The Polielectrolytic Plus Braun Miniplasco solution should be added to the Parenteral Nutrition solution at the time of administration. The mixture can be used for a maximum of 24 hours.

Before use, shake the mixture and only use it if the emulsion is homogeneous.

This medicine is incompatible with solutions containing phosphates, oxalates, or carbonates/bicarbonates, as calcium ion precipitation may occur. Magnesium sulfate, streptomycin, and tetracyclines are incompatible with calcium solutions, as they form insoluble compounds. In any case, before mixing the solution with other medicines, possible incompatibilities should be considered.