Prospecto:Information for the Patient

Polielectrolítica Plus Braun Miniplasco Concentrate for Infusion Solution

Polielectrolítica Plus Braun Miniplasco is a water-based injectable solution of electrolytes that belongs to a group of medications called combinations of electrolytes.

Polielectrolítica Plus Braun Miniplasco is used as a complement to Parenteral Nutrition (nutrition directly into the vein) 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).

No use Polielectrolítica Plus Braun Miniplasco:

• if you are allergic to the active ingredients or any of the other components of this medication (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 damage
• heart damage
• fluid accumulation (edema)
• high blood pressure (hypertension)
• eclampsia (pregnancy complication with seizures)
• anuria (absence of urine production)
• The composition of Polielectrolítica Plus Braun Miniplasco does not make it advisable to use in children and adolescents.

Warnings and precautions

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

Polielectrolítica Plus Braun Miniplasco is a concentrated solution of electrolytes, hypertonic (7.620 mOsm/l) andmust be used always diluted in parenteral nutrition solutions. Do not administer directly.

You will need to perform different analytical controls: water balance, acid-base balance, and blood analysis (serum ionogram) and, according to the results, you may administer separate additional electrolytes; this is especially important in the case of phosphate, necessary for the metabolism of nutritional substances. 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 (inflammation medications) or those patients with salt retention.

The administration of potassium should be monitored by 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 solutions containing magnesium potentiate the depressive effects of these medications.

Due to its content in magnesium and/or calcium and/or potassium, it should be administered with extreme caution in patients receiving digital preparations (heart medications, for example, digoxin)

Since Polielectrolítica Plus Braun Miniplasco is administered in conjunction with parenteral nutrition solutions, consider the precautions related to the administration of glucose, fats, and amino acids. Regularly control plasma triglyceride levels, bilirubin, and transaminases if you suspect disorders of fat and glucose metabolism in cases of reduced tolerance.

Children and adolescents

The composition of Polielectrolítica Plus Braun Miniplasco does not make it advisable to use in children and adolescents.

Use of Polielectrolítica Plus Braun Miniplasco with other medications

Inform your doctor or pharmacist if you are taking, or have recently taken, any other medication or may need to take any other medication.

No interactions are observed between Polielectrolítica Plus Braun Miniplasco Injectable Solution and parenteral nutrition solutions. Interactions between electrolyte solutions and amino acid, carbohydrate, and fat solutions only occur when electrolytes are presented in concentrations much higher than those presented by Polielectrolítica Plus Braun Miniplasco.

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

• Corticosteroids/steroids (anti-inflammatory medications)
• Barbiturates, narcotics, or hypnotics (tranquilizers)
• Cardiotonic glucosides (digoxin, methyldigoxin)

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

If the medication is used following the recommendations of this prospectus and adequate control is performed, there are no specific complications related to the use of this medication during pregnancy and lactation.

Driving and operating machinery

No.

This medication will be administered by healthcare personnel.

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

Polielectrolítica Plus Braun Miniplasco solution must be added to the Parenteral Nutrition solution at the time of administration. The mixture may be used for a maximum of 24 hours.

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

The dosage will depend on the patient's condition and blood test results.

If you use more Polielectrolítica Plus Braun Miniplasco than you should

Due to the administration method (diluted in parenteral nutrition mixtures), it is difficult to produce an overdose. In the event of accidental overdose, administration will be suspended and symptoms will be treated.

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

All components of the solution are usual constituents of the body, so it is not anticipated that adverse effects will occur.

The levels of electrolytes in the blood should be monitored, as an excess or deficiency of one or more ions in the solution may cause adverse effects:

• An excess of sodium may cause edema and subsequent congestive heart failure in patients with cardiovascular insufficiency.

• An excess of potassium may cause an abnormal electrocardiogram, cardiac arrhythmias leading to cardiac arrest, paresthesias, and flaccid paralysis, mental confusion, and weakness. A deficiency of potassium may alter neuromuscular function and cause intestinal dilation or even paralytic ileus.

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

• An excess of calcium may cause depression, headaches, drowsiness, disorientation, syncope, dysphagia, hypotonia of skeletal and smooth muscle, arrhythmias, and coma. A deficiency of calcium may produce neuromuscular hyperexcitability (paresthesias, cramps, tetany, and characteristic alterations of the grand mal).

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

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

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 theSpanish 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 this medication out of the sight and reach of children.

No special storage conditions are required.

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

Do not use this medication 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 been in contact with it should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medications. In this way, you will help protect the environment.

Composition of Polielectrolítica Plus Braun Miniplasco

Appearance of the product and contents of the packaging

Polielectrolítica Plus Braun Miniplasco is a clear and colorless concentrate for perfusion solution that is presented in polyethylene ampoules (MiniPlasco) of 20 ml in boxes of 10 and 100 ampoules

Holder of the marketing authorization and responsible for the manufacture

B|BRAUN

B. Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

Date of the last review of this prospectus: April 2018.

The detailed information of this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).

This information is intended solely for doctors or healthcare professionals:

Polielectrolítica 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 any remaining unused solution.

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

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

This medication is incompatible with solutions containing phosphates, oxalates or carbonates/bicarbonates, as it may cause precipitation of calcium ions. Magnesium sulfate, streptomycin, and tetracyclines are incompatible with calcium solutions, as they form insoluble compounds. In any case, before mixing the solution with other medications, consider the possible incompatibilities.