Polielectrolítica Plus Braun Miniplasco concentrate for infusion solution

Patient Information Leaflet

Introduction

Package leaflet: information for the patient

Polielectrolítica Plus Braun Miniplasco concentrate for solution for infusion

Package leaflet:

1. What Polielectrolítica Plus Braun Miniplasco is and what it is used for
2. What you need to know before using Polielectrolítica Plus Braun Miniplasco
3. How to use Polielectrolítica Plus Braun Miniplasco
4. Possible side effects
5. How to store Polielectrolítica Plus Braun Miniplasco
6. Contents of the pack and other information

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

Polielectrolítica Plus Braun Miniplasco is an injectable aqueous electrolyte solution belonging to a group of medicines called electrolyte combinations.

Polielectrolítica Plus Braun Miniplasco is used as a supplement to Parenteral Nutrition solutions (direct intravenous feeding) to facilitate the utilization of amino acids (a type of nutrient that forms the basis of proteins) and to maintain appropriate levels of salts and acidic substances in the body (electrolyte and acid-base balance).

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

Do not use Polielectrolítica Plus Braun Miniplasco:

• if you are allergic to the active substances or to any of the other components of this medicine (listed in section 6).
• in cases where administration of sodium, calcium, potassium, magnesium, zinc, chloride, or acetate could be harmful, such as:
• excess body water (hyperhydration)
• excess sodium, potassium, calcium, or chloride in the blood
• kidney disorders
• heart disorders
• fluid accumulation (edema)
• high blood pressure (hypertension)
• eclampsia (pregnancy complication involving seizures)
• anuria (absence of urine production)
• The composition of Polielectrolítica Plus Braun Miniplasco does not make it advisable for 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 electrolyte solution, hypertonic (7,620 mOsm/l), and must always be used diluted in Parenteral Nutrition solutions. It must not be administered directly.

You will require several laboratory controls: monitoring of fluid balance, acid-base equilibrium, and blood tests (serum ionogram). Based on the results, additional electrolytes may be administered separately; this is particularly important for phosphate, which is necessary for the metabolism of nutrients. In such cases, phosphate is added after the polyelectrolyte solution has been dissolved to prevent possible precipitation with calcium present in the solution.

Solutions containing more than 30 mEq of sodium and 40 mEq of potassium per liter should be administered with caution in patients with renal or cardiovascular insufficiency, especially in elderly patients or those in the postoperative period.

Due to its sodium content, special caution is required in patients treated with corticosteroids or corticotropin (medications used to treat inflammation), or in those with salt retention.

Potassium administration should be monitored by serial electrocardiograms, as blood potassium levels are not necessarily indicative of potassium levels in tissues.

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

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

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

Children and adolescents

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

Use of Polielectrolítica Plus Braun Miniplasco with other medicines

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

No interactions have been 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 present at concentrations much higher than those in Polielectrolítica Plus Braun Miniplasco.

It is important that you inform your doctor if you are using any of the following medicines:

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might 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 in this leaflet and adequate monitoring is performed, there are no specific complications associated with the use of this medicine during pregnancy and breastfeeding.

Driving and operating machinery

Not applicable.

3. How to use Polielectrolítica Plus Braun Miniplasco

This medicine will be administered by healthcare professionals.

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

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

Before use, 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 route of administration (diluted in parenteral nutrition mixtures), overdose is unlikely. In case of accidental overdose, administration will be stopped and symptoms treated accordingly.

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

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.

All components of the solution are normal constituents of the body, so the occurrence of adverse effects is not expected.

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

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

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

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

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

• Phosphorus deficiency may lead to impaired tissue oxygenation and acute hemolytic anemia. With regard to calcium, excessive intake of phosphorus may 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 of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Polielectrolítica Plus Braun Miniplasco

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

No special storage conditions are required.

Do not use Polielectrolítica Plus Braun Miniplasco after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

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

Medicines and materials that have been in contact with it must not be disposed of via wastewater or in household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Polielectrolítica Plus Braun Miniplasco

Appearance of the product and contents of the container

Polielectrolítica Plus Braun Miniplasco is a clear, colourless concentrate for infusion solution, supplied in 20 ml polyethylene ampoules (MiniPlasco), 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 most recent revision of this leaflet: April 2018.

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

This information is intended exclusively for healthcare professionals:

Polielectrolítica Plus Braun Miniplasco is a hypertonic solution and therefore must be appropriately diluted before use. It must not be administered directly to the patient.

Single-use solution. After opening the container, any unused solution should be discarded.

It must be administered diluted in a parenteral nutrition solution, which will be given by central or peripheral intravenous route. Polielectrolítica Plus Braun Miniplasco solution should be added to the parenteral nutrition solution at the time of administration. The mixture may be used for up to 24 hours after preparation.

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

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