Normofundina with potassium solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Normofundina with potassium solution for infusion

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.

  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Normofundina with potassium is and what it is used for
2. What you need to know before using Normofundina with potassium
3. How to use Normofundina with potassium
4. Possible adverse effects
5. How to store Normofundina with potassium
6. Contents of the pack and other information

1. What Normofundina with potassium is and what it is used for

Normofundina with potassium is a solution for the administration of fluids and electrolytes (salts). It also contains glucose to ensure minimum carbohydrate requirements.

Normofundina with potassium is used:

• In patients with a deficiency of body fluids (isotonic dehydration).
• In patients who have a deficiency of body fluids and elevated sodium levels (hypertonic dehydration).
• To meet water and fluid requirements and, partially, energy requirements, when eating or drinking is not allowed or possible after surgery or injury (postoperative or post-traumatic).
• As a vehicle for concentrated electrolyte solutions that are physically and chemically compatible, and for medications.

Normofundina with potassium is a medicine that will be administered to you by your doctor or a healthcare professional.

2. What you need to know before using Normofundina with potassium

Do not use Normofundina with potassium:

• If you are allergic (hypersensitive) to the active substances in Normofundina with potassium or to any of the other components of this medicine (listed in section 6).
• If you have excess body fluids (hyperhydration).
• If you have a deficiency of fluids and sodium (hypotonic dehydration).
• If your blood potassium levels are high (hyperkalemia).
• If you have severe weakness of the heart muscle (congestive heart failure).
• If you have severe kidney problems with little or no urine production (severe renal failure with oliguria or anuria).
• If your blood sugar levels are high and do not respond to 6 units of insulin per hour.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Normofundina with potassium.

Take special care when using Normofundina with potassium in the following cases:

• If your blood sodium levels are low (hyponatremia).
• If your kidney function is impaired (renal insufficiency).
• If you suffer from conditions in which high blood potassium levels (hyperkalemia) are common, for example, if your adrenal gland is not functioning properly (Addison's disease) or in certain inherited disorders affecting red blood cells (sickle cell anemia).
• If you are being treated with other medicines that increase blood potassium levels (see section “Use of Normofundina with potassium with other medicines”).
• If you need to follow a low-salt diet due to a medical condition such as heart muscle weakness (heart failure), fluid accumulation in tissues (generalized edema), fluid in the lungs (pulmonary edema), or high blood pressure with seizures during pregnancy (eclampsia).
• If you need to follow a low-calcium diet due to a medical condition such as sarcoidosis.

Elderly patients should be monitored with particular caution, as the recommended dose may need to be adjusted to prevent kidney and circulatory problems related to hydration.

If you have high blood pressure, administration of sodium chloride and fluids should be adjusted according to the severity of your condition.

Your doctor will exercise special caution when administering Normofundina with potassium if your blood acetate levels are high or if you have any metabolic disturbances, for example, in cases of severe liver failure.

Solutions containing potassium and calcium, such as Normofundina with potassium, should be administered with caution to patients receiving cardiac glycosides (digitalis preparations) (see section “Use of Normofundina with potassium with other medicines”).

While receiving Normofundina with potassium, your fluid balance, acid-base balance, and levels of electrolytes and blood sugar will be monitored.

If your blood sugar levels rise rapidly during treatment with Normofundina with potassium, insulin will be administered.

An adequate supply of vitamins (particularly vitamin B1) must be ensured.

This solution may alter your electrolyte levels; therefore, the administration regimen will depend on your clinical condition and your ability to metabolize glucose.

Your doctor will exercise special caution if you have a condition that increases the release of vasopressin (a hormone that reduces water excretion), such as infections, heart, liver, or kidney disease, or after surgery, or if you are taking certain medications (see section “Use of Normofundina with potassium with other medicines”).

Normofundina with potassium will also be administered with caution if you are at special risk of developing cerebral edema (fluid accumulation in the brain) due to a drop in sodium levels (acute hyponatremia), for example, in children, women of childbearing age, or patients with meningitis or other complications.

Children

In newborns and premature infants with low birth weight, blood sugar levels should be monitored with particular caution.

Use of Normofundina with potassium with other medicines

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

Caution is required when potassium-containing solutions are co-administered with other medicines that increase blood potassium levels, such as:

• Diuretics that reduce potassium excretion (potassium-sparing diuretics)
• Certain medicines for high blood pressure (ACE inhibitors)
• Certain painkillers (non-steroidal anti-inflammatory drugs, NSAIDs)
• Cyclosporine or tacrolimus (medicines used to suppress immune system reactions)
• Suxamethonium (a muscle relaxant used in anesthesia)

Caution is required when co-administering medicines that increase the effect of vasopressin (a hormone that reduces water excretion), such as:

• Some medicines that increase vasopressin release (e.g.: chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics)
• Some medicines that enhance the effect of vasopressin (e.g.: chlorpropamide, NSAIDs, cyclophosphamide)
• Some medicines that have the same effect as vasopressin (analogues) (e.g.: desmopressin, oxytocin, vasopressin, terlipressin)

Medicines that may cause a decrease in sodium levels (diuretics and antiepileptics such as oxcarbazepine).

Cardiac rhythm problems may occur if these medicines are administered together with potassium, as significantly elevated blood potassium levels may be reached.

The potassium contained in this solution may reduce the effect of cardiac glycosides (digitalis preparations).

Co-administration of medicines that reduce sodium excretion (e.g., corticosteroids or non-steroidal anti-inflammatory drugs) may lead to fluid retention (edema).

The calcium contained in the solution may enhance the harmful effects of cardiac glycosides (digitalis preparations) and cause cardiac rhythm disturbances.

Some diuretics (thiazide diuretics) and vitamin D may reduce calcium excretion.

Your doctor will also consider interactions with medicines that affect glucose metabolism, such as corticosteroids.

Pregnancy and breastfeeding

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

Normofundina with potassium should be administered with special caution to pregnant women during labor, especially if administered in combination with oxytocin, due to the risk of hyponatremia (low sodium levels).

Your doctor will administer Normofundina with potassium cautiously.

Driving and use of machines

Normofundina with potassium has no influence on the ability to drive or operate machinery.

3. How to use Normofundina with potassium

This medicine will always be administered to you by a doctor or healthcare professional.

The dose will depend on the type and severity of the illness, as well as your individual requirements for carbohydrates, fluids, and electrolytes. Your doctor will decide the frequency and duration of treatment with Normofundina with potassium.

Always follow exactly the administration instructions for Normofundina with potassium provided by your doctor. If in doubt, consult your doctor or pharmacist again.

Administration is by intravenous infusion, meaning that the solution will be given directly into a vein through a cannula (a thin tube).

If you use more Normofundina with potassium than you should

As a result of an overdose, excess fluid may occur, accompanied by increased skin turgor, venous congestion, and accumulation of fluid in body tissues (edema), including the lungs (pulmonary edema). Electrolyte imbalances may occur, including high blood potassium levels and low blood sodium levels, acid-base imbalances, and increased blood glucose levels.

Treatment

The infusion will be stopped immediately. Diuretics (medicines used to increase urine production) will be administered, and your fluid and electrolyte balance will be monitored. Your doctor will decide whether further measures are needed depending on the nature and severity of the situation.

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

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number (91) 562 04 20 immediately, stating the medicine and the amount taken.

4. Possible adverse effects

Like all medicines, Normofundina with potassium may produce adverse effects, although not everyone experiences them.

Frequency not known (cannot be estimated from available data):

• Local reactions at the site of administration, including local pain
• Venous irritation, phlebitis (inflammation of the vein wall), and leakage of the solution from the vein into surrounding tissue (extravasation)
• Hospital-acquired hyponatremia (reduced sodium levels) and hyponatremic encephalopathy, which may cause brain damage

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 via 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 Normofundina with potassium

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

Do not use this medicine after the expiry date stated on the packaging after “EXP”. The expiry date refers to the last day of the month indicated.

Do not use Normofundina with potassium if the solution is cloudy, contains particles at the bottom of the container, or if the container or its closure shows visible signs of deterioration.

No special storage conditions are required.

Medicines and materials that have been in contact with it must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and additional information

Composition of Normofundina with potassium:

The other components are: water for injections.

Appearance of the product and contents of the container

Normofundin with potassium is an infusion solution to be administered directly into the bloodstream. It is a clear, aqueous solution, colourless to pale yellow.

It is supplied in polyethylene bottles (Ecoflac Plus) of 500 ml and 1000 ml in pack sizes of:

1 x 500 ml, 10 x 500 ml

1 x 1000 ml, 10 x 1000 ml

Marketing Authorization Holder and Manufacturer

B|BRAUN

• Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

Date of latest revision of this leaflet: April 2025

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

This information is intended for healthcare professionals only:

Before mixing this solution with other medicinal products, possible incompatibilities must be considered. Normofundin with potassium is incompatible with tetracyclines (precipitation), sodium thiopental and amphotericin B (oxidation).

Medicinal products containing oxalates, phosphates and carbonates/bicarbonates may precipitate when mixed with Normofundin with potassium and therefore should not be mixed with this solution.

Glucose-containing solutions must not be administered through the same infusion set, either simultaneously or before or after blood administration, due to the risk of pseudo-agglutination.

Dosage

Adults

Maximum daily dose

As routine maintenance, the daily dose should not exceed 40 ml per kg of body weight (BW) per day, equivalent to 2 g of glucose per kg BW per day, 4 mmol of sodium per kg BW per day and 0.7 mmol of potassium per kg BW per day.

Monitoring of fluid balance, serum glucose, serum sodium and other electrolytes may be required before and during administration, especially in patients with increased non-osmotic release of vasopressin (syndrome of inappropriate antidiuretic hormone secretion, SIADH) and in patients receiving concomitant treatment with vasopressin agonists due to the risk of hyponatraemia.

Monitoring of serum sodium is particularly important when physiologically hypotonic solutions are administered. Normofundin with potassium may become extremely hypotonic after administration due to the metabolism of glucose in the body.

Paediatric population

As routine maintenance, the following daily doses should not be exceeded:

Any additional losses (e.g., due to fever, diarrhea, vomiting, etc.) must be compensated according to the composition and volume of the fluids lost.

In cases of dehydration, the maximum daily dose may be exceeded in certain situations. The dose should be calculated based on the severity of dehydration and the patient's clinical condition.

Maximum infusion rate

Adults

For routine maintenance, infusion rates should not exceed 100 mL/hour.

When treating acute hypertonic dehydration, acute hypernatremia should be corrected within 24 hours. In cases of chronic hypernatremia (>24 hours) or hypernatremia of unknown duration, correction should proceed at a rate not exceeding 0.5 mmol/L/hour. Normal serum sodium levels should be achieved within 48 hours. A more rapid reduction in serum sodium levels may cause cerebral edema.

Pediatric population

For routine maintenance, the following infusion rates should not be exceeded:

Mild to moderate hypernatremia should be corrected over 48 hours. In cases of severe hypertonic dehydration (serum sodium ≥ 170 mmol/l), rehydration should last 72–96 hours. The initial correction rate should not exceed 10–12 mmol/l in 24 hours (0.5 mmol/l/hour). A more rapid decrease in serum sodium levels may cause cerebral edema, seizures, and irreversible brain damage.

All ages

For the treatment of dehydration, the maximum infusion rate is 5 ml per kg of body weight per hour, equivalent to 0.25 g of glucose per kg of body weight and 0.09 mmol of potassium per kg of body weight per hour. The maximum drip rate is 1.7 drops per kg of body weight per minute.