HIDROFUNDIN GLUCOSADO SOLUTION FOR INFUSION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Hidrofundin Glucosado solution for infusion

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

• Keep this leaflet as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet:

1. What is Hidrofundin Glucosado and what is it used for
2. What you need to know before you use Hidrofundin Glucosado
3. How to use Hidrofundin Glucosado
4. Possible side effects
5. Storage of Hidrofundin Glucosado
6. Contents of the pack and other information

1. What is Hidrofundin Glucosado and what is it used for

Hidrofundin Glucosado is a solution for intravenous infusion (administered drop by drop directly into a vein through a drip) that belongs to the group of medicines called osmotic diuretic solutions.

Hidrofundin Glucosado is used to hydrate and maintain urine volume (diuretic) in patients undergoing therapy with cisplatin (a medicine used to treat some types of cancer) when their doctor deems it necessary to force urine elimination due to the administered dose of cisplatin.

2. What you need to know before you use Hidrofundin Glucosado

Do not use Hidrofundin Glucosado

If you are allergic (hypersensitive) to mannitol, potassium chloride, glucose monohydrate (active ingredients) or any of the other components of Hidrofundin Glucosado.

If you have any of the following conditions:

• Severe kidney failure or progressive kidney dysfunction with decreased urine secretion, unless a test dose produces a diuretic response.
• Congestive heart failure or any cardiovascular disease, as fluid expansion outside the cells (extracellular) can lead to heart failure.
• Severe pulmonary congestion or pulmonary edema.
• Fluid accumulation (edema) with capillary fragility or abnormal membrane permeability.
• Intracranial hemorrhages (except during craniotomy).
• If analytical results reveal excess potassium in the plasma from various causes.
• Decreased salt levels in the blood.
• Glucose or carbohydrate intolerance.
• Severe or uncontrolled diabetes or excess glucose (sugar) in the blood (hyperglycemia).
• A disease called Addison's disease.
• Severe arterial hypertension (high blood pressure).

Warnings and precautions

• If you are a susceptible patient and when the volume of solution administered is very high, as there may be a risk of cardiovascular system overload with pulmonary edema (fluid accumulation in the lung).
• If you have heart and lung (cardiopulmonary) or kidney dysfunction, including kidney tissue inflammation (acute nephritis), as mannitol (a component of Hidrofundin Glucosado) causes an expansion of the fluid surrounding the cells (extracellular fluid) that can lead to congestive heart failure.
• Prolonged administration of solutions containing glucose (such as Hidrofundin Glucosado) may cause a decrease in potassium, phosphorus, and magnesium levels in the blood and may increase the volume of extracellular fluid, causing water intoxication. Additionally, insulin production may be altered, so in certain circumstances, insulin administration may be advised.
• Rapid administration of solutions with high amounts of glucose may lead to elevated plasma glucose concentrations and cause the so-called hyperosmolar syndrome (characterized by insulin deficiency and increased glucose in the blood).
• In diabetic patients and individuals with transient carbohydrate intolerance, blood and urine glucose levels should be monitored and controlled.
• In cases of low sodium levels in the blood or high potassium levels, traumatic injuries, severe burns, extensive infections, or massive hemodialysis, as their situation may worsen due to changes in electrolyte balance (salts) produced after solution administration.
• Adequate vitamin intake (particularly vitamin B1) should be ensured.

Consult your doctor, even if any of the above circumstances have occurred to you at any time.

Athletes are informed that this medicine contains a component that may result in a positive doping test result.

Using Hidrofundin Glucosado with other medicines

Certain medicines may influence the action of others. In these cases, it may be necessary to change the dose or interrupt treatment with one of the medicines.

Hidrofundin Glucosado contains mannitol. The concomitant administration of mannitol solutions with digitalis glycosides (used to treat some heart disorders) may potentiate the possibility of digitalis toxicity associated with low potassium levels in the blood (hypokalemia).

Mannitol increases lithium excretion by the kidneys. Therefore, lithium concentration in the blood should be monitored in patients undergoing treatment with lithium salts who receive Hidrofundin Glucosado at the same time.

Hidrofundin Glucosado also provides potassium chloride to prevent or correct hypokalemia, so careful monitoring of potassium levels in the blood will be important.

Medicines of the ACE inhibitor type, potassium-sparing diuretics alone or in combination, and salt substitutes containing potassium or other medicines that contain potassium may increase serum potassium levels and lead to severe hyperkalemia, especially in patients with kidney failure.

This medicine should not be used with sodium thiopental (general anesthetic), as the acidity of the Hidrofundin Glucosado solution may cause precipitation of the latter.

Hidrofundin Glucosado contains glucose. The administration of glucose to diabetic patients treated with antidiabetics (hypoglycemics) may lead to a reduction in the effect of these latter medicines. Antidiabetic drugs aim to reduce blood glucose levels. Consequently, an extra intake of glucose could reduce the effectiveness of antidiabetic drugs.

Administer Hidrofundin Glucosado with caution in patients receiving tacrolimus, cyclosporin (medicines used in organ transplants to prevent rejection, drugs that involve kidney toxicity) due to the risk of inducing a decrease in potassium levels in the blood (hypokalemia).

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

Pregnancy and breastfeeding

In case of pregnancy or breastfeeding, your doctor will decide whether to use this medicine.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

None known.

3. How to use Hidrofundin Glucosado

This medicine will always be administered by healthcare personnel.

Your doctor will indicate the most suitable dose for your needs.

The administration of this medicine is done directly into a vein through a drip (intravenous infusion).

If you have been given more Hidrofundin Glucosado than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service. Telephone 915 620 420, indicating the medicine and the amount used.

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

For information for healthcare professionals, please see the corresponding section below.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The frequency of side effects is classified into the following categories:

Common:

The most important adverse reaction is fluid and electrolyte imbalance (salts) that can cause circulatory disorders. In some cases, if the electrolyte imbalance is severe, the acid-base balance (balance between acidic and basic substances in the body) may also be altered.

If glucose tolerance is impaired, elevated blood glucose and urine glucose levels may occur. If left untreated, they can trigger dehydration, hyperosmolar coma, and death.

Other described side effects include: dry mouth or thirst, headache, nausea or vomiting.

Uncommon:

Blurred vision, dizziness, skin rash or hives.

Rare:

Chest pain, tachycardia, chills or fever, urinary difficulty, electrolyte imbalance, pulmonary congestion, kidney failure, swelling in the lower limbs or feet, and thrombophlebitis (formation of a clot with vein inflammation).

Very rarely, allergic reactions have been observed.

Additionally, reactions due to the solution or administration technique may occur, such as fever, injection site infection, venous thrombosis (clot formation inside veins), or phlebitis (vein inflammation), extravasation (fluid leakage), and hypervolemia (abnormal increase in plasma volume).

If any side effect occurs, your doctor should immediately interrupt the administration of the solution, evaluate the patient, and initiate appropriate treatment.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Hidrofundin Glucosado

Keep out of sight and reach of children.

No special storage conditions are required.

Do not use Hidrofundin Glucosado after the expiry date stated on the packaging: after "EXP". The expiry date is the last day of the month indicated.

Do not use Hidrofundin Glucosado if the solution is turbid or sedimented. Do not use if the packaging shows visible signs of deterioration.

Any unused solution should be disposed of in accordance with local requirements.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Hidrofundin Glucosado

The active ingredients are:

Per 1 ml Per 500 ml Per 1,000 ml

Mannitol 10.00 mg 5,000 g 10,000 g

Potassium chloride 1.49 mg 0.745 g 1.49 g

Glucose monohydrate 55.00 mg 27,500 g 55,000 g

Electrolyte composition:

Potassium (K+) 20 mmol/l or 20 mEq/l

Chlorides (Cl-) 20 mmol/l or 20 mEq/l

The other ingredients are water for injectable preparations

Appearance of the product and pack contents

Hidrofundin Glucosado is a clear and transparent solution for infusion that comes in 500 ml and 1,000 ml (Ecoflac Plus) plastic bottles, in packs of 10 units.

Marketing authorization holder and manufacturer

• Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

This leaflet was approved in: December 2024

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

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This information is intended only for doctors or healthcare professionals:

Hidrofundin Glucosado solution for intravenous infusion is a ready-to-use solution.

Compatibility with solutions administered simultaneously through a common entry cannula should be ensured.

The dose and amounts administered in hydration may vary depending on the needs of each patient, so they will be defined individually according to medical criteria.

Posology and method of administration:

The patient should drink 2 liters of fluids in the 24 hours prior to cisplatin administration

Cisplatin administrations ? 75 mg/m2:

Pre-hydration phase: 1000 ml of fluids will be administered over 1 hour with the following regimen: Hidrofundin Glucosado (500 ml) and Hidrofundin Fisiológico (500 ml), alternately, at a rate of 500 ml every half hour.

After 1 hour of hydration, cisplatin will be administered alone over 1 hour.

Post-hydration phase: After completing the cisplatin administration, the previous regimen will be repeated with Hidrofundin Glucosado (500 ml) and Hidrofundin Fisiológico (500 ml), alternately, at a rate of 500 ml every half hour.

The administration of a cisplatin cycle will last approximately three hours.

Cisplatin administrations > 75 mg/m2:

The patient should drink 2 liters of fluids in the 24 hours prior to cisplatin administration

Pre-hydration phase: 2000 ml of fluids will be administered over 2 hours with the following regimen: Hidrofundin Glucosado (1000 ml) and Hidrofundin Fisiológico (1000 ml), alternately, at a rate of 1000 ml per hour. After the 2 hours of hydration, cisplatin will be administered alone over 1 hour and 30 minutes.

Post-hydration phase: After completing the cisplatin administration, the previous regimen will be repeated with Hidrofundin Glucosado (500 ml) and Hidrofundin Fisiológico (1000 ml), alternately, at a rate of 500 ml in half an hour and 1000 ml in one hour.

The administration of a cisplatin cycle will last approximately five hours.

No more than 1 liter of Hidrofundin Glucosado should be administered per hour.

The doctor should continuously evaluate the patient's kidney function, urine output, acid-base balance, hydration status, and electrolyte status (determination of serum potassium, magnesium, and sodium) and blood glucose levels. Significant changes in these parameters may require additional electrolyte supplements or other therapies to avoid potentially hazardous situations. Additionally, they should assess their cardiovascular status and monitor central venous pressure in case of evidence of circulatory overload.

Handle under usual asepsis conditions for the use of intravenous infusion solutions. Once the packaging is opened, discard the unused portion of the solution.

For more information on dosing instructions, please see section 3 of the leaflet.

In case of overdose, administration of this medicine should be suspended, and symptomatic treatment should be initiated.

Overhydration can be corrected with hemodialysis or the administration of a potent diuretic (e.g., furosemide). If necessary, the cardiotonic effects of hyperkalemia should be antagonized by the intravenous administration of calcium gluconate and sodium chloride.

In case of acidosis, sodium bicarbonate should be administered intravenously.