PROSPECTO: INFORMATION FOR THE USER

Hidrofundin Glucosado solution for perfusion

Read this prospect carefully before starting to use this medication,because it contains important information for you.

• Keep this prospect as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Hidrofundin Glucosado is an intravenous infusion solution(administered drop by drop directly into a vein via a drip) that belongs to the group of medications known as osmotic diuretics.

Hidrofundin Glucosado is used to hydrate and maintain urine volume (diuretic) in patients undergoing cisplatino therapy(a medication used to treat certain types of cancer)when their doctor determines that it is necessary to force urine elimination due to the dose of cisplatino administered.

No use Hidrofundin Glucosado

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

If you have any of the following conditions:

• Severe kidney insufficiency or progressive kidney dysfunction with decreased urine production, unless a test dose produces a diuretic response.
• Heart failure of the congestive type or any cardiovascular disease, as the expansion of fluid outside of cells (extracellular) may 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 laboratory results show an excess of potassium in the plasma due to various causes.
• Decreased levels of salts in the blood.
• Intolerance to glucose or carbohydrates.
• Severe or uncontrolled diabetes or high blood sugar (hyperglycemia).
• A disease called Addison's disease.
• Severe high blood pressure (hypertension).

Warnings and precautions

• If you are a susceptible patient and when a very high volume of solution is administered, as there may be a risk of cardiovascular overload with pulmonary edema.
• If you have heart and lung dysfunction (cardiopulmonary) or kidney dysfunction, including acute nephritis, as mannitol (component of Hidrofundin Glucosado) causes an expansion of the fluid surrounding cells (extracellular fluid) that may lead to congestive heart failure.
• The 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, it may be advisable to administer insulin.
• The rapid administration of solutions with high glucose concentrations may lead to high plasma glucose concentrations and provoke the so-called hyperosmolar syndrome (characterized by insulin deficiency and increased glucose in the blood).
• In diabetics and individuals with transient intolerance to carbohydrates, the level of glucose in the blood and urine should be closely monitored and controlled.
• In cases of low sodium levels in the blood or high potassium levels, severe trauma, severe burns, extensive infections, or massive hemodialysis, as their situation may worsen due to changes in electrolyte balance (salts) produced after administration of the solution.
• Adequate vitamin intake (particularly vitamin B1) should be ensured.

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

It is reported to athletes that this medication contains a component that may result in a positive analytical control for doping.

Use of Hidrofundin Glucosado with other medications

Certain medications may affect the action of others, in these cases, it may be necessary to change the dose or discontinue treatment with one of the medications.

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

Mannitol increases the excretion of lithium by the kidneys. Therefore, the concentration of lithium in the blood should be closely monitored in patients receiving lithium salts who are also receiving Hidrofundin Glucosado.

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

The medications of the type inhibitors of the ECA (angiotensin-converting enzyme) enzyme, diuretics (medications that increase the elimination of water and sodium by the urine) of the type potassium-sparing alone or in combination, and medications that contain potassium, may increase serum potassium levels and lead to severe hyperkalemia, especially in patients with kidney insufficiency.

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

Hidrofundin Glucosado contains glucose, the administration of glucose to diabetic patients treated with antidiabetic medications (hypoglycemic agents) may lead to a reduction in the effect of these medications. The antidiabetic medications have a therapeutic objective of reducing blood glucose levels. Therefore, an additional supply of glucose could reduce the effectiveness of antidiabetic medications.

Hidrofundin Glucosado should be administered with caution in patients receiving tacrolimus, cyclosporine (medications used in organ transplants to prevent rejection, medications that involve renal toxicity) due to the risk of causing a decrease in potassium levels in the blood (hypokalemia).

Inform your doctor or pharmacist if you are using or have recently used other medications, including those acquired without a prescription.

Pregnancy and Lactation

In the case of pregnancy or lactation, your doctor will decide whether it is advisable to use this medication.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

Unknown.

This medication will always be administered by healthcare personnel.

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

This medication is administered directly into a vein through an infusion set (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 Toxicological Information Service. Phone 915 620 420, indicating the medication and the amount used.

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

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

Like all medications,this medicationmay cause side effects, although not everyone will experience 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 disturbancesin the blood. 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, and if not treated, may trigger dehydration, hyperosmolar coma, and death.

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

Uncommon::

Blurred vision, dizziness, skin rash, or urticaria.

Rare::

Chest pain, tachycardia, chills, or fever, urinary difficulties, electrolyte imbalance, pulmonary congestion, renal insufficiency, lower limb or foot swelling, and thrombophlebitis (blood clot with inflammation of veins).

Very rarely, allergic reactions have been observed.

Similarly, reactions due to the solution or administration technique, such as fever, infection at the injection site, venous thrombosis(formation of a blood clot in veins), phlebitis(inflammation of veins), extravasation(escape of liquid), and hypervolemia(abnormal increase in plasma volume)may occur.

If any side effect appears, your doctor should immediately discontinue the solution administration, evaluate the patient, and initiate appropriate treatment.

Reporting of 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 prospectus. You can also report them directly to theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep out of sight and reach of children.

No special storage conditions are required.

Do not use Hydrofundin Glucosated after the expiration date indicated on the packaging: after “CAD”. The expiration date is the last day of the month indicated.

Do not use Hydrofundin Glucosated if the solution shows turbidity or sedimentation. Do not use if the packaging shows visible signs of deterioration.

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

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of unused packaging and medicines. This will help protect the environment.

Composition of Hydrofundin Glucosado

The active principles are:

Per 1 mlPer 500 mlPer 1,000 ml

Manitol10.00 mg5,000 g10.00 g

Potassium chloride1.49 mg0.745 g1.49 g

Glucose monohydrate55.00 mg27,500 g55.00 g

Electrolyte composition:

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

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

The other components are water for injectable preparations

Appearance of the product and contents of the package

Hydrofundin Glucosado is a colorless and transparent solution for perfusion that is presented in plastic bottles of 500 ml and 1,000 ml(Ecoflac Plus), in packages of 10 units.

Holder of the marketing authorization and responsible for the manufacture

B. Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

This prospectus has been approved in: December 2024

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

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This information is intended solely for doctors or healthcare professionals:

Hydrofundin Glucosado intravenous perfusion solution is a ready-to-administer solution.

Ensure compatibility with solutions administered simultaneously through a common entry cannula.

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

Posology and administration form:

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

Administration of cisplatin ?75 mg/m2:

Pre-hydration phase: 1000 ml of fluids will be administered over 1 hour with the following schedule: Hydrofundin Glucosado (500 ml) and Hydrofundin Physiological (500 ml), alternately, at a rate of 500 ml every 30 minutes.

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

Post-hydration phase: After completing the administration of cis-platin, the previous schedule will be repeated with Hydrofundin Glucosado (500 ml) and Hydrofundin Physiological (500 ml), alternately, at a rate of 500 ml every 30 minutes.

The administration of a cycle of cisplatin will have a duration of approximately 3 hours.

Administration of cisplatin > 75 mg/m2:

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

Pre-hydration phase: Administer 2000 ml of fluids over 2 hours with the following schedule: Hydrofundin Glucosado (1000 ml) and Hydrofundin Physiological (1000 ml), alternately, at a rate of 1000 ml every hour. After 2 hours of hydration, cisplatin will be administered alone for 1 hour and 30 minutes.

Post-hydration phase: After completing the administration of cis-platin, the previous schedule will be repeated with Hydrofundin Glucosado (500 ml) and Hydrofundin Physiological (1000 ml), alternately, at a rate of 500 ml every 30 minutes and 1000 ml every 60 minutes.

The administration of a cycle of cisplatin will have a duration of approximately 5 hours.

Do not administer more than 1 L of Hydrofundin Glucosado per hour.

The doctor should continuously evaluate renal function, urine output, acid-base balance, hydration status, and electrolyte balance (determination of serum potassium, magnesium, and sodium) and blood glucose levels. Significant changes in these parameters may require additional supplements of electrolytes or other therapies to avoid potentially dangerous situations. In addition, they should assess cardiovascular status and monitor central venous pressure if there is evidence of circulatory overload.

Manage in the usual conditions of asepsis in the use of intravenous perfusion solutions. Once the package is opened, discard the unused portion of the solution.

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

In case of overdose, discontinue administration of this medication and initiate symptomatic treatment.

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

In case of acidosis, administer sodium bicarbonate intravenously.