Glucose hydroxyethyl starch solution for infusion

Package leaflet: Information for the user

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.

• 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 could 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.

Leaflet contents:

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

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

Hidrofundin Glucosado is an intravenous infusion solution (administered drop by drop directly into a vein through an infusion set) that belongs to a 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 certain types of cancer), when the doctor considers it necessary to promote urine elimination due to the administered dose of cisplatin.

2. What you need to know before using Hidrofundin Glucosado

Do not 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 failure or progressive kidney dysfunction with reduced urine output, unless a test dose produces a diuretic response.
• Congestive heart failure or any cardiovascular disease, as expansion of extracellular fluid volume may lead to congestive heart failure.
• Severe pulmonary congestion or pulmonary edema.
• Fluid accumulation (edema) associated with capillary fragility or abnormal membrane permeability.
• Intracranial hemorrhage (except during craniotomy).
• Laboratory results showing elevated plasma potassium levels from various causes.
• Decreased blood electrolyte (salt) levels.
• Glucose or carbohydrate intolerance.
• Severe or uncontrolled diabetes, or high blood sugar (glucose) levels (hyperglycemia).
• A disease called Addison's disease.
• Severe arterial hypertension (high blood pressure).

Warnings and precautions

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

Consult your doctor, even if any of the above-mentioned conditions have occurred in the past.

Athletes are advised that this medicine contains a component that may result in a positive analytical finding in doping controls.

Use of Hidrofundin Glucosado with other medicines

Certain medicines may affect each other’s actions. In such cases, it may be necessary to adjust the dose or discontinue treatment with one of the medicines.

Hidrofundin Glucosado contains mannitol. Concomitant administration of mannitol solutions with drugs known as digitalis glycosides (used to treat certain heart disorders) may enhance the risk of digitalis toxicity associated with low blood potassium levels (hypokalemia).

Mannitol increases renal excretion of lithium. Therefore, lithium blood concentrations should be monitored in patients receiving lithium salts who are also administered Hidrofundin Glucosado.

Hidrofundin Glucosado also provides potassium chloride to prevent or correct hypokalemia; thus, careful monitoring of blood potassium concentration is important.

Medicines such as ACE inhibitors (angiotensin-converting enzyme inhibitors), potassium-sparing diuretics (alone or in combination), potassium-containing salt substitutes, or other potassium-containing medicines may increase serum potassium levels and lead to severe hyperkalemia (high blood potassium), especially in patients with kidney failure.

This medicine must not be used concomitantly with sodium thiopental (a general anesthetic), as the acidity of the Hidrofundin solution may cause precipitation of the anesthetic.

Hidrofundin Glucosado contains glucose. Administration of glucose to diabetic patients treated with antidiabetic agents (hypoglycemics) may reduce the effectiveness of these drugs. Since antidiabetic drugs aim to lower blood glucose levels, additional glucose intake may diminish their efficacy.

Administer Hidrofundin Glucosado with caution in patients receiving tacrolimus or cyclosporine (medicines used in organ transplantation to prevent rejection, drugs that may cause kidney toxicity), due to the risk of lowering blood potassium levels (hypokalemia).

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

Pregnancy and Lactation

If you are pregnant or breastfeeding, your doctor will decide whether it is appropriate to use this medicine.

Consult your doctor or pharmacist before using any medicine.

Driving and use of machines

Not known.

3. How to use Hidrofundin Glucosado

This medicine will always be administered by healthcare professionals.

Your doctor will determine the most appropriate dose according to your needs.

This medicine is administered directly into a vein through an intravenous infusion (drip).

If you have been given more Hidrofundin Glucosado than you should have

In case of overdose or accidental ingestion, consult your doctor or pharmacist, or call the Toxicology Information Service at telephone number 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 intended for healthcare professionals, please see the section below.

4. Possible adverse effects

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

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

Frequent:

The most important adverse reaction is fluid and electrolyte (salts) imbalance, which may cause disturbances in blood circulation. In some cases, if the electrolyte imbalance is severe, the acid-base balance (the balance between acidic and basic substances in the body) may also be disturbed.

If glucose tolerance is impaired, increased blood glucose levels and glucose in urine may occur. If left untreated, these may lead to dehydration, hyperosmolar coma, and death.

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

Uncommon:

Blurred vision, dizziness, skin rash, or urticaria.

Rare:

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

Very rarely, allergic reactions have been observed.

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

If any adverse reaction occurs, your doctor should immediately stop the administration of the solution, evaluate the patient, and initiate appropriate treatment.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Hidrofundin Glucosado

Keep out of the sight and reach of children.

No special storage conditions are required.

Do not use Hidrofundin Glucosado after the expiry date stated on the container: following “EXP”. The expiry date refers to the last day of the month indicated.

Do not use Hidrofundin Glucosado if the solution is cloudy or contains sediment. Do not use if the container shows any visible signs of damage.

Any unused solution must be disposed of according to local requirements.

Medicines must not be disposed of via wastewater drains or household waste. Ask your pharmacist how to dispose of containers 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 substances are:

Per 1 ml Per 500 ml Per 1,000 ml
Mannitol 10.00 mg 5.000 g 10.00 g
Potassium chloride 1.49 mg 0.745 g 1.49 g
Monohydrate glucose 55.00 mg 27.500 g 55.00 g

Electrolytic composition:
Potassium (K+) 20 mmol/l or 20 mEq/l
Chloride (Cl-) 20 mmol/l or 20 mEq/l

The other components are water for injections.

Appearance of the product and pack contents

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

Marketing Authorisation Holder and Manufacturer

• Braun Medical, S.A.
  Ctra. de Terrassa, 121
  08191-Rubí (Barcelona)

This leaflet was approved in: December 2024

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

This information is intended exclusively for physicians or healthcare professionals:

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

Compatibility with solutions administered simultaneously through a common infusion line must be ensured.

The dosage and volume administered for hydration may vary depending on individual patient needs and should therefore be individually determined according to medical judgment.

Dosing and method of administration:

The patient should drink 2 litres of fluids during the 24 hours prior to cisplatin administration.

Cisplatin doses ? 75 mg/m²:

Prehydration phase: Administer 1,000 ml of fluid over 1 hour using the following regimen: Hidrofundin Glucosado (500 ml) and Hidrofundin Fisiológico (500 ml), alternately, at a rate of 500 ml every 30 minutes.

After one hour of hydration, cisplatin is administered alone over 1 hour.

Posthydration phase: After completion of cisplatin administration, repeat the previous regimen with Hidrofundin Glucosado (500 ml) and Hidrofundin Fisiológico (500 ml), alternately, at a rate of 500 ml every 30 minutes.

A complete cycle of cisplatin administration will last approximately three hours.

Cisplatin doses > 75 mg/m²:

The patient should drink 2 litres of fluids during the 24 hours prior to cisplatin administration.

Prehydration phase: Administer 2,000 ml of fluid over 2 hours using the following regimen: Hidrofundin Glucosado (1,000 ml) and Hidrofundin Fisiológico (1,000 ml), alternately, at a rate of 1,000 ml per hour. After two hours of hydration, cisplatin is administered alone over 1 hour and 30 minutes.

Posthydration phase: After completion of cisplatin administration, repeat the previous regimen with Hidrofundin Glucosado (500 ml) and Hidrofundin Fisiológico (1,000 ml), alternately, at a rate of 500 ml every 30 minutes and 1,000 ml per hour.

A complete cycle of cisplatin administration will last approximately five hours.

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

The physician must continuously monitor renal function, urinary output, acid-base balance, hydration and electrolyte status (serum potassium, magnesium, and sodium levels), and blood glucose levels. Significant changes in these parameters may require additional electrolyte supplementation or other therapies to prevent potentially dangerous conditions. Cardiovascular status should also be assessed, and central venous pressure monitored for signs of circulatory overload.

Handle under normal aseptic conditions used for intravenous infusion solutions. After opening, any unused portion of the solution should be discarded.

For further information on dosing instructions, please refer to section 3 of the package leaflet.

In case of overdose, administration of this medicinal product should be discontinued and symptomatic treatment initiated.

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

In case of acidosis, administer sodium bicarbonate intravenously.