HIDROFUNDIN FISIOLOGICO SOLUTION FOR PERFUSION

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

Do not use Hidrofundin Fisiológico

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

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 the expansion of fluid outside the cells (extracellular) can lead to heart failure.
• Severe lung congestion or fluid accumulation in the lung (pulmonary edema).
• Fluid accumulation (edema) with capillary fragility or abnormal membrane permeability.
• Intracranial hemorrhages (except during craniotomy).
• If analytical results reveal an excess of sodium, chloride, or potassium in plasma due to various causes.
• Metabolic acidosis (excess of acidic substances in the blood).
• States of hyperhydration (excess water in the body) and conditions of sodium retention, hypertonic dehydration, as an excess of sodium may occur.
• A disease called Addison's disease.
• Severe arterial hypertension

Warnings and precautions

• If you are a susceptible patient and when the volume of solution administered is very high, the risk of cardiovascular system overload with pulmonary edema should be considered.
• If you have heart and lung (cardiopulmonary) dysfunction or kidney dysfunction, including kidney tissue inflammation (acute nephritis), as mannitol causes an expansion of fluid outside the cells (extracellular) that can lead to congestive heart failure.
• If you have high blood pressure (hypertension).
• If you have a liver disorder called decompensated liver cirrhosis.
• If you are receiving treatment with corticosteroids, corticotropin, or salt-retaining drugs.
• In case of elevated serum potassium levels, traumatic injuries, severe burns, extensive infections, or massive hemodialysis, as their situation may worsen due to changes in electrolyte balance produced after administration of the solution.
• Hidrofundin Fisiológico should not be administered at a rate of more than 1 liter per hour.

Tell 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 can establish a positive doping control result.

Using Hidrofundin Fisiológico 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.

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). Hidrofundin Fisiológico also provides potassium chloride to prevent or correct possible hypokalemia, so careful control of potassium concentration in the blood will be important.

The concomitant administration of lithium salts and sodium may cause a decrease in lithium levels, with possible inhibition of its effect. Furthermore, mannitol increases the renal excretion of lithium. Therefore, the blood concentration of lithium should be monitored in patients undergoing therapy with lithium salts who receive Hidrofundin Fisiológico at the same time.

Medicines of the type ACE inhibitors (angiotensin-converting enzyme), diuretics of the type that spare potassium alone or in combination, and salt substitutes containing potassium or other medicines that contain potassium may increase serum potassium concentrations and lead to severe hyperkalemia, especially in patients with kidney failure.

Due to its sodium chloride content, it should be administered with caution in patients treated with corticoids or corticotropin, as prolonged treatment may alter the balance of salts in the body.

Administer with caution in patients receiving tacrolimus, cyclosporin (medicines used in organ transplants to prevent rejection, which involves kidney toxicity) due to the risk of causing 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.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

None known.

3. How to use Hidrofundin Fisiológico

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 the vein through a drip (by intravenous infusion).

If you have been given too much Hidrofundin Fisiológico

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

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, which 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.

Other adverse effects described are: dry mouth or thirst, headache, nausea, vomiting, fever, flushing or redness of the face.

Uncommon:

Blurred vision, dizziness, skin rash or urticaria.

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 blood clot with inflammation of the 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 the veins), or phlebitis (inflammation of the veins), extravasation (leakage of fluid), and hypervolemia (abnormal increase in plasma volume) may occur.

If any side effect occurs, your doctor should immediately stop 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 side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Hidrofundin Fisiológico

Keep out of the sight and reach of children.

No special storage conditions are required.

Do not use Hidrofundin Fisiológico after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.

Do not use Hidrofundin Fisiológico if the solution is not clear, if you observe particles at the bottom. 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 medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Hidrofundin Fisiológico

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

Sodium chloride 9.00 mg 4,500 g 9,00 g

Electrolyte composition:

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

Sodium (Na+) 154 mmol/l or 154 mEq/l

Chlorides (Cl-) 174 mmol/l or 174 mEq/l

The other components are water for injectable preparations.

Appearance of the product and packaging contents

Hidrofundin Fisiológico is a colorless and transparent solution for infusion, which 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: October 2014

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

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This information is intended only for doctors or healthcare professionals:

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

Compatibility with solutions administered simultaneously through a common entry cannula must 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.

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

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: At the end of 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 the administration of cisplatin.

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 2 hours of hydration, cisplatin will be administered alone over 1 hour and 30 minutes.

Post-hydration phase: At the end of 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 Fisiológico should be administered per hour.

The doctor should continuously evaluate kidney 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 electrolyte supplements or other therapies to avoid potentially dangerous situations. Similarly, they should assess cardiovascular status and monitor central venous pressure in case of evidence of circulatory overload.

Handle under usual asepsis conditions for the use of solutions for intravenous infusion. 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 discontinued, 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 cardiotoxic effects of hyperkalemia can be antagonized by the intravenous administration of calcium gluconate and sodium chloride.

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