PROSPECTO: INFORMATION FOR THE USER

Hidrofundin Fisiológico solution for perfusion

Read this prospect thoroughly 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.

Contents of the package and additional information

Physiological Hydrofundin is a perfusion solution(administered drop by drop directly into the vein through a drip) that belongs to the group of medications called osmotic diuretics.

Physiological Hydrofundin is used to hydrate and maintain urine volume (diuretic) in patients undergoing therapy with cisplatin (medication used to treat some types of cancer) when their doctor estimates that it is necessary to force urine elimination due to the dose of cisplatin administered.

No use Hidrofundin Fisiológico

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

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.Kidney dysfunction
• 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 accumulation of fluid in the lungs (pulmonary edema).
• Accumulation of fluid (edema) with capillary fragility or abnormal membrane permeability.
• Intracranial hemorrhages (except during craniotomy).
• Abnormal serum levels of sodium, chloride, or potassium due to various causes.
• Metabolic acidosis (excess of acidic substances in the blood).
• States of hyperhydration (excess of water in the body) and conditions of sodium retention, hypertonic dehydration, as it may lead to excess sodium.
• Addison's disease.
• Severe high blood pressure.

Warnings and precautions

• If you are susceptible and when a large volume of solution is administered, consider the risk of cardiovascular overload with pulmonary edema.
• If you have heart and lung dysfunction (cardiopulmonary) or kidney dysfunction, including acute nephritis, as mannitol causes an expansion of fluid outside of cells (extracellular) that may lead to congestive heart failure.
• If you have high blood pressure.
• If you have a liver condition called decompensated cirrhosis.
• If you are receiving corticosteroids, corticotropin, or medications that retain salts.
• In case of elevated serum potassium levels, severe trauma, severe burns, extensive infections, or massive hemodialysis, as your situation may worsen due to changes in electrolyte balance produced after administration of the solution.
• Do not administer more than 1 liter of Hidrofundin Fisiológico per hour.

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 establish a positive analytical result for doping control.

Use of Hidrofundin Fisiológico 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.

The concomitant administration of mannitol solutions with the medications called digitalis glycosides (used to treat some heart conditions) may potentiate the possibility of digitalis toxicity associated with low blood potassium levels (hypokalemia). Hidrofundin Fisiológico also provides potassium chloride to prevent or correct possible hypokalemia, so careful control of potassium levels in the blood will be necessary.

The concomitant administration of lithium salts and sodium may cause a decrease in lithium levels, with possible inhibition of its effect. On the other hand, mannitol increases the excretion of lithium by the kidneys. Therefore, the concentration of lithium in the blood should be controlled in patients under lithium therapy who are also receiving Hidrofundin Fisiológico.

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

Due to its content of sodium chloride, it should be administered with caution in patients treated with corticosteroids (hormones used to treat certain types of inflammation) or corticotropin, as prolonged treatment may alter the balance of salts in the body.

Administer with caution in patients receiving tacrolimus, ciclosporin (medications used in organ transplants to prevent rejection that cause kidney 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 case of pregnancy or lactation, your doctor will decide whether 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.

The administrationof this medication is performed directly into a vein through a drip(by intravenous perfusion).

If you have been administered more Hidrofundin Fisiológico 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, which can cause circulatory disturbances.In some cases, if the imbalancein salt levels (electrolyte)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, shortness of breath or flushing of the face.

Uncommon::

Blurred vision, dizziness, skin rash or urticaria.

Rare::

Chest pain, tachycardia, chills or fever, urinary difficulty, electrolyte imbalance, pulmonary congestion, renal insufficiency, swelling in the lower extremities or feet and thrombophlebitis (blood clot formation 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(blood clot formation in veins)or 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 stop administering the solution, evaluate the patient, and initiateappropriate treatment.

Reporting of adverse effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus.You can also report them directly throughSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:www.notificaRAM.es. By reporting adverse 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 Physiological after the expiration date indicated on the packaging. The expiration date is the last day of the month indicated.

Do not use Hydrofundin Physiological 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 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 Physiological Hydrofundin

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

Sodium Chloride9.00 mg4,500 g9.00 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.

Aspect of the product and content of the packaging

Physiological Hydrofundin is a colorless and transparent perfusion solution that is presented in 500 ml and 1,000 ml plastic bottles (Ecoflac Plus), in packs 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 was approved in: October 2014

The detailed information of this medicine 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:

Physiological Hydrofundin intravenous perfusion solution is a ready-to-use 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.

The patient must drink 2 liters of fluids in the 24 hours prior to the administration of cisplatino

Administration of cisplatino ?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 Fisiológico (500 ml), alternately, at a rate of 500 ml every 30 minutes.

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

Post-hydration phase: At the end of the administration of cis-platino, the previous schedule will be repeated with Hydrofundin Glucosado (500 ml) and Hydrofundin Fisiológico (500 ml), alternately, at a rate of 500 ml every 30 minutes.

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

Administration of cisplatino > 75 mg/m2:

The patient must drink 2 liters of fluids in the 24 hours prior to the administration of cisplatino

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

Post-hydration phase: At the end of the administration of cis-platino, the previous schedule will be repeated with Hydrofundin Glucosado (500 ml) and Hydrofundin Fisiológico (1000 ml), alternately, at a rate of 500 ml every 30 minutes and 1000 ml every hour.

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

No more than 1 liter of Hydrofundin Fisiológico should be administered per hour.

The doctor must continuously evaluate renal function, urine output, acid-base balance, hydration and electrolyte status (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 must assess cardiovascular status and monitor central venous pressure if there is evidence of circulatory overload.

Use in the usual conditions of asepsis in the use of intravenous perfusion 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 prospectus.

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

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

In case of acidosis, administer sodium bicarbonate intravenously.