Hydrofundin physiological solution for infusion

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Hidrofundin Fisiotonic infusion solution

Read the entire 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, consult your doctor or pharmacist.

• This medicine has been prescribed for you only and must not be given to other people, 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 Fisiotonic is and what it is used for
2. What you need to know before using Hidrofundin Fisiotonic
3. How to use Hidrofundin Fisiotonic
4. Possible adverse effects
5. How to store Hidrofundin Fisiotonic

Pack contents and additional information

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

Hidrofundin Fisiológico is an infusion solution (administered drop by drop directly into the vein through an infusion set) that belongs to a group of medicines called solutions producing osmotic diuresis.

Hidrofundin Fisiológico 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 your doctor considers it necessary to promote urine elimination due to the dose of cisplatin administered.

2. What you need to know before using Hidrofundin Fisiological

Do not use Hidrofundin Fisiológico

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

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 system disease, since extracellular fluid expansion may lead to heart failure.
• Severe pulmonary congestion or fluid accumulation in the lungs (pulmonary edema).
• Fluid accumulation (edema) with capillary fragility or abnormal membrane permeability.
• Intracranial hemorrhage (except during craniotomy).
• If laboratory results show excess sodium, chloride, or potassium in plasma from various causes.
• Metabolic acidosis (excess acidic substances in the blood).
• States of hyperhydration (excess water in the body) and conditions involving sodium retention, hypertonic dehydration, as excess 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, consider the risk of cardiovascular system overload with pulmonary edema (swelling).
• If you have cardiopulmonary (heart and lung) or kidney dysfunction, including acute nephritis (inflammation of kidney tissue), since mannitol causes extracellular fluid expansion which may lead to congestive heart failure.
• If you have high blood pressure (hypertension).
• If you have a liver disorder called decompensated hepatic cirrhosis.
• If you are concurrently receiving treatment with corticosteroids, corticotropin, or drugs that retain salts.
• In cases of elevated serum potassium levels, traumatic injuries, severe burns, extensive infections, or massive hemodialysis, because your condition may worsen due to electrolyte balance changes following administration of the solution.
• More than 1 liter of Hidrofundin Fisiológico should not be administered per hour.

Consult your doctor, even if any of the above-mentioned circumstances occurred previously.

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

Use of Hidrofundin Fisiológico with other medicines

Certain medicines may influence the action of others; in such cases, it may be necessary to adjust the dose or discontinue treatment with one of the medicines.

Concomitant administration of mannitol solutions with drugs known as digitalis glycosides (used to treat certain heart disorders) may enhance the possibility of digitalis toxicity associated with low blood potassium levels (hypokalemia). Hidrofundin Fisiológico contains potassium chloride to prevent or correct potential hypokalemia; therefore, careful monitoring of blood potassium concentration is important.

Concomitant administration of lithium salts and sodium may cause a decrease in lithium levels, possibly inhibiting its effect. Furthermore, mannitol increases renal excretion of lithium. Therefore, blood lithium concentrations should be monitored in patients on lithium therapy who are also receiving Hidrofundin Fisiológico.

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

Due to its sodium chloride content, Hidrofundin Fisiológico should be administered with caution in patients treated with corticosteroids (hormones used to treat certain types of inflammation) or corticotropin, since prolonged treatment may alter the body's electrolyte balance.

Administer with caution in patients receiving tacrolimus or cyclosporine (medicines used in organ transplantation to prevent rejection, which carry a risk of kidney toxicity), due to the potential risk of causing low blood potassium levels (hypokalemia).

Inform your doctor or pharmacist if you are taking or have recently taken 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 Fisiológico

This medicine will always be administered by healthcare professionals.

Your doctor will determine the most appropriate dose for your needs.

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

If you have been given more Hidrofundin Fisiológico than you should

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 to healthcare professionals, please see the corresponding section below.

4. Possible adverse effects

Like all medicines, this medicine can 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 imbalance, which may cause disturbances in blood circulation. In some cases, if the imbalance in salt levels (electrolytic) is severe, the acid-base balance (the balance between acidic and basic substances in the body) may also be disturbed.

Other reported adverse effects include: dry mouth or thirst, headache, nausea, vomiting, fever, hot flushes or facial redness.

Uncommon:

Blurred vision, dizziness, skin rash or urticaria.

Rare:

Chest pain, tachycardia, chills or fever, urinary difficulty, electrolyte imbalance, pulmonary congestion, renal 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 due to the solution or the administration technique may occur, such as fever, injection site infection, venous thrombosis (blood clot formation within veins), phlebitis (vein inflammation), extravasation (leakage of fluid), and hypervolemia (abnormal increase in plasma volume).

If any adverse effect 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 via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse reactions, 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 expiry date stated on the container. The expiry date refers to the last day of the month indicated.

Do not use Hidrofundin Fisiológico if the solution is not clear or if you observe particles at the bottom. Do not use if the container shows 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 medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Hidrofundin Fisiológico

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
Sodium chloride | 9.00 mg | 4.500 g | 9.00 g

Electrolytic composition:

Potassium (K+) 20 mmol/l or 20 mEq/l
Sodium (Na+) 154 mmol/l or 154 mEq/l
Chloride (Cl-) 174 mmol/l or 174 mEq/l

The other component is water for injections.

Appearance of the product and contents of the container

Hidrofundin Fisiológico 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 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 of Medicines and Health Products (AEMPS) http://www.aemps.es/

This information is intended exclusively for physicians or healthcare professionals:

Hidrofundin Fisiológico infusion solution is a ready-to-administer solution.

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

The dosage and volume administered for hydration may vary according to individual patient needs and will therefore be individually determined at the physician's discretion.

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

Cisplatin administrations ≥ 75 mg/m²:

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

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

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

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

Cisplatin administrations > 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 according to the following regimen: Hidrofundin Glucosado (1,000 ml) and Hidrofundin Fisiológico (1,000 ml), administered 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: At the end of cisplatin administration, repeat the previous regimen with Hidrofundin Glucosado (500 ml) and Hidrofundin Fisiológico (1,000 ml), administered alternately at a rate of 500 ml every 30 minutes and 1,000 ml per hour.

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

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

The physician must continuously evaluate 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 situations. Cardiovascular status should also be assessed, and central venous pressure monitored for signs of circulatory overload.

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

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

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

Overhydration can be corrected by haemodialysis or administration of a potent diuretic (e.g. furosemide). If necessary, cardiac toxic effects of hyperkalaemia may be counteracted by intravenous administration of calcium gluconate and sodium chloride.

In case of acidosis, administer sodium bicarbonate intravenously.