Prospect: information for the user

Freeflex Ringer Lactate 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 only to you, 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 adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is Freeflex Ringer Lactate and for what it is used

2.What you need to know before starting to use Freeflex Ringer Lactate

3.How to use Freeflex Ringer Lactate

4.Possible adverse effects

5.Storage of Freeflex Ringer Lactate

6.Contents of the package and additional information

Freeflex Ringer Lactato is a perfusion solution that provides a mineral salt and water supplement for hydration.

The Freeflex Ringer Lactato solution is included within the group of medications known as perfusion solutions.

This medication will be administered intravenously by specialized personnel and is indicated in the following cases:

• When dehydration exists with high losses of salts and water, such as occurs when there are vomiting, diarrhea, fistulas, or severe burns.
• When the body fluids are too acidic (mild or moderate metabolic acidosis).
• When a significant decrease in blood volume occurs, in the case of hemorrhages, burns, shock, etc.
• During or after a surgical operation to prevent a drop in blood pressure.

As a vehicle for administering other compatible medications.

No use Freeflex Ringer Lactato

• If you are allergic to the active ingredients or any of the other components of this medication (listed in section 6).
• If you have been diagnosed with excess fluid in the body (hyperhydration or hyper-volemia) and if this causes swelling (edema).
• If you have high blood pressure.
• If you have an excess of potassium, sodium, calcium, or chloride in the body.
• If the body fluids are too alkaline (metabolic alkalosis).
• If the body fluids are excessively acidic (severe metabolic acidosis).
• If you have been diagnosed with high levels of lactic acid in the blood.
• If you have severe kidney or liver disease.
• If you have severe heart disease.
• If you are being treated for a long time with steroids or with a hormone called ACTH.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Freeflex Ringer Lactato.

Be especially careful with Freeflex Ringer Lactato:

-If the kidneys, heart, and/or lungs do not function correctly. In these cases, the administration of large volumes of this solution should be carried out under strict clinical control.

-It is recommended that, during the administration of this solution, regular clinical status checks and blood and urine analyses (electrolytes in blood and urine, acid-base balance, hematocrit) be performed.Blood potassium checks should be performed if there is a risk of hyperkalemia (high levels of potassium in the blood).

If you have any of the following conditions, this medication will be administered with special caution and it is likely that additional tests will be performed to determine if you can receive the medication:

-Due to the presence of sodium: If you have high blood pressure (hypertension), heart failure, pulmonary edema, or swelling in the legs, feet, and ankles, preeclampsia (a condition that occurs during pregnancy or postpartum with an increase in blood pressure), aldosteronism (a disease associated with an increase in the secretion of a hormone called aldosterone) or have impaired renal function or other conditions associated with sodium retention.

-Due to the presence of potassium: Ifyou suffer from heart disease or other conditions that may cause high potassium levels in the blood, such as renal insufficiency or adrenocortical insufficiency, acute dehydration, or massive tissue destruction, such as in severe burns.

-Due to the presence of calcium:If you have impaired renal function or if you have or have had kidney stones caused by a buildup of calcium or diseases associated with high concentrations of vitamin D such as sarcoidosis.

-Due to the presence of lactate ions:If Freeflex Ringer Lactato is administered in large quantities, it can cause metabolic alkalosis.

-If you have severe potassium deficiency. Although the Freeflex Ringer Lactato solution has a potassium concentration similar to that of plasma, it is insufficient to produce a beneficial effect in these situations.

• If the liver does not function correctly, the Freeflex Ringer Lactato solution may not produce its effect, as the metabolism of lactate may be impaired.

• Be careful when administering the solution Freeflex Ringer Lactato if you are at risk of cerebral edema or intracranial hypertension.

• If you are being treated with corticosteroids, adrenocorticotropic hormone, or digitalis medications, the administration of the Freeflex Ringer Lactato solution should be carried out with caution (see sectionUse of Freeflex Ringer Lactato with other medications).

The perfusion of large volumes will require special vigilance in patients with heart or lung failure and in patients with non-osmotic vasopressin release (including SIADH), due to the risk of hospital-acquired hyponatremia.

Hyponatremia:

Patients with non-osmotic vasopressin release (e.g., in the presence of critical states, pain, postoperative stress, infections, burns, and CNS diseases), patients with heart, liver, and kidney diseases, and patients exposed to vasopressin agonists have a special risk of experiencing acute hyponatremia after perfusion with hypotonic solutions.

Acute hyponatremia can cause acute hyponatremic encephalopathy (cerebral edema) characterized by headache, nausea, seizures, lethargy, and vomiting. Patients with cerebral edema have a special risk of suffering severe and potentially fatal brain damage.

Children, fertile women, and patients with reduced cerebral compliance (e.g., in cases of meningitis, intracranial hemorrhage, cerebral contusion, and cerebral edema) have a special risk of suffering severe and potentially fatal cerebral edema caused by acute hyponatremia.

Special attention should be paid to patients of advanced age, as they may have impaired renal, hepatic, and/or cardiac function.

Administration in the same place should be avoided due to the risk of thrombophlebitis.

Use of Freeflex Ringer Lactato with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Certain medications may interact with the lactate Ringer solution. In this case, it may be necessary to change the dose or discontinue one of the medications.

In general, it is recommended to avoid the concomitant administration of the Freeflex Ringer Lactato solution with any medication that presents or may present renal toxicity, as it may cause fluid and electrolyte retention.

It is essential to inform your doctor if you are using any of the following medications, as they may interact with one of the electrolytes present in the Freeflex Ringer Lactato solution:

-Corticosteroids/steroids or adrenocorticotropic hormone

-Lithium carbonate

-Potassium-sparing diuretics (amiloride, spironolactone, triamterene) alone or in combination

-Angiotensin-converting enzyme inhibitors (ACEIs) (captopril, enalapril) or angiotensin II receptor antagonists (candesartan, telmisartan, eprosartan, irbesartan, losartan, valsartan)

-Tacrolimus and cyclosporine (medications with renal toxicity)

-Cardiotonic digitalis glycosides (digoxin, metildigoxin)

-Thiazide diuretics (hydrochlorothiazide, altizide, mebutizide, bendroflumethiazide) or vitamin D

-Acidic medications such as salicylates and/or barbiturates

-Alkaline medications such as sympathomimetics (ephedrine, pseudoephedrine) and/or stimulants (amphetamine, dexamphetamine).

-Medications that potentiate the effect of vasopressin:

The following medications increase the effect of vasopressin, which reduces renal water excretion without electrolytes and increases the risk of hospital-acquired hyponatremia after receiving an insufficiently balanced treatment with perfusion solutions.

• Medications that stimulate vasopressin release; are, among others, the following:

chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics

• Medications that potentiate the action of vasopressin; are, among others, the following:

chlorpropamide, NSAIDs, cyclophosphamide

• Vasopressin analogs; are, among others, the following:

desmopressin, oxytocin, vasopressin, terlipressin

• Other medications that are known to increase the risk of hyponatremia are diuretics in general and antiepileptics such as oxcarbazepine.

Use of Freeflex Ringer Lactato with foods and beverages

No interactions with foods and beverages are known.

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Freeflex Ringer Lactato should be administered with special caution in pregnant women during delivery and regular sodium serum checks will be required if it is administered in combination with oxytocin.

Driving and operating machinery

Freeflex Ringer Lactatodoes not affect the ability to drive or operate machinery.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Freeflex Ringer Lactate will be administered always under the direct supervision of your doctor, who will closely monitor the administered dose.

Freeflex Ringer Lactate is administered by slow injection into a vein (intravenous infusion). The speed, as well as the amount administered, will depend on your needs and the condition being treated.

The recommended dose is 500-2,500 ml/day, at a speed of 40-60 drops/minute. Your doctor will indicate the duration of treatment with Freeflex Ringer Lactate.

Use in children

Children will be administered lower doses, proportional to their weight.

If you use more Freeflex Ringer Lactate than you should

In case of overdose or too rapid administration, the following symptoms may appear:

• hyperhydration (edema, hyperolemia), disorders in the electrolyte balance, and/or induction of a metabolic alkalosis, especially in patients with impaired renal function. In these cases, the administration will be reduced or suspended, and symptomatic treatment will be used. If renal function is compromised, dialysis may be necessary.

• water and sodium overload with a risk of edema, particularly when there is a defective renal excretion of sodium.

The excessive administration of potassium salts can lead to the development of hyperkalemia, especially in patients with impaired renal function. Symptoms include tingling, numbness, and/or burning sensations in the hands and feet, muscle weakness, paralysis, cardiac arrhythmias, cardiac block, cardiac arrest, and mental confusion.

The excessive administration of calcium salts can lead to hypercalcemia. Symptoms of hypercalcemia may include anorexia, nausea, vomiting, constipation, abdominal pain, muscle weakness, mental alteration, excessive thirst, excessive urine production, kidney stones, and, in severe cases, cardiac arrhythmias and coma, as well as a metallic taste, burning, and peripheral vasodilation. Mild asymptomatic hypercalcemia will usually resolve by stopping calcium administration and using other contributing medications such as vitamin D. If hypercalcemia is severe, urgent treatment is required (such as diuretic cycles, hemodialysis, calcitonin, bisphosphonates, and edetate trisodium).

The excessive administration of sodium lactate can lead to hypokalemia and metabolic alkalosis. Symptoms may include changes in behavior, fatigue, respiratory insufficiency, muscle weakness, and irregular heartbeats. Tetany (neuromuscular hyperexcitability) may develop, especially in hypocalcemic patients, along with increased muscle tone and muscle spasms. Treatment of metabolic alkalosis associated with bicarbonate overdose consists mainly of correcting the appropriate fluid and electrolyte balance.

In cases of overdose related to medication added to the perfused solution, signs and symptoms of overperfusion may be related to the nature of the added medication used. In case of accidental overdose, treatment should be interrupted, and the patient should be observed for symptoms and signs related to the administered medication. If necessary, symptomatic and supportive measures should be taken.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

The most commonly described adverse effects are hyperhydration (edema) and electrolyte imbalances (mainly after administration of a significant volume of Freeflex Ringer Lactato solution), as well as allergic reactions.

The possible adverse effects are:

-Electrolyte imbalances

- Hospital-acquired hyponatremia*

- Acute hyponatremic encephalopathy*

-Thrombosis (clots), phlebitis (vein inflammation) (associated with intravenous administration)

-Nasal congestion, cough, sneezing, difficulty breathing during solution administration, chest pain with altered heart rhythm

-Allergic reactions such as urticaria, skin eruptions, skin redness, itching, swelling, fluid accumulation in tissues

-Hyperhydration (edema)

-Fever, injection site infection, local reaction or local pain (associated with intravenous administration).

*Hospital-acquired hyponatremia may cause irreversible brain damage and death due to the occurrence of acute hyponatremic encephalopathy, frequency unknown.

When using Freeflex Ringer Lactato as a vehicle to administer other medications, adverse effects may be associated with the added medications to the solution.

In case of adverse effect appearance, the infusion should be interrupted.

If you consider that any of the adverse effects you experience is severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not appearing in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Store below25ºC.

Keep this medication out of the sight and reach of children.

Do not use this medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not usethis medicationif you observe that the solution is not transparent, free of particles or the packaging is damaged

Medicines should not be disposed of through drains or inthe trash. Askyour pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of FreeflexRinger Lactate

• The active principles are: sodium lactate, sodium chloride, potassium chloride, and calcium chloride dihydrate. Each 100 ml of solution contains 317 mg of sodium lactate, 600 mg of sodium chloride, 40 mg of potassium chloride, and 27 mg of calcium chloride dihydrate.

• The other components are: hydrochloric acid and/or sodium hydroxide (for pH adjustment) and water for injection.

Appearance of the product and contents of the package

Freeflex Ringer Lactate is a transparent, colorless, and particle-free intravenous infusion solution, contained in freeflex?bags of 50 ml, 100 ml, 250 ml, 500 ml, and 1000 ml, with an overbag.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Fresenius Kabi España S.A.U.

Marina 16-18,

08005 – Barcelona

Spain

Responsible for manufacturing

Fresenius Kabi Deutschland GmbH

Freseniusstraße 1

61169, Friedberg

Germany

Or

HP Halden Pharma AS

Svinesundsveien 80

1788 Halden

Norway

Or

Fresenius Kabi France

6, Rue du Rempart B.P. 611

27400 Louviers Cedex

France

Last review date of this leaflet: January 2020

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

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This information is intended only for doctors or healthcare professionals:

This medicine is administered by infusion.

The contents of each vial are for a single infusion. Once the package is opened, the solution must be administered immediately and any unused portion must be discarded.

The solution must be transparent and not contain precipitates. Do not administer otherwise.

To administer the solution and in the event of adding medications, maximum asepsis must be maintained. It is recommended to disinfect the rubber stopper before piercing it with the injection equipment. From a microbiological point of view, when the solution is used as a vehicle for other medications, it must be used immediately unless the dilution has been performed in controlled and validated aseptic conditions. If it is not used immediately, the conditions and periods of conservation during use are the responsibility of the user.

It is recommended to consult compatibility tables before adding medications to the Freeflex Ringer Lactate solution or administering them simultaneously with other medications. It is recommended to consult the medication's leaflet, as well as verify if they are soluble and stable in aqueous solution at the pH of the Freeflex Ringer Lactate solution (pH 5.0-7.0).

When compatible medication is added, the solution must be administered immediately.

The Freeflex Ringer Lactate solution must not be used as a vehicle for medications containing ions capable of forming insoluble calcium salts.

It is not recommended to mix or administer simultaneously in the same infusion set Freeflex Ringer Lactate solution with whole blood or with blood components preserved with an anticoagulant containing citrate (such as CPD), as the calcium ions present in this solution may exceed the citrate's chelating capacity, potentially leading to the formation of clots. These clots may perfuse directly into the circulation and cause an embolism.

General advice

Monitor the patient's water balance, serum electrolytes, and acid-base balance before and during administration, with special attention to serum sodium levels in patients with increased non-osmotic vasopressin release (SIADH syndrome) and in patients receiving concomitant medication with vasopressin agonists due to the risk of hospital-acquired hyponatremia.

Monitoring serum sodium levels is especially important with hypotonic solutions.

Freeflex Ringer Lactate tonicity: 280 mOsmol/l.

The infusion rate and volume depend on the patient's age, weight, and clinical condition (e.g., burns, surgery, head injury, infections); the responsible physician, with experience in pediatric treatments with infusion solutions, must decide on the need for concomitant treatment.

INSTRUCTIONS FOR CORRECT ADMINISTRATION OF THE MEDICINE

Visual inspection

1. Do not remove the freeflex?from its overbag until the moment immediately before its use.
2. Check the composition, batch number, and expiration date.
3. Inspect the set, checking the integrity of the primary packaging. Do not use if this packaging is not intact.

Removing the overbag

Some freeflex?have an overbag for protection during storage. The overbag, with a "peel" opening system, can be removed as follows:

1. Locate the tabs at the end where the ports are located.
2. Separate the two halves of the overbag, leaving the bag on a clean surface.

Preparing for administration

The freeflex?bags are designed for administration without air entry. If an infusion set with air entry is to be used, ensure that it is always closed.

1. Tighten the freeflex?to ensure that there are no leaks and inspect the solution to observe the presence of visible particles or precipitates. DO NOT ADMINISTER IF THE SOLUTION IS NOT TRANSPARENT AND/OR THE PACKAGE IS NOT INTACT.
2. Using aseptic technique, prepare the infusion set with the closed flow regulator.
3. Identify the administration port (blue) in the form of an arrow indicating the exit from the bag.
4. Remove the protective cap from the administration port of the freeflex?by grasping the lower tabs firmly with one hand and breaking the cap in the form of an arrow by a sustained twisting motion.
5. Hold the administration port by placing your fingers behind the cap and push the injection equipment's needle into the port. You should feel a slight resistance when the membrane breaks. To prevent leaks, insert the needle to the bottom of the administration port.
6. Suspend the bag on a hanger and purge the infusion set according to the manufacturer's instructions. Perform the venipuncture and immediately connect the infusion set to the intravenous cannula. Adjust the flow regulator to the desired infusion rate.
7. The freeflex?are calibrated to indicate the approximate volume infused. The scale should be read by stretching the bag and reading the volume on the surface of the liquid. For a more accurate measurement of the fluid volume, a infusion set with a measurement chamber should be used.

Adding medication

The freeflex?bags have a separate port for adding medication with a self-closing cap. Since the port is protected by a hermetically welded cap, it is not necessary to disinfect the medication addition site before its first use.

Adding medication with syringes

1. Identify the medication addition port (white) in the form of an arrow indicating an entry flow into the bag.
2. Using aseptic technique, prepare a syringe with the medication, using a 20-22 G needle.
3. Remove the protective cap from the medication addition port of the bag by grasping the lower tabs firmly with one hand and breaking the cap in the form of an arrow by a sustained twisting motion.
4. Hold the medication addition port by placing your fingers behind the cap and insert the needle completely, so that it pierces the outer cap and the internal membrane. Its rigid construction prevents the needle from entering the port through the sides.
5. Add the medication and withdraw the needle. To prevent any aerosol formation, it is recommended to maintain a sterile swab around the cap.

Recommended maximum volumes for addition:

Freeflex?size (ml)Recommended maximum addition (ml)

1. 70

1. 50

1. 75

1. 150

1. 150

NOTE: Additives may be incompatible, so expert advice should be sought before adding medication to freeflex?. If the doctor decides to add medication, it must be done using aseptic technique. It is recommended that the medication be added only under the supervision of a pharmacist. Do not store solutions to which medication has been added.

1. Shake and tighten the freeflex?to ensure a complete mixing of the medication. With dense medications such as potassium chloride, it is recommended to tighten both ports while the bag is in a vertical position and invert the bag several times.
2. If necessary, a protective cap can be placed over the medication addition port to prevent further additions.

Adding medication with reconstitution equipment

1. Identify the medication addition port (white) in the form of an arrow indicating an entry flow into the bag.
2. Remove the protective cap from the medication addition port of the bag by grasping the lower tabs firmly with one hand and breaking the cap in the form of an arrow by a sustained twisting motion.
3. Using aseptic technique, remove the reconstitution equipment from its packaging and push the narrow end onto the medication addition port so that the tabs of the port adjust with the slots of the reconstitution equipment. Stop when the top of the tabs reaches the first stop. At this position, the top of the needle of the reconstitution equipment is between the cap and the internal membrane, so that fluid cannot escape from the freeflex?.
4. Using aseptic technique, prepare the medication vial and connect it to the open end of the reconstitution equipment.
5. Connect the medication to the intravenous solution by rotating the reconstitution equipment so that the tabs of the port adjust with the internal slot and push the vial and reconstitution equipment until the top of the tabs reaches the second stop.
6. With the vial inverted, tighten and release the freeflex?several times to transfer solution to the medication vial. Shake to dissolve the medication.Nota:If the medication is a liquid, this step 6 can be omitted.
7. Invert the freeflex?so that the vial is on top of the bag and transfer the medication to the bag by tightening and releasing the bag several times to push the sterile air out of the vial.
8. When the transfer is complete, remove the reconstitution equipment from the freeflex?and discard the vial and reconstitution equipment in a safe place. The reconstitution equipment is designed for single use and should not be used for subsequent additions to this or another freeflex?.

NOTE: Additives may be incompatible, so expert advice should be sought before adding medication to freeflex?. If the doctor decides to add medication, it must be done using aseptic technique. It is recommended that the medication be added only under the supervision of a pharmacist. Do not store solutions to which medication has been added.

1. Shake and tighten the freeflex?to ensure a complete mixing of the medication. With dense medications such as potassium chloride, it is recommended to tighten both ports while the bag is in a vertical position and invert the bag several times.
2. If necessary, a protective cap can be placed over the medication addition port to prevent further additions.

Warnings:

1. Do not vent
2. Do not administer if the solution is not transparent and the freeflex?is not intact
3. Stop the infusion if adverse reactions occur
4. It is recommended to change the infusion sets at least once every 24 hours

The used freeflex?must be discarded