Prospecto: information for the user

Viaflo Plasmalyte 148 (pH 7.4) solution for infusion

Active ingredients: sodium chloride, potassium chloride, magnesium chloride hexahydrate, sodium acetate trihydrate, and sodium gluconate

Read this prospectus carefully before starting to use this medication, because it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or nurse.
• If you experience adverse effects, consult your doctor or nurse even if they do not appear in this prospectus. See section 4.

This medication is called “Viaflo Plasmalyte 148 (pH 7.4) solution for infusion”, but we will refer to it as “Viaflo Plasmalyte 148 (pH 7.4)” throughout the text.

1What is Viaflo Plasmalyte 148 (pH 7.4) and what is it used for

2What you need to know before Viaflo Plasmalyte 148 (pH 7.4) is administered to you

3How Viaflo Plasmalyte 148 (pH 7.4) will be administered to you

4.Possible adverse effects

5.Storage of Viaflo Plasmalyte 148 (pH 7.4)

6. Contents of the package and additional information

Pharmacotherapeutic group: “Electrolytes” - ATC code: “B05BB01”

Viaflo Plasmalyte 148 (pH 7.4) is a solution of the following substances in water:

• sodium chloride
• potassium chloride
• magnesium chloride hexahydrate
• sodium acetate trihydrate
• sodium gluconate

The sodium, potassium, magnesium, chloride, acetate, and gluconate are chemical substances present in the blood.

Viaflo Plasmalyte 148 (pH 7.4) is used:

• to provide fluids, for example, in cases of:
• burns
• head trauma
• fractures
• infections
• peritoneal irritation (inflammation in the abdominal cavity)
• to provide fluids during a surgical operation
• to treat shock caused by blood loss and for other disorders that require rapid replenishment of blood, fluids, or both
• in metabolic acidosis (when the blood becomes too acidic) that does not pose a life-threatening risk
• in lactic acidosis (a type of metabolic acidosis caused by the accumulation of lactic acid in the body). Lactic acid is produced mainly in the muscles and eliminated by the liver.

Viaflo Plasmalyte 148 (pH 7.4) may be used

in adults, the elderly, and adolescents

in infants and young children from 28 days to 23 months and in children from 2 to 11 years.

You should not be administered Viaflo Plasmalyte 148 (pH 7,4) if you have any of the following clinical situations

• if your blood contains high levels of potassium above normal (hyperkalemia).
• if you have kidney failure.
• if you have a heart block (very slow heartbeats).
• if you have a disorder in which your blood becomes too alkaline (metabolic or respiratory alkalosis).
• if you have a deficiency in stomach acid secretion (hypochlorhydria).
• if you are allergic to the active ingredients or to any of the other components of this medication (listed in section 6)

Warnings and precautions

Inform your doctor if you have or have had any of the following medical conditions.

• heart failure.
• respiratory failure (pulmonary disease).
• kidney failure.

(In these cases, special monitoring may be necessary).

• high blood pressure (hypertension).
• fluid accumulation under the skin, particularly in the ankles (peripheral edema).
• fluid accumulation in the lungs (pulmonary edema).
• high blood pressure during pregnancy (preeclampsia or eclampsia).
• aldosteronism (a disease that causes an increase in a hormone called aldosterone).
• any other condition associated with sodium retention (when the body retains too much sodium), such as steroid treatment (see also "Other medications and Viaflo Plasmalyte 148 (pH 7,4)")
• If you have a condition that could cause high levels of vasopressin, a hormone that regulates the fluid in your body. You may have too much vasopressin in your body because, for example:
• You have had a sudden and severe illness,
• You have pain,
• You have had surgery,
• You have infections, burns, or brain injury
• You have diseases related to your heart, liver, kidneys, or central nervous system,
• You are taking certain medications (see below "Other medications and Viaflo Plasmalyte 148 (pH 7,4))

This may increase the risk of having low sodium levels in the blood and can cause headaches, nausea, seizures, lethargy, coma, brain inflammation, and death. Brain inflammation increases the risk of death and brain damage. People at higher risk of brain inflammation are:

• children
• women (particularly if they are of childbearing age)
• people who have problems with their cerebrospinal fluid levels, for example, due to meningitis, bleeding in the skull, or brain injury.

• if your blood contains high levels of chloride above normal (hyperchloremia).
• if your blood contains high levels of sodium above normal (hypernatremia).
• if your blood contains low levels of calcium below normal (hypocalcemia).

• any situation that indicates that you are prone to having high levels of potassium in your blood (hyperkalemia), for example:
• kidney failure.
• adrenal insufficiency (a disease of the adrenal glands that affects the hormones that control the concentration of substances in the body).
• acute dehydration (loss of water from the body, e.g., due to vomiting or diarrhea).
• considerable tissue damage (such as that caused by severe burns).

(In these cases, it is necessary to closely monitor the potassium concentration in the blood)

• myasthenia gravis (a disease that causes progressive muscle weakness).
• recovery from surgery.

When you are receiving this solution, your doctor may take blood and urine samples to monitor:

• the amount of fluid in your body.
• the amount of substances such as sodium and chloride present in the blood and urine (your plasma and urinary electrolytes).
• your acid-base balance (the acidity of the blood and urine).

Although Viaflo Plasmalyte 148 (pH 7,4) contains potassium, the amount is not sufficient to treat severe potassium deficiency (very low potassium levels in the blood).

Viaflo Plasmalyte 148 (pH 7,4) contains substances that can cause metabolic alkalosis (the blood becomes too alkaline).

If you need to repeat the treatment, your doctor will administer additional types of infusions, which will cover the needs of other substances and nutrients (food).

If your blood is analyzed for the presence of a fungus called Aspergillus, the test may detect the presence of Aspergillus even if it is not present.

Other medications and Viaflo Plasmalyte 148 (pH 7,4)

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

The following medicationsshould not be usedwhile receiving a Viaflo Plasmalyte 148 (pH 7,4) infusion:

• potassium-sparing diuretics (a certain type of diuretic, such as amiloride, spironolactone, triamterene, potassium canrenoate)
• angiotensin-converting enzyme inhibitors (ACE inhibitors) (used to treat high blood pressure).
• angiotensin II receptor antagonists (used to treat high blood pressure).
• tacrolimus (used to prevent transplant rejection and to treat certain skin diseases).
• ciclosporina (used to prevent transplant rejection).

These medications may increase the concentration of potassium in the blood, which could put your life in danger. It is more likely that you will experience an increase in potassium levels in the blood if you have kidney disease.

Some medications act on the vasopressin hormone. These may include:

• diabetes medications (chlorpropamide)
• cholesterol medications (clofibrate)
• some cancer medications (vincristine, ifosfamide, cyclophosphamide)
• selective serotonin reuptake inhibitors (used to treat depression)
• antipsychotics
• opioids for severe pain relief
• medications for pain and/or inflammation (also known as NSAIDs)

• medications that mimic or enhance the effects of vasopressin, such as desmopressin (used to treat excessive thirst and urination), terlipressin (used to treat bleeding from the esophagus), and oxytocin (used to induce labor)
• antiepileptic medications (carbamazepine and oxcarbazepine)
• diuretics

Other medications that may affect Viaflo Plasmalyte 148 (pH 7,4) or be affected by it:

• corticosteroids (anti-inflammatory medications).
• carbenoxolone (an anti-inflammatory medication used to treat stomach ulcers).
• neuromuscular blockers (e.g., tubocurarine, suxamethonium, and vecuronium). These medications are used in surgical operations and are controlled by the anesthesiologist.
• Acetylcholine.
• aminoglycosides (a type of antibiotic)
• nifedipine (used to treat high blood pressure and chest pain).
• acidic medications, for example:
• • salicylates used to treat inflammation (aspirin).
  • sleeping pills (barbiturates).
  • lithium (used to treat psychiatric diseases).
• basic medications (alkaline), for example:
• • sympathomimetics (stimulants, such as ephedrine and pseudoephedrine, used in cough and cold preparations).
  • other stimulants (e.g., dexfenfluramine, fenfluramine).

Use of Viaflo Plasmalyte 148 (pH 7,4) with food and drinks

Ask your doctor about what you can eat or drink.

Pregnancy, breastfeeding, and fertility

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

You may receive Viaflo Plasmalyte 148 (pH 7,4) if you are pregnant or breastfeeding. Your doctor will monitor the concentration of substances in the blood and the amount of fluid in the body.

However, if another medication is added to the infusion solution during pregnancy or breastfeeding, you should:

• Ask your doctor
• Read the medication's leaflet

Driving and operating machines

Ask your doctor or pharmacist for advice before driving or operating machines.

Plasmalyte 148 (pH 7.4) Viaflo will be administered by a doctor or a nurse. Your doctor will decide how much you need and when to administer it. This will depend on your age, weight, physical condition, and the reason for treatment. The amount you receive may also be influenced by other treatments you are receiving.

DO NOT receive Plasmalyte 148 (pH 7.4) Viafloif there are particles floating in the solution or if the container is damaged in any way.

Plasmalyte 148 (pH 7.4) Viaflo is usually administered through a plastic tube connected to a vein in your arm using a needle. However, your doctor may use another method to administer the medication.

Before and during the infusion, your doctor will monitor:

• the amount of fluid in your body
• the acidity of your blood and urine
• the amount of electrolytes in your body (particularly sodium, in patients with high levels of vasopressin, or those taking other medications that increase the effect of vasopressin).

Any remaining solution should be discarded. You should NOT receive Plasmalyte 148 (pH 7.4) Viaflo from a partially used bag.

If you receive more Plasmalyte 148 (pH 7.4) Viaflo than you should

If you receive an excessive amount of Plasmalyte 148 (pH 7.4) Viaflo or if it is administered too quickly, you may experience the following symptoms:

• fluid overload or sodium overload and accumulation of fluid in tissues (edema) causing swelling.
• tingling in your arms and legs (paresthesia).
• muscle weakness.
• inability to move (paralysis).
• irregular heartbeats (cardiac arrhythmias).
• cardiac arrest (heart stops beating and life is in danger).
• confusion.
• loss of tendon reflexes.
• reduced breathing (respiratory depression).
• nausea.
• vomiting.
• skin redness.
• thirst.
• low blood pressure (hypotension).
• drowsiness.
• slow heart rate (bradycardia).
• coma (loss of consciousness).
• blood acidification (acidosis), which causes fatigue, confusion, lethargy, and increased respiratory rate.
• hypokalemia (potassium levels in the blood below normal) and metabolic alkalosis (blood becomes too alkaline), especially in patients with renal insufficiency.
• mood changes.
• fatigue.
• difficulty breathing.
• muscle stiffness.

• muscle spasms.
• muscle contractions.

If you experience any of these symptoms, you should inform your doctor immediately. Your infusion will be stopped and you will be treated depending on the symptoms.

If you are not hospitalized, go to the nearest hospital or contact the Toxicological Information Service. Phone: 91 562 04 20, indicating the medication and the amount used. It is recommended to bring the container and the medication package to the healthcare professional.

If another medication has been added to Plasmalyte 148 (pH 7.4) Viaflo before the overdose occurred, it may be that the other medication also caused symptoms. You should read the package insert of the added medication to see the list of possible symptoms.

If you interrupt treatment with Plasmalyte 148 (pH 7.4) Viaflo

Your doctor will decide when to stop administering the infusion.

If you have any other questions about the use of this medication, ask your doctor or nurse.

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

Inform your doctor or nurse immediately if you experience any of the following symptoms, as they may be signs of a severe or even life-threatening allergic reaction:

• Swelling of the skin on the face, lips, and throat
• Difficulty breathing
• Skin rash
• Redness of the skin (erythema)

You will be given the necessary treatment based on your symptoms.

The other side effects are listed in order of frequency.

Rare(observed in fewer than one in 1,000 patients, but more than one in 10,000)

• Reactions due to administration technique:
• Fever (febrile response),
• Infection at the injection site,
• Burning sensation,
• Local pain or reaction (redness or swelling) at the administration site
• Irritation and inflammation of the vein through which the solution is infused (phlebitis). This may cause redness, pain, or burning and swelling along the vein through which the solution has been infused,
• Formation of blood clots (thrombosis) in the infusion site causing pain, swelling, or redness in the area of the clot,
• Escape of the solution into the surrounding tissues (extravasation). This may damage the tissues causing scarring,
• Excess fluid in the blood vessels (hypervolemia),
• Seizures,
• Hives,
• Severe allergic reaction causing difficulty breathing or dizziness (anaphylactic reaction)
• Fast heart rate (tachycardia),
• Palpitations,
• Chest pain,
• Chest discomfort,
• Difficulty breathing (dyspnea),
• Increased respiratory rate,
• Redness,
• Hyperemia,
• Feeling of weakness (asthenia),
• Abnormal sensation,
• Priapism,
• Peripheral edema,
• Fever (pyrexia).
• Low sodium levels in the blood that may occur during hospitalization (nosocomial hyponatremia) and related neurological disorder (acute hyponatremic encephalopathy). Hyponatremia may cause irreversible brain damage and death due to cerebral edema (inflammation) (see also “Warnings and precautions”).

If another medicine has been added to the infusion solution, it may also cause side effects. These will depend on the added medicine. You should read the prospectus of the added medicine to see the list of possible symptoms.

Otherside effectsappeared with similar products:

• Other manifestations of hypersensitivity or toinfusion:decreased blood pressure (hypotension), wheezing, cold sweat, chills,
• Hyperkalemia.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children

This medication does not require special storage conditions.

DO NOT use this medication after the expiration date that appears on the bag after CAD. The expiration date is the last day of the month indicated.

Do not use this medicationif you observe particles floating in the solution or if the container is damaged in any way.

Composition ofViafloPlasmalyte 148 (pH 7.4)

The active principles are:

• sodium chloride: 5.26 g per liter
• potassium chloride: 0.37 g per liter
• magnesium chloride hexahydrate: 0.30 g per liter
• sodium acetate trihydrate: 3.68 g per liter
• sodium gluconate: 5.02 g per liter

The other components are:

• water for injection
• sodium hydroxide

Appearance of the product and contents of the package

Viaflo Plasmalyte 148 (pH 7.4) is a transparent, particle-free solution. It is supplied in polyolefin/polyamide (Viaflo) plastic bags. Each bag is introduced into a sealed plastic protective overbag.

The bag sizes are:

• 500 ml
• 1,000 ml

The bags are delivered in boxes, each containing the following quantities:

• 1 bag of 500 ml
• 20 bags of 500 ml
• 1 bag of 1,000 ml
• 10 bags of 1,000 ml
• 12 bags of 1,000 ml

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturers

Marketing authorization holder:

Baxter S.L.

Pouet de Camilo 2, 46394 Ribarroja del Turia (Valencia)

Responsible manufacturers:

Baxter S.A.

Boulevard René Branquart, 80 7860 Lessines

Belgium

Bieffe Medital S.A.

Ctra. Biescas-Senegüé, 22666 Sabiñánigo (Huesca), Spain

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria: Plasmalyt – Infusionslösung

Belgium, Luxembourg: Plasmalyte A Viaflo, solution pour perfusion

Croatia: Plasma-Lyte 148 (pH 7.4) Viaflo, otopina za infuziju

Czech Republic: Plasmalyte roztok

Cyprus: Plasma-Lyte 148 (pH 7.4) δι?λυμα για ?γχυση

Spain: Viaflo Plasmalyte 148 (pH 7.4), solución para perfusión

Denmark: Plasmalyte, infusionsvæske, opløsning

Finland: Plasmalyte infuusioneste, liuos

France: Plasmalyte Viaflo, solution pour perfusion

Greece: Plasma-Lyte 148 (pH 7.4) δι?λυμα για ?γχυση

Iceland: Plasmalyte innrennslislyf, lausn

Ireland: Plasma-Lyte 148 (pH 7.4) Solution for infusion

Italy: CrystalSol Solution for infusion

Lithuania: Plasmalyte infuzinis tirpalas

Malta: Plasma-Lyte 148 (pH 7.4) Solution for infusion

Netherlands: Plasma-Lyte 148, oplossing voor infusie

Norway: Plasmalyte infusjonsvæske, oppløsning

Poland: Plasmalyte roztwór do infuzji

Portugal: Plasma-lyte (pH 7,4) 148 Viaflo

Slovenia: Plaslyte raztopina za infundiranje

Slovakia: Plasmalyte infúzny roztok

Sweden: Plasmalyte infusionsvätska, lösning

United Kingdom (Northern Ireland): Plasma-Lyte 148 (pH 7.4) Solution for Infusion

Last review of this leaflet was in October 2023

For detailed and updated information on this medicinal product, please consult 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 solely for healthcare professionals:

Handling and preparation

When the solution and packaging permit, visually inspect the solution for visible particles and discoloration before administration. Do not administer unless the solution is transparent and the packaging is intact.

Do not remove the bag from its protective overbag until it is ready for use. The inner bag maintains the sterility of the product.Administer immediately after connecting the infusion equipment

Do not connect in series plastic containers. This type of use may cause gas embolism due to residual air carried from the primary container before the secondary container is completely administered. Pressurizing intravenous solutions in flexible plastic containers to increase flow rates may cause gas embolism if residual air in the container is not completely evacuated before administration.

The use ofan intravenous administration set with a ventilation filter in the open positionmay cause agas embolism. This type of intravenous administration set with the ventilation filter in the open positionshould not be used withflexible plasticcontainers.

The solution must be administered intravenously with a sterile equipment using an aseptic technique. The equipment must be primed with the solution to prevent air entry into the system.

Medicines may be introduced before or during infusion through the injection port.

The addition of other medicines or the use of an incorrect administration technique may cause the appearance of fever reactions due to the possible introduction of pyrogens. In case of an adverse reaction, the infusion must be interrupted immediately.

Dispose of after single use.

Dispose of partially used containers.

Do not reconnect partially used bags.

1-To open

a.Remove the Viaflo bag from the protective overbag immediately before use.

b.Check for small leaks by compressing the inner bag firmly. If leaks are detected, discard the solution, as it may not be sterile.

c.Check the transparency of the solution and the absence of foreign particles. Discard the solution if it is not transparent or contains foreign particles.

2-Preparation for administration

Use sterile material for preparation and administration.

a.Hang the container by the hanger.

b.Remove the plastic protector from the outlet in the lower part of the container.

-Hold one hand on the small handle of the outlet tube.

-Hold the other hand on the large handle of the closure cap and turn.

-The cap will come off.

c.Use an aseptic technique to prepare the infusion.

d.Connect the administration equipment. Consult the instructions accompanying the equipment for its connection, priming, and administration of the solution.

3-Techniques for injection of added medication

Warning: Added medicines may be incompatible.Before adding a medicine, verify its compatibility with the bag and the solution. When adding medicines, verify the isotonicity before parenteral administration. A complete and careful aseptic mixing of any medicineisnecessary. Solutions containing medicines mustbe usedimmediately and not stored.(see section 5 “incompatibilities of added medicines”).

To add medication before administration

a.Disinfect the injection port.

b.Using a syringe with a 19(1.10 mm)to 22(0.70 mm)gauge needle, pierce the injection port resellable and inject.

c.Mix the medicine and solution carefully. For high-density medicines, such as potassium chloride, gently move the tubes while in the vertical position and mix.

Precaution: do not store bags with added medication.

To add medication during administration

a.Close the clamp of the equipment.

b.Disinfect the injection port.

c.Using a syringe with a 19(1.10 mm)to 22(0.70 mm)gauge needle, pierce the injection port resellable and inject.

d.Remove the container from the intravenous support and/or turn to place it in the vertical position.

e.Empty both tubes by gently tapping them while the container is in the vertical position.

f.Mix the solution and medicine carefully.

g.Replace the container in the use position, reopen the clamp, and continue the administration.

4.Expiry after first opening:

The product must be used immediately after opening.

Expiry in use after reconstitution with added medicines

Before use, the physical and chemical stability of any additional medicine to the pH of the Viaflo Plasmalyte 148 (pH 7.4) solution in the Viaflo container must be established.

From a microbiological point of view, the diluted product must be used immediately. If not used immediately, the storage time and conditions before use are the responsibility of the userand normally should not be greater than 24 hours between 2 and 8 °C, unless the reconstitution has taken place in controlled and validated aseptic conditions.

5-Incompatibilities of added medicines

When adding medicines to Viaflo Plasmalyte 148 (pH 7.4), aseptic technique must be used. When added, mix the solution vigorously. Do not store bags containing added medicines.

As with all parenteral solutions, the incompatibility of the added medicines with the solution in the Viaflo bag must be verified before addition.

Consult the prospectus of the medicine to be added.

Before adding a medicine, verify that it is soluble and/or stable in water and that the pH range of the Viaflo Plasmalyte 148 (pH 7.4) solution (pH 6.5 - 8.0) is appropriate.After addition, observe for possible color change and/or the appearance of precipitates, insoluble complexes, or crystals.

Medicines that are known to be incompatible should not be used.