VIAFLO PLASMALYTE 148 (pH 7.4) SOLUTION FOR INFUSION

2. What you need to know before you are given Viaflo Plasmalyte 148 (pH 7.4)

Viaflo Plasmalyte 148 (pH 7.4) should not be given to you if you have any of the following conditions

• 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 the blood becomes too alkaline (metabolic or respiratory alkalosis).
• if you have a deficiency of acid secretion in the stomach (hypochlorhydria).
• if you are allergic to the active substances or to any of the other components of this medicine (listed in section 6)

Warnings and precautions

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

• heart failure.
• respiratory failure (lung 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 elevated levels of a hormone called aldosterone).
• any other condition associated with sodium retention (when the body retains too much sodium), such as treatment with steroids (see also “Other medicines and Viaflo Plasmalyte 148 (pH 7.4)”).
• if you have a condition that could cause high levels of vasopressin, a hormone that regulates 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 are in pain,
• you have had surgery,
• you have infections, burns, or head injury
• you have diseases related to your heart, liver, kidneys, or central nervous system,
• you are taking certain medications (see below Other medicines and Viaflo Plasmalyte 148 (pH 7.4))

This may increase the risk of low sodium levels in the blood and can cause headache, 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 (especially if they are of childbearing age)
• people with problems with their brain fluid levels, for example, due to meningitis, bleeding in the skull, or head 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 you are prone to having high potassium levels in the 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).
• significant tissue damage (such as that caused by severe burns).

(In these cases, close monitoring of potassium levels in the blood is necessary)

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

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

• the amount of fluid in your body.
• the amount of chemical 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 it is necessary to repeat the treatment, your doctor will also give you other types of infusions, which will cover the needs of other chemical substances and nutrients (food).

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

Other medicines and Viaflo Plasmalyte 148 (pH 7.4)

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

The following medicines must not be usedwhile you are receiving an infusion of Viaflo Plasmalyte 148 (pH 7.4):

• 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).
• cyclosporin (used to prevent transplant rejection).

These medicines can increase the level of potassium in the blood, which could be life-threatening. It is more likely that you will suffer from high potassium levels in the blood if you have kidney disease.

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

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

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

Other medicines that may affect Viaflo Plasmalyte 148 (pH 7.4) or be affected by it:

• corticosteroids (anti-inflammatory medicines).
• carbenoxolone (an anti-inflammatory medicine used to treat stomach ulcers).
• neuromuscular blockers (e.g., tubocurarine, suxamethonium, and vecuronium). These medicines 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 medicines, for example:
• • salicylates used to treat inflammation (aspirin).
  • sleeping pills (barbiturates).
  • lithium (used to treat psychiatric diseases).
• alkaline medicines (basic), for example:
• • sympathomimetics (stimulants, such as ephedrine and pseudoephedrine, used in cough and cold preparations).
  • other stimulants (e.g., dexamphetamine, fenfluramine).

Using 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 are planning to have a baby, ask your doctor for advice before using this medicine.

You can receive Viaflo Plasmalyte 148 (pH 7.4) if you are pregnant or breastfeeding. Your doctor will monitor your blood chemical levels and the amount of fluid in your body.

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

• Ask your doctor
• Read the package leaflet of the medicine to be added

Driving and using machines

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

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

Viaflo Plasmalyte 148 (pH 7.4) will be given to you by a doctor or nurse. Your doctor will decide how much you need and when it should be given. 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.

You must not be given Viaflo Plasmalyte 148 (pH 7.4) if there are particles floating in the solution or if the container is damaged in any way.

Usually, Viaflo Plasmalyte 148 (pH 7.4) will be given to you through a plastic tube connected to a needle in a vein, usually in your arm. However, your doctor may use another method to give you the medicine.

Before and during the infusion, your doctor will monitor:

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

Any unused solution should be discarded. You must notreceive Viaflo Plasmalyte 148 (pH 7.4) from a bag that has been used partially.

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

If you receive too much Viaflo Plasmalyte 148 (pH 7.4) or if it is given too quickly, you may experience the following symptoms:

• fluid overload or sodium (salt) and fluid accumulation in the tissues (edema) that causes swelling.
• tingling in the arms and legs (paresthesia).
• muscle weakness.
• inability to move (paralysis).
• irregular heartbeats (cardiac arrhythmias).
• heart block (very slow heartbeats).
• cardiac arrest (the heart stops beating and life is in danger).
• Confusion.
• loss of tendon reflexes.
• reduced breathing (respiratory depression).
• nausea.
• vomiting.
• redness of the skin.
• thirst.
• low blood pressure (hypotension).
• drowsiness.
• slow heart rate (bradycardia).
• coma (loss of consciousness).
• acidification of the blood (acidosis), which produces fatigue, confusion, lethargy, and increased respiratory rate.
• hypokalemia (low potassium levels in the blood) and metabolic alkalosis (the blood becomes too alkaline), especially in patients with kidney failure.
• mood changes.
• fatigue.
• breathing difficulties.
• 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 in the hospital, go to the nearest hospital or contact the Toxicology Information Service. Telephone: 91 562 04 20, indicating the medicine and the amount used. It is recommended to take the container and the package leaflet of the medicine to the healthcare professional.

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

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

Your doctor will decide when to stop the infusion.

If you have any further questions on the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor or nurse immediately if you experience any of the following symptoms, as they may be signs of a severe allergic reaction (hypersensitivity) that can be life-threatening:

• 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 depending on the symptoms.

Other side effects are listed by frequency.

Rare(occur in less than 1 in 1,000 patients but more than 1 in 10,000)

• Reactions due to the administration technique:
• fever (febrile response),
• infection at the injection site,
• burning sensation,
• local pain or reaction (redness or swelling) at the injection site
• irritation and inflammation of the vein in which the solution is infused (phlebitis). This can cause redness, pain, or burning and swelling along the vein in which the solution is infused,
• formation of blood clots (thrombosis) at the infusion site, which can cause pain, swelling, or redness in the area of the clot,
• leakage of the solution into the tissues surrounding the vein (extravasation). This can damage the tissues, causing scarring,
• excess fluid in the blood vessels (hypervolemia),
• seizures (convulsions),
• hives (urticaria),
• severe allergic reaction that causes difficulty breathing or dizziness (anaphylactic reaction)
• fast heartbeat (tachycardia),
• palpitations,
• chest pain,
• chest discomfort,
• breathing difficulties (dyspnea),
• increased respiratory rate,
• redness,
• hyperemia,
• feeling of weakness (asthenia),
• abnormal sensation,
• goosebumps,
• peripheral edema,
• fever (pyrexia).
• low sodium levels in the blood that can be acquired during hospitalization (nosocomial hyponatremia) and related neurological disorder (acute hyponatremic encephalopathy). Hyponatremia can cause irreversible brain damage and death due to swelling (cerebral edema/inflammation) (see also “Warnings and precautions”).

If another medicine has been added to the infusion solution, it may be that this medicine also caused side effects. These will depend on the medicine that has been added. You should read the package leaflet of the added medicine to see the list of possible symptoms.

Other side effects that have occurred with similar products:

• other manifestations of hypersensitivity or infusion reaction: low blood pressure (hypotension), wheezing, cold sweat, chills,
• hyperkalemia.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible that they are 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 Viaflo Plasmalyte 148 (pH 7.4)

Keep this medicine out of the sight and reach of children

This medicine does not require any special storage conditions.

DO NOT use this medicine after the expiry date which is stated on the bag after CAD. The expiry date is the last day of the month indicated.

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

6. Contents of the pack and additional information

Composition ofViafloPlasmalyte 148 (pH 7.4)

The active substances 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 injections
• sodium hydroxide

Appearance of the product and pack contents

Viaflo Plasmalyte 148 (pH 7.4) is a clear, particle-free solution. It is supplied in polyolefin/polyamide (Viaflo) plastic bags. Each bag is placed in a protective overpouch.

The bag sizes are:

• 500 ml
• 1,000 ml

The bags are supplied 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 certain pack sizes may be marketed.

Marketing authorisation holder and manufacturers

Marketing authorisation holder:

Baxter S.L.

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

Manufacturers:

Baxter S.A.

Boulevard René Branquart, 80 7860 Lessines

Belgium

Bieffe Medital S.A.

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

This medicine is authorised 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

The last revision of this leaflet was in October 2023

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

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This information is intended only for healthcare professionals:

Handling and preparation

When the solution and container allow, the solution should be inspected visually for particulate matter and discoloration prior to administration. Do not administer unless the solution is clear and the container is intact.

Do not remove the bag from the overpouch until ready for use. The inner bag maintains the sterility of the product. Administer immediately after connecting the infusion equipment

Do not connect plastic containers in series. This type of use can produce gas embolisms due to residual air drawn from the primary container before the liquid contained in the secondary container is completely administered. The pressurization of intravenous solutions in flexible plastic containers to increase flow rates can lead to a gas embolism if the residual air in the container is not fully evacuated before administration.

The use of an intravenous administration set with a vented filter in the open position could cause a gas embolism. This type of intravenous administration set with the vented filter in the open position should not be used with flexible plastic containers.

The solution should be administered intravenously with a sterile set using an aseptic technique. The set should be primed with the solution to prevent air from entering the system.

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

The addition of other medicines or the use of an incorrect administration technique can cause the appearance of febrile reactions due to the possible introduction of pyrogens. In the event of an adverse reaction, the infusion should be interrupted immediately.

Discard after a single use.

Discard partially used containers.

Do not reconnect partially used bags.

1-To open

• Remove the Viaflo bag from the protective overpouch immediately before use.

• Check for the absence of small leaks by squeezing the inner bag firmly. If leaks are detected, discard the solution, as it may not be sterile.

• 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.

• Hang the container by the hanger.

• Remove the plastic protector from the outlet port at the bottom of the container.
  • Hold the small wing of the neck of the outlet tube with one hand.
  • Hold the large wing of the closure cap with the other hand and twist.
  • The cap will come off.

• Use an aseptic technique to prepare the infusion.

• Connect the administration set. Consult the instructions accompanying the set for connection, priming, and administration of the solution.

3-Techniques for injecting added medication

Warning: Added medications may be incompatible. Before adding a medication, check its compatibility with both the bag and the solution. When medications are added, check the isotonicity before parenteral administration. A complete and careful aseptic mix of any medication is necessary. Solutions containing medications should be used immediately and not stored. (See section 5 "Incompatibilities of added medications").

To add medication before administration

• Disinfect the injection point.

• Using a syringe with a 19-gauge (1.10 mm) to 22-gauge (0.70 mm) needle, puncture the resealable injection point and inject.

• Mix the medication and solution carefully. For high-density medications, such as potassium chloride, gently move the tubes while in a vertical position and mix.

Precaution: do not store bags with added medication.

To add medication during administration

• Close the clamp on the set.

• Disinfect the injection point.

• Using a syringe with a 19-gauge (1.10 mm) to 22-gauge (0.70 mm) needle, puncture the resealable injection point and inject.

• Remove the container from the intravenous support and/or turn to put it in a vertical position.

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

• Mix the solution and medication carefully.

• Return the container to the position of use, reopen the clamp, and continue administration.

1. Expiry after first opening:

The product should be used immediately after opening.

Expiry during use after reconstitution with added medications

Prior to use, the physical and chemical stability of any added medication in the pH of the Viaflo Plasmalyte 148 (pH 7.4) solution in the Viaflo container should be established.

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

5-Incompatibilities of added medications

When medications are added to Viaflo Plasmalyte 148 (pH 7.4), an aseptic technique should be used. After addition, mix the solution vigorously. Do not store bags containing added medications.

As with all parenteral solutions, the compatibility of added medications with the Viaflo bag solution should be verified before addition.

Consult the summary of product characteristics of the medication to be added.

Before adding a medication, 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 suitable. After addition, observe for any possible change in color and/or the appearance of precipitates, insoluble complexes, or crystals.

Medications known to be incompatible should not be used.