VIAFLO GLUCOSA 5% & POTASSIUM CHLORIDE 0.3%, SOLUTION FOR INFUSION

2. What you need to know before you are given Viaflo Glucose 5% and Potassium Chloride 0.3%

Viaflo Glucose 5% and Potassium Chloride 0.3% must 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 your blood contains high levels of chloride above normal (hyperchloremia)
• severe kidney failure (when your kidneys do not work well and you need dialysis)
• if your blood contains high levels of sugar above normal (hyperglycemia)
• if you have uncompensated heart failure. This is heart failure that is not receiving proper treatment and causes symptoms such as:
• breathing difficulties
• swelling of the ankles.
• Addison's disease (impaired adrenal gland function. This gland produces hormones that help control the concentration of substances in the body).
• if you have diabetes that is not receiving proper treatment, so that the blood glucose concentration is above normal (uncontrolled diabetes).
• if you have situations of glucose intolerance, for example:
• metabolic stress (when the body's metabolism is not working properly, for example, due to severe illness).
• hyperosmolar coma (loss of consciousness). This is a type of coma that can occur if you have diabetes and are not receiving proper medication.
• high levels of lactate in the blood (hyperlactatemia).
• if you are allergic to potassium chloride and glucose monohydrate or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Viaflo Glucose 5% and Potassium Chloride 0.3% is a hypertonic solution (concentrated). Your doctor will take this into account when calculating the amount of solution to be given to you.

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

• changes in the levels of substances in the blood (electrolyte disorders)
• excess fluid in the blood vessels (hypervolemia)
• fluid accumulation under the skin, affecting all parts of the body (generalized edema), around the ankles (peripheral edema), or in the lungs (pulmonary edema)

Infusion may cause:

• a high level of sugar in the blood (hyperglycemia), especially in states of glucose intolerance, for example:
• • diabetes that is not properly treated, allowing blood sugar levels to rise above normal (diabetes mellitus)
  • a head injury in the last 24 hours
  • metabolic stress (when the body's metabolism is not working properly; for example, due to severe illness)

• a high level of potassium in the blood (hyperkalemia), especially with:

• burns and injuries

• heart failure

• severe muscle weakness or paralysis
• muscle weakness in children (congenital paramyotonia)
• adrenocortical insufficiency. This is a disease that affects the hormones that control the concentration of substances in the body
• a disorder in which the blood becomes too alkaline (metabolic alkalosis)
• muscle weakness and periodic paralysis due to low thyroid activity (thyrotoxic periodic paralysis)
• rapid loss of water from the body, for example due to vomiting or diarrhea
• being on a low-potassium diet for a long time
• aldosteronism (a disease that causes high levels of a hormone called aldosterone)
• allergy, particularly to corn (Viaflo Glucose 5% and Potassium Chloride 0.3% contains corn-derived sugar)

• If you have a condition that could cause high levels of vasopressin, a hormone that regulates the body's fluid. 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 "Other medicines and Viaflo Glucose 5% and Potassium Chloride 0.3%")

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

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

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

• the amount of fluid in your body,
• the amount of sugar (glucose),
• your vital signs,
• the amount of substances such as sodium and potassium in your body (your plasma electrolytes),
• the concentration in the blood of a substance called creatinine (your plasma creatinine),
• the concentration in the blood of a substance called urea (your BUN levels),
• the acidity of the blood and urine (your acid-base balance),
• the graph of your heart (ECG).

Your doctor will consider whether you are receiving parenteral nutrition (nutrition given by infusion into a vein). During prolonged treatment with Viaflo Glucose 5% and Potassium Chloride 0.3%, you may need to receive extra nutrition.

Children

Viaflo Glucose 5% and Potassium Chloride 0.3% should be given with special care to children.

Newborns - especially premature and low-birth-weight babies - are at higher risk of developing low or high blood sugar levels (hypo or hyperglycemia) due to glucose solution infusion. Low blood sugar levels in newborns can cause prolonged seizures, coma, and brain damage. High blood sugar levels can cause brain hemorrhages, bacterial or fungal infections, intestinal infections (necrotizing enterocolitis), eye damage (retinopathy of prematurity), lung problems (bronchopulmonary dysplasia), prolonged hospital stay, and death.

The pediatric population should be closely monitored. In cases where normal water regulation in the blood is disturbed due to an increase in the secretion of antidiuretic hormone (ADH), infusion of fluids with low sodium chloride concentration (hypotonic fluids) may cause low sodium levels in the blood (hyponatremia). This can cause headache, nausea, seizures, lethargy, coma, brain swelling (cerebral edema), and death; therefore, these symptoms (symptomatic acute hyponatremic encephalopathy) are considered a medical emergency.

Other medicines and Viaflo Glucose 5% and Potassium Chloride 0.3%

Tell your doctor or nurse if you are using, have recently used, or might use any other medicines.

It is especially important that you tell your doctor if you are taking medicines that increase potassium levels in the blood, such as:

• potassium-sparing diuretics (certain water pills, such as amiloride, spironolactone, triamterene),
• angiotensin-converting enzyme inhibitors (ACE inhibitors) (used to treat high blood pressure),
• corticosteroids (anti-inflammatory medicines),
• cyclosporins (used to prevent transplant rejection),
• tacrolimus (used to prevent transplant rejection and treat skin disorders)
• medicines that contain potassium (e.g., potassium supplements or salt substitutes with potassium)
• medicines that increase the risk of hyponatremia or sodium and fluid retention

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

• antidiabetic medication (chlorpropamide)
• cholesterol medication (clofibrate)
• certain anticancer medicines (vincristine, ifosfamide, cyclophosphamide)
• selective serotonin reuptake inhibitors (used to treat depression)
• antipsychotics or 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

Viaflo Glucose 5% and Potassium Chloride 0.3% must not be added to or given with the same needle used with anticoagulated/preserved blood with citrate. Red blood cells may be damaged or clumped.

Using Viaflo Glucose 5% and Potassium Chloride 0.3% with food and drinks

Ask your doctor about what you can eat or drink.

Pregnancy, breastfeeding, and fertility

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

If you are given Viaflo Glucose 5% and Potassium Chloride 0.3% during labor, there is a small chance that glucose may affect the fetus, causing:

• hyperglycemia (high blood sugar levels, which cause intense thirst, dry mouth, and frequent urination)
• hyperinsulinemia (high insulin levels, the hormone that regulates blood sugar. Blood sugar levels may become too low.)
• acidosis (a biochemical imbalance in the blood) that can cause low blood sugar levels and jaundice (yellowing of the skin or the whites of the eyes)

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

• consult your doctor
• read the package leaflet of the medicine to be added.

Driving and using machines

Viaflo Glucose 5% and Potassium Chloride 0.3% does not affect your ability to drive or use machines.

3. How Viaflo Glucose 5% and Potassium Chloride 0.3% will be given to you

A doctor or nurse will give you the infusion. Your doctor will decide how much you need and when it will be given to you, depending on your age, weight, condition, hydration status (the amount of water in your body), 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 Glucose 5% and Potassium Chloride 0.3% if there are particles floating in the solution or if the container is damaged in any way.

The infusion rate will be decided by your doctor.

If you need a large volume or rapid infusion of Viaflo Glucose 5% and Potassium Chloride 0.3%, your doctor may monitor your ECG (heart graph).

It will usually 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 check:

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

If you have kidney failure, you will receive a lower dose.

Any unused solution should be discarded. You must not be given Viaflo Glucose 5% and Potassium Chloride 0.3% from a partially used bag.

If you are given too much Viaflo Glucose 5% and Potassium Chloride 0.3%

If you are given too much Viaflo Glucose 5% and Potassium Chloride 0.3% (overdose), or if it is infused too quickly, the following symptoms may occur:

• high blood sugar levels (hyperglycemia), which cause intense thirst, dry mouth, and frequent urination)
• low sodium levels in the blood (hyponatremia). Hyponatremia can cause headache, nausea, seizures, lethargy, coma, brain swelling (cerebral edema), and death
• fluid accumulation under the skin (peripheral edema), particularly around the ankles
• high potassium levels (hyperkalemia), symptoms include:

• tingling in the arms and legs (paresthesia)
• respiratory paralysis (difficulty breathing)
• gastrointestinal symptoms (painful intestinal obstruction, nausea, vomiting, abdominal pain)
• low blood pressure (hypotension)
• muscle weakness
• inability to move (paralysis)
• irregular heartbeats (cardiac arrhythmias)
• heart block (very slow heartbeats)
• cardiac arrest (the heart stops beating, and life is at risk)

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

If another medicine has been added to Viaflo Glucose 5% and Potassium Chloride 0.3% before the overdose, that medicine may also cause symptoms. You should read the list of possible symptoms in the package leaflet of the added medicine.

Stopping treatment with Viaflo Glucose 5% and Potassium Chloride 0.3%

Your doctor will decide when you should stop receiving this infusion.

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

4. Possible Adverse Effects

Like all medicines, this medicine may cause adverse effects, although not all people suffer from them.

Adverse effects:

The adverse effects that may occur due to the administration technique include:

• irritation and inflammation of the vein through which the perfusion is performed (phlebitis). This can cause redness, pain or burning and swelling of the vein
• skin itching (pruritus)
• fever (pyrexia)
• infection at the injection site
• local pain or reaction (redness or swelling at the injection site)
• blisters at the injection site
• feeling of cold (chills)
• formation of a clot in the injected vein (venous thrombosis) that causes pain, swelling or redness
• leakage of the perfusion solution (extravasation) to the tissues surrounding the vein. This can damage the tissues and cause scarring,

• hypersensitivity reactions, including a serious allergic reaction called anaphylaxis (potential manifestation in patients with corn allergy)
• increase in potassium levels in the blood (hyperkalemia)
• decrease in potassium levels in the blood (hypokalemia)
• cardiac arrest
• sweating
• excess fluid in the blood vessels (hypervolemia)
• 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 cerebral edema/inflammation (see also section 2 "Warnings and Precautions").

If another medicine has been added to the perfusion solution, it may also cause adverse effects. These adverse effects will depend on the added medicine. You should read the list of possible symptoms in the leaflet of the added medicine.

Tell your doctor or nurse if you notice any of the listed adverse effects or any other. If you have any of them, the perfusion should be stopped.

Reporting of Adverse Effects:

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Viaflo Glucose 5% and Potassium Chloride 0.3%

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

No special storage conditions are required.

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

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

Medicines should not be thrown away through the drains or into the trash. Ask your pharmacist how to dispose of the containers and medicines that you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Viaflo Glucose 5% and Potassium Chloride 0.3%

The active ingredients are:

• potassium chloride: 3 g per liter
• monohydrated glucose: 50 g per liter.

The other components are:

• concentrated hydrochloric acid
• water for injectable preparations

Appearance of the Product and Package Contents

Viaflo Glucose 5% and Potassium Chloride 0.3% is a clear solution, free of visible particles. It is presented in polyolefin/polyamide plastic bags (Viaflo). Each bag is packaged in a sealed protective overbag.

The bag sizes are:

• 500 ml
• 1000 ml

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

• 20 bags of 500 ml
• 10 or 12 bags of 1000 ml

Only some package sizes may be marketed

Marketing Authorization Holder and Manufacturer

Holder

Baxter S.L.

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

Baxter, AG

Boulevard Rene Branquart, 80

Lessines B -7860

Bieffe Medital, S.A.

Ctra. de Biescas, Senegüé

Sabiñanigo 22666 (Huesca)

Date of the Last Revision of this Leaflet: August 2020

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

…………………………………………………………………………………………………….

This information is intended only for healthcare professionals

Handling and Preparation

Use only if the solution is clear, without visible particles and if the container is not damaged. Administer immediately after connecting the perfusion equipment.

Do not remove the bag from its overbag until it is ready for use.

The inner bag maintains the sterility of the product.

Do not connect plastic containers in series. This type of use can produce gas embolisms due to residual air dragged from the primary container before the administration of the liquid contained in the secondary container is completed.

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

The solution must be administered with sterile equipment using an aseptic technique. The equipment must be purged with the solution to prevent air from entering the system.

Added medicines can be introduced before or during perfusion through the resellable medication port.

Medicines that are known or determined to be incompatible should not be added.

Before adding a medicine, verify that it is soluble and/or stable in Viaflo Glucose 5% and Potassium Chloride 0.3% and that the pH range of Viaflo Glucose 5% and Potassium Chloride 0.3% is appropriate.

You should read the leaflet of the added medicine or other relevant documentation.

After adding a medicine, do not use the solution if there is a change in color and/or the appearance of precipitates, insoluble complexes or crystals.

Mix the solution completely when adding medicines.

Do not store solutions that contain added medicines.

For single use.

Discard any unused portion

When adding medicines, isotonicity should be checked before parenteral administration. It is essential that the mixing of products is done under extreme aseptic conditions. Solutions containing medicines should be used immediately and not stored unless the addition of medicines has been carried out in validated aseptic conditions.

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 case of an adverse reaction, the perfusion should be interrupted immediately.

Pediatric Population

In order to avoid a potentially fatal overdose during the perfusion of intravenous solutions to newborns, special attention should be paid to the administration method. When using a syringe pump to administer liquids or medicines intravenously to newborns, a solution bag should not be left connected to the syringe.

When using a perfusion pump, all clamps on the intravenous administration set should be closed before removing the administration set from the pump or disconnecting the pump. This is required regardless of whether the administration set has an anti-free flow device.

The intravenous perfusion device and administration set should be frequently supervised.

Discard after a single use.

Discard unused leftovers.

Do not reconnect partially used bags.

1. To Open

1. Remove the Viaflo bag from the protective overbag immediately before use.
2. Check for small leaks by squeezing the inner bag firmly. If you detect leaks, discard the solution, as it may not be sterile.
3. Check the transparency of the solution and the absence of foreign particles. Discard the solution if it is not transparent or contains foreign particles.

1. Preparation for Administration

Use sterile material for preparation and administration.

1. Hang the container by the handle
2. Remove the plastic protector from the outlet in the lower part 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 turn,
• The cap will come off.
  1. Use an aseptic technique to prepare the perfusion
  2. Connect the administration set. Consult the instructions that accompany the set for its connection, purging, and administration of the solution.

1. Techniques for Injecting Added Medication

To avoid localized hyperkalemia, the solution should not be administered in the atrium or ventricle, but rather through a central vein or a large peripheral vein to reduce the risk of sclerosis.

Warning: Added medicines may be incompatible (see section 5 "Incompatibilities of Added Medicines").

To Add Medication Before Administration

1. Disinfect the medication addition port.
2. Using a syringe with a 19 (1.10 mm) to 22 (0.70 mm) gauge needle, puncture the resellable medication addition port and inject.
3. Mix the medication and solution carefully. For high-density medications, such as potassium chloride, gently move the tubes while they are in a vertical position and mix.

Precaution: Do not store bags with added medication.

To Add Medication During Administration

1. Close the clamp on the administration set.
2. Disinfect the medication addition port.
3. Using a syringe with a 19 (1.10 mm) to 22 (0.70 mm) gauge needle, puncture the resellable medication addition port and inject.
4. Remove the container from the intravenous support and/or turn to put it in a vertical position.
5. Empty both tubes by gently tapping them while the container is in a vertical position.
6. Mix the solution and medication carefully.
7. Put the container back in the position of use, open the clamp again, and continue administration.

1. Expiry Date for Use (Added Medicines)

Before use, the physical and chemical stability of any added medication in the pH of the glucose 5% and potassium chloride 0.3% solution in the Viaflo container should be established.

From a microbiological point of view, the diluted product should be used immediately unless the addition of medicines has been carried out in validated aseptic conditions. If it is not used immediately, the conditions and storage times used before its use are the responsibility of the user.

1. Incompatibilities of Added Medicines

As with all parenteral solutions, before adding medicines, their compatibility with the solution in the Viaflo container should be evaluated.

Before adding a medicine, verify that it is soluble and stable in water at the pH of the Viaflo Glucose 5% and Potassium Chloride 0.3% solution (pH: 3.5 - 6.5).

The following list of incompatible medicines with Viaflo Glucose 5% and Potassium Chloride 0.3% serves as a guide (non-exhaustive list):

• Amphotericin B
• Dobutamine

Glucose should not be administered through the same perfusion equipment as whole blood, as hemolysis and clot formation may occur.

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