Label: information for the user

Glucose 5% and potassium chloride 0.3% solution for intravenous infusion

Active ingredient: glucose monohydrate and potassium chloride

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

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

Throughout this label, we refer to the glucose 5% and potassium chloride solution for infusion as glucose 5% and potassium chloride.

1.What is glucose 5% and potassium chloride and what it is used for

2.What you need to know before you are administered glucose 5% and potassium chloride

3.How you will be administered glucose 5% and potassium chloride

4.Possible adverse effects

5.Storage of glucose 5% and potassium chloride

6.Contents of the package and additional information

Viaflo glucosa 5% and cloruro potásico 0.3% is a glucose and potassium chloride solution in water. Potassium chloride is a chemical substance (commonly referred to as “a salt”) found in the blood.

Glucose is one of the body's energy sources. This perfusion solution provides 200 kilocalories per liter.

Viaflo glucosa 5% and cloruro potásico 0.3% is used as a source of carbohydrates (sugar) in the prevention and treatment of:

• potassium loss in the body (potassium loss, for example, after treatment with certain diuretics)
• low potassium levels in the blood (hypokalemia) in situations that may cause water and potassium chloride loss, including:
• when unable to eat or drink due to illness or after surgery

• excessive sweating caused by high fever
• extensive skin loss, such as in severe burns

Do not administer Viaflo Glucose 5% and Potassium Chloride 0.3% if you have any of the following clinical conditions:

• if your blood contains high levels of potassium above normal (hyperkalemia)
• if your blood contains high levels of chloride above normal (hyperchloremia)
• severe renal insufficiency (when your kidneys do not function well and require dialysis)
• if your blood contains high levels of sugar above normal (hyperglycemia)
• if you have uncompensated heart failure. This is heart failure that does not receive adequate treatment and causes symptoms such as:
• difficulty breathing
• swelling of the ankles.
• Addison's disease (deteriorated function of the adrenal gland. This gland produces hormones that help control the concentrations of chemical substances in the body)
• if you have diabetes that does not receive adequate treatment, so that the blood glucose concentration is above normal (uncontrolled diabetes)
• if you have glucose intolerance, for example:
• metabolic stress (when the body's metabolism does not function correctly, for example, due to severe illnesses)
• hyperosmolar coma (loss of consciousness). This is a type of coma that can occur if you have diabetes and do not receive adequate medication.
• if you have high blood lactate levels (hyperlactatemia)
• if you are allergic to potassium chloride and glucose monohydrate or to any of the other components of this medication (listed in section 6)

Warnings and precautions

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

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

-changes in the concentrations of chemical 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)

The infusion may cause:

• a high level of sugar in the blood (hyperglycemia), especially with glucose intolerance, for example:
• • uncontrolled diabetes, allowing your blood sugar levels to rise above normal (diabetes mellitus)
  • a head injury in the last 24 hours
  • metabolic stress (when the body's metabolism does not function correctly; for example, due to severe illnesses)

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

• burns and injuries

• heart failure

• extreme muscle weakness or paralysis
• extreme muscle weakness in children (congenital paramyotonia)
• adrenocortical insufficiency. This is a disease that affects the hormones that control the concentration of chemical 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 (periodic paralysis due to hypothyroidism)
• rapid loss of body water, for example due to vomiting or diarrhea
• long-term low-potassium diet
• 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 vasopresin, a hormone that regulates the fluid in your body. You may have too much vasopresin 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 head injury
• you have heart, liver, kidney or central nervous system diseases
• you are taking certain medications (see "Other medications and Viaflo Glucose 5% and Potassium Chloride 0.3%")

This may increase the risk of low sodium levels in the blood and may cause headache, nausea, convulsions, lethargy, coma, inflammation of the brain 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 head injury.

When you are receiving this solution, your doctor will be able to take blood and urine samples to control:

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

Your doctor will take into account if you are receiving parenteral nutrition (nutrition given by infusion through 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 administered with special care in children.

Newborns - especially premature and low-birth-weight babies - are at higher risk of developing low or high blood glucose levels (hypoglycemia or hyperglycemia) due to the infusion of glucose solutions. Low blood sugar levels in newborns can cause prolonged convulsions, coma, and brain damage. High blood sugar levels can cause bleeding in the brain, 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 the normal regulation of water in the blood is disturbed due to an increase in the secretion of the antidiuretic hormone (ADH), the infusion of fluids with a low concentration of sodium chloride (hypotonic fluids) may cause low sodium levels in the blood (hyponatremia). This can cause headache, nausea, convulsions, lethargy, coma, brain inflammation (cerebral edema), and death; therefore, these symptoms (acute symptomatic encephalopathy due to hyponatremia) are considered a medical emergency.

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

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

It is particularly important to inform your doctor if you are taking medications that increase the concentration of potassium in the blood, such as:

• potassium-sparing diuretics (certain tablets to urinate such as: amiloride, spironolactone, triamterene),
• angiotensin-converting enzyme inhibitors (ACE inhibitors) (used to treat high blood pressure),
• corticosteroids (anti-inflammatory medications),
• ciclosporins (used to prevent transplant rejection),
• tacrolimus (used to prevent transplant rejection and treat skin disorders)
• medications containing potassium (for example, potassium supplements or salt substitutes containing potassium)
• medications that increase the risk of hyponatremia or sodium retention

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

• diabetic medications (chlorpropamide)
• cholesterol-lowering medications (clofibrate)
• some cancer medications (vincristine, ifosfamide, cyclophosphamide)
• selective serotonin reuptake inhibitors (used to treat depression)
• antipsychotics or opioids for severe pain relief
• medications for pain and/or inflammation (also known as NSAIDs)
• medications that mimic or enhance the effects of vasopresin, such as: desmopressin (used to treat excessive thirst and urination), terlipressin (used to treat bleeding in the esophagus) and oxytocin (used to induce labor)
• antiepileptic medications (carbamazepine and oxcarbazepine)
• diuretics

Do not add or administer Viaflo Glucose 5% and Potassium Chloride 0.3% with the same needle used with anticoagulated/conserved blood with citrate. The red blood cells may be damaged or clumped.

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

If you are administered Viaflo Glucose 5% and Potassium Chloride 0.3% during labor, there is a small chance that the 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 levels. Blood glucose levels may become too low)
• acidosis (a biochemical imbalance in the blood) that may cause low blood sugar levels and jaundice (yellowing of the skin or eyes)

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

• consult your doctor
• read the medication's leaflet.

Driving and operating machines

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

A healthcare professional, such as a doctor or nurse, will administer the infusion. Your doctor will decide how much you need and when it will be administered, which will depend on your age, weight, condition, hydration level (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.

Do not receive 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 require a high volume or rapid infusion of Viaflo glucose 5% and potassium chloride 0.3%, your doctor may monitor your ECG (heart graph).

Generally, you will be administered through a plastic tube connected to a needle in a vein, usually in your arm. However, your doctor may use another method to administer the medication.

Before and during the infusion, your doctor will monitor:

-potassium levels

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

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

Any unused solution must be discarded. You should not receive Viaflo glucose 5% and potassium chloride 0.3% from a bag that has been partially used.

If you receive more Viaflo glucose 5% and potassium chloride 0.3% than you should

If you are administered 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 causes 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)
• cardiac block (slow heartbeats)
• cardiac arrest (the heart stops beating, and life is at risk)

If you observe 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 a medication has been added to Viaflo glucose 5% and potassium chloride 0.3% before the excessive administration, that medication may also cause symptoms. You should read the list of possible symptoms in the medication's package insert.

Discontinuation of Viaflo glucose 5% and potassium chloride 0.3% treatment

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

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

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

Side effects:

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

• irritation and inflammation of the vein through which the infusion is administered (phlebitis). This may cause redness, pain, or burning and swelling of the vein
• itching of the skin (pruritus)
• fever (pyrexia)
• infection at the injection site
• local pain or reaction (redness or swelling at the injection site)
• vesicles at the injection site
• sensation of cold (chills)
• formation of a blood clot in the injected vein (venous thrombosis) that causes pain, swelling, or redness
• leakage of the infusion solution (extravasation) into the tissues surrounding the vein. This may damage the tissues and cause the formation of scars,

• hypersensitivity reactions, including a serious allergic reaction called anaphylaxis (potential manifestation in patients with corn allergy)
• increased levels of potassium in the blood (hyperkalemia)
• decreased levels of potassium in the blood (hypokalemia)
• cardiac arrest
• sweating
• excess fluid in the blood vessels (hypervolemia)
• low levels of sodium in the blood that may be acquired 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 section 2 "Warnings and precautions").

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

Inform your doctor or nurse if you notice any of the listed side effects or any other. If you have any of them, the infusion should be stopped.

Reporting side effects:

If you experience any type of side effect, consult your doctor or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System of 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.

No special storage conditions are required.

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 medication if it is observed that there are particles floating in the solution or if the container is damaged in any way.

Medications should not be disposed of through drains or in the trash.Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of Viaflo glucose 5% and potassium chloride 0.3%

The active principles are:

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

The other components are:

• concentrated hydrochloric acid
• water for injectable preparations

Aspect of the product and content of the package

Viaflo glucose 5% and potassium chloride 0.3% is a transparent, particle-free solution. It is presented in polyolefin/polyamide (Viaflo) plastic bags. Each bag is packaged in a sealed plastic 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 sizes of packaging may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder

Baxter S.L.

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

Bater, AG

Boulevard Rene Branquart, 80

Lessines B -7860

Bieffe Medital,, S.A.

Ctra. de Biescas, Senegüé

Sabiñanigo 22666 (Huesca)

Last review date of this leaflet: August 2020

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

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

This information is intended solely for healthcare professionals

Handling and preparation

Use only if the solution is transparent, free of visible particles, and the package is not damaged. Administer immediately after connecting the infusion equipment.

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

The inner bag maintains the sterility of the product.

Do not connect plastic bags in series. This type of use may cause gas embolism due to residual air carried from the primary package before the secondary package is completed.

The pressurization of intravenous solutions in flexible plastic containers to increase flow rates may cause gas embolism if the residual air in the container is not completely evacuated before administration.The use ofan intravenous administrationequipmentwith a ventilation filter in open positionmay cause agasembolism. This type ofintravenous administrationequipmentwith the ventilation filter in open positionshould not be used withflexible plasticcontainers.

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.

Medicines added may be introduced before or during infusion through the resellable medication port.

Do not add medicines that are known or determined to be incompatible.

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.

Read the prospectus of the added medicine or other relevant documentation.

Do not use the solution if there is a change in color and/or the appearance of precipitates, insoluble complexes, or crystals after adding medicines.

Mix the solution thoroughly when adding medicines.

Do not store solutions containing added medicines.

For single use only.

Dispose of any unused portion

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

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

Pediatric population

To avoid a potentially fatal overdose during the infusion of intravenous solutions in newborns, special attention must be paid to the administration method. When using a syringe pump to administer liquids or medicines intravenously to newborns, do not leave a solution bag connected to the syringe.

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

The intravenous infusion device and administration equipment must be frequently supervised.

Dispose of after single use.

Dispose of unused remnants.

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 pressing the inner bag firmly. If leaks are detected, 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.

- 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.

1. Techniques for injecting added medication

To avoid localized hyperpotasemia, the solution should not be administered in the auricle or ventricle. It should be administered through a central vein or a large peripheral vein to reduce the risk of sclerosis.

Warning: Added medicines may be incompatible (see below the section 5 "incompatibilities of added medicines").

To add medication before administration

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

Caution: Do not store bags with added medication.

To add medication during administration

1. Close the clamp on the equipment.
2. Disinfect the medication port.
3. Using a syringe with a 19 (1.10 mm) to 22 (0.70 mm) gauge needle, pierce the resellable medication port and inject.
4. Remove the container from the intravenous support and/or turn it to 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. Replace the container in the administration position, reopen the clamp, and continue administration.

1. Expiry in use (added medicines)

Before use, establish the physical and chemical stability of any added medicine in the pH of the glucose 5% and potassium chloride 0.3% solution in the Viaflo container.

From a microbiological point of view, the diluted product should be used immediately unless the addition of medicines has been carried out in aseptic and validated conditions. If 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 Viaflo solution should be evaluated.

It is the responsibility of the doctor to judge the incompatibility of the added medicine with Viaflo glucose 5% and potassium chloride 0.3% by examining any eventual change in color and/or precipitation, as well as the appearance of insoluble complexes or crystals. The prospectus and/or technical data sheet of the medicine to be added should be consulted.

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% (non-exhaustive list):

• Anfotericina B
• Dobutamina

Glucose should not be administered through the same infusion equipment as whole blood, as it may cause hemolysis and clot formation.

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