Viaflo glucose 5% and potassium chloride 0.3%, solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Viaflo glucose 5% and potassium chloride 0.3%, solution for intravenous infusion

Active substances: glucose monohydrate and potassium chloride

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you experience any side effects, talk to your doctor or nurse, even if they are side effects not listed in this leaflet. See section 4.

Throughout this leaflet, Viaflo glucose 5% and potassium chloride 0.3%, solution for intravenous infusion is referred to as Viaflo glucose 5% and potassium chloride 0.3%.

Contents of this leaflet:

1. What Viaflo glucose 5% and potassium chloride 0.3% is and what it is used for
2. What you need to know before being administered Viaflo glucose 5% and potassium chloride 0.3%
3. How Viaflo glucose 5% and potassium chloride 0.3% will be administered to you
4. Possible side effects
5. How to store Viaflo glucose 5% and potassium chloride 0.3%
6. Contents of the pack and other information

1. What Viaflo glucose 5% and potassium chloride 0.3% is and what it is used for

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

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

Viaflo glucose 5% and potassium chloride 0.3% is used as a source of carbohydrates (sugar) in the prevention and treatment of:

• loss of potassium from the body (potassium loss, for example, after treatment with certain diuretics)

• low blood potassium levels (hypokalemia) in situations that may cause loss of water and potassium chloride, including:

• when eating or drinking is not possible due to illness or after surgery

• excessive sweating caused by high fever

• extensive skin loss, as occurs in severe burns

2. What you need to know before Viaflo 5% glucose and 0.3% potassium chloride is administered to you

Do NOT administer Viaflo 5% glucose and 0.3% potassium chloride if you have any of the following clinical conditions:

• high levels of potassium in your blood above normal (hyperkalemia)
• high levels of chloride in your blood above normal (hyperchloremia)
• severe renal insufficiency (when your kidneys do not function properly and you require dialysis)
• high levels of blood sugar above normal (hyperglycemia)
• uncompensated heart failure. This refers to heart failure that is not receiving adequate treatment and causes symptoms such as:
  • shortness of breath
  • swelling of the ankles.
• Addison's disease (impaired function of the adrenal gland. This gland produces hormones that help regulate chemical concentrations in the body).
• untreated or poorly managed diabetes, resulting in abnormally high blood glucose levels (uncontrolled diabetes).
• conditions involving glucose intolerance, for example:
  • metabolic stress (when the body's metabolism is not functioning properly, e.g., due to severe illness).
  • hyperosmolar coma (loss of consciousness). This is a type of coma that may occur in patients with diabetes who are not receiving adequate medication.
• abnormally high blood lactate concentration (hyperlactatemia).
• allergy to potassium chloride or monohydrated glucose, or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

Viaflo 5% glucose and 0.3% potassium chloride is a hypertonic (concentrated) solution. Your doctor will take this into account when calculating the amount of solution to administer.

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

• disturbances in blood chemical concentrations (electrolyte imbalances)
• 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:

• blood sugar levels higher than normal (hyperglycemia), especially in cases of glucose intolerance, for example:

  • diabetes that is not adequately treated, allowing blood sugar levels to rise above normal (diabetes mellitus)
  • head injury within the last 24 hours
  • metabolic stress (when the body's metabolism is not functioning properly; for example, due to a serious illness)

• blood potassium levels higher than normal (hyperkalemia), especially with:

• burns and tissue injuries

• heart failure

• extreme muscle weakness or paralysis

• muscle weakness in children (congenital paramyotonia)

• adrenocortical insufficiency. This is a disorder affecting hormones that regulate chemical concentrations in the body

• a condition in which blood becomes too alkaline (metabolic alkalosis)

• muscle weakness and periodic paralysis due to low thyroid activity (thyrotoxic periodic paralysis)

• rapid loss of body water, for example due to vomiting or diarrhea

• long-term low-potassium diet

• aldosteronism (a disorder causing high levels of a hormone called aldosterone)

• allergy, particularly to corn (Viaflo 5% glucose and 0.3% potassium chloride contains corn-derived sugar)

• If you have a condition that could lead to elevated levels of vasopressin, a hormone that regulates your body's fluid balance. You may have excess vasopressin due to, for example:

• sudden and severe illness

• pain

• recent surgery

• infections, burns, or brain injury

• heart, liver, kidney, or central nervous system disorders

• taking certain medications (see “Other medicines and Viaflo 5% glucose and 0.3% potassium chloride”)

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

• children
• women (particularly those of childbearing age)
• individuals with conditions affecting cerebral fluid levels, such as meningitis, intracranial bleeding, or brain injury.

While receiving this solution, your doctor may take blood and urine samples to monitor:

• your body's fluid levels,
• your blood glucose levels,
• your vital signs,
• levels of chemicals such as sodium and potassium in your body (plasma electrolytes),
• blood levels of a substance called creatinine (plasma creatinine),
• blood levels of a substance called urea (BUN levels),
• blood and urine acidity (acid-base balance),
• your heart tracing (ECG).

Your doctor will consider whether you are receiving parenteral nutrition (nutrition delivered via intravenous infusion). During prolonged treatment with Viaflo 5% glucose and 0.3% potassium chloride, you may require additional nutritional support.

Children

Viaflo 5% glucose and 0.3% potassium chloride must be administered with special caution in children.

Newborns—especially those born prematurely and with low birth weight—are at increased risk of developing abnormally low or high blood glucose levels (hypo- or hyperglycemia) due to glucose solution infusion. Low blood sugar in newborns may cause prolonged seizures, coma, and brain damage. High blood sugar may lead to brain hemorrhage, bacterial or fungal infections, intestinal tract infections (necrotizing enterocolitis), eye damage (retinopathy of prematurity), lung problems (bronchopulmonary dysplasia), prolonged hospitalization, and death.

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

Other medicines and Viaflo 5% glucose and 0.3% potassium chloride

Inform your doctor or nurse if you are taking, have recently taken, or might need to take any other medicines.

It is particularly important to inform your doctor if you are taking medicines that increase blood potassium levels, such as:

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

Some medicines affect the vasopressin hormone. These may include:

• antidiabetic medicines (chlorpropamide)
• cholesterol-lowering medicines (clofibrate)
• certain cancer medicines (vincristine, ifosfamide, cyclophosphamide)
• selective serotonin reuptake inhibitors (used to treat depression)
• antipsychotics or opioids for severe pain relief
• pain and/or anti-inflammatory medicines (also known as NSAIDs)
• medicines that mimic or enhance the effects of vasopressin, such as: desmopressin (used to treat excessive thirst and urination), terlipressin (used to treat esophageal bleeding), and oxytocin (used to induce labor)
• antiepileptic medicines (carbamazepine and oxcarbazepine)
• diuretics

Viaflo 5% glucose and 0.3% potassium chloride must not be mixed or administered through the same intravenous line used for citrate-anticoagulated/conserved blood. This could damage red blood cells or cause them to clump together.

Use of Viaflo 5% glucose and 0.3% potassium chloride with food and drink

Ask your doctor what you may eat or drink.

Pregnancy, breastfeeding, and fertility

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

If you receive Viaflo 5% glucose and 0.3% potassium chloride during labor, there is a small possibility that glucose may affect the fetus, causing:

• hyperglycemia (high blood sugar levels, causing intense thirst, dry mouth, and frequent urination)
• hyperinsulinemia (high levels of insulin, the hormone that regulates blood sugar. Blood glucose levels may subsequently become too low.)
• acidosis (a biochemical imbalance in the blood) that may lead to low blood sugar and jaundice (yellowing of the skin or 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 being added.

Driving and use of machines

Viaflo 5% glucose and 0.3% potassium chloride does not affect your ability to drive or operate machinery.

3. How Viaflo glucose 5% and potassium chloride 0.3% will be administered to you

A doctor or nurse will administer the infusion. Your doctor will decide how much you need and when it will be given, based 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.

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 determined by your doctor.

If you require a large volume or a rapid infusion of Viaflo glucose 5% and potassium chloride 0.3%, your doctor may monitor your ECG (heart tracing).

The solution is usually administered through a plastic tube connected by a needle to a vein, most commonly in your arm. However, your doctor may use another method to administer the medicine.

Before and during the infusion, your doctor will monitor:

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

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

Any unused portion of the solution must be discarded. You MUST 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 given too much Viaflo glucose 5% and potassium chloride 0.3% (overdose), or if it is infused too rapidly, the following symptoms may occur:

• high blood sugar levels (hyperglycaemia), causing intense thirst, dry mouth, and frequent urination

• low blood sodium levels (hyponatraemia). Hyponatraemia may cause headache, nausea, seizures, lethargy, coma, brain swelling (cerebral oedema), and death

• fluid accumulation under the skin (peripheral oedema), particularly around the ankles

• high potassium levels (hyperkalaemia), symptoms include:

• tingling in the arms and legs (paraesthesia)

• respiratory paralysis (difficulty breathing)

• gastrointestinal symptoms (painful intestinal obstruction, nausea, vomiting, abdominal pain)

• hypotension (low blood pressure)

• muscle weakness

• inability to move (paralysis)

• irregular heartbeats (cardiac arrhythmias)

• heart block (very slow heartbeats)

• cardiac arrest (heart stops beating, life-threatening)

If you notice any of these symptoms, you must inform your doctor immediately. Your infusion will be stopped and you will be treated according to your symptoms.

If any 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 side effects in the package leaflet of the added medicine.

Discontinuation of 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 everyone will experience them.

Adverse effects:

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

• irritation and inflammation of the vein through which the infusion is given (phlebitis). This may 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

• sensation of cold (chills)

• formation of a blood clot in the injected vein (venous thrombosis), causing pain, swelling, or redness

• leakage of the infusion solution (extravasation) into the surrounding tissues. This may damage tissues and lead to scarring

• 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 develop during hospitalization (nosocomial hyponatremia) and associated neurological disorder (acute hyponatremic encephalopathy). Hyponatremia may cause irreversible brain damage and death due to brain edema/inflammation (see also section 2 "Warnings and precautions").

If another medicine has been added to the infusion 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.

Inform your doctor or nurse if you notice any of the listed adverse effects or any others. If you experience any of them, the infusion 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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide 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 expiry date stated on the bag after EXP. The expiry date is the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Viaflo 5% glucose and 0.3% potassium chloride

The active substances are:

• potassium chloride: 3 g per litre
• glucose monohydrate: 50 g per litre.

The other components are:

• concentrated hydrochloric acid
• water for injections

Appearance of the medicinal product and contents of the container

Viaflo 5% glucose and 0.3% potassium chloride is a clear solution, free from visible particles. It is supplied in plastic bags made of polyolefin/polyamide (Viaflo). Each bag is contained within a sealed protective plastic overpouch.

The bag sizes are:

• 500 ml
• 1000 ml

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

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Baxter S.L.

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

Manufacturer responsible:

Bater, AG

Boulevard Rene Branquart, 80

Lessines B -7860

Bieffe Medital, S.A.

Ctra. de Biescas, Senegüé

Sabiñanigo 22666 (Huesca)

Date of the most recent review of this leaflet: August 2020

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

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

This information is intended for healthcare professionals only

Handling and preparation

Use only if the solution is clear, free from visible particles, and if the container is undamaged. Administer immediately after connecting the infusion set.

Do not remove the bag from its overpouch until ready for use.

The inner bag maintains the sterility of the product.

Do not connect plastic containers in series. This type of use may result in gas embolism due to residual air being drawn from the primary container before completion of administration of the fluid in the secondary container.

Pressurization of intravenous solutions in flexible plastic containers to increase flow rates may lead to gas embolism if residual air in the container is not completely evacuated prior to administration. The use of an intravenous administration set with an air-venting filter in the open position may cause gas embolism. Such intravenous administration sets with the venting filter in the open position must not be used with flexible plastic containers.

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

Medications may be added before or during infusion through the resealable medication port.

Do not add medications known or determined to be incompatible.

Before adding a medication, verify that it is soluble and/or stable in Viaflo 5% glucose and 0.3% potassium chloride and that the pH range of Viaflo 5% glucose and 0.3% potassium chloride is appropriate.

Read the package leaflet of the added medication or other relevant documentation.

After adding medications, 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 thoroughly after adding medications.

Do not store solutions containing added medications.

For single use only.

Discard any unused portion.

When medications are added, osmolarity must be checked before parenteral administration. It is essential that mixing be performed under strict aseptic conditions. Solutions containing added medications should be used immediately and not stored unless the addition of medication has been carried out under validated aseptic conditions.

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

Paediatric population

To avoid potentially fatal overdosage during intravenous infusion in neonates, special attention must be paid to the method of administration. When using a syringe pump to administer fluids or medications intravenously to neonates, a solution bag must not be left connected to the syringe.

When using an infusion pump, all clamps on the intravenous administration set must be closed before removing the administration set from the pump or disconnecting the pump. This requirement applies regardless of whether the administration set has an anti-siphon device.

The intravenous infusion device and administration set must be frequently monitored.

Discard after single use.

Discard any unused portions.

Do not reconnect partially used bags.

1. To open

2. Remove the Viaflo bag from its protective overpouch immediately before use.

3. Check for small leaks by firmly squeezing the inner bag. If leaks are detected, discard the solution, as it may no longer be sterile.

4. Check the clarity of the solution and absence of foreign particles. Discard the solution if it is not clear or contains foreign particles.

5. Preparation for administration

Use sterile materials for preparation and administration.

1. Hang the container by the hanger loop.
2. Remove the plastic protector from the outlet port at the bottom of the container:

• Hold the small fin on the neck of the outlet tube with one hand,
• Hold the large fin of the closure cap with the other hand and twist,
• The cap will detach.
  1. Use an aseptic technique to prepare the infusion.
  2. Connect the administration set. Refer to the instructions accompanying the administration set for connection, priming, and administration of the solution.

1. Techniques for injection of added medication

To avoid localized hyperkalemia, the solution must not be administered into 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 medications may be incompatible (see section 5 “Incompatibilities of added medications” below).

To add medication before administration

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

Caution: 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-gauge (1.10 mm) to 22-gauge (0.70 mm) needle, pierce the resealable medication addition port and inject.

4. Remove the container from the intravenous stand and/or rotate it to place it in vertical position.

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

6. Carefully mix the solution and medication.

7. Return the container to its use position, reopen the clamp, and continue administration.

8. In-use expiry (added medications)

Prior to use, the physical and chemical stability of any medication added to 5% glucose and 0.3% potassium chloride solution in the Viaflo container at the solution's pH must be established.

From a microbiological standpoint, the diluted product should be used immediately unless the addition of medication was performed under validated aseptic conditions. If not used immediately, the conditions and duration of storage prior to use are the responsibility of the user.

1. Incompatibilities of added medications

As with all parenteral solutions, compatibility of any added medication with the solution in the Viaflo container must be evaluated before addition.

It is the physician's responsibility to assess incompatibility of the added medication with Viaflo 5% glucose and 0.3% potassium chloride by checking for any change in color and/or precipitation, as well as the appearance of insoluble complexes or crystals. The package leaflet and/or summary of product characteristics of the medication to be added should be consulted.

Before adding a medication, verify that it is soluble and stable in water at the pH of Viaflo 5% glucose and 0.3% potassium chloride solution (pH: 3.5 – 6.5).

The following list serves as a guide for medications incompatible with Viaflo 5% glucose and 0.3% potassium chloride (non-exhaustive list):

• Amphotericin B
• Dobutamine

Glucose must not be administered through the same infusion set as whole blood, as this may cause haemolysis and clot formation.

Medications known to be incompatible must not be used.