Viaflo Glucosalino Potasico 4%, 0.18%, 0.15% solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Viaflo Glucosalino Potásico 4%, 0.18%, 0.15%, solution for infusion

Active substances: glucose monohydrate, sodium chloride 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, as you may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you experience any adverse effects, consult your doctor or nurse, even if they are not listed in this leaflet. See section 4.

In this leaflet, Viaflo Glucosalino Potásico 4%, 0.18%, 0.15%, solution for infusion will be referred to as Viaflo Glucosalino Potásico.

Contents of this leaflet:

1. What Viaflo Glucosalino Potásico is and what it is used for
2. What you need to know before being administered Viaflo Glucosalino Potásico
3. How Viaflo Glucosalino Potásico will be administered to you
4. Possible adverse effects
5. How to store Viaflo Glucosalino Potásico
6. Contents of the pack and other information

1. What Viaflo Glucosalino Potásico is and what it is used for

Viaflo Glucosalino Potásico is a solution of monohydrated glucose, sodium chloride, and potassium chloride in water. Sodium chloride and potassium chloride are chemical substances (often referred to as "salts") found in the blood.

It is used to prevent and treat the following conditions:

• low levels of potassium, sodium, and chloride in the blood. This may occur when gastrointestinal (gastric) fluid is lost. It may be caused by:

• vomiting

• diarrhea

• drainage from a surgical wound (by collecting body fluid into a bag)

• gastric suction to empty the contents of the stomach

• a diversion of part of the digestive system that prevents food from passing through the small intestine. This procedure is called intestinal bypass

• a perforation in the small intestine (small intestinal fistula)

  • excessive intake of laxatives (medicines used to empty the bowels)
  • development of malabsorption syndrome (insufficient absorption of nutrients)
  • tumor in the small intestine that produces mucus (mucus-secreting villous adenoma)
  • kidney problems that may cause excessive loss of salts
  • excessive intake of diuretics (tablets that increase urine production)

inability to take food orally, necessitating the need to obtain energy from another source

2. What you need to know before Viaflo Glucosalino Potásico is administered to you

Viaflo Glucosalino Potásico will not be administered to you in the following cases:

• elevated levels of potassium in the blood (hyperkalemia)

• elevated levels of chloride in the blood (hyperchloremia)

• severe renal insufficiency (when kidneys are not functioning properly and dialysis is required)

• decompensated heart failure. This is a heart condition that is not adequately treated and causes symptoms such as:

  • difficulty breathing
  • swelling of the ankles

• Addison's disease (impaired function of the adrenal gland, which produces hormones that help regulate the concentration of chemicals in the body)

• inadequately treated diabetes allowing blood sugar levels to rise above normal (uncompensated diabetes)

• conditions involving glucose intolerance, such as:

  • metabolic stress (when the body's metabolism is not functioning properly, for example due to a serious illness)
  • hyperosmolar coma (unconsciousness). This is a type of coma that may occur if you have diabetes and do not receive enough medication.
  • blood sugar levels higher than normal (hyperglycemia)
  • elevated levels of lactate in the blood (hyperlactacidemia)

• recent cerebral infarction

• cranioencephalic trauma within the last 24 hours

• if you are allergic to potassium chloride, sodium chloride, or monohydrated glucose, or to any of the other components of this medicine (listed in section 6).

Your doctor must exercise special caution when administering Viaflo Glucosalino Potásico.

Viaflo Glucosalino Potásico is a hypertonic (concentrated) solution. When administered, the solution will become hypotonic due to its low sodium content. Your doctor will take this into account when calculating the dose to be administered.

Warnings and precautions

If you have developed or previously had any of the following medical conditions, inform your doctor:

• If you have a condition that could cause elevated levels of vasopressin, a hormone that regulates fluid in your body. 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 Glucosalino Potásico")

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 brain swelling include:

• children

• women (particularly those of childbearing age)

• individuals with conditions affecting cerebral fluid levels, such as meningitis, intracranial bleeding, or brain injury.

• any disorder that causes elevated blood potassium levels (hyperkalemia), such as:

  • renal insufficiency
  • adrenocortical insufficiency. A disorder affecting hormones that regulate chemical concentrations in the body
  • acute dehydration (rapid loss of water, for example due to vomiting or diarrhea)
  • extensive tissue damage (such as in severe burns)

• high blood pressure (hypertension)

• accumulation of fluid under the skin (peripheral edema), especially around the ankles

• accumulation of fluid in the lungs (pulmonary edema)

• high blood pressure during pregnancy (preeclampsia)

• any disorder associated with sodium retention (when there is elevated sodium in the body), such as treatment with steroids (medications that reduce inflammation) (see also “Other medicines and Viaflo Glucosalino Potásico”)

• diabetes, as insulin treatment may need to be adjusted due to the presence of glucose (a type of sugar) in the solution

• allergy to corn (Viaflo Glucosalino Potásico contains glucose derived from corn)

If any of these disorders develop, additional tests may be required to monitor your condition. Your doctor will take blood and urine samples to monitor levels of chemicals in the blood (plasma electrolytes). An electrocardiogram (ECG) may also be performed.

It may be necessary to adjust your other medications.

Children

Viaflo Glucosalino Potásico must be administered with caution in children.

Newborns, especially premature infants and those with low birth weight, are at increased risk of developing abnormally high or low blood sugar levels (hypoglycemia or hyperglycemia) due to glucose-containing infusions. Low blood sugar in newborns may lead to prolonged seizures, coma, and brain damage. High blood sugar has been associated with intracranial hemorrhage, late-onset bacterial and fungal infections, intestinal infection (necrotizing enterocolitis), eye problems (retinopathy of prematurity), lung problems (bronchopulmonary dysplasia), prolonged hospitalization, and death.

Children are at higher risk of having or developing abnormally low sodium concentration in the blood (hyponatremia). Hyponatremia may cause headache, nausea, seizures, drowsiness, coma, brain swelling (cerebral edema), and death. Acute hyponatremic encephalopathy is a serious complication, particularly in children.

Your doctor is aware of this and will closely monitor the levels of chemicals such as sodium and chloride in your child’s blood (plasma electrolytes).

Other medicines and Viaflo Glucosalino Potásico

Inform your doctor or pharmacist if you are currently using, have recently used, or might use other medicines.

Other medicines that may interact with or be affected by potassium chloride, sodium chloride, and glucose infusion include:

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

Some medications affect the hormone vasopressin. These may include:

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

If you require a blood transfusion at the same time as the infusion, the blood will be administered through a different vein.

Use of Viaflo Glucosalino Potásico with food and drinks

You should consult your doctor about what you may 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 Viaflo Glucosalino Potásico is administered 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 regulating blood sugar. Blood glucose levels may drop drastically)
• acidosis (imbalance of blood chemical parameters), which may lead to low blood sugar and jaundice (yellowing of the skin or whites of the eyes)

However, a causal relationship between glucose infusion and the mentioned effects has not been demonstrated.

If another medicine is added to this infusion solution during pregnancy or breastfeeding, you must:

• consult your doctor
• read the package leaflet of the added medicine

Driving and use of machines

The infusion does not affect your ability to drive or operate machinery.

3. How Viaflo Glucosaline Potassium 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, clinical and biological condition (your health status). This may also be influenced by other treatments you are receiving.

If you require a large volume or a rapid infusion of Viaflo Glucosaline Potassium, your doctor will monitor your ECG (electrocardiogram).

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

Before and during the infusion, your doctor will monitor:

• the amount of potassium in your body
• the amount of fluid in your body
• the acidity of your blood and urine
• the level 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 renal failure, you will receive a lower dose.

If you receive more Viaflo Glucosaline Potassium than you should

If you are given too much Viaflo Glucosaline Potassium (overdose), the following symptoms may occur:

• high blood sugar levels (hyperglycemia), causing intense thirst, dry mouth, and frequent urination
• low sodium levels in the blood (hyponatremia). Hyponatremia can cause headache, nausea, seizures, drowsiness, coma, brain swelling (cerebral edema), and death.
• fluid accumulation under the skin (peripheral edema), especially around the ankles
• high potassium levels (hyperkalemia), symptoms include:
• tingling sensations (paresthesia) in arms and legs
• respiratory paralysis (inability to breathe)
• gastrointestinal symptoms (painful intestinal obstruction, nausea, vomiting, abdominal pain)
• hypotension (low blood pressure)
• muscle weakness
• inability to move muscles (paralysis)
• changes in heart rhythm (cardiac arrhythmia)
• cardiac block (very slow heart rhythm)
• cardiac arrest (heart stops beating, which may lead to death)

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 the symptoms present.

If any medicine has been added to Viaflo Glucosaline Potassium before the overdose, that medicine may also cause adverse effects. You should read the list of possible symptoms in the leaflet of the added medicine.

If you interrupt the Viaflo Glucosaline Potassium infusion

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

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

4. Possible adverse effects

Like all medicines, Viaflo Glucosalino Potásico may cause adverse effects, although not everyone experiences them.

Some of the possible adverse effects related to the method of administration are the following:

• hypersensitivity reactions, including a severe allergic reaction called anaphylaxis (potential manifestation in patients with corn allergy).
• low levels of sodium in the blood that may occur during hospitalization (nosocomial hyponatremia) and associated 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”)
• hyperglycemia (high blood sugar levels)
• irritation and inflammation of the vein through which the infusion is administered (phlebitis). This may cause redness, pain or burning sensation, and swelling in the vein
• rash
• pruritus (itching of the skin)
• fever (pyrexia)
• infection at the injection site
• local pain or reaction (redness or swelling) at the site of administration
• blisters at the injection site
• chills
• high levels of potassium in the blood (hyperkalemia)
• cardiac arrest
• formation of a blood clot (venous thrombosis) at the infusion site, causing pain, swelling, or redness
• leakage of the infusion solution into the surrounding tissues (extravasation), which may damage tissues and lead to scarring
• excess fluid in the blood vessels (hypervolemia)

If a 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.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or nurse, even if they are adverse effects not listed in this leaflet.

You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Viaflo Glucosaline Potassium

Viaflo Glucosaline Potassium does not require special storage conditions.

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

Do not use Viaflo Glucosaline Potassium after the expiry date stated on the bag following EXP. The expiry date refers to the last day of the month indicated.

Do not administer Viaflo Glucosaline Potassium if:

• there are particles in the solution,
• the solution changes colour, or
• the container is damaged.

6. Contents of the pack and other information

This patient leaflet does not contain all the information about this medicine. If you have any questions, please ask your doctor, pharmacist, or nurse.

Composition of Viaflo Glucosalino Potásico

The active substances are potassium chloride (1.5 g per litre), sodium chloride (1.8 g per litre), and glucose (40 g per litre, equivalent to 44 g monohydrated glucose).

The only excipient is water for injections.

Appearance of the product and contents of the pack

Viaflo Glucosalino Potásico is a clear, particle-free solution. It is supplied in plastic bags made of polyolefin/polyamide (Viaflo). Each bag is contained within a sealed protective overpouch.

Bag sizes:

• 500 ml
• 1000 ml

Bags are supplied in cartons 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

Baxter S.L.
Pouet de Camilo 2, 46394 Ribarroja del Turia (Valencia), Spain

Manufacturer

Bieffe Medital SA
Ctra de Biescas-Senegüé, 22666 Sabiñánigo (Huesca), Spain

Date of latest revision of this leaflet: April 2018

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (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 the container is undamaged. Administer immediately after connecting the infusion set.

Do not remove the unit from the overpouch until ready for use. The inner bag maintains the sterility of the product.

Do not connect plastic containers in series. This practice may lead to gas embolism due to residual air being drawn from the primary container before complete administration of the fluid in the secondary container.

Pressurizing intravenous solutions in flexible plastic containers to increase flow rates may result in gas embolism if residual air in the container is not completely evacuated prior to administration.

Using an intravenous administration set with a vent filter in the open position may cause gas embolism. Such intravenous administration sets with vent filters in the open position must not be used with flexible plastic containers.

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

Medications may be added before or during infusion through the resealable injection site.

Do not use medications known or determined to be incompatible.

Before adding a medication, verify that it is soluble and/or stable in Viaflo Glucosalino Potásico 4%, 0.18%, 0.15% and that the solution's pH range is appropriate.

Refer to the package leaflet of the medication to be added and any other relevant literature.

After addition, if there is a change in colour and/or precipitation, formation of insoluble complexes or crystals, do not use the solution.

Mix the solution thoroughly after adding medications.

Do not store solutions containing added medications.

For single use only.

When medications are added, tonicity should be checked before parenteral administration. Complete and careful aseptic mixing of any added medication is required. Solutions containing added medications should be used immediately after preparation, unless preparation was carried out under controlled and validated aseptic conditions.

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

Paediatric population

To avoid potentially fatal overdosing during intravenous infusion in newborns, special attention must be paid to the method of administration. When using a syringe pump to administer fluids or medications intravenously to newborns, do not leave a solution bag 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 is required regardless of whether the administration set has an anti-siphoning device.

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

Discard after single use.

Dispose of any unused solution.

Do not reconnect partially used bags.

1. To open

a- Remove the Viaflo bag from the protective overpouch immediately before use.

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

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

2. Preparation for administration

Use sterile materials for preparation and administration.

a- Hang the container by the hanger loop.

b- 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 on the closure cap with the other hand and twist.
• The cap will detach.

c- Use an aseptic technique for preparing the infusion.

d- Connect the administration set. Refer to the instructions accompanying the administration set for connection, priming, and administration of the solution.

3. Techniques for adding medication

Warning: Added medications may be incompatible (see section 5 “Incompatibilities of added medications” below)

To add medication before administration

a Disinfect the injection site.

b Using a syringe with a 19G to 22G needle, puncture the resealable injection site and inject the medication.

c Mix the medication and solution thoroughly. For high-density medications such as potassium chloride, gently tap the bag while in vertical position and mix.

Caution: do not store bags with added medication.

To add medication during administration

a Close the administration set clamp.

b Disinfect the injection site.

c Using a syringe with a 19G to 22G needle, puncture the resealable injection site and inject the medication.

d Remove the container from the IV stand and/or turn it to a vertical position.

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

f Mix the solution and medication thoroughly.

g Return the container to the upright position, reopen the clamp, and continue administration.

1. In-use stability period (after addition of medications)

Prior to use, the physical and chemical stability of any medication added to Viaflo Glucosalino Potásico at its pH and in its bag must be established. From a microbiological standpoint, the diluted product should be used immediately unless dilution was performed under aseptic and validated conditions.

If not used immediately, the conditions and duration of storage prior to use are the responsibility of the user.

5. Incompatibilities of added medications

As with all parenteral solutions, compatibility of additional medications with the solution in the Viaflo container must be evaluated before addition.

It is the physician’s responsibility to assess incompatibility of added medication by observing any change in colour and/or precipitation, formation of insoluble complexes or crystals.

Refer to the package leaflet of the medication to be added.

Before adding a medication, verify that it is soluble and stable in water at the pH of Viaflo Glucosalino Potásico.

When compatible medication is added to this formulation, the solution should be administered immediately, unless dilution was performed under controlled and validated aseptic conditions.

As a guide, the following medications are incompatible with Viaflo Glucosalino Potásico, although this list is not exhaustive:

• amphotericin B
• dobutamine

Do not administer glucose simultaneously with whole blood through the same infusion set, as haemolysis and agglutination may occur.

Do not use added medications known to be incompatible.