Viaflo glucose 10% solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Viaflo Glucose 10% solution for infusion

Active substance: Glucose

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, pharmacist or nurse.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, including any possible side effects not listed in this leaflet. See section 4.

This medicine is called "Viaflo Glucose 10% solution for infusion", but will be referred to as "Viaflo Glucose 10%" throughout the rest of this leaflet.

Leaflet contents:

1. What Viaflo Glucose 10% is and what it is used for
2. What you need to know before Viaflo Glucose 10% is administered to you
3. How Viaflo Glucose 10% will be administered to you
4. Possible side effects
5. How to store Viaflo Glucose 10%
6. Contents of the pack and other information

1. What Viaflo Glucose 10% is and what it is used for

Viaflo Glucose 10% is a sugar (glucose) solution in water. Glucose is one of the body's main sources of energy. This infusion solution provides 400 kilocalories per litre.

Viaflo Glucose 10% is used to:

• provide a source of sugar (carbohydrate) alone or, if required, for parenteral nutrition. Parenteral nutrition is used to feed patients who cannot eat. It is given as a slow injection (infusion) into a vein.
• prevent or treat low blood sugar levels (hypoglycaemia, which causes symptoms but is not life-threatening).
• provide additional fluid to the patient when the body does not have enough water (dehydration) and when extra sugar (carbohydrate) is needed.

dilute with water other medicines that are to be administered intravenously.

2. What you need to know before Viaflo Glucose 10% is administered to you

DO NOT administer Viaflo Glucose 10% if you have any of the following conditions:

• diabetes that is not properly treated, resulting in blood glucose levels higher than normal (uncompensated diabetes),

• loss of consciousness (hyperosmolar coma). This is a type of coma that may occur if you have diabetes and are not receiving adequate medication,

• blood dilution due to excessive fluid administration (hemodilution),

• excess fluid in the body's extracellular spaces (extracellular hyperhydration),

• abnormally high blood volume in blood vessels (hypervolemia),

• elevated blood glucose concentration (hyperglycemia),

• elevated blood lactate concentration (hyperlactatemia),

• severe renal failure (when kidneys do not function properly and dialysis is required),

• uncompensated heart failure. If heart failure has not been adequately treated and causes symptoms such as:

• difficulty breathing,

• swollen ankles,

• fluid accumulation under the skin affecting the entire body, including the brain and lungs (generalized edema),

• liver disease causing fluid accumulation in the abdomen (ascitic cirrhosis),

• any other condition affecting your body’s ability to regulate blood sugar levels,

• intolerance (hypersensitivity) to glucose. This may occur in patients with corn allergy.

If another medicine is added to your infusion solution, read its package leaflet to ensure that you can safely receive that medicine.

Warnings and precautions

Viaflo Glucose 10% 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 conditions:

• diabetes,

• renal failure,

• an acute, potentially life-threatening illness (acute critical illness),

• tell your doctor if you have had a head injury within the last 24 hours,

• increased pressure inside the skull (intracranial hypertension),

• stroke caused by a blood clot in a blood vessel (cerebral stroke),

• heart disease (heart failure),

• lung disease (respiratory failure),

• reduced urine production (oliguria or anuria),

• excess water in the body (water intoxication),

• low sodium levels in the blood (hyponatremia),

• corn allergy (Viaflo Glucose 10% infusion contains glucose derived from corn).

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

• a 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 Glucose 10%).

This may increase the risk of low blood sodium levels (hyponatremia) 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.

While receiving this infusion, your doctor will monitor:

• levels of electrolytes such as sodium and potassium in the blood (plasma electrolytes),
• blood glucose levels,
• your body's fluid balance (fluid balance),
• acidity of your blood and urine (acid-base balance changes).

Your doctor will adjust the infusion rate based on laboratory test results. These tests will indicate whether you require additional potassium, a blood chemical. If needed, potassium may be administered intravenously.

Because Viaflo Glucose 10% contains sugar (glucose), it may cause high blood sugar levels (hyperglycemia). If this occurs, your doctor may:

• adjust the infusion rate,
• administer insulin to lower blood glucose levels,
• if necessary, administer additional potassium.

This is particularly important if:

• you have diabetes,
• your kidneys are not functioning as well as normal,
• you recently had a stroke (acute ischemic stroke). High blood sugar levels may worsen stroke effects and impair recovery,
• you have metabolic disorders due to starvation or a diet lacking proper nutrient balance (malnutrition),
• you have low thiamine levels (vitamin B1). This may occur in individuals with chronic alcoholism.

This solution must not be administered through the same needle used for blood transfusion, as this may damage red blood cells or cause them to clump together.

Children

Viaflo Glucose 10% must be administered with special care in children.

Children should receive Viaflo Glucose 10% only under the supervision of a doctor or nurse. The dose must be determined by a physician experienced in pediatric treatment and will depend on the child’s age, weight, and clinical condition. The dose may also be affected if the solution is used to administer or dilute another medicine or if other medicines are given simultaneously.

When administering the infusion to children, your doctor will take blood and urine samples to monitor electrolyte levels, such as potassium (plasma electrolytes).

Newborns—especially those born prematurely and with low birth weight—are at increased risk of developing low or high blood glucose levels (hypo- or hyperglycemia). Therefore, they require close monitoring during intravenous glucose infusion to ensure appropriate blood sugar control and prevent potential long-term adverse effects. 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, eye damage (retinopathy of prematurity), intestinal tract infections (necrotizing enterocolitis), lung problems (bronchopulmonary dysplasia), prolonged hospitalization, and death.

When administered to a newborn, the solution bag may be connected to an infusion pump device, which ensures accurate delivery of the required amount over a defined time interval. Your doctor or nurse will monitor the device to ensure safe administration.

Children (including neonates and older children) receiving Viaflo Glucose 10% are at increased risk of developing low blood sodium levels (hypotonic hyponatremia) and a brain disorder caused by low plasma sodium levels (hyponatremic encephalopathy).

Other medicines and Viaflo Glucose 10%

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

Viaflo Glucose 10% and any other medicines taken concurrently may interact with each other.

Do not use Viaflo Glucose 10% with certain hormones (catecholamines), including adrenaline, or steroids, as they increase blood sugar levels.

Some medicines affect the hormone vasopressin. These may include:

• antidiabetic medications (chlorpropamide),
• cholesterol-lowering drugs (clofibrate),
• certain anticancer drugs (vincristine, ifosfamide, cyclophosphamide),
• selective serotonin reuptake inhibitors (used to treat depression),
• antipsychotics,
• opioid pain relievers for severe pain,
• 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 drugs (carbamazepine and oxcarbazepine),
• diuretics.

Use of Viaflo Glucose 10% with food and drink

You should ask your doctor what you may eat or drink.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

Viaflo Glucose 10% may be used during pregnancy. However, caution is advised when using glucose solutions during labor.

Fertility

There are insufficient data on the effect of glucose on fertility, although no effect on fertility is expected.

Breastfeeding

There are insufficient data on the use of glucose solutions during breastfeeding, although no adverse effects on breastfeeding are expected. Viaflo Glucose 10% may be used during breastfeeding.

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

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

Driving and using machines

Consult your doctor or nurse before driving or operating machinery.

3. How Viaflo Glucose 10% will be administered to you

Viaflo Glucose 10% will be administered by a doctor or nurse. Your doctor will decide how much you need and when it should be given. This will depend on your age, weight, physical condition, and the reason for treatment. The amount you receive may also be influenced by other treatments you are receiving.

Do not receive Viaflo Glucose 10% if there are particles floating in the solution or if the container is damaged in any way.

Usually, Viaflo Glucose 10% is administered through a plastic tube connected to a needle inserted into a vein. A vein in the arm is typically used for the infusion. However, your doctor may administer the medicine differently if needed.

Before and during the infusion, your doctor will monitor:

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

Any unused portion of the solution must be discarded. DO NOT receive Viaflo Glucose 10% from an opened bag.

If you receive more Viaflo Glucose 10% than you should

If you receive too much Viaflo Glucose 10% (overdose), or if it is administered too quickly or too frequently, the following symptoms may occur:

• fluid accumulation in tissues causing swelling (edema) or water intoxication, with blood sodium levels lower than normal (hyponatremia),
• higher than normal blood sugar levels (hyperglycemia),
• excessive concentration of the blood (hyperosmolarity),
• presence of glucose in the urine (glucosuria),
• increased urine production (osmotic diuresis),
• loss of body water (dehydration).

If you develop any of these symptoms, inform your doctor immediately. Your infusion will be stopped or slowed down. Insulin may be administered, and treatment will be provided according to your symptoms.

If any medicine has been added to Viaflo Glucose 10% before the overdose occurred, that medicine may also cause symptoms. You should read the list of possible side effects in the package leaflet of the added medicine.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone 915 620 420.

If you interrupt the infusion with Viaflo Glucose 10%

Your doctor will decide when the infusion should be stopped.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Adverse effects may include:

• Hypersensitivity reactions, including a severe allergic reaction called anaphylaxis (potential manifestation in patients with corn allergy),

• difficulty breathing,

• skin swelling of the face and lips or swelling of the throat,

• fever,

• hives (urticaria),

• skin rash,

• redness of the skin (cutaneous erythema),

• chills,

• changes in blood electrolyte levels (electrolyte disturbances), including:

• low levels of sodium in the blood that may occur during hospitalization (nosocomial hypotremia) and associated neurological disorder (acute hyponatremic encephalopathy). Hypotremia may cause irreversible brain damage and death due to cerebral edema/inflammation (see also section “Warnings and precautions”).

• low blood potassium level (hypokalemia),

• low blood magnesium level (hypomagnesemia),

• low blood phosphate level (hypophosphatemia),

• high blood sugar level (hyperglycemia),

• excess fluid in the blood vessels (hemodilution and hypervolemia),

• sugar in urine (glucosuria),

• administration route-related reactions:

• fever, febrile reaction (pyrexia),

• sweating,

• infection at the injection site,

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

• formation of a blood clot (venous thrombosis) at the infusion site, causing pain, swelling, or redness in the area of the clot,

• irritation and inflammation of the vein used for infusion (phlebitis). This may cause redness, pain, burning, or swelling along the infused vein,

• local reaction or pain (redness or swelling at the infusion site),

• sweating.

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.

If any adverse effect occurs, the infusion should be stopped.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, 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 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 Glucose 10%

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

This medicine does not require any special storage conditions.

Viaflo Glucose 10% must NOT be administered after the expiry date stated on the bag and the outer carton following "exp." The expiry date refers to the last day of the month indicated.

Do not administer Viaflo Glucose 10% if there are floating particles in the solution or if the container is damaged in any way.

6. Contents of the pack and other information

Composition of Viaflo Glucose 10%

The active substance is glucose (as monohydrate): 100 g per litre.

The only other component is water for injections.

Formula per 250 ml

Glucose (as monohydrate): 25 g

Formula per 500 ml

Glucose (as monohydrate): 50 g

Formula per 1000 ml

Glucose (as monohydrate): 100 g

Appearance of Viaflo Glucose 10% and contents of the pack

Viaflo Glucose 10% is a clear solution without visible particles. It is supplied in plastic bags made of polyolefin/polyamide (Viaflo). Each bag is enclosed in a sealed protective overpouch.

Bag sizes:

• 250 ml
• 500 ml
• 1000 ml

Contents of the outer carton:

• 30 or 36 bags of 250 ml
• 1 bag of 250 ml
• 20 or 24 bags of 500 ml
• 1 bag of 500 ml
• 10 or 12 bags of 1000 ml
• 1 bag 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)

Spain

Manufacturer:

Bieffe Medital S.A.

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 Health Products (AEMPS) http://www.aemps.gob.es/

This information is intended for healthcare professionals only:

Handling and preparation

The infusion solution should be visually inspected before use.

Parenteral solutions should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Use the bag only if the solution is clear, contains no visible particles, and the container is undamaged. It should be administered immediately after insertion of 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 air embolism due to residual air being entrained 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 air embolism if residual air in the container is not completely evacuated prior to administration. Use of an intravenous administration set with a vent filter in the open position could cause air embolism. Such intravenous administration sets with vent filter in the open position must not be used with flexible plastic containers.

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

Addition of electrolytes may be indicated depending on the patient's clinical needs.

Medications may be added before or during infusion through the resealable medication addition port. When used, the final osmolarity should be checked before parenteral administration. The mixture must be prepared aseptically and with care and thoroughness. Solutions containing added medications should not be stored and must be used immediately.

To avoid potentially fatal overdosing 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 bag of fluid 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 changing it. This is required regardless of whether the administration set has an anti-siphon device.

The complete infusion device and its intravenous administration must be frequently monitored.

Discard after single use.

Dispose of unused portions.

Do not reconnect partially used bags.

Do not store solutions containing other medications.

Aseptic technique must be used when adding medications to Viaflo Glucose 10%.

Mix the solution thoroughly after adding medications.

1. Opening

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

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

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

1. Preparation for administration

Use sterile materials for preparation and administration.

• Hang the container by the hanger loop.

• Remove the plastic protector from the outlet port at the bottom of the container:

  • hold the small protrusion on the neck of the port with one hand,
  • hold the long protrusion on the cap with the other hand and twist,
  • the cap will detach.

• Use an antiseptic method to prepare the infusion.

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

1. Techniques for injection of added medications

Warning: Added medications may be incompatible.

To add medication before administration

• Disinfect the medication addition port.

• Using a syringe with a needle gauge 19 (1.10 mm) to 22 (0.70 mm), pierce the resealable medication addition port and inject.

• 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

• Close the clamp on the administration set.

• Disinfect the medication addition port.

• Using a syringe with a needle gauge 19 (1.10 mm) to 22 (0.70 mm), pierce the resealable medication addition port and inject.

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

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

• Carefully mix the solution and medication.

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

1. In-use expiry (added medications)

The chemical and physical stability of medications added to Viaflo Glucose 10% at its pH must be determined before use.

From a microbiological standpoint, the diluted product should be used immediately unless reconstitution has been carried out under controlled and validated aseptic conditions. If not used immediately, the storage conditions and duration are the responsibility of the user.

1. Incompatibilities of added medications

Glucose solution must not be administered simultaneously with, before, or after blood through the same infusion set, as this may cause haemolysis and clot formation.

Incompatibility of medications intended for addition with Viaflo Glucose 10% should be evaluated before addition.

In the absence of incompatibility studies, this product must not be mixed with others.

The package leaflet of the medication to be added should be consulted.

Before adding a medication, verify that it is soluble and stable in water within the pH range of Viaflo Glucose 10% (pH 3.5 to 6.5).

When compatible medication is added to Viaflo Glucose 10%, the solution should be administered immediately.

Medications that are not compatible must not be used.