VIAFLO GLUCOSA 10% SOLUTION FOR INFUSION

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 further questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is 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 this leaflet.

Contents of the pack:

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

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

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

Viaflo Glucose 10% is used to:

• provide a source of sugar (carbohydrates) alone or, if required, for parenteral nutrition. Parenteral nutrition is used to feed patients who cannot eat. It is given by slow injection (infusion) through a vein.
• prevent or treat low blood sugar levels (hypoglycemia, which causes symptoms but is not fatal)
• provide the patient with extra fluid when the body does not have enough water (dehydration) and you need extra sugar (carbohydrates).

dilute with water other medicines that are to be given by intravenous injection.

2. What you need to know before you are given Viaflo Glucose 10%

You will not be given Viaflo Glucose 10% if you have any of the following conditions:

• if you have diabetes that is not being treated, so that the blood glucose concentration is higher than normal (uncontrolled diabetes),
• loss of consciousness (hyperosmolar coma). This is a type of coma that can occur if you have diabetes and are not taking your medication,
• thinning of the blood due to the addition of too much fluid (hemodilution),
• when there is too much fluid in the body's extracellular spaces (extracellular hyperhydration),
• when there is more blood in the blood vessels than there should be (hypervolemia),
• high blood glucose levels (hyperglycemia),
• high blood lactate levels (hyperlactatemia),
• severe kidney failure (when the kidneys are not working well and dialysis is needed)
• uncompensated heart failure. If heart failure has not been treated properly and is causing symptoms such as:

• difficulty breathing,
• swelling of the ankles,
• if there is fluid accumulation under the skin, affecting the whole body including the brain and lungs (generalized edema),
• liver disease that causes fluid accumulation in the abdomen (ascitic cirrhosis),
• any other condition that affects the way your body controls blood sugar levels,
• intolerance (hypersensitivity) to glucose. This can occur in patients with a corn allergy.

If another medicine is added to your infusion solution, read its package leaflet. This will ensure that you can take 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 be given.

If you develop or have developed any of the following conditions, inform your doctor.

• Diabetes,
• kidney failure,
• a life-threatening illness (critical illness),
• tell your doctor if you have had a head injury in the last 24 hours,
• increased pressure inside the skull (intracranial hypertension),
• stroke due to 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),
• allergy to corn (Viaflo Glucose 10% infusion contains corn-derived sugar).

• If you have a condition that could cause high levels of vasopressin, a hormone that regulates your body's fluid. You may have too much vasopressin in your body because, for example:

• you have had a sudden and severe illness,
• you are in pain,
• you have had surgery,
• you have infections, burns, or head injury
• you have diseases related to your heart, liver, kidneys, or central nervous system,
• you are taking certain medications (see Other medicines and Viaflo Glucose 10%).

This can increase the risk of low sodium levels in the blood and can cause headache, nausea, seizures, lethargy, coma, brain inflammation, 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 brain fluid levels, for example, due to meningitis, bleeding in the skull, or a head injury.

When you receive this infusion, your doctor will monitor:

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

Your doctor will adjust the amount of infusion solution to be given according to the results of the tests. These tests will indicate to your doctor if you need additional potassium, a blood chemical. If necessary, it can be given intravenously.

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

• adjust the infusion rate,
• give you insulin to reduce your blood sugar levels,
• if necessary, give you more potassium.

This is very important:

• if you have diabetes,
• if your kidneys are not working as well as normal,
• if you have recently had a stroke (acute ischemic stroke). High blood sugar levels can worsen the effects of the stroke and affect recovery,
• if you have metabolic disorders due to starvation or a diet that does not provide the right proportion of necessary nutrients (malnutrition),
• if you have low thiamine (vitamin B1) levels. This can occur if you have chronic alcoholism.

This solution will not be given using the same needle as a blood transfusion, as it could damage the red blood cells or cause them to clump together.

Children

Viaflo Glucose 10% should be given to children with special care.

Children should receive Viaflo Glucose 10% from a doctor or nurse. The amount given will be determined by a doctor specializing in pediatric treatment and will depend on the child's age, weight, and condition. If it is used to administer or dilute another medicine, or if other medicines are given at the same time, the dose may also be affected.

When the infusion is given to children, your doctor will take blood and urine samples to monitor the amount of electrolytes such as potassium in the blood (plasma electrolytes).

Newborns - especially premature and low-birth-weight babies - are at higher risk of developing low or high blood sugar levels (hypo- or hyperglycemia). Therefore, they need close monitoring during treatment with intravenous glucose solutions to ensure adequate control of blood sugar levels and prevent possible long-term adverse effects. Low blood sugar levels in newborns can cause prolonged seizures, coma, and brain damage. High blood sugar levels can cause brain hemorrhages, bacterial or fungal infections, eye damage (retinopathy of prematurity), intestinal infections (necrotizing enterocolitis), lung problems (bronchopulmonary dysplasia), prolonged hospital stay, and death.

When given to a newborn, the solution bag may be connected to an infusion pump device, which allows for the exact administration of the required amount over a defined time interval. Your doctor or nurse will be monitoring the device to ensure safe administration.

Children (including neonates and older children) who are given Viaflo Glucose 10% are at higher risk of having low sodium levels in the blood (hyponatremia) and a brain disorder due to low sodium levels (hyponatremic encephalopathy).

Other medicines and Viaflo Glucose 10%

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

Viaflo Glucose 10% and any other medicine taken at the same time may affect 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 vasopressin hormone. These may include:

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

Using Viaflo Glucose 10% with food and drinks

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

Viaflo glucose 10% can be used during pregnancy. However, caution should be exercised when using a glucose solution during labor.

Fertility

There is not enough data on the effect of glucose on fertility, although no effect is expected.

Breastfeeding

There is not enough data on the use of a glucose solution during breastfeeding, although no effect is expected. Viaflo glucose 10% can be used during breastfeeding.

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

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

Driving and using machines

Ask your doctor or nurse for advice before driving or using machines.

3. How you will be given Viaflo Glucose 10%

Viaflo Glucose 10% will be given to you 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 affected by other treatments you are receiving.

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

Generally, Viaflo Glucose 10% will be given to you through a plastic tube attached to a needle inserted into a vein. A vein in the arm is usually used to give the infusion. However, your doctor may give you the medicine in another way.

Before and during the infusion, your doctor will monitor:

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

Any unused solution should be discarded. You should not receive Viaflo Glucose 10% from a started bag.

If you receive more Viaflo Glucose 10% than you should

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

• fluid accumulation in the tissues causing swelling (edema) or water intoxication, with low sodium levels in the blood (hyponatremia),

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• a higher than normal blood sugar level (hyperglycemia),
• excessive blood concentration (hyperosmolarity),
• glucose in the urine (glucosuria),
• increased urine production (osmotic diuresis),
• water loss in the body (dehydration),

If you develop any of these symptoms, tell your doctor immediately. Your infusion will be stopped or the infusion rate will be reduced. You will be given insulin and will receive treatment according to the symptoms.

If another medicine was added to Viaflo Glucose 10% before the overdose, that medicine may also cause symptoms. You should read the list of possible symptoms in the package leaflet of the added medicine.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Phone 915.620.420

If you stop the infusion with Viaflo Glucose 10%

Your doctor will decide when you should stop this infusion.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects may include:

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

• difficulty breathing,
• swelling of the face and lips or throat inflammation,
• fever,
• hives (urticaria),
• rash,
• redness of the skin (cutaneous erythema),
• chills,

• changes in blood electrolyte levels (electrolyte disturbances), including:
• low sodium levels in the blood that can be acquired during hospitalization (nosocomial hyponatremia) and related neurological disorder (acute hyponatremic encephalopathy). Hyponatremia can cause irreversible brain damage and death due to brain edema/inflammation (see also the section “Warnings and precautions”).
• low potassium levels in the blood (hypokalemia),
• low magnesium levels in the blood (hypomagnesemia),
• low phosphate levels in the blood (hypophosphatemia),
• high blood sugar levels (hyperglycemia),

• excess fluid in the blood vessels (hemodilution and hypervolemia),
• glucose in the urine (glucosuria),
• reactions related to the route of administration:
• fever, febrile reaction (pyrexia),
• sweating,
• infection at the injection site,
• leakage of the infusion solution into the tissues surrounding the vein (extravasation). This can damage the tissues and cause scarring,
• formation of a blood clot (thrombosis) at the infusion site, causing pain, inflammation, or redness in the area of the clot,
• irritation and inflammation of the vein through which the infusion is given (phlebitis). This can cause redness, pain, or itching or swelling in the infusion vein,
• local reaction or pain (redness or swelling at the infusion site),
• sweating.

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 package leaflet of the added medicine.

If you experience any side effects, the infusion should be stopped.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side 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% should not be administered after the expiry date stated on the bag and carton after EXP. The expiry date is the last day of the month shown.

Viaflo Glucose 10% should not be administered if there are particles floating in the solution or if the unit is damaged in any way.

6. Container Contents and Additional Information

Composition ofViaflo Glucose 10%

The active ingredient is glucose (as monohydrate): 100 g per liter.

The only other component is water for injectable preparations.

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 Container Contents

Viaflo Glucose 10% is a clear solution, without visible particles. It is supplied in polyolefin/polyamide plastic bags (Viaflo). Each bag is wrapped with a sealed protective overbag.

The bag sizes are:

• 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 some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturers

Marketing Authorization 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 Last Revision of this Leaflet:April 2018

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

This information is intended only for healthcare professionals:

Handling and Preparation

The solution for infusion 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, does not contain visible particles, and the container is not damaged. It should be administered immediately after insertion of the infusion equipment.

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

The inner bag maintains the sterility of the product.

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

The pressurization of intravenous solutions in flexible plastic containers to increase flow rates can result in a gas embolism if the residual air in the container is not fully evacuated before administration. The use of an intravenous administration set with a ventilation filter in the open position could cause a gas embolism. This type of intravenous administration set with the ventilation filter in the open position should not be used with flexible plastic containers.

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

The addition of electrolytes may be indicated based on the patient's clinical needs.

Medicines can be added before infusion or during it through the resalable medication addition port. When used, the final osmolarity should be checked before parenteral administration. The mixture should be aseptic and performed carefully and meticulously. Solutions containing added medicines should not be stored and should be used immediately.

In order to avoid a potentially fatal overdose during the infusion of intravenous solutions in newborns, special attention should be paid to the method of administration. When using a syringe pump to administer fluids or medications intravenously to newborns, a liquid bag should not be left connected to the syringe.

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

The complete device equipment and its administration through intravenous infusion should be frequently monitored.

Discard after single use.

Discard unused remnants.

Do not reconnect partially used bags.

Do not store solutions containing other medications.

An aseptic technique should be used when adding medications to Viaflo Glucose 10%.

Mix the solution well when adding medications.

1. Opening

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

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

• 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.

• Hang the container by the hanger.

• Remove the plastic protector from the outlet port at the bottom of the container:
  • grasp the small protrusion on the neck of the port with one hand,
  • grasp the long protrusion on the cap with the other hand and twist,
  • the cap will come loose.

• Use an antisepsis method to prepare the infusion.

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

1. Techniques for Injecting Added Medications

Warning: Added medications may be incompatible.

To add medication before administration

• Disinfect the medication addition port.

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

• Mix the medication and solution carefully. For high-density medications, such as potassium chloride, gently move the tubes while in a vertical position and mix.

• Precaution: do not store bags with added medication.

To add medication during administration

• Close the clamp on the equipment.

• Disinfect the medication addition port.

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

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

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

• Mix the solution and medication carefully.

• Put the container back in the position of use, reopen the clamp, and continue with the administration.

1. In-Use Shelf-Life (Added Medications)

The chemical and physical stability of the added medications in the pH of Viaflo Glucose 10% in the Viaflo container should be determined before use.

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

1. Incompatibilities of Added Medications

The glucose solution should not be administered simultaneously with, before, or after a blood transfusion through the same infusion equipment, as it may cause hemolysis and clot formation.

The incompatibility of the medications to be added with Viaflo Glucose 10% should be evaluated before adding them.

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

The 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 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.

Incompatible added medications should not be used.