Glucose 5% and sodium chloride 0.33% Baxter solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Glucose 5% and Sodium Chloride 0.33% Baxter solution for infusion

Active substances: sodium chloride, glucose

Read the entire 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, consult your doctor or nurse.

• If you experience any adverse effects, consult your doctor or nurse, even if they are effects not listed in this leaflet. See section 4.

This medicine is called Glucose 5% and Sodium Chloride 0.33% Baxter solution for infusion, but will be referred to as "Glucose 5% and Sodium Chloride 0.33% Baxter" throughout the rest of this leaflet.

Leaflet contents:

1. What Glucose 5% and Sodium Chloride 0.33% Baxter is and what it is used for
2. What you need to know before being administered Glucose 5% and Sodium Chloride 0.33% Baxter
3. How Glucose 5% and Sodium Chloride 0.33% Baxter is administered
4. Possible adverse effects
5. Storage of Glucose 5% and Sodium Chloride 0.33% Baxter
6. Contents of the pack and other information

1. What Glucosa 5% en cloruro sodico 0,33% Baxter is and what it is used for

Glucosa 5% y cloruro sódico 0,33% Baxter is a solution containing the following substances in water:

• Sugar (glucose)
• Sodium chloride

Glucose is one of the body's sources of energy. This solution provides 200 kilocalories per liter. Sodium and chloride are chemical substances present in the blood.

Glucosa 5% y cloruro sódico 0,33% Baxter is used:

• as a source of carbohydrates (sugar)
• to treat loss of water (dehydration) and loss of chemical substances (e.g., excessive sweating, renal disorders) from the body
• for treatment when blood volume in the blood vessels is low (hypovolemia).

2. What you need to know before Glucosa 5% in 0.33% Sodium Chloride Baxter is administered to you

DO NOT administer Glucose 5% and 0.33% sodium chloride Baxter if you have any of the following clinical conditions:

• If you are allergic to any of the components of this medicine.

• When there is excessive fluid in the spaces surrounding the body's cells (extracellular overhydration)

• When there is a higher blood volume in the blood vessels than normal (hypervolemia)

• Excess fluid and sodium in the body (fluid and sodium retention)

• Severe kidney problems meaning you produce less urine than normal or none at all (oliguria or anuria)

• If you have uncompensated heart failure. This refers to heart failure that is not receiving adequate treatment and causes symptoms such as:

  • Difficulty breathing.
  • Swelling of the ankles.

• If you have lower than normal levels of sodium in the blood (hyponatremia).

• If you have lower than normal levels of chloride in the blood (hypochloremia).

• If there is accumulation of fluid under the skin affecting the entire body (generalized edema).

• If you have liver disease causing fluid buildup in the abdomen (ascitic cirrhosis).

• If you have diabetes that is not adequately treated, resulting in higher than normal blood sugar concentration (uncompensated diabetes).

• Other 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 if you have diabetes and are not receiving appropriate medication.
  • Higher than normal blood glucose concentration (hyperglycemia)
  • Higher than normal blood lactate concentration (hyperlactatemia).

Warnings and precautions

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

• conditions associated with sodium retention, fluid overload, and edema, such as:

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

• high blood pressure (hypertension)

• Heart failure

• impaired liver function or liver disease causing fluid accumulation in the abdomen (ascitic cirrhosis)

• Renal failure

• high blood pressure during pregnancy (pre-eclampsia)

• taking certain medications (see also “Other medicines and Glucose 5% and sodium chloride 0.33% Baxter”)

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

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

• rapid loss of body water, e.g., due to vomiting or diarrhea

• long-term low-potassium diet

• allergy, particularly to corn (Glucose 5% and sodium chloride 0.33% Baxter contains glucose derived from corn)

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

• you have had a sudden and severe illness,

• you have pain,

• you have undergone surgery,

• you have infections, burns, or brain injury,

• you have diseases affecting your heart, liver, kidneys, or central nervous system,

• you are taking certain medications (see Other medicines and Glucose 5% and sodium chloride 0.33% Baxter).

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 if of childbearing age)

• individuals who have problems with cerebral fluid levels, for example, due to meningitis, bleeding in the skull, or brain injury.

• changes in the concentrations of chemicals in the blood (electrolyte imbalances)

• accumulation of fluid under the skin, affecting all parts of the body (generalized edema), around the ankles (peripheral edema), or in the lungs (pulmonary edema)

While this solution is being administered, your doctor may take blood and urine samples to monitor:

• the levels of chemicals such as sodium and chloride in your blood (your plasma electrolytes)
• the level of sugar (glucose)

Since Glucose 5% and sodium chloride 0.33% Baxter contains sugar (glucose), it may increase blood sugar levels (hyperglycemia). If this occurs, your doctor may:

• adjust the infusion rate
• administer insulin to reduce blood glucose concentration

This is particularly important:

• if you are diabetic
• if you have not been eating properly or have been consuming excessive alcohol over a long period
• if you have recently suffered a brain injury (acute stroke). High blood sugar levels may worsen the effects of brain damage and affect your recovery
• if you have had a head injury within the last 24 hours. Your doctor should consider whether you are receiving parenteral nutrition (nutrition delivered via intravenous infusion). During prolonged treatment with Glucose 5% and sodium chloride 0.33% Baxter, you may require additional nutritional support. Your doctor should monitor your blood potassium levels to prevent them from dropping below normal (hypokalemia).

Children

Special care must be taken when administering this solution to children, infants, and newborns (especially premature infants and those with low birth weight). Children, infants, and newborns may have limited capacity to handle the chemicals in the solution.

Younger children are at increased risk of developing low or high blood glucose levels and therefore require careful monitoring during treatment to ensure appropriate blood sugar control. Low blood sugar in newborns may cause prolonged seizures, coma, and brain damage. High blood sugar levels have been associated with brain hemorrhages, bacterial or fungal infections, eye damage (retinopathy of prematurity), intestinal tract infections, respiratory problems, prolonged hospitalization, and death.

Children are at higher risk of developing low sodium levels in the blood (hypoosmolar hyponatremia). Hyponatremia may cause headache, nausea, seizures, lethargy, coma, brain swelling (cerebral edema), and death. Acute hyponatremic encephalopathy is a serious complication, especially in children.

Your doctor is aware of the above and will carefully monitor the levels of chemicals such as glucose (sugar), sodium, and chloride in your child's blood (plasma electrolytes).

Other medicines and Glucose 5% and sodium chloride 0.33% Baxter

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

It is particularly important that you inform your doctor if you are taking:

• corticosteroids (anti-inflammatory medicines).

These medicines can cause the body to retain sodium and water, leading to tissue swelling due to fluid accumulation under the skin (edema) or high blood pressure (hypertension).

Some medicines affect the hormone vasopressin. These may include:

• antidiabetic medicines (chlorpropamide)
• cholesterol-lowering medicines (clofibrate)
• certain anticancer 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

Other medicines that may be affected by or may affect Glucose 5% and sodium chloride 0.33% Baxter include:

• lithium (used to treat psychiatric conditions)
• insulin (used to treat diabetes)
• beta-blockers (heart medications)

Use of Glucosa 5% and sodium chloride 0.33% Baxter with food and drink

Ask your doctor about 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 or nurse before using this medicine.

Glucose 5% and sodium chloride 0.33% Baxter can be used safely during pregnancy and breastfeeding.

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

• ask your doctor
• read the package leaflet of the medicine to be added

Driving and use of machines

Glucosa 5% and sodium chloride 0.33% Baxter does not affect your ability to drive or use machines.

3. How Glucosa 5% and sodium chloride 0.33% Baxter will be administered to you

Glucosa 5% and sodium chloride 0.33% Baxter 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 any other treatments you are receiving.

You must not receive Glucosa 5% and sodium chloride 0.33% Baxter if there are particles floating in the solution or if the container is damaged in any 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 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).

Any unused portion of the solution must be discarded. DO NOT receive Glucosa 5% and sodium chloride 0.33% Baxter from a bag that has already been opened or started.

If you receive more Glucosa 5% y cloruro sódico 0,33% Baxter than you should

If you receive too much Glucosa 5% y cloruro sódico 0,33% Baxter solution or if it is administered too quickly, you may experience the following symptoms:

• High blood sugar levels (hyperglycemia). Symptoms include:

  • dry mouth due to lack of water in body tissues (dehydration)
  • thirst
  • increased urine production (osmotic diuresis)
  • blurred vision
  • fatigue.
  • Low sodium levels in the blood (hyponatremia). Hyponatremia can cause headache, nausea, seizures, drowsiness, coma, brain swelling (cerebral edema), and death.
  • Fluid accumulation in the body causing swelling (edema).

If you notice these symptoms, inform your doctor immediately. The infusion will be stopped and you will receive treatment depending on your symptoms.

If any medicine has been added to Glucosa 5% y cloruro sódico 0,33% Baxter before the overdose, that medicine may also cause symptoms. You should read the list of possible side effects in the leaflet of the added medicine.

If the infusion of Glucose 5% and Sodium Chloride 0.33% Baxter is interrupted

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

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

4. Possible adverse effects

Like all medicines, Glucosa 5% y cloruro sódico 0,33% Baxter may produce adverse effects, although not everyone will experience them.

The adverse effects may be related to Glucosa 5% y cloruro sódico 0,33% Baxter. These include:

• hypersensitivity reactions, including a severe allergic reaction called anaphylaxis (potential manifestation in patients with corn allergy).
• high blood sugar levels (hyperglycemia).
• low sodium levels in the blood that may be acquired during hospitalization (nosocomial hyponatremia) and associated neurological disorder (acute hyponatremic encephalopathy). Hyponatremia can cause irreversible brain damage and death due to cerebral edema/inflammation (see also section 2 “Warnings and precautions”).

Adverse effects may also be due to the administration technique. These include:

• fever (febrile response)
• chills
• pruritus or itching
• local pain or reaction (redness or swelling at the site of administration)
• irritation and inflammation of the vein used for infusion of the solution (phlebitis), which may cause redness, pain or burning, and swelling along the vein where the solution was infused.

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 package leaflet of the added medicine.

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. If any of these occur, the infusion should be stopped. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Glucose 5% and Sodium Chloride 0.33% Baxter

Keep out of the sight and reach of children.

Do not store above 25°C.

Glucose 5% and Sodium Chloride 0.33% Baxter must not be administered after the expiry date stated on the bag after EXP. The expiry date refers to the last day of the month indicated.

Do not use Glucose 5% and Sodium Chloride 0.33% Baxter if particles are floating in the solution or if the container is damaged in any way.

6. Contents of the container and additional information

The active ingredients are:

• sugar (glucose): 50 g per litre
• sodium chloride: 3.3 g per litre

The other component is water for injections.

Appearance of the product and contents of the pack

Glucose 5% and sodium chloride 0.33% Baxter 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:

• 250 ml
• 500 ml
• 1000 ml

The bags are packaged in cardboard boxes. Each cardboard box contains one of the following quantities:

• 30 bags of 250 ml
• 20 bags of 500 ml
• 10 bags of 1000 ml
• 12 bags of 1000 ml

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturing Responsible

Title

Baxter S.L.

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

Date of last revision of this leaflet: October 2023

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 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 displaced from the primary container before completion of administration of the fluid in the secondary container.

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

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

The solution must be administered using sterile equipment and aseptic technique. The administration set should be primed with the solution to prevent entry of air into the system.

Medications may be added before or during infusion through the injection site. When adding medications, isotonicity should be checked prior to parenteral administration.

From a physico-chemical standpoint, the solution containing added medications should be used immediately unless chemical and physical stability in use has been established.

From a microbiological standpoint, solutions with added medications should be used immediately. If not used immediately, the conditions and duration of storage prior to use are the responsibility of the user and normally should not exceed 24 hours at 2–8°C, unless reconstitution has been carried out under controlled and validated aseptic conditions.

Discard after single use.

Discard partially used containers.

Do not re-connect partially used bags.

1- To open

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

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

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

2-Preparation for Administration

Use sterile supplies for preparation and administration.

• Hang the container by the tab.

• • Remove the plastic protector from the outlet port at the bottom of the container.
  • Hold with one hand the small fin on the neck of the outlet tube.
  • Hold with the other hand the large fin on the closure cap and twist.
  • The cap will detach.

• Use an aseptic technique when preparing the infusion.

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

3-Techniques for adding medication by injection

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

To add medication prior to administration

• Disinfect the injection site.

• Using a syringe with a needle gauge 19 (1.10 mm) to 22 (0.70 mm), puncture the resealable injection site and inject the medication.

• Completely mix the medication and solution. For high-density medications, such as potassium chloride, gently tap the tubes while in an upright position and mix thoroughly.

Caution: Do not store bags with added medication.

To add medication during administration

• Close the clamp on the administration set

• Disinfect the injection site

• Using a syringe with a needle gauge 19 (1.10 mm) to 22 (0.70 mm), puncture the resealable injection site and inject the medication.

• Remove the container from the drip chamber base and/or rotate it to position it vertically.

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

• Mix the solution and medication thoroughly.

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

4. In-use shelf life (added medications)

Prior to use, the physical and chemical stability of any additional medication added to the Glucose 5% and Sodium Chloride 0.33% Baxter solution in the Viaflo container should be established at the pH of this solution.

From a physicochemical standpoint, the solution containing added medications should be used immediately, unless the in-use chemical and physical stability has been established.

From a microbiological standpoint, the diluted product should be used immediately. If not used immediately, the storage duration and conditions prior to use are the responsibility of the user and should normally not exceed 24 hours at 2–8°C, unless the addition of medications has been carried out under controlled and validated aseptic conditions.

5- Incompatibilities of added medications

As with all parenteral solutions, the compatibility of added medications with the Viaflo bag solution must be verified before addition.

It is the physician's responsibility to assess the incompatibility of any medication added to Glucose 5% and Sodium Chloride 0.33% Baxter by examining for potential changes in color and/or precipitation, formation of insoluble complexes, or appearance of crystals. The package leaflet of the medication to be added should be consulted.

Before adding any medication, ensure that it is soluble and stable in water at the pH of Glucose 5% and Sodium Chloride 0.33% Baxter (pH 3.5 – 6.5).

When compatible medication is added, the solution should be administered immediately, unless chemical and physical stability under use conditions has been established.

As a guide, the following medications are incompatible with Glucose 5% and Sodium Chloride 0.33% Baxter (this is not an exhaustive list):

• Sodium ampicillin
• Mitomycin
• Erythromycin lactobionate
• Human insulin

Because it contains glucose, Glucose 5% and Sodium Chloride 0.33% Baxter must not be administered with whole blood through the same infusion set, due to the risk of hemolysis and agglutination.

Medications known to be incompatible must not be used.