Glucose 3.33% and sodium chloride 0.3% Baxter solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Glucose 3.33% and Sodium Chloride 0.3% Baxter solution for infusion

Active substances: sodium chloride, glucose

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 side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. See section 4.

This medicine is called Glucose 3.33% and Sodium Chloride 0.3% Baxter solution for infusion, but will be referred to as "Glucose 3.33% and Sodium Chloride 0.3% Baxter" throughout this leaflet.

Leaflet contents:

1. What Glucose 3.33% and Sodium Chloride 0.3% Baxter is and what it is used for
2. What you need to know before you are given Glucose 3.33% and Sodium Chloride 0.3% Baxter
3. How Glucose 3.33% and Sodium Chloride 0.3% Baxter will be administered to you
4. Possible side effects
5. How to store Glucose 3.33% and Sodium Chloride 0.3% Baxter

Pack contents and other information

1. What Glucosa 3.33% and Sodium Chloride 0.3% Baxter is and what it is used for

Glucosa 3.33% and Sodium Chloride 0.3% 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 132 kilocalories per liter. Sodium and chloride are chemical substances found in the blood.

Glucosa 3.33% and Sodium Chloride 0.3% Baxter is used:

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

2. What you need to know before Glucosa 3.33% and Sodium Chloride 0.3% Baxter is administered to you

DO NOT administer Glucose 3.33% and Sodium Chloride 0.3% Baxter if you have any of the following clinical conditions:

• if you are allergic to this medicine

  • when there is excess fluid in the spaces surrounding the body's cells (extracellular hyperhydration)
  • when there is an abnormally high volume of blood in the blood vessels (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 your blood sodium levels are lower than normal (hyponatremia)
  • if your blood chloride levels are lower than normal (hypochloremia)
  • if there is accumulation of fluid under the skin affecting the entire body (generalized edema)

• if you have liver disease causing fluid accumulation in the abdomen (ascitic cirrhosis)

• if you have diabetes that is not adequately treated, resulting in higher-than-normal blood sugar levels (uncompensated diabetes)

• other conditions involving glucose intolerance, for example:

• metabolic stress (when the body’s metabolism is not functioning properly, e.g., due to serious 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

• blood glucose concentration higher than normal (hyperglycemia)

• blood lactate concentration higher than normal (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

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

• kidney failure

• high blood pressure during pregnancy (pre-eclampsia)

• taking certain medications (see also “Other medicines and Glucose 3.33% and Sodium Chloride 0.3% 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 adherence to a low-potassium diet

• allergy, particularly to corn (Glucose 3.33% and Sodium Chloride 0.3% 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 excessive vasopressin in your body 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 Glucose 3.33% and Sodium Chloride 0.3% 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. People at higher risk of brain swelling include:

• children

• women (particularly those of childbearing age)

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

• changes in blood chemical concentrations (electrolyte imbalances)

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

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

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

Since Glucose 3.33% and Sodium Chloride 0.3% 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 brain damage (acute stroke). High blood sugar levels may worsen the effects of brain injury and affect 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 3.33% and Sodium Chloride 0.3% Baxter, you may require additional nutrition. Your doctor should monitor 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 this solution.

Younger children are at higher risk of developing low or high blood glucose levels and therefore require careful monitoring during intravenous infusion therapy to ensure adequate 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 hemorrhage, bacterial or fungal infections, eye damage (retinopathy of prematurity), intestinal tract infections, lung problems, prolonged hospitalization, and death.

Children are at increased risk of developing low blood sodium levels (hypoosmolar hyponatremia). Hyponatremia can 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 these risks and will carefully monitor levels of chemicals such as glucose (sugar), sodium, and chloride in your child’s blood (plasma electrolytes).

Other medicines and Glucose 3.33% and Sodium Chloride 0.3% Baxter

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

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

• corticosteroids (anti-inflammatory medicines)

These medicines may 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 cancer treatments (vincristine, ifosfamide, cyclophosphamide)
• selective serotonin reuptake inhibitors (used to treat depression)
• antipsychotics or opioids used 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 affect Glucose 3.33% and Sodium Chloride 0.3% Baxter include:

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

Use of Glucose 3.33% and Sodium Chloride 0.3% 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 3.33% and Sodium Chloride 0.3% Baxter can be safely used during pregnancy and 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 being added

Driving and use of machines

Glucose 3.33% and Sodium Chloride 0.3% Baxter does not affect your ability to drive or operate machinery.

3. How Glucosa 3.33% and Sodium Chloride 0.3% Baxter will be administered to you

Glucosa 3.33% and Sodium Chloride 0.3% 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, clinical condition, and the reason for treatment. The amount you receive may also be influenced by other treatments you are receiving.

You must not receive Glucosa 3.33% and Sodium Chloride 0.3% Baxter if there are floating particles in the solution or if the container is damaged in any way.

Glucosa 3.33% and Sodium Chloride 0.3% Baxter is usually administered through a plastic tube attached 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 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 level of electrolytes in your body (particularly sodium, in patients with high levels of vasopressin hormone, or those taking other medicines that enhance the effect of vasopressin).

Any unused portion of the solution must be discarded. DO NOT receive Glucosa 3.33% and Sodium Chloride 0.3% Baxter from a bottle that has already been used.

If you receive more Glucosa 3.33% and Sodium Chloride 0.3% Baxter than you should

If you receive too much Glucosa 3.33% and Sodium Chloride 0.3% Baxter solution, or if it is given 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 output (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 develop these symptoms, inform your doctor immediately. The infusion will be stopped and you will receive treatment according to your symptoms.

If another medicine has been added to Glucosa 3.33% and Sodium Chloride 0.3% Baxter before an overdose occurs, you should be aware that this added medicine may also cause symptoms. You should read the list of possible side effects in the package leaflet of the added medicine.

If the infusion of Glucosa 3.33% and Sodium Chloride 0.3% Baxter is stopped

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

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

4. Possible adverse effects

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

• Adverse effects may be related to Glucose 3.33% and Sodium chloride 0.3% Baxter. These include: hypersensitivity reactions, including severe allergic reactions known as anaphylaxis (potential manifestation in patients with corn allergy)
• High blood sugar levels (hyperglycemia)
• Low sodium levels in the blood that may develop during hospitalization (hospital-acquired hyponatremia) and associated neurological disorder (acute hyponatremic encephalopathy). Hyponatremia may lead to 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 reaction)
• 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). This may cause redness, pain or burning sensation, 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 they are possible adverse effects 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 3.33% and Sodium Chloride 0.3% Baxter

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

Do not store above 25°C.

Glucose 3.33% and Sodium Chloride 0.3% Baxter must not be used after the expiry date stated on the bottle after EXP. The expiry date refers to the last day of the month indicated.

Do not use Glucose 3.33% and Sodium Chloride 0.3% Baxter if you notice particles floating in the solution or if the container is damaged in any way.

6. Contents of the container and additional information

Composition of Glucose 3.33% and Sodium Chloride 0.3% Baxter

The active substances are:

• sugar (glucose): 33.3 g per litre
• sodium chloride: 3 g per litre

The other component is water for injections.

Appearance of the medicinal product and content of the container

Glucose 3.33% and Sodium Chloride 0.3% Baxter is a clear, particle-free solution. It is supplied in Type II glass bottles.

The bottle sizes are 50 ml, 100 ml, 250 ml, 500 ml or 1,000 ml.

The bottles are packed in cardboard boxes. Each cardboard box contains one of the following quantities:

25 bottles of 50 ml
25 bottles of 100 ml
30 bottles of 250 ml
10 bottles of 500 ml
10 bottles of 1000 ml

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Holder:

Baxter S.L.
Polígono Industrial Sector 14. Pouet de Camilo 2,
46394 Ribarroja del Turia (Valencia)
Spain

Manufacturer:

Date of the most recent review of this package leaflet: June 2019

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

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

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

Medications may be added before or during infusion via the injection site. When adding medications, isotonicity must be verified prior to parenteral administration.

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

From a microbiological standpoint, solutions containing added medications should be used immediately. If not used immediately, storage times 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 was performed under controlled, validated aseptic conditions.

Discard after single use.

Discard partially used vials.

Do not reconnect partially used vials.

1- To open

• Remove the aluminum cap protecting the closure.

• Check the clarity of the solution and absence of foreign particles. If the solution is not clear or contains foreign particles, discard the solution.

2- Preparation for administration

Use sterile materials for preparation and administration.

• Hang the container using the hanger provided in the shipping box.

• Use an aseptic method to prepare the infusion.

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

3- Techniques for injection of added medication

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

To add medications before administration:

• Disinfect the medication injection site.

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

• Mix the solution and medication thoroughly. For high-density medications, such as potassium chloride, gently agitate while in upright position to ensure mixing.

Caution: Do not store vials with added medication; see paragraph 4 “In-use shelf life (added medications)”.

To add medications during administration:

• Close the clamp on the administration set.

• Disinfect the medication injection site.

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

• Remove the container from the infusion stand and/or place it in an upright position.

• Empty both tubing chambers by gently tapping them while the container is in upright position.

• Mix the solution and medication thoroughly.

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

4. In-use shelf life (added medications)

Prior to use, the physical and chemical stability of any additional medication added to Glucose 3.33% and Sodium Chloride 0.3% Baxter at the solution's pH must be established.

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

From a microbiological standpoint, the diluted product should be used immediately. If not used immediately, storage times 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 was carried out under controlled, validated aseptic conditions.

5- Incompatibilities of added medications

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

It is the physician’s responsibility to assess incompatibility of the added medication with Glucose 3.33% and Sodium Chloride 0.3% Baxter by examining for any change 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 a medication, verify that it is soluble and stable in water at the pH of Glucose 3.33% and Sodium Chloride 0.3% Baxter (pH 3.5–6.5).

When compatible medication is added to Glucose 3.33% and Sodium Chloride 0.3% Baxter, 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 3.33% and Sodium Chloride 0.3% Baxter (this is not an exhaustive list):

• Sodium ampicillin
• Mitomycin
• Erythromycin lactobionate
• Human insulin

Because it contains glucose, Glucose 3.33% and Sodium Chloride 0.3% Baxter must not be administered through the same infusion set as whole blood, due to the risk of hemolysis and agglutination.

Medications known to be incompatible must not be used.