Glucose with potassium chloride Baxter

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Glucosio con Potassio Cloruro Baxter, 5% + 0.3% solution for infusion

Active substances: potassium chloride and glucose monohydrate
Please read this leaflet carefully before you are given this medicine, as it
contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you get any side effects, including those not listed in this leaflet, inform your doctor or nurse.

In this package leaflet, the infusion solution Gluciose with Potassium Chloride Baxter, 5% + 0.3%,
solution for infusion will be referred to as Glucose with Potassium Chloride Baxter, 5% + 0.3%.
Contents of this leaflet

1. What Glucose with Potassium Chloride Baxter, 5% + 0.3% is and what it is used for
2. What you need to know before you are given Glucose with Potassium Chloride Baxter, 5% + 0.3%
3. How Glucose with Potassium Chloride Baxter, 5% + 0.3% will be administered to you
4. Possible side effects
5. How to store Glucose with Potassium Chloride Baxter, 5% + 0.3%
6. Contents of the pack and other information

1. What Glucosio Con Potassio Cloruro Baxter, 5 %+ 0.3% is and what it is used for

Glucosio con Potassio Cloruro Baxter 5 % + 0.3% is a solution of potassium chloride and glucose in water.
Potassium chloride is a chemical substance (often referred to as “salt”) naturally present in the blood.
Glucose is one of the body's sources of energy. This infusion solution provides 200 kilocalories per liter.
Infusion of Glucosio con Potassio Cloruro Baxter 5 % + 0.3% is used as a source of carbohydrates (sugar) in the prevention and treatment of:

• loss of potassium from the body (potassium depletion, for example after treatment with certain diuretics [water tablets])
• low blood potassium levels (hypokalemia) in conditions that may cause loss of potassium chloride and water, including:
• when you are unable to eat or drink due to illness or after surgery
• excessive sweating due to high fever
• extensive skin loss, as may occur in severe burns

2. What you should know before being given Glucosio Con Potassio Cloruro Baxter, 5 %+ 0.3%

DO NOT use Glucosio con Potassio Cloruro Baxter if you have any of the following conditions:

• higher than normal levels of potassium in the blood (hyperkalemia)
• higher than normal levels of chloride in the blood (hyperchloremia)
• higher than normal blood sugar levels (hyperglycemia)
• severe renal failure (when your kidneys do not function properly and you require dialysis)
• decompensated heart failure. This is heart failure that is not adequately treated and causes symptoms such as:
• shortness of breath
• swelling of the ankles
• Addison’s disease (reduced function of the adrenal gland. The adrenal gland produces hormones that help regulate concentrations of chemicals in the body)
• inadequately treated diabetes, causing your blood sugar levels to rise above normal (uncompensated diabetes)
• conditions of glucose intolerance, for example:
• metabolic stress (when the body's metabolism is not functioning properly, e.g. due to severe illness)
• hyperosmolar coma (state of unconsciousness). This is a type of coma that may occur if you have diabetes and do not receive sufficient medication
• higher than normal levels of lactate in the blood (hyperlactatemia)
• if you are allergic to potassium chloride or glucose monohydrate or to any of the other components of this medicine (listed in section 6)

Warnings and Precautions
Glucosio con Potassio Cloruro Baxter 5 % + 0.3% is a hypertonic (concentrated) solution. Your doctor will take this into account when calculating the amount of solution to administer to you.
Inform your doctor if you have or have had any of the following medical conditions:

• changes in the concentrations of chemicals in the blood (electrolyte disturbances)
• excess fluid in the blood vessels (hypervolemia)
• fluid accumulation under the skin affecting all parts of the body (generalized edema), around the ankles (peripheral edema), or in the lungs (pulmonary edema)

The infusion may cause:

• blood sugar levels higher than normal (hyperglycemia), especially in conditions of glucose intolerance, for example:
• inadequately treated diabetes, allowing blood sugar levels to rise above normal (diabetes mellitus)
• head trauma within the last 24 hours
• metabolic stress (when the body's metabolism is not functioning properly, for example due to severe illness)
• higher than normal potassium levels in the blood (hyperkalemia), especially with:
• burns and wounds
• heart failure
• extreme muscle weakness or paralysis
• muscle weakness in children (paramyotonia congenita)
• adrenocortical insufficiency (this adrenal gland disease affects hormones that regulate chemical concentrations in the body)
• a condition in which the blood becomes too alkaline (metabolic alkalosis)
• periodic muscle weakness and paralysis due to low thyroid activity (thyrotoxic periodic paralysis)
• rapid loss of body water, for example caused by vomiting or diarrhea
• following a low-potassium diet for a prolonged period
• aldosteronism (a disorder causing high levels of a hormone called aldosterone)
• allergy, particularly to corn (Glucosio con Potassio Cloruro 5 % + 0.3% infusion contains sugar derived from corn)
• if you are in a condition that may cause high levels of vasopressin, a hormone that regulates fluids in your body. You may have excess vasopressin in your body, for example, if:
• you have a sudden and severe illness
• you have pain
• you have undergone surgery
• you have infections, burns, or brain diseases
• you have diseases affecting your heart, liver, kidneys, or central nervous system
• you are taking certain medications (see also section below “Other medicines and Glucosio con Potassio Cloruro Baxter, 5 %+ 0.3%”)
  This may increase the risk of low sodium levels in your blood and may lead to headache, nausea, seizures, lethargy, coma, cerebral edema, and death. Cerebral edema increases the risk of death and brain damage. People at higher risk of cerebral edema include:
• children
• women (especially if of childbearing age)
• individuals who have problems with their brain fluid levels, for example due to meningitis, intracranial hemorrhage, or brain injury

When you are receiving the infusion, your doctor will take blood and urine samples to monitor:

• the amount of fluid in your body
• blood sugar (glucose) levels
• your vital signs
• levels of chemical compounds such as sodium and potassium in the blood (plasma electrolytes)
• blood concentration of a substance called creatinine (plasma creatinine)
• blood concentration of a substance called urea (BUN levels)
• blood and urine acidity (acid-base balance)
• your heart tracing (ECG)
  Your doctor will consider whether you are receiving parenteral nutrition (nutrition administered by intravenous infusion). During long-term treatment with Glucosio con Potassio Cloruro Baxter, you may require additional nutritional support.

Children
Infusion of Glucosio con Potassio Cloruro 5 % + 0.3% must be administered with special care in children.
Newborns, especially those born prematurely and with low birth weight, are at high risk of developing blood sugar levels that are too low or too high (hypo- or hyperglycemia) due to glucose solution infusions. Low blood sugar levels in newborns may cause prolonged seizures, coma, and brain damage. High blood sugar levels have been associated with brain hemorrhage, bacterial and fungal infections, eye damage (retinopathy of prematurity), intestinal infections (necrotizing enterocolitis), lung problems (bronchopulmonary dysplasia), prolonged hospitalization, and death.
Pediatric patients must be closely monitored. In cases where normal regulation of water content in the blood is disturbed by increased secretion of antidiuretic hormone (ADH), infusion of fluids with low sodium chloride concentration (hypotonic fluids) may cause low sodium levels (hyponatremia). This may lead to headache, nausea, seizures, lethargy, coma, brain swelling (cerebral edema), and death; therefore, these symptoms (acute symptomatic hyponatremic encephalopathy) are considered a medical emergency.

Other medicines and Glucosio con Potassio Cloruro Baxter, 5 %+ 0.3%
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 medicines that increase potassium levels in the blood, such as:

• potassium-sparing diuretics (certain water tablets, for example amiloride, spironolactone, triamterene)
• angiotensin-converting enzyme (ACE) inhibitors (used to treat high blood pressure)
• corticosteroids (anti-inflammatory medicines)
• cyclosporine (used to prevent transplant rejection)
• tacrolimus (used to prevent transplant rejection and to treat certain skin diseases)
• medicines containing potassium (for example potassium supplements, potassium-containing salt substitutes)
• medicines that increase the risk of hyponatremia or sodium and fluid retention
• Some medicines affect the vasopressin hormone. These may include:
• antidiabetic drugs (chlorpropamide)
• cholesterol-lowering drugs (clofibrate)
• certain anticancer drugs (vincristine, ifosfamide, cyclophosphamide)
• selective serotonin reuptake inhibitors (used to treat depression)
• antipsychotics or opioids for severe pain relief
• painkillers and/or anti-inflammatory drugs (also known as NSAIDs)
• drugs that mimic or enhance the effect of vasopressin, such as desmopressin (used to treat increased thirst and urination), terlipressin (used to treat esophageal bleeding), and oxytocin (used to induce labor)
• antiepileptic drugs (carbamazepine and oxcarbazepine)
• diuretics (medicines to increase urine output)

Glucosio con Potassio Cloruro infusion must not be mixed or administered through the same needle with citrates, used as anticoagulants and preservatives for blood. This may damage red blood cells or cause their agglutination.

“Glucosio con Potassio Cloruro Baxter” 5 %+ 0.3% with food and drink
You should ask your doctor what you may drink or eat.

Pregnancy, breastfeeding, and fertility
Ask your doctor or nurse for advice before taking this medicine.
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or nurse before taking this medicine.
There is a small possibility that if Glucosio con Potassio Cloruro Baxter 5 % + 0.3% is administered during labor, glucose may affect the newborn, causing:

• hyperglycemia (high blood sugar, causing excessive thirst, dry mouth, and frequent urination)
• hyperinsulinemia (high levels of insulin, the hormone that regulates blood sugar. Blood glucose levels may then become too low.)
• acidosis (a chemical imbalance in the blood) that may lead to low blood sugar levels and jaundice (yellowing of the skin or whites of the eyes).

In any case, if you are pregnant or breastfeeding and any drug is to be added to your infusion solution, you must:

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

Driving and using machines
Glucosio con Potassio Cloruro Baxter has no effect on your ability to drive or operate machinery.

3. How Glucosio Con Potassio Cloruro Baxter, 5% + 0.3% will be administered to you

Glucosio con Potassio Cloruro Baxter 5% + 0.3% will be administered to you by a doctor or nurse. The doctor will decide how much product you need and when it will be administered. This will depend on your age, weight, condition, hydration status (amount of water in your body), and the reason for treatment. The amount you receive will also depend on any other treatments you are undergoing.
Glucosio con Potassio Cloruro Baxter must NOT be administered to you if the solution contains suspended particles or if the packaging is in any way damaged.
The infusion rate will be determined by the doctor.
If you require a large volume or rapid infusion of Glucosio con Potassio Cloruro Baxter 5% + 0.3%, your doctor may monitor your ECG (heart trace).
Glucosio con Potassio Cloruro Baxter 5% + 0.3% is usually administered intravenously through a plastic tube connected to a needle. Typically, a vein in your arm is used for administering the solution. However, your doctor may choose a different route of administration.
Before and during the infusion, your doctor will monitor:

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

If you have impaired kidney function, you may receive a lower dose.
Any unused solution must be discarded. NEVER administer an infusion of Glucosio con Potassio Cloruro Baxter 5% + 0.3% from a partially used bag.
If you are given more Glucosio con Potassio Cloruro Baxter, 5% + 0.3% than you should
If you are given too much Glucosio con Potassio Cloruro Baxter 5% + 0.3% (over-infusion) or if it is administered too quickly, this could lead to the following symptoms:

• high blood sugar levels (hyperglycaemia), causing excessive thirst, dry mouth, and frequent urination
• low sodium levels in the blood (hyponatraemia). Hyponatraemia can lead to headache, nausea, seizures, lethargy, coma, brain swelling (cerebral oedema), and death
• fluid accumulation under the skin (peripheral oedema), particularly around the ankles
• high potassium levels (hyperkalaemia), symptoms include:
• tingling in the arms and legs (paraesthesia)
• respiratory paralysis (inability to breathe)
• gastrointestinal symptoms (painful intestinal obstruction, nausea, vomiting, abdominal pain)
• hypotension (low blood pressure)
• muscle weakness
• inability to move (paralysis)
• irregular heartbeat (cardiac arrhythmias)
• heart block (a very slow heartbeat)
• cardiac arrest (the heart stops beating; a life-threatening condition)

If you develop any of these symptoms, you must inform your doctor immediately. Your infusion must be stopped and you will be given treatment depending on your symptoms.
If a medicine has been added to the Glucosio con Potassio Cloruro Baxter solution before the over-infusion, that medicine may also cause symptoms. You should read the package leaflet of the added medicine for a list of all possible symptoms.
Stopping the infusion of Glucosio con Potassio Cloruro Baxter, 5% + 0.3%
Your doctor will decide when to stop administering the infusion.
If you have any doubts about the use of Glucosio con Potassio Cloruro Baxter 5% + 0.3%, consult your doctor.

4. Possible side effects

Like all medicines, the infusion of Glucose with Potassium Chloride Baxter 5% + 0.3% can cause side effects, although not everybody will experience them.
Side effects: The side effects that may occur due to the administration technique include:

• irritation and inflammation of the vein into which the solution is infused (phlebitis). This may cause redness, pain or burning, and swelling of the vein
• skin itching (pruritus)
• fever (pyrexia)
• infection at the infusion site
• localized pain or reaction (redness and/or swelling at the infusion site)
• blisters at the injection site
• sensation of cold (chills)
• formation of a clot in the injection vein (venous thrombosis), causing pain, swelling, or redness
• leakage of the infused solution (extravasation) into the surrounding tissues. This may damage tissues and cause scarring
• hypersensitivity reactions, including a severe allergic reaction called anaphylaxis (potential manifestation in patients with maize allergy)
• increased levels of potassium in the blood (hyperkalaemia)
• decreased levels of potassium in the blood (hypokalaemia)
• cardiac arrest
• sweating
• excess fluid in the blood vessels (hypervolaemia)
• low levels of sodium in the blood that may develop during hospitalization (hospital-acquired hyponatraemia), associated with neurological disorders (acute hyponatraemic encephalopathy). Hyponatraemia may cause irreversible brain damage and death due to the development of cerebral oedema/swelling (see also section “Warnings and Precautions”)

If a medicine has been added to the infusion solution, the added medicine may also cause side effects. These side effects will depend on the medicine that has been added. Please read the package leaflet of the added medicine for a list of possible symptoms.
If you experience any side effect, inform your doctor or nurse. This includes any possible side effect not listed in this leaflet.
Reporting of side effects
If you experience any side effect, inform your doctor or nurse. This includes any possible side effect not listed in this leaflet. You can also report side effects directly via the national reporting system at the following address:
http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Glucosio Con Potassio Cloruro Baxter, 5% + 0.3%

Keep this medicine out of the sight and reach of children.
Glucosio con Potassio Cloruro Baxter 5% + 0.3% does not require any special storage conditions.
DO NOT use Glucosio con Potassio Cloruro Baxter after the expiry date stated on the packaging after “Scad”. The expiry date refers to the last day of the month indicated.
DO NOT use Glucosio con Potassio Cloruro Baxter if particles are present in the solution or if the packaging is damaged in any way.

6. Package contents and other information

What Glucosio con Potassio Cloruro Baxter, 5% + 0.3% contains
The active substances are:

• potassium chloride: 3 g per litre
• glucose (as monohydrate): 50 g per litre

The other components are:

• concentrated hydrochloric acid
• water for injections

Description of the appearance of Glucosio con Potassio Cloruro Baxter, 5% + 0.3% and contents of the pack
Glucosio con Potassio Cloruro Baxter is a clear solution free from visible particles. It is supplied in plastic polyolefin/polyamide bags (Viaflo). Each bag is enclosed in a sealed protective plastic overwrap.
Available bag sizes are:

• 500 ml
• 1000 ml

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

• 20 bags of 500 ml
• 10 bags of 1000 ml

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturers
Marketing Authorisation Holder:
Baxter S.p.A., Via del Serafico 89, 00142 Roma, Italy

Manufacturers:
Baxter S.A.
Boulevard Rene Branquart, 80
B–7860 Lessines, Belgium

Baxter Healthcare Ltd.
Caxton Way,
Thetford Norfolk IP24 3SE
United Kingdom

Bieffe Medital Sabiñanigo
Ctra de Biescas, Senegüé
22666 Sabiñanigo (Huesca)
Spain

The following information is intended exclusively for healthcare professionals:

Handling and Preparation
Use the product only if the solution is clear, free from visible particles, and the container is intact.
Administer immediately after insertion of the infusion set.
Do not remove the bag from its overwrap until the time of use.
The inner bag maintains the sterility of the product.
Do not use plastic containers for tandem connection. Such use may result in air embolism due to aspiration of residual air from the primary container before completion of fluid administration from the secondary container.
Pressurizing intravenous solutions contained in flexible plastic containers to increase flow rates may cause air embolism if residual air in the container is not completely expelled before administration.
Using an intravenous administration set with the vent in the open position may cause air embolism. Intravenous administration sets with the vent in the open position must not be used with flexible plastic containers.
The solution must be administered using sterile equipment and employing aseptic technique. The administration set must be filled with the solution to prevent air from entering the system.
Medicinal additions may be made before or during infusion through the resealable access port.
Additives known or considered incompatible must not be used.
Before adding any substance or drug, verify that it is soluble and/or stable in Glucosio con Potassio Cloruro Baxter, 5 %+ 0,3% and that the pH range of Glucosio con Potassio Cloruro Baxter, 5 %+ 0,3% is appropriate.
It is necessary to consult the package insert of the drug to be added and other relevant literature.
After addition, if there is a change in color and/or formation of precipitates, insoluble complexes, or crystals, do not use.
Mix the solution thoroughly after additives have been introduced.
Do not store solutions containing additives.
For single use only.
Discard any unused portion.
When medicinal additives are introduced, verify isotonicity before parenteral administration.
Complete and accurate aseptic mixing of any additive is mandatory.
Solutions containing additives must be administered immediately and must not be stored.
The addition of drugs or improper administration technique may lead to the occurrence of febrile reactions due to the potential introduction of pyrogens. In case of adverse reactions, the infusion must be immediately stopped.

Paediatric Population
To avoid potentially fatal excessive intravenous fluid infusions in neonates, special attention must be paid to the method of administration. When using a syringe pump to administer intravenous fluids or medications to neonates, a fluid bag 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 turning off the pump. This is required regardless of whether or not the administration set has an anti-siphon device.
The intravenous infusion device and administration equipment must be frequently monitored.
Dispose of the product after each single use.
Discard any unused residue of the product.
Do not reconnect partially used bags.

1. Opening

a. Remove the Viaflo container from the outer wrapper immediately before use.
b. Check for possible small leaks by firmly compressing the inner bag. If any leaks are detected, discard the solution as sterility may be compromised.
c. Check that the solution is clear and that no foreign particles are visible. Discard the solution if foreign material and/or cloudiness is visible.

2. Preparation for administration

Use sterile equipment for both preparation and administration.
a. Hang the container by the support hole.
b. Remove the plastic cap from the outlet port located at the bottom of the container:

• firmly hold with one hand the small tab on the neck of the outlet port,
• with the other hand grasp the large tab on the cap and twist,
• the cap will open.
  c. Use an aseptic technique to prepare the infusion.
  d. Connect the infusion set. Refer to the instructions provided with the infusion set for connection, priming the device, and administering the solution.

3. Techniques for Adding Medicinal Additives

The solution must not be administered into the atrium or ventricle to avoid localized hyperkalemia, but rather into a large peripheral or central vein to reduce the risk of causing sclerosis.
Warning: additives may be incompatible (see section 5 "Incompatibility of Additives" below).

Adding Medications Prior to Administration
a. Disinfect the medication injection site
b. Using a syringe with a 19-gauge (1.10 mm) to 22-gauge (0.70 mm) needle, puncture the resealable medication injection port and inject the drug.
c. Mix the solution and medication thoroughly. For high-density drugs, such as potassium chloride, gently tap the injection sites while maintaining the container in an upright position and mix well.
Caution: Do not store bags containing medicinal additives.

Adding Medications During Administration
a. Close the clamp on the infusion set
b. Disinfect the medication injection site
c. Using a syringe with a 19-gauge (1.10 mm) to 22-gauge (0.70 mm) needle, puncture the resealable medication injection port and inject the drug
d. Remove the container from the infusion pole and invert it
e. Eliminate any residual medication and solution from both injection sites by gently tapping while the container is in an upright position
f. Mix the solution and added medication thoroughly
g. Return the container to its correct upright position, reopen the clamp, and continue administration

4. Use-Period Stability (Additives)
The chemical and physical stability of each medicinal additive added to the pH of Glucose with Potassium Chloride Baxter 5% + 0.3% solution in the Viaflo container must be assessed prior to use. From a microbiological standpoint, the diluted product should be used immediately unless dilution occurred under validated, controlled aseptic conditions.

If the solution is not used immediately, the duration and conditions of storage are the responsibility of the user.

5. Incompatibility of Medicinal Additives
As with all parenteral solutions, incompatibility of medicinal additives with the solution in the Viaflo container must be evaluated before addition.

In the absence of compatibility studies, this solution must not be mixed with other medicinal products.

It is the physician's responsibility to assess the incompatibility of a medicinal additive with Glucose with Potassium Chloride 5% + 0.3% solution by checking for any change in color and/or the formation of precipitate, insoluble complexes, or crystals. The package leaflet of the medicinal product to be added must be consulted.

Before adding a drug, verify whether it is soluble and/or stable in water at the same pH as Glucose with Potassium Chloride 5% + 0.3% solution (pH: 3.5–6.5).

As a guide, the following medicinal products are incompatible with Glucose with Potassium Chloride 5% + 0.3% infusion solution (non-exhaustive list):

• Amphotericin B
• Dobutamine

Glucose must not be administered through the same equipment used for whole blood, as hemolysis and agglutination may occur. Medicinal additives known to be incompatible must not be used.

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Glucose with Potassium Chloride Baxter, 5% + 0.15% infusion solution

Active substances: potassium chloride and glucose monohydrate
Please read this leaflet carefully before this medicine is administered to you, as
it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse.

In this package leaflet, the infusion solution Glucose with Potassium Chloride Baxter, 5% + 0.15%,
infusion solution will be referred to as Glucose with Potassium Chloride Baxter, 5% + 0.15%.
Contents of this leaflet:

7. What Glucose with Potassium Chloride Baxter, 5% + 0.15% is and what it is used for
8. What you must know before being administered Glucose with Potassium Chloride Baxter, 5% + 0.15%
9. How Glucose with Potassium Chloride Baxter, 5% + 0.15% will be administered to you
10. Possible side effects
11. How to store Glucose with Potassium Chloride Baxter, 5% + 0.15%
12. Contents of the pack and other information

1. What Glucosio con Potassio Cloruro Baxter, 5% + 0.15% is and what it is used for

Glucosio con Potassio Cloruro Baxter is a solution of potassium chloride and glucose in water. Potassium chloride is a chemical substance (often referred to as "salt") naturally present in the blood.
Glucose is one of the body's sources of energy. This infusion solution provides 200 kilocalories per liter.
Infusion of Glucosio con Potassio Cloruro Baxter is used as a source of carbohydrates (sugar) in the prevention and treatment of:

• loss of potassium from the body (potassium depletion, for example after treatment with certain diuretics [water tablets])
• low levels of potassium in the blood (hypokalemia) in conditions that may cause loss of potassium chloride and water, including:
• when you are unable to eat or drink due to illness or after surgery
• excessive sweating due to high fever
• extensive skin loss, as may occur in severe burns

2. What you need to know before you are given Glucosio con Potassio Cloruro Baxter, 5% + 0.15%

DO NOT use Glucosio con Potassio Cloruro Baxter 5% + 0.15% if you have any of the following conditions:

• higher than normal levels of potassium in the blood (hyperkalemia)
• higher than normal levels of chlorides in the blood (hyperchloremia)
• higher than normal blood sugar levels (hyperglycemia)
• severe renal failure (when your kidneys do not function properly and you require dialysis)
• decompensated heart failure. This is heart failure that is not adequately treated and causes symptoms such as:
• shortness of breath
• swelling of the ankles
• Addison’s disease (reduced function of the adrenal gland. The adrenal gland produces hormones that help regulate the concentrations of chemicals in the body)
• inadequately treated diabetes, leading to elevated blood sugar levels (uncompensated diabetes)
• 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 (a state of unconsciousness). This is a type of coma that may occur if you have diabetes and do not receive sufficient medication
• higher than normal levels of lactate in the blood (hyperlactatemia)
• if you are allergic to potassium chloride and glucose monohydrate or to any of the other components of this medicine (listed in section 6)

Warnings and Precautions
Inform your doctor if you have or have had any of the following medical conditions:

• changes in the concentrations of chemicals in the blood (electrolyte disturbances)
• excess fluid in the blood vessels (hypervolemia)
• fluid accumulation under the skin, affecting all parts of the body (generalized edema), around the ankles (peripheral edema), or in the lungs (pulmonary edema)

The infusion may cause:

• blood sugar levels higher than normal (hyperglycemia), especially in conditions of glucose intolerance, for example:
• inadequately treated diabetes, allowing blood sugar levels to rise above normal (diabetes mellitus)
• traumatic brain injury within the last 24 hours
• metabolic stress (when the body's metabolism is not functioning properly, e.g., due to severe illness)
• higher than normal potassium levels in the blood (hyperkalemia), especially with:
• burns and wounds
• heart failure
• extreme muscle weakness or paralysis
• muscle weakness in children (congenital paramyotonia)
• adrenocortical insufficiency (this adrenal gland disease affects hormones that regulate chemical concentrations in the body)
• a condition 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, for example due to vomiting or diarrhea
• following a low-potassium diet for a prolonged period
• aldosteronism (a disorder causing high levels of a hormone called aldosterone)
• allergy, particularly to corn (the Glucosio con Potassio Cloruro 5% + 0.15% infusion contains sugar derived from corn)
• if you are in a condition that may cause high levels of vasopressin, a hormone that regulates fluids in your body. You may have excessive vasopressin in your body, for example, if:
• you have a sudden and severe illness
• you have pain
• you have undergone surgery
• you have infections, burns, or brain disorders
• you have diseases affecting your heart, liver, kidneys, or central nervous system
• you are taking certain medications (see also the section below “Other medicines and Glucosio con Potassio Cloruro Baxter, 5% + 0.15%”)

This may increase the risk of low sodium levels in your blood and may lead to headache, nausea, seizures, lethargy, coma, cerebral edema, and death. Cerebral edema increases the risk of death and brain damage. People at higher risk of cerebral edema include:

• children
• women (especially those of childbearing age)
• individuals with conditions affecting their brain fluid levels, for example, due to meningitis, intracranial hemorrhage, or brain injury

When you are given this infusion, your doctor will take blood and urine samples to monitor:

• the amount of fluid in your body
• the level of sugar (glucose)
• your vital signs
• the levels of chemical compounds such as sodium and potassium in the blood (plasma electrolytes)
• the concentration in the blood of a substance called creatinine (plasma creatinine)
• the concentration in the blood of a substance called urea (BUN levels)
• the acidity of blood and urine (acid-base balance)
• your heart tracing (ECG)

The doctor will consider whether you are receiving parenteral nutrition (nutrition delivered by intravenous infusion).
During long-term treatment with Glucosio con Potassio Cloruro Baxter 5% + 0.15%, you may need additional nutritional support.

Children
Infusion of Glucosio con Potassio Cloruro 5% + 0.15% must be administered with special caution in children.
Newborns, especially those born prematurely and with low birth weight, are at high risk of developing blood sugar levels that are too low or too high (hypo- or hyperglycemia) due to glucose solution infusions. Low blood sugar levels in newborns can cause prolonged seizures, coma, and brain damage. High blood sugar levels have been associated with brain hemorrhage, bacterial and fungal infections, intestinal infections (necrotizing enterocolitis), eye damage (retinopathy of prematurity), lung problems (bronchopulmonary dysplasia), prolonged hospitalization, and death.
Pediatric patients must be closely monitored. In cases where the normal regulation of water content in the blood is disturbed by increased secretion of antidiuretic hormone (ADH), infusion of fluids with low sodium chloride concentration (hypotonic fluids) may cause low sodium levels (hyponatremia). This can lead to headache, nausea, seizures, lethargy, coma, brain swelling (cerebral edema), and death; therefore, these symptoms (acute symptomatic hyponatremic encephalopathy) are considered a medical emergency.

Other medicines and Glucosio con Potassio Cloruro Baxter, 5% + 0.15%
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 medicines that increase potassium levels in the blood, such as:

• potassium-sparing diuretics (certain water tablets, for example amiloride, spironolactone, triamterene)
• angiotensin-converting enzyme (ACE) inhibitors (used to treat high blood pressure)
• corticosteroids (anti-inflammatory medicines)
• cyclosporine (used to prevent transplant rejection)
• tacrolimus (used to prevent transplant rejection and to treat certain skin conditions)
• potassium-containing medicines (e.g., potassium supplements, potassium-containing salt substitutes)

Some medicines affect the vasopressin hormone. 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
• painkillers and/or anti-inflammatory medicines (also known as NSAIDs)
• medicines that mimic or enhance the effect 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 (medicines to increase urine output)

The infusion of Glucosio con Potassio Cloruro must not be mixed or administered through the same needle with citrates, used as anticoagulants and blood preservatives. This may damage red blood cells or cause their agglutination.

Glucosio con Potassio Cloruro Baxter 5% + 0.15% with food and drink
You should ask your doctor what you may drink or eat.

Pregnancy, breastfeeding, and fertility
Ask your doctor or nurse for advice before taking this medicine.
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or nurse before taking this medicine.
There is a small possibility that if you are given Glucosio con Potassio Cloruro Baxter during labor, glucose may affect the newborn, causing:

• hyperglycemia (high blood sugar, causing excessive thirst, dry mouth, and frequent urination)
• hyperinsulinemia (high levels of insulin, the hormone regulating blood sugar. Blood glucose levels may become too low.)
• acidosis (a chemical imbalance in the blood) that may lead to low blood sugar and jaundice (yellowing of the skin or whites of the eyes).

In any case, if you are pregnant or breastfeeding and any medicine needs to be added to your infusion solution, you must:

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

Driving and using machines
Glucosio con Potassio Cloruro Baxter has no effect on your ability to drive or operate machinery.

3. How Glucosio con Potassio Cloruro Baxter, 5% + 0.15% will be administered to you

Glucosio con Potassio Cloruro Baxter will be administered to you by a doctor or nurse. The doctor will decide how much of the product you need and when it will be administered. This will depend on your age, weight, condition, hydration status (amount of water in your body), and the reason for treatment. The amount administered will also depend on any other treatments you are receiving.
Glucosio con Potassio Cloruro Baxter must NOT be administered to you if particles are present in the solution or if the packaging is in any way damaged.
The infusion rate will be determined by the doctor.
If you require a large volume or rapid infusion of Glucosio con Potassio Cloruro Baxter, your doctor may monitor your ECG (heart tracing).
Glucosio con Potassio Cloruro Baxter is commonly administered intravenously through a plastic tube connected to a needle. Usually, a vein in your arm is used for administration of the solution. However, your doctor may choose a different route of administration.
Before and during the infusion, the doctor will monitor:

• potassium levels
• fluid volume in your body
• blood and urine acidity (pH)
• electrolyte levels in your body (particularly sodium, in patients with high levels of vasopressin, or those taking other medications that increase the effect of vasopressin).

If you have impaired kidney function, you may receive a lower dose.
Any unused solution must be discarded. NEVER administer an infusion of Glucosio con Potassio Cloruro Baxter from a partially used bag.
If you are administered more Glucosio con Potassio Cloruro Baxter, 5% + 0.15% than required
If you receive too much Glucosio con Potassio Cloruro Baxter (over-infusion) or if it is administered too quickly, this may lead to the following symptoms:

• high blood sugar levels (hyperglycaemia), causing excessive thirst, dry mouth, and frequent urination
• low sodium levels in the blood (hyponatraemia). Hyponatraemia may lead to headache, nausea, seizures, lethargy, coma, brain swelling (cerebral oedema), and death
• fluid accumulation under the skin (peripheral oedema), particularly around the ankles
• high potassium levels (hyperkalaemia), symptoms include:
• tingling in the arms and legs (paraesthesia)
• respiratory paralysis (inability to breathe)
• gastrointestinal symptoms (painful intestinal obstruction, nausea, vomiting, abdominal pain)
• hypotension (low blood pressure)
• muscle weakness
• inability to move (paralysis)
• irregular heartbeat (cardiac arrhythmias)
• heart block (very slow heartbeat)
• cardiac arrest (heart stops beating; a life-threatening condition)

If you develop any of these symptoms, you must immediately inform your doctor. Your infusion must be stopped, and you will be given appropriate treatment depending on the symptoms.
If a medication has been added to the Glucosio con Potassio Cloruro Baxter solution before the over-infusion, that medication may also cause symptoms. You should read the package leaflet of the added medicine for a list of all possible symptoms.
Stopping the infusion of Glucosio con Potassio Cloruro Baxter, 5% + 0.15%
Your doctor will decide when to stop administering the infusion.
If you have any doubts about the use of Glucosio con Potassio Cloruro Baxter, consult your doctor.

4. Possible side effects

Like all medicines, the Glucose with Potassium Chloride infusion from Baxter may cause side effects,
although not everyone experiences them.
Side effects:
The side effects that may occur due to the administration technique include:

• irritation and inflammation of the vein into which the solution is infused (phlebitis). This may cause redness, pain or burning, and swelling of the vein
• itching of the skin (pruritus)
• fever (pyrexia)
• infection at the infusion site
• localized pain or reaction (redness or swelling at the infusion site)
• blisters at the injection site
• sensation of cold (chills)
• formation of a clot in the vein used for injection (venous thrombosis), causing pain, swelling, or redness
• leakage of the infused solution (extravasation) into the surrounding tissues. This may damage tissues and lead to scarring
• hypersensitivity reactions, including a severe allergic reaction called anaphylaxis (potential occurrence in patients allergic to maize)
• increased levels of potassium in the blood (hyperkalaemia)
• decreased levels of potassium in the blood (hypokalaemia)
• cardiac arrest
• sweating
• excess fluid in the blood vessels (hypervolaemia)
• low levels of sodium in the blood that may develop during hospitalization (nosocomial hyponatraemia), associated with neurological disorders (acute hyponatraemic encephalopathy). Hyponatraemia may cause irreversible brain damage and death due to the development of cerebral oedema/swelling (see also section “Warnings and Precautions”)

If a medicine has been added to the infusion solution, the added medicine may also cause
side effects. These side effects will depend on the medicine that has been added. Please read the
package leaflet of the added medicine for a list of possible symptoms.
If you experience any side effect, inform your doctor or nurse. This includes any
possible side effect not listed in this leaflet.
Reporting of side effects
If you experience any side effect, inform your doctor or nurse. This includes any
possible side effect not listed in this leaflet. You may also report side effects
directly via the national reporting system at
http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you
can help provide more information on the safety of this medicine.

5. How to store Glucosio Con Potassio Cloruro Baxter, 5 % + 0,15%

Keep this medicine out of the sight and reach of children.
Glucosio con Potassio Cloruro Baxter does not require any special storage conditions.
DO NOT use Glucosio con Potassio Cloruro Baxter after the expiry date stated on the container after "Exp.". The expiry date refers to the last day of the stated month.
DO NOT use Glucosio con Potassio Cloruro Baxter if particles are present in the solution or if the packaging is damaged in any way.

6. Package contents and other information

What Glucosio con Potassio Cloruro Baxter 5 %+ 0,15% contains
The active substances are:

• potassium chloride: 1.5 g per litre
• glucose (as monohydrate): 50 g per litre

The other components are:

• concentrated hydrochloric acid for pH adjustment
• water for injections

Description of the appearance of Glucosio con Potassio Cloruro Baxter 5 %+ 0,15% and contents of the
package
Glucosio con Potassio Cloruro Baxter is a clear solution free from visible particles. It is supplied in plastic bags made of polyolefin/polyamide (VIAFLO). Each bag is enclosed in a sealed protective overwrap made of plastic material.
The bag sizes are:

• 500 ml
• 1000 ml

The bags are packed into cardboard boxes. Each box contains one of the following quantities:

• 20 bags of 500 ml
• 10 bags of 1000 ml

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturers
Marketing Authorisation Holder:
Baxter S.p.A., Via del Serafico 89, 00142 Rome, Italy

Manufacturers:
Baxter S.A.
Boulevard Rene Branquart, 80
B–7860 Lessines, Belgium
Baxter Healthcare Ltd.
Caxton Way,
Thetford Norfolk IP24 3SE
United Kingdom
Bieffe Medital Sabiñanigo
Ctra de Biescas, Senegüé
22666 Sabiñanigo (Huesca)
Spain

The following information is intended exclusively for healthcare professionals:

Handling and Preparation
Use the product only if the solution is clear, free of visible particles, and the container is intact.
Administer immediately after inserting the infusion set.
Do not remove the bag from its overwrap until the time of use.
The inner bag maintains the sterility of the product.
Do not use plastic containers in series (piggy-back) setups. Such use may result in air embolism due to aspiration of residual air from the primary container before complete administration of fluid from the secondary container.
Pressurizing intravenous solutions contained in flexible plastic containers to increase flow rates may cause air embolism if residual air in the container is not completely expelled before administration.
Using an intravenous administration set with the vent in the open position may cause air embolism. Intravenous administration sets with the vent in the open position must not be used with flexible plastic containers.
The solution must be administered using sterile equipment and employing aseptic technique. The administration set must be primed with the solution to prevent air from entering the system.
Medicinal additions may be made before or during infusion through the resealable access port.
Additives known or suspected to be incompatible must not be used.
Before adding any substance or drug, verify its solubility and/or stability in Glucose with Potassium Chloride Baxter, 5% + 0.15%, and ensure that the pH range of Glucose with Potassium Chloride Baxter, 5% + 0.15% is appropriate.
Consult the package insert of the drug to be added and other relevant literature.
After addition, if there is a change in color and/or formation of precipitates, insoluble complexes, or crystals, do not use the solution.
Mix the solution thoroughly after additives have been introduced.
Do not store solutions containing additives.
For single use only.
Discard any unused portion.
When adding medicinal substances, verify isotonicity prior to parenteral administration.
Complete and accurate aseptic mixing of any additive is mandatory.
Solutions containing additives must be administered immediately and not stored.
The addition of drugs or incorrect administration techniques may lead to febrile reactions due to potential introduction of pyrogens. In case of adverse reactions, the infusion must be immediately stopped.

Paediatric population
To avoid potentially fatal excessive intravenous fluid administration in neonates, special attention must be paid to the method of administration. When using a syringe pump to administer intravenous fluids or medications to neonates, a fluid bag 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 turning off the pump, regardless of whether or not the administration set has a free-flow protection device.
The intravenous infusion device and administration equipment must be monitored frequently.
Discard the product after each single use.
Dispose of any unused product residue.
Do not reconnect partially used bags.

4. Opening

a. Remove the VIAFLO container from the outer wrapper immediately before use.
b. Check for any small leaks by firmly compressing the inner bag. If leaks are detected, discard the solution as sterility may be compromised.
c. Ensure the solution is clear and free from visible particulate matter. Discard the solution if foreign material and/or cloudiness is visible.

5. Preparation for Administration

Use sterile equipment for both preparation and administration.
a. Hang the container by the support hole.
b. Remove the plastic cap from the outlet port located at the bottom of the container:

• firmly hold with one hand the small tab on the neck of the outlet port,
• with the other hand grasp the large tab on the cap and twist,
• the cap will open.
  c. Use an aseptic technique to prepare the infusion.
  d. Connect the infusion set. Refer to the instructions provided with the infusion set for connection, priming the device, and administering the solution.

6. Techniques for Adding Medication Additives

The solution must not be administered into the atrium or ventricle to avoid localized hyperkalemia, but rather into a large peripheral or central vein to reduce the risk of causing sclerosis.
Warning: additives may be incompatible (see section 5 below, “Incompatibility of Additives”).
Adding medications prior to administration
d. Disinfect the medication injection site
e. Using a syringe with a 19 gauge (1.10 mm) to 22 gauge (0.70 mm) needle, puncture the resealable medication injection site and inject the drug.
f. Mix the solution and medication thoroughly. For high-density medications, such as potassium chloride, gently tap the injection sites while keeping them in an upright position and mix well.
Caution: Do not store bags containing added medications.
Adding medications during administration
h. Close a clamp on the infusion set
i. Disinfect the medication injection site
j. Using a syringe with a 19 gauge (1.10 mm) to 22 gauge (0.70 mm) needle, puncture the resealable medication injection site and inject the drug.
k. Remove the container from the infusion device pole and invert it
l. Remove any residual medication and solution from both injection sites by gently tapping while the container is in vertical position
m. Mix the solution and added medication thoroughly
n. Return the container to its correct upright position, reopen the clamp, and continue administration

6. In-Use Stability (Additives)
The chemical and physical stability of each medication added to the Glucose with Potassium Chloride Baxter 5% + 0.15% solution at its pH within the VIAFLO container must be evaluated before use. From a microbiological standpoint, the diluted product should be used immediately unless dilution has occurred under validated and controlled aseptic conditions.
If the solution is not used immediately, the storage times and conditions are the responsibility of the user.

7. Incompatibility of Medication Additives
As with all parenteral solutions, incompatibility of medication additives with the solution in the VIAFLO container must be assessed before addition.
In the absence of compatibility studies, this solution must not be mixed with other medicinal products.
It is the physician’s responsibility to evaluate the incompatibility of a medication additive with Glucose with Potassium Chloride 5% + 0.15% solution, checking for any change in color and/or formation of precipitate, insoluble complexes, or crystals. The instructions for use of the medication to be added must be consulted.
Before adding a drug, verify whether it is soluble and/or stable in water at the same pH as Glucose with Potassium Chloride 5% + 0.15% solution (pH: 3.5–6.5).
As a guide, the following medications are incompatible with Glucose with Potassium Chloride 5% + 0.15% infusion solution (non-exhaustive list):

• amphotericin B
• dobutamine

Glucose must not be administered through the same equipment used for whole blood, as hemolysis and agglutination may occur. Medications known to be incompatible must not be used.