Glucose and potassium chloride Bioindustria L.I.M.: detailed information

Package leaflet: Information for the user

GLUCOSE WITH POTASSIUM CHLORIDE Bioindustria L.I.M. 5%/0.2% Infusion solution I

GLUCOSE WITH POTASSIUM CHLORIDE Bioindustria L.I.M. 10%/0.3% Infusion solution II
glucose monohydrate and potassium chloride
Equivalent medicine
Please read this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

What GLUCOSE WITH POTASSIUM CHLORIDE Bioindustria L.I.M. is and what it is used for
What you need to know before using GLUCOSE WITH POTASSIUM CHLORIDE Bioindustria L.I.M.
How to use GLUCOSE WITH POTASSIUM CHLORIDE Bioindustria L.I.M.
Possible side effects
How to store GLUCOSE WITH POTASSIUM CHLORIDE Bioindustria L.I.M.
Contents of the pack and other information

1. What GLUCOSIO CON POTASSIO CLORURO Bioindustria L.I.M. is and what it is used for

GLUCOSIO CON POTASSIO CLORURO Bioindustria L.I.M. is an intravenous solution (intravenous infusion) containing the active substances potassium chloride and glucose monohydrate, belonging to the class of electrolyte solutions associated with carbohydrates.
This medicinal product is indicated to provide water, sugars, and potassium to the body in emergency situations, and for the treatment of low blood sugar levels (hypoglycemia).

2. What you should know before using GLUCOSIO CON POTASSIO CLORURO Bioindustria L.I.M.

Do not use GLUCOSIO CON POTASSIO CLORURO Bioindustria L.I.M.

if you are allergic to glucose monohydrate, potassium chloride, or any of the other ingredients of this medicine (listed in section 6);
if you have problems urinating (anuria);
if you have bleeding occurring in the spinal cord or within the skull (intracranial hemorrhage);
if you experience hallucinations, tremors, and sweating (delirium tremens) associated with a dehydrated state;
if you have low levels of body fluids (severe dehydration);
if you suffer from liver problems leading to loss of consciousness (hepatic coma);
if you have severe kidney problems (severe renal failure);
if you have high levels of potassium in the blood (hyperkalemia or conditions of potassium retention);
if you have untreated adrenal gland disorder (Addison's disease);
if you experience painful, brief muscle cramps (heat cramps). Glucose solutions must not be administered through the same infusion catheter as whole blood due to the possible risk of red blood cell clumping (pseudoagglutination) or red blood cell rupture (hemolysis).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using GLUCOSIO CON POTASSIO CLORURO Bioindustria L.I.M.
Use this medicine with caution and inform your doctor in the following cases:

if you have diabetes mellitus or are glucose intolerant. To minimize the risk of high blood sugar levels (hyperglycemia) and presence of sugar in the urine (glycosuria), blood and urine glucose levels must be monitored during administration, and insulin should be administered if necessary;
if you have severe kidney problems (severe renal failure), as this may reduce the amount of potassium excreted by the body (potassium retention);
if you are taking anti-inflammatory medicines (corticosteroids);
if you are taking the hormone corticotropin;
if you have heart problems (heart failure), especially if you are taking digitalis drugs for treating certain heart conditions;
if you have adrenal gland problems (adrenal insufficiency);
if you have liver problems (hepatic insufficiency);
if you have a disorder characterized by sudden attacks of muscle weakness (familial periodic paralysis);
if you have severe congenital myotonia, a disease characterized by prolonged muscle contractions;
if you have recently undergone surgery (early post-operative phase);
if you have swelling due to fluid accumulation (edema);
if you have reduced excretion of fluids and electrolytes (water and electrolyte retention);
if you are in any of the following conditions that may cause elevated levels of vasopressin hormone:
acute illness
pain
recent surgery
infections, burns
brain diseases
liver, heart, and kidney diseases
These conditions may increase the risk of low sodium levels in the blood (hyponatremia), leading to headache, nausea, seizures, drowsiness, vomiting, cerebral edema, which may be fatal. Individuals at higher risk of cerebral edema include:
children
women (especially those of childbearing age)
individuals with altered fluid levels in the brain (e.g., due to meningitis, intracranial bleeding, or cerebral contusion).
During prolonged treatment with this medicine, excess water in the body (fluid overload), congestion, and excessive loss of electrolytes may occur. Your doctor should periodically monitor electrolyte concentrations (electrolyte balance, plasma osmolarity), correcting any excessive losses as needed with electrolyte and vitamin supplementation.

High potassium levels in the blood may cause death due to cardiac activity blockade (cardiac depression, arrest) or severe disturbances in heart rhythm (arrhythmias). To avoid potassium's toxic effects, intravenous infusion must be slow. During administration of this medicine, heart function (serial electrocardiograms) and fluid and electrolyte levels (electrolyte balance and acid-base equilibrium) must be monitored.

The solution must be used immediately after opening the container. The solution should be clear, colorless or pale yellow, and free from visible particles, and must be used for a single, uninterrupted administration. Any remaining solution must not be reused.

Children
In children, particularly in neonates and low-birth-weight infants, administration of glucose may increase the risk of elevated blood glucose levels (hyperglycemia). Furthermore, in low-birth-weight children, rapid or excessive infusion may increase blood osmolarity and cause intracerebral hemorrhage.

Other medicines and GLUCOSIO CON POTASSIO CLORURO Bioindustria L.I.M.
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines.

GLUCOSIO CON POTASSIO CLORURO Bioindustria L.I.M. should be administered with caution if you are taking:

steroid anti-inflammatory drugs (corticosteroids) or corticotropin, as they may reduce your tolerance to sugars and may trigger latent diabetes mellitus;
medicines that promote urine elimination and reduce potassium loss (potassium-sparing diuretics). These medicines, when taken together with GLUCOSIO CON POTASSIO CLORURO Bioindustria L.I.M., especially if you have kidney problems (renal dysfunction), may cause increased potassium levels in the blood (hyperkalemia);
medicines used to lower blood pressure (ACE inhibitors), as they may reduce potassium excretion. In such cases, potassium levels in the blood must be closely monitored;
medicines acting on vasopressin hormone, e.g.: chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics, NSAIDs, cyclophosphamide, desmopressin, oxytocin, vasopressin, terlipressin, diuretics in general, and oxcarbazepine, as they may increase the risk of hyponatremia.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Do not use this medicine during pregnancy and breastfeeding unless absolutely necessary and always under strict medical supervision.
If you are pregnant, this medicine should be administered with particular caution during labor due to the risk of hyponatremia, especially if administered in combination with a drug inducing labor (oxytocin).

Driving and using machines
GLUCOSIO CON POTASSIO CLORURO Bioindustria L.I.M. does not affect the ability to drive or operate machinery.

GLUCOSIO CON POTASSIO CLORURO Bioindustria L.I.M. 10% 0.3% contains sodium metabisulfite
This medicine contains sodium metabisulfite. Rarely, it may cause severe hypersensitivity reactions and bronchospasm.

3. How to use GLUCOSIO CON POTASSIO CLORURO Bioindustria L.I.M.

This medicine will be administered to you by a doctor or other trained medical personnel. If you have any doubts, consult your doctor, pharmacist, or nurse.
This medicine will be administered cautiously directly into a vein (intravenous infusion) and at a controlled infusion rate.
Your doctor will choose the appropriate glucose solution concentration based on your age, weight, clinical condition, and blood electrolyte levels and pH.
Before and during administration, your doctor will monitor your body fluid levels, glucose, and electrolytes—especially sodium—in the blood.
Shake well before administration.
GLUCOSIO CON POTASSIO CLORURO Bioindustria L.I.M. should only be administered if you do not have kidney problems and only via slow infusion (rate not exceeding 10 mEq potassium/hour).

Use in children and adolescents
Dosage and infusion rate must be adjusted according to the child's age, weight, and clinical condition. This medicine must be administered with caution in children, especially in neonates and those with low body weight, and at a controlled infusion rate (see section "Children").

Use in elderly patients
If you are elderly, your doctor will closely monitor you during treatment with this medicine.

If you use more GLUCOSIO CON POTASSIO CLORURO Bioindustria L.I.M. than you should
Since this medicine is administered by a doctor or trained medical staff, it is unlikely that you will receive an overdose. However, if you think you have been given too much GLUCOSIO CON POTASSIO CLORURO Bioindustria L.I.M., inform your doctor immediately or go to the nearest hospital.
In case of accidental administration of excessive doses of GLUCOSIO CON POTASSIO CLORURO Bioindustria L.I.M., an increase in body water and solute concentration may occur (hyperhydration and solute overload). In such cases, the doctor or nurse must immediately stop administration of the medicine and initiate corrective therapy to reduce elevated blood potassium levels and correct acid-base balance.

If you forget to use GLUCOSIO CON POTASSIO CLORURO Bioindustria L.I.M.
Since this medicine is administered by a doctor or trained medical personnel, it is unlikely that a dose will be missed. However, if you think a dose has been missed, contact your doctor or nurse.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
The following side effects may occur:
Not known (frequency cannot be estimated from the available data):

allergic reactions (hypersensitivity), skin irritation (urticaria);
increased internal blood pressure due to dissolved substances (hyperosmolarity);
increased blood volume (hypervolemia);
increased metabolic rate (speed at which substances are burned in the body);
increased blood sugar (hyperglycemia);
decreased blood sugar (hypoglycemia);
increased insulin levels;
increased adrenaline levels;
low sodium levels in the blood (hospital-acquired hyponatremia) **cerebral edema (hyponatremic encephalopathy)**
decreased blood pressure (hypotension);
changes in heart rhythm (arrhythmias, conduction disorders, disappearance of the P wave, widening of the QRS complex on the electrocardiogram);
cessation of heart function (cardiac arrest);
fluid accumulation causing swelling in legs and ankles (peripheral edema);
fluid accumulation in the lungs (pulmonary edema);
cerebral hemorrhage;
damage to brain tissue (cerebral ischemia);
muscle and nerve disorders (neuromuscular disorders);
altered sensation in arms and legs (paresthesia), loss of muscle tone (flaccid paralysis), weakness, confusion;
stomach and intestinal disorders (gastrointestinal disorders);
increased body temperature (fever);
leakage of the medicine into surrounding tissues at the injection site (extravasation);
infection at the infusion site and local pain;
formation of blood clots and inflammation of veins at the infusion site (thrombosis and thrombophlebitis). **Hospital-acquired hyponatremia may lead to irreversible brain damage and death due to the development of acute hyponatremic encephalopathy.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store GLUCOSIO CON POTASSIO CLORURO Bioindustria L.I.M.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP.".
The expiry date refers to the last day of that month.
Keep the container tightly closed. Do not refrigerate or freeze.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What GLUCOSIO CON POTASSIO CLORURO Bioindustria L.I.M. 5%/0,2% Solution for infusion I contains

The active substances are glucose monohydrate and potassium chloride. Each liter of solution contains 55 g of glucose monohydrate (equivalent to 50 g of anhydrous glucose) and 2.0 g of potassium chloride (27 mEq/liter K+, 27 mEq/liter Cl-, 278 mOsm/L, pH 3.5 - 6.5).
The other component is water for injections.

GLUCOSIO CON POTASSIO CLORURO Bioindustria L.I.M. 10%/0,3% Solution for infusion II

The active substances are glucose monohydrate and potassium chloride. Each liter of solution contains 110 g of glucose monohydrate (equivalent to 100 g of anhydrous glucose) and 3.0 g of potassium chloride (40 mEq/liter K+, 40 mEq/liter Cl-, 555 mOsm/L, pH 3.5 - 6.5).
Other components are water for injections and sodium metabisulfite.

Description of the appearance of GLUCOSIO CON POTASSIO CLORURO Bioindustria L.I.M. and contents of the package

GLUCOSIO CON POTASSIO CLORURO Bioindustria L.I.M. 5%/0,2% Solution for infusion I
GLUCOSIO CON POTASSIO CLORURO Bioindustria L.I.M. 10%/0,3% Solution for infusion II
Sterile, pyrogen-free infusion solution.
1 vial of 50-100-250-500 ml;
50 ml in a 100 ml vial;
100 ml in a 250 ml vial;
250 ml in a 500 ml vial.

Marketing Authorization Holder and Manufacturer
Bioindustria Laboratorio Italiano Medicinali S.p.A. - Via De Ambrosiis, 2 - Novi Ligure (AL) - Italy

The following information is intended exclusively for healthcare professionals

Dosage and administration
The 5% glucose solution (solution I) is slightly hypertonic to blood. The 10% glucose solution (solution II) is hypertonic to blood and must be infused with caution and at a controlled infusion rate; this solution should not be used unless specifically prescribed.
Shake well before administration.
The dose depends on the patient's age, weight, clinical condition, fluid and electrolyte balance, and acid-base status.
The solutions are administered intravenously.
The medicinal product should only be administered when renal function is intact and at a rate not exceeding 10 mEq of potassium per hour.
Monitoring of electrolyte balance, serum glucose, serum sodium, and other electrolytes may be necessary before and during administration, especially in patients with non-osmotic release of vasopressin (syndrome of inappropriate antidiuretic hormone secretion, SIADH) and in patients receiving concomitant therapy with vasopressin agonists, due to the risk of hyponatremia.
Monitoring of serum sodium is particularly important for physiologically hypotonic solutions.
Glucose with potassium chloride Bioindustria L.I.M. may become extremely hypotonic after administration due to the metabolism of glucose in the body.
Intravenous glucose infusions are generally isotonic solutions. However, in the body, glucose-containing solutions may become extremely hypotonic physiologically due to the rapid metabolism of glucose.
Depending on the tonicity of the solution, volume and frequency of infusion, underlying clinical conditions of the patient, and the ability to metabolize glucose, intravenous administration of glucose may cause electrolyte disturbances, particularly hypo- or hyperosmolar hyponatremia.

Hyponatremia:
Patients with non-osmotic release of vasopressin (e.g., in the acute phase of illness, pain, post-operative stress, infections, burns, and central nervous system disorders), patients with cardiac, hepatic, or renal diseases, and patients treated with vasopressin agonists are particularly at risk of acute hyponatremia following infusion of hypotonic solutions.
Acute hyponatremia may cause acute hyponatremic encephalopathy (cerebral edema), characterized by headache, nausea, seizures, lethargy, and vomiting. Patients with cerebral edema are particularly at risk of severe, irreversible, and life-threatening brain damage.
Children, women of childbearing age, and patients with reduced cerebral compliance (e.g., meningitis, intracranial hemorrhage, and cerebral contusion) are particularly at risk of severe and life-threatening cerebral edema caused by acute hyponatremia.

Elderly
Clinical studies and clinical practice have not shown differences in response between elderly and younger patients following glucose administration. As a general rule, caution should be exercised when administering drugs to elderly patients.

Children
In children, the safety and efficacy of Glucose with potassium chloride have not been established.
The dosage and rate of glucose administration must be selected based on the patient's age, weight, and clinical condition. Particular caution is required in pediatric patients, especially in neonates or children with low body weight.

After first opening of the packaging, the medicinal product must be used immediately for a single, uninterrupted administration, and any unused portion must not be retained.
Store in the original packaging and in a tightly closed container. Do not refrigerate or freeze.
Shake well before administration. Do not use the medicinal product if the solution is not clear and colorless or slightly yellowish, or if it contains particles.
Adopt all standard precautions to maintain sterility before and during intravenous infusion.
Unused medicinal product and waste material derived from this medicinal product must be disposed of in accordance with local regulations.

Incompatibilities
If used to dilute medicinal products, consult the pharmacist, if available, before adding any additives; consider the characteristics of the products to be added; use aseptic techniques.
Due to the presence of glucose, the medicinal product is incompatible with:

cyanocobalamin;
kanamycin sulfate;
novobiocin sodium;
warfarin sodium.
Furthermore, there are conflicting opinions regarding the compatibility of glucose with hydroxyethyl starch (hetastarch). Ampicillin and amoxicillin are stable in glucose solutions only for a short period.

Unless otherwise indicated, it is generally advised not to mix this medicinal product with other medicinal products.
For further information, refer to the Summary of Product Characteristics.

Glucose and potassium chloride Bioindustria L.I.M.