Glucose and potassium chloride Galenica Senese: detailed information

Package leaflet: Information for the user

GLUCOSIO CON POTASSIO CLORURO GALENICA SENESE 5%/0,2% Solution for infusion I

GLUCOSIO CON POTASSIO CLORURO GALENICA SENESE 10%/0,3% Solution for infusion
II
Glucose monohydrate and potassium chloride
Equivalent medicine
Please read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any 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, because it could be harmful.
If you experience any adverse reaction, including any not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

What GLUCOSIO CON POTASSIO CLORURO GALENICA SENESE is and what it is used for
What you need to know before using GLUCOSIO CON POTASSIO CLORURO GALENICA SENESE
How to use GLUCOSIO CON POTASSIO CLORURO GALENICA SENESE
Possible side effects
How to store GLUCOSIO CON POTASSIO CLORURO GALENICA SENESE
Contents of the pack and other information

1. What GLUCOSIO CON POTASSIO CLORURO GALENICA SENESE is and what it is used for

GLUCOSIO CON POTASSIO CLORURO GALENICA SENESE is a solution for direct intravenous administration (intravenous infusion) containing the active substances glucose monohydrate and potassium chloride, belonging to the class of electrolyte solutions combined 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 need to know before using GLUCOSIO CON POTASSIO CLORURO GALENICA SENESE

DO NOT USE GLUCOSIO CON POTASSIO CLORURO GALENICA SENESE

if you are allergic to glucose, potassium, or any of the other ingredients of this medicine (listed in section 6);
if you have problems urinating (anuria);
if you have bleeding (hemorrhage) occurring in the spinal area or within the skull (intracranial hemorrhage);
if you experience hallucinations, tremors, and sweating (delirium tremens) caused by excessive loss of body water (dehydration);
if you have severely low fluid levels in the body (severe dehydration);
if you suffer from liver problems leading to loss of consciousness (hepatic coma);
if you have severe kidney problems (severe renal insufficiency);
if you have high levels of potassium in the blood (hyperkalemia or conditions of potassium retention);
if you have Addison's disease (a hormonal disorder) and are not receiving treatment for it;
if you experience painful, brief muscle cramps (heat cramps).

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During blood transfusions, 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 breakdown (hemolysis).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using GLUCOSIO CON POTASSIO CLORURO GALENICA SENESE.
Use this medicine with caution and inform your doctor in the following cases:

if you have diabetes mellitus or glucose intolerance. Blood sugar levels (glycemia) and sugar in the urine (glycosuria) must be closely monitored during infusion to minimize the risk of elevated levels; insulin may need to be administered if necessary;
if you have severe kidney problems (renal insufficiency), as this may reduce the amount of potassium eliminated from the body (potassium retention);
if you are taking steroid anti-inflammatory medicines (corticosteroids);
if you are taking a hormonal medicine (corticotropin);
if you have heart problems (heart failure), especially if you are taking medicines for certain heart conditions (digitalis drugs);
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 were born with a serious condition causing prolonged muscle contractions (congenital myotonia);
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 minerals (water and salt retention).
if you are in any of the following conditions that may cause high levels of the hormone vasopressin:
acute illness
pain
recent surgery
infections, burns
brain diseases
liver, heart, or kidney diseases
This may increase the risk of low sodium levels in the blood (hyponatremia), which can lead to headache, nausea, seizures, drowsiness, vomiting (symptoms of cerebral edema). Cerebral edema increases the risk of severe, irreversible, and life-threatening brain damage. 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 fluid in the body (fluid overload and congestive state) and excessive loss of minerals (electrolyte deficit) may occur. Your doctor should periodically monitor fluid balance, electrolyte concentrations, and plasma osmolarity, correcting any imbalances as needed, possibly by administering minerals and vitamins.
High potassium levels in the blood may cause death due to heart function suppression (cardiac depression, arrest) or severe disturbances in heart rhythm (arrhythmias). To avoid potassium's toxic effects, infusions must be administered slowly. During administration of this medicine, heart function (serial electrocardiograms), electrolyte levels, and fluid balance (electrolyte balance and acid-base equilibrium) must be monitored.
Use the solution immediately after opening the container. The solution must be clear, colorless or slightly yellowish and free from visible particles, and should be used for a single, uninterrupted administration only. Any remaining solution must not be reused.

Children
In children, particularly in newborns and those with low body weight, glucose administration may increase the risk of elevated blood glucose levels (hyperglycemia). Additionally, in low-birth-weight children, rapid or excessive infusion may increase blood osmolarity and cause bleeding within the brain (intracerebral hemorrhage).

Other medicines and GLUCOSIO CON POTASSIO CLORURO GALENICA SENESE
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
GLUCOSIO CON POTASSIO CLORURO GALENICA SENESE should be administered with caution if you are taking:

steroid anti-inflammatory medicines (corticosteroids) or hormonal medicines (corticotropin), as they may reduce sugar tolerance and potentially unmask latent diabetes mellitus;
medicines that promote urine elimination while reducing potassium loss (potassium-sparing diuretics). When taken together with GLUCOSIO CON POTASSIO CLORURO GALENICA SENESE, especially if you have kidney problems (renal dysfunction), these medicines 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. The following medicines may increase the risk of low sodium levels in the blood (hospital-acquired hyponatremia) after inadequately balanced intravenous fluid therapy:
medicines that stimulate the release of a hormone called vasopressin (chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics);
medicines that enhance the effect of a hormone called vasopressin (chlorpropamide, NSAIDs, cyclophosphamide);
medicines similar to a hormone called vasopressin (desmopressin, oxytocin, vasopressin, terlipressin);
Other medicines that increase the risk of low sodium levels in the blood (hyponatremia) also include those that increase urine production (diuretics in general) and antiepileptic medicines such as oxcarbazepine.

Fertility, pregnancy, and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or 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.
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Glucosio con potassio cloruro Galenica Senese should be administered with particular caution to pregnant women during labor, especially if administered concomitantly with a hormone called oxytocin, due to the risk of hyponatremia (see sections 2 and 4).

Driving and using machines
GLUCOSIO CON POTASSIO CLORURO GALENICA SENESE does not affect the ability to drive or use machinery.

3. How to use GLUCOSE WITH POTASSIUM CHLORIDE GALENICA SENESE

This medicine will be administered to you by a doctor or other specialized 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 glucose solution concentration based on your age, weight, health condition, and blood electrolyte and pH levels.
Before and during administration, your doctor will monitor your body fluid levels, glucose, and electrolytes, particularly sodium, in the blood.
Shake well before administration.
GLUCOSE WITH POTASSIUM CHLORIDE GALENICA SENESE must be administered to you only if you do not
have kidney problems and at a rate not exceeding 10 mEq potassium/hour.
Use in children and adolescents
In children with low body weight, this medicine must be administered cautiously and at a controlled rate (See section "Children"). Dosage and administration rate must be determined according to the patient's age, weight, and clinical condition.
Use in elderly patients
If you are elderly, your doctor will closely monitor you during treatment with this medicine.
If you are given more GLUCOSE WITH POTASSIUM CHLORIDE GALENICA SENESE than you should
This medicine will be administered by a doctor or specialized personnel; it is unlikely that an excessive dose will be administered. However, if you think you have been given an excessive dose of GLUCOSE WITH POTASSIUM CHLORIDE GALENICA SENESE, inform your doctor immediately or go to the nearest hospital.
In case of accidental administration of excessive doses of GLUCOSE WITH POTASSIUM CHLORIDE GALENICA SENESE, an increase in water and solute concentration in the body (hyperhydration and solute overload) may occur. In such cases, the doctor or nurse must immediately stop administration of the medicine and initiate corrective therapy.
If you miss a dose of GLUCOSE WITH POTASSIUM CHLORIDE GALENICA SENESE
This medicine will be administered by a doctor or specialized personnel; it is unlikely that a dose will be missed. However, if you think a dose may have been missed, contact your doctor or nurse.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.
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4. Possible side effects

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

allergic reactions (hypersensitivity), skin rash (urticaria);
increased osmotic pressure of the blood (hyperosmolarity);
increased blood volume circulating in the body (hypervolemia);
increased metabolic rate;
increased blood sugar levels (hyperglycemia);
decreased blood sugar levels (hypoglycemia);
increased insulin levels;
increased adrenaline levels;
decreased blood pressure (hypotension);
heart rhythm disturbances (arrhythmias, conduction disorders, disappearance of the P wave, widening of the QRS complex on the electrocardiogram);
cardiac arrest;
fluid accumulation causing swelling in the legs and ankles (peripheral edema);
fluid accumulation in the lungs (pulmonary edema);
bleeding in the brain (cerebral hemorrhage);
poor blood circulation to the brain (cerebral ischemia);
neuromuscular disorders;
altered sensation in arms and legs (paresthesia), loss of muscle tone (flaccid paralysis), weakness, confusion;
stomach and intestinal disorders (gastrointestinal disturbances);
increased body temperature (fever);
leakage of the medicine into surrounding tissues at the injection site (extravasation);
infection at the infusion site and local pain;
circulation problems due to blood clot formation and vein inflammation at the infusion site (thrombosis and thrombophlebitis);
reduced sodium levels in the blood (hospital-acquired hyponatremia)*;
a brain disorder called acute hyponatremic encephalopathy*.

*Reduced sodium levels in the blood (hospital-acquired hyponatremia) can cause irreversible brain damage and death due to the development of acute hyponatremic encephalopathy (see sections 3 and 2).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://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 GALENICA SENESE

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.
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Vials: Store in the original packaging and in a tightly closed container. Do not refrigerate or freeze.
Bags: Store at a temperature not exceeding 30°C. Store in the original packaging and in a tightly closed container. Do not refrigerate or freeze.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What GLUCOSIO CON POTASSIO CLORURO contains
GLUCOSIO CON POTASSIO CLORURO GALENICA SENESE 5%/0,2% Infusion solution I

The active substances are glucose monohydrate and potassium chloride. Each litre of solution contains 55 g of glucose monohydrate (50 g of anhydrous glucose) and 2.0 g of potassium chloride (27 mEq/litre K+, 27 mEq/litre Cl-, 277 mmol/L glucose monohydrate, pH 3.5 - 6.5).
The other component is water for injections.

GLUCOSIO CON POTASSIO CLORURO GALENICA SENESE 10%/0,3% Infusion solution II

The active substances are glucose monohydrate and potassium chloride. Each litre of solution contains 110 g of glucose monohydrate (100 g anhydrous glucose) and 3.0 g of potassium chloride (40 mEq/litre K+, 40 mEq/litre Cl-, 555 mmol/L glucose monohydrate, pH 3.5 - 6.5).
The other components are water for injections.

Description of the appearance of GLUCOSIO CON POTASSIO CLORURO GALENICA SENESE and contents of the package
Infusion solution.
Glass vial of 50-100-250-500-1000 ml;
Plastic bag of 50-100-250-500-1000 ml.

Marketing Authorisation Holder and Manufacturer
Industria Farmaceutica Galenica Senese S.r.l.
Via Cassia Nord 351
53014 Monteroni d’Arbia (Siena).

The following information is intended exclusively for physicians or healthcare professionals

Dosage and method of administration
It may be necessary to monitor the electrolyte balance, serum glucose, serum sodium, and other electrolytes before and during administration, particularly in patients with increased 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.

Warnings and precautions
Intravenous glucose infusions are generally isotonic solutions. However, in the body, glucose-containing solutions may become physiologically highly hypotonic due to the rapid metabolism of glucose.
Depending on the tonicity of the solution, the volume and frequency of infusion, the patient's underlying clinical condition, and the capacity for glucose metabolism, intravenous administration of glucose may cause electrolyte disturbances, particularly hypo- or hyperosmolar hyponatremia.

Hyponatremia:
Patients with non-osmotic vasopressin release (e.g., during acute 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 isotonic solutions.
Acute hyponatremia may cause acute hyponatremic encephalopathy (cerebral edema), characterized by headache, nausea, seizures, lethargy, and vomiting. Patients with cerebral edema are at particular risk of severe, irreversible, and life-threatening brain injury.
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, life-threatening cerebral edema caused by acute hyponatremia.

Management of overdose

Prolonged administration of glucose may lead to overhydration and solute overload. In such cases, the patient's clinical condition should be reassessed and appropriate corrective measures initiated.
In case of overdose, immediately discontinue the infusion of the potassium-containing solution and initiate corrective therapy to reduce elevated plasma potassium levels and, if necessary, restore acid-base balance (see section 4.4).
The patient should be closely monitored for the onset of any signs and symptoms related to the administered drug, providing appropriate symptomatic and supportive measures as required.

Incompatibilities

Due to the presence of glucose, the medicinal product is incompatible with:
- cyanocobalamin;
- kanamycin sulfate;
- sodium novobiote;
- sodium warfarin.
Furthermore, there are conflicting opinions regarding the compatibility of glucose with hydroxyethyl starch (hetastarch).
Ampicillin and amoxicillin remain stable in glucose solutions only for a short period.
Unless otherwise indicated, it is advisable not to mix this medicinal product with other medicinal products.

For further information, please refer to the Summary of Product Characteristics.
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