Electrolyte rehydration solution with glucose and calcium gluconate FKI: detailed information

Warnings and precautions
Consult your doctor or nurse before using ELETTROLITICA REIDRATANTE CON GLUCOSIO E CALCIO GLUCONATO FRESENIUS KABI ITALIA
This medicine must be administered via a very slow intravenous infusion,
as potassium intoxication may occur, potentially leading to death due to loss of heart function (cardiac depression), disturbances in heart rhythm (arrhythmias), up to cardiac arrest (see section “How to use ELETTROLITICA REIDRATANTE CON GLUCOSIO E CALCIO GLUCONATO FRESENIUS KABI ITALIA”).
Due to the presence of sodium, this medicine must be administered with caution in the following cases:

if you have heart problems (congestive heart failure, cardiac insufficiency) or kidney problems (severe renal failure, reduced renal function);
if you have fluid accumulation (edema with salt retention), either in the lungs (pulmonary edema) or associated with swelling of the legs and ankles (peripheral edema);
if you are taking heart medications (cardiotonic drugs), anti-inflammatory steroid medicines (corticosteroids), or hormonal medicines (corticotropins);
if you have high blood pressure (hypertension);
if you suffer from a condition called pre-eclampsia, characterized by high blood pressure, swelling due to fluid accumulation, and presence of proteins in the urine, or other conditions caused by sodium accumulation.

Due to the presence of potassium, this medicine must be administered with caution in the following cases:

if you have kidney problems (renal failure), as potassium retention may worsen;
if you have heart problems (cardiac insufficiency) and are taking other heart medications (digitalis);
if you have an adrenal gland disorder (adrenal insufficiency);
if you have liver problems (hepatic insufficiency);
if someone in your family suffers from a disorder characterized by episodes of sudden muscle weakness (familial periodic paralysis);
if you suffer from a condition characterized by muscle stiffness (congenital myotonia);
if you have recently undergone surgery (early post-operative phase).

Due to the presence of calcium, this medicine must be administered with caution in the following cases:

if you have kidney problems (renal failure, kidney diseases) or heart problems (cardiac diseases), as this may increase the risk of irregular heartbeats (arrhythmias);
if you have received a blood transfusion, as calcium ion concentrations may differ from expected levels;
if you suffer from kidney problems (kidney diseases) or lung problems that may cause heart enlargement (pulmonary heart disease), if you have breathing difficulties (respiratory failure) and a decrease in blood pH due to respiratory problems (respiratory acidosis); these conditions may promote an increase in blood calcium levels (hypercalcemia) and increased blood acidity, which may worsen your clinical condition;
if you suffer from chronic renal failure, if you have low body water levels (dehydration), or if you have an imbalance in mineral salt levels (electrolyte imbalance);
if you have low blood pressure, as administration of calcium chloride may cause vasodilation and consequently lower blood pressure. Calcium chloride solution is irritating and must not be administered via intramuscular, subcutaneous, or perivascular injection, as tissue damage and tissue death (necrosis) may occur. Calcium levels in urine should be monitored frequently to prevent excessive increases (hypercalciuria), as high calcium levels in urine may lead to increased blood calcium levels (hypercalcemia).

Due to the presence of magnesium, the medicine must be administered with caution in the following cases:

if you have kidney problems (renal failure);
if you have heart problems (cardiac insufficiency) and are taking other heart medications (digitalis);
if you have a muscle disorder (myasthenia gravis);
if you are being treated with sedatives, hypnotics (central nervous system depressants), or drugs used to block muscles during surgery (neuromuscular blockers). Magnesium concentration in blood should be monitored frequently to prevent excessive increases.

Due to the presence of phosphates, infusion of the medicine may cause a reduction in blood calcium levels (hypocalcemia).
Due to the presence of glucose, the medicine must be administered with caution in individuals suffering from diabetes mellitus or glucose intolerance, and in individuals taking corticosteroid anti-inflammatory drugs (corticosteroids) or hormonal medicines (corticotropin).
During treatment, blood and urine glucose levels must be monitored, and insulin administered if required, to minimize the risk of increased blood glucose (hyperglycemia) and glucose in urine (glycosuria). Prolonged use of glucose solutions may lead to fluid accumulation (water overload, congestive state) and deficiency of mineral salts in blood (electrolytes).
Due to the presence of acetate, the medicine must be used with caution in individuals with increased pH (metabolic and respiratory alkalosis) or increased blood acetate levels, such as in individuals with liver problems (mild or moderate hepatic insufficiency).
Special attention must be paid in the following cases:

acute illness, pain, post-operative stress, infections, burns, diseases of the central nervous system;
heart, liver, or kidney diseases treated with a drug that enhances the effect of vasopressin (a hormone regulating water retention in the body), as this may increase the risk of hospital-acquired low blood sodium (hyponatremia). (See also section "Other medicines and GLUCOSIO FRESENIUS KABI ITALIA")
All patients must be closely monitored. In cases where normal regulation of blood water content is affected due to increased secretion of vasopressin, also known as antidiuretic hormone, infusion of fluids with low sodium chloride concentration (hypotonic fluids) may lead to low blood sodium levels (hyponatremia). This may result in headache, nausea, seizures, lethargy, coma, brain swelling (cerebral edema), and death. Consequently, these symptoms (acute symptomatic hyponatremic encephalopathy) are considered a medical emergency (see also section "Possible side effects").
Children, women of childbearing age, and patients with reduced cerebral compliance (e.g., meningitis, intracranial hemorrhage, cerebral contusion) are particularly at risk of severe, life-threatening cerebral edema caused by acute hyponatremia.
During treatment with this medicine, your doctor must periodically check heart function (via serial electrocardiograms) and blood electrolyte concentrations (plasma osmolarity), glucose levels (glycemia), fluid status, and blood pH (acid-base balance). It is also advisable to monitor blood pressure and osteotendinous reflexes to detect possible respiratory muscle paralysis.
This medicine must be used immediately after opening the container. The solution must be clear, colorless or slightly yellowish and free from visible particles, and is intended for single, uninterrupted administration. Any remaining unused solution must not be reused.
Children
This medicine must be administered with caution in children, particularly in neonates and children with low body weight, as blood glucose levels may increase (hyperglycemia). Furthermore, in children with low body weight, rapid or excessive intravenous infusion may cause an increase in blood electrolyte concentration (serum osmolarity) and cerebral hemorrhage due to rupture of blood vessels (intracerebral hemorrhage).
As with other calcium-containing solutions, concomitant treatment with ceftriaxone is contraindicated in neonates (under 28 days of age) due to the risk of fatal precipitation of ceftriaxone-calcium salt in the neonatal bloodstream (see section "Possible undesirable effects").
Other medicines and ELETTROLITICA REIDRATANTE CON GLUCOSIO E CALCIO GLUCONATO FRESENIUS KABI ITALIA
Inform your doctor if you are currently using, have recently used, or might use any other medicines, particularly if you are taking:
Medicines that increase the effect of vasopressin (see also section "Warnings and precautions"):
Medicines stimulating vasopressin release, e.g.: chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics;
Medicines enhancing vasopressin action, e.g.: chlorpropamide, NSAIDs, cyclophosphamide;
Vasopressin analogs, e.g.: desmopressin, oxytocin, vasopressin, terlipressin;
Other medicines increasing the risk of hyponatremia include diuretics in general and antiepileptics such as oxcarbazepine.

This medicine must be administered with caution if you are taking:

medicines used to lower blood pressure such as potassium-sparing diuretics, ACE inhibitors, or other medicines causing decreased aldosterone levels, as these may lead to increased blood potassium (hyperkalemia) and reduced potassium excretion (potassium retention), especially in individuals with kidney problems (renal dysfunction); in such cases, blood potassium levels must be closely monitored;
anti-inflammatory steroid medicines (corticosteroids), which may cause sodium and water retention, leading to fluid accumulation (edema) and increased blood pressure (hypertension). These drugs are associated with reduced sugar tolerance and possible manifestation of latent diabetes mellitus; therefore, careful monitoring is required when glucose is administered concurrently.

Due to the presence of calcium chloride, be cautious if you are using the following medicines:

thiazide diuretics, used to treat high blood pressure, as they may increase blood calcium levels due to reduced excretion capacity;
medicines used for heart problems (cardiac glycosides, digoxin, digitoxin), as their effects may add to those of calcium, increasing the risk of heart rhythm disturbances;
verapamil (and other calcium channel blockers), used to treat high blood pressure, as concomitant use may reduce the antihypertensive effect of this medicine;
medicines containing magnesium, as they may increase the risk of elevated calcium (hypercalcemia) or magnesium (hypermagnesemia) levels, especially in patients with kidney disorders;
medicines used to block muscles during surgery (neuromuscular blockers), as calcium salts may counteract the effect of these medicines;
ceftriaxone (an antibiotic), due to the risk of particle formation.

Due to the presence of magnesium chloride, pay particular attention if you are using the following medicines:

central nervous system depressants such as barbiturates, narcotics, or other hypnotics (or systemic anesthetics). In this case, dosage must be carefully adjusted, as magnesium enhances the central nervous system depressant effect;
medicines used for heart problems (cardiac glycosides, digoxin, digitoxin);
medicines used to block muscles during surgery (competitive and depolarizing neuromuscular blockers), such as rocuronium, as their effect may be enhanced by magnesium chloride;
aminoglycoside antibiotics, used to treat bacterial infections;
eltrombopag, a medicine used to treat low blood platelet levels;
labetalol, a medicine used to treat heart rhythm disturbances (arrhythmias);
medicines used to treat high blood pressure (isradipine, felodipina, nicardipine, nifedipine), as concomitant use with magnesium may cause a significant drop in blood pressure (hypotension).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before this medicine is administered.
This medicine must not be administered during pregnancy or breastfeeding unless absolutely necessary.
Elettrolitica Reidratante con Glucosio e Calcio Gluconato, solution for infusion, must be administered with particular caution in pregnant women during labor, especially if administered concomitantly with oxytocin (a hormone used to induce labor and control bleeding), due to the risk of hyponatremia (see sections "Warnings and precautions", "Other medicines and ELETTROLITICA REIDRATANTE CON GLUCOSIO E CALCIO GLUCONATO FRESENIUS KABI ITALIA", "Possible undesirable effects").
Due to the presence of magnesium, this medicine must not be administered within 2 hours before delivery. If magnesium chloride is administered (especially for more than 24 hours before delivery), newborns may show signs of magnesium toxicity, including neuromuscular and respiratory depression.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.

3. How to use ELETTROLITICA REIDRATANTE CON GLUCOSIO E CALCIO GLUCONATO FRESENIUS KABI ITALIA

This medicine will be prepared by a doctor, pharmacist, or nurse and must not be mixed or administered simultaneously with injections containing ceftriaxone or other incompatible medicines.
This medicine must be administered directly into a vein (intravenous infusion) by trained medical personnel. It must not be injected via other routes (intramuscular, subcutaneous, or perivascular tissues).
THE MEDICINE MUST BE ADMINISTERED ONLY IF RENAL FUNCTION IS INTACT AND AT A RATE NOT EXCEEDING 10 MEQ OF POTASSIUM PER HOUR AND 0.4–0.8 G OF GLUCOSE PER KG OF BODY WEIGHT PER HOUR.
After administration, remain lying down for a short period.
The dose will be adjusted according to age, weight, and health status.
The recommended dose in adults is 2 liters per day, administered at an infusion rate of approximately 300 ml per hour.
Infusions that are too rapid may cause local pain; the infusion rate must be adjusted according to your needs.
Administration must be stopped if you experience pain or redness at the injection site, as this may indicate leakage of the medicine from the vein (drug extravasation).
Use in children
In children, the safety and efficacy of this medicine have not been established.
Glucose dosage and administration rate must be determined based on the patient's age, weight, and health condition. Particular caution is required in neonates and underweight children (see section "Children").
Preparation of the medicine: Use immediately after opening the container. The container is intended for single, uninterrupted administration and any remaining solution must not be reused.
Shake well before administration. Do not use the medicine if the solution is not clear, colorless or slightly yellowish, or if it contains particles. Do not mix with incompatible solutions.
Adopt all standard precautions to maintain sterility before and during intravenous infusion.
If you use more ELETTROLITICA REIDRATANTE CON GLUCOSIO E CALCIO GLUCONATO FRESENIUS KABI ITALIA than you should
Since this medicine will be administered by a doctor or trained personnel, it is unlikely that you will receive an excessive dose. However, if you think you have been given an excessive dose of ELETTROLITICA REIDRATANTE CON GLUCOSIO E CALCIO GLUCONATO FRESENIUS KABI ITALIA, inform your doctor or healthcare provider immediately.
Following administration of an excessive dose of this medicine, the following may occur:

increased blood potassium levels (hyperkalemia), which may lead to death due to heart damage (cardiac depression, arrhythmias, or arrest);
increased blood sodium levels (hypernatremia) and increased blood volume (hypervolemia). If blood sodium levels rise too much, internal organ dehydration (particularly of the brain) may occur, along with fluid accumulation affecting cerebral, pulmonary, and peripheral circulation, leading to fluid accumulation around the lungs (pulmonary edema) or swelling of the legs and ankles (peripheral edema);
increased blood calcium levels (hypercalcemia), especially in patients with kidney diseases, manifesting with symptoms such as: thirst, nausea, vomiting, constipation, increased urine production (polyuria), abdominal pain, muscle weakness, mental disturbances, and, in severe cases, cardiac arrhythmia and coma.

In case of excessive magnesium chloride administration, the following signs of intoxication may occur: flushing, sweating, reduced blood pressure (hypotension), paralysis of certain muscles such as respiratory muscles (flaccid paralysis), reduced body temperature (hypothermia), circulatory collapse, cardiac and central nervous system depression, potentially progressing to respiratory paralysis.
Magnesium intoxication manifests with a sudden increase in blood pressure, breathing difficulties (respiratory paralysis), and loss of leg extension response after a percussion stimulus (patellar reflex).
Prolonged administration of high glucose doses may lead to intracellular fluid accumulation (hyperhydration) and solute overload.
In case of overdose, stop the infusion immediately and initiate corrective therapy to reduce excess blood glucose and ion levels, and restore, if necessary, acid-base balance.
If you have any doubts about the use of this medicine, consult your doctor or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
The following adverse effects may occur:

allergic reactions and urticaria;
stomach and intestinal (gastrointestinal) disorders, nausea, vomiting, diarrhoea, abdominal pain, constipation, intestinal disturbances (delayed intestinal transit and paralytic ileus);
thirst, reduced salivation, metallic taste, chalky taste;
nerve and muscle (neuromuscular) disturbances, muscle stiffness, altered limb sensation (paraesthesiae), paralysis of certain muscles such as respiratory muscles (flaccid paralysis), weakness;
mental confusion, headache, dizziness, restlessness, irritability;
seizures, coma, death;
drowsiness, confusional states, psychiatric disorders;
irregular heartbeat (arrhythmias), increased heart rate (tachycardia), decreased heart rate (bradycardia), disturbances in cardiac conduction, disappearance of the P wave, widening of the QRS complex on the electrocardiogram, syncope, ventricular fibrillation, cardiac arrest;
low or high blood pressure (hypotension, hypertension), swelling of legs and ankles (peripheral oedema), vasodilation, hot flushes, sweating, and shock;
increased or decreased levels of sodium (hypernatraemia/hyponatraemia, hospital-acquired hyponatraemia** ), chloride (hyperchloraemia), and blood volume (hypervolaemia);
breathing difficulties (dyspnoea, respiratory arrest);
fluid accumulation in the lungs (pulmonary oedema) and air around the lung (pneumothorax);
reduced tear production;
kidney problems (renal failure) and excessive urine production (polyuria);
increased calcium levels in the blood (hypercalcaemia), Burnett's syndrome (milk-alkali syndrome), reduced calcium levels in the blood (hypocalcaemia);
muscle weakness;
increased metabolic rate, increased blood glucose levels (hyperglycaemia), decreased blood glucose levels (hypoglycaemia), increased insulin levels, increased adrenaline levels;
fever, infection at the infusion site, pain or local reaction, redness, skin irritation (rash);
venous irritation, formation of blood clots in veins (venous thrombosis);
inflammation of veins (venous phlebitis) extending from the infusion site;
leakage of infused solution from the vein (extravasation), tissue damage and tissue death (tissue necrosis);
calcium deposits in tissues (cutaneous calcification), inflammation due to pus accumulation (abscesses);
kidney problems caused by calcium-ceftriaxone deposits. Pain during urination or reduced urine output may occur.
brain damage and death caused by very low sodium levels in the blood (hyponatraemic encephalopathy);
When sodium levels in the blood become very low, water enters brain cells and causes them to swell. This leads to increased intracranial pressure and results in hyponatraemic encephalopathy.

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, consult your doctor or pharmacist.
You may also report adverse effects directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting adverse effects, you can help provide more information on the safety of this medicine.

The following information is intended exclusively for physicians or healthcare professionals

Dosage and method of administration
It may be necessary to monitor 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 hyponatraemia.
Monitoring of serum sodium is particularly important for products with a concentration lower than serum sodium concentration. After infusion of Elettrolitica Reidratante con Glucosio e Calcio Gluconato Fresenius Kabi Italia solution for infusion, rapid active transport of glucose into the cell occurs. This condition may lead to severe hyponatraemia (see sections “Warnings and precautions”, “Other medicines and ELETTROLITICA REIDRATANTE CON GLUCOSIO E CALCIO GLUCONATO FRESENIUS KABI ITALIA”, “Possible adverse effects”).
Intravenous glucose infusions are generally isotonic solutions. However, in the body, glucose-containing solutions may become extremely hypotonic at a physiological level due to the rapid metabolism of glucose (see section “How to use ELETTROLITICA REIDRATANTE CON GLUCOSIO E CALCIO GLUCONATO FRESENIUS KABI ITALIA”).
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 imbalances, especially hypo- or hyperosmolar hyponatraemia.

Incompatibilities
Due to the presence of glucose, the medicine is incompatible with:

cyanocobalamin;
kanamycin sulfate;
sodium novobiocinate;
sodium warfarin.
Moreover, 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.
Due to the presence of calcium chloride, the medicine is incompatible with:
magnesium sulfate: formation of a precipitate;
phosphate-containing medicines: formation of calcium phosphate precipitate;
carbonate-containing medicines: formation of calcium carbonate precipitate;
tartrate-containing medicines: formation of calcium tartrate precipitate.
Incompatibilities of calcium chloride have been observed with:
aminophylline: due to precipitate formation;
amphotericin B: due to cloudiness development;
cefamandole: due to presence of sodium carbonate in the cefamandole formulation;
ceftriaxone sodium: due to precipitate formation; therefore, calcium-containing solutions must not be administered within 48 hours following ceftriaxone administration;
cephalothin: due to physical incompatibility;
cefradine: due to presence of sodium carbonate in the cefradine formulation;
chlorphenamine: due to physical incompatibility;
dobutamine: due to cloudiness development;
fat emulsion: due to flocculation;
sodium heparin;
indomethacin: due to precipitate formation;
sodium nitrofurantoin;
promethazine: due to precipitate formation;
propofol: due to precipitate formation;
streptomycin: since calcium may inhibit streptomycin activity;
tetracyclines: calcium salts may complex with tetracyclines.
Calcium salts may form complexes with many drugs, potentially leading to precipitate formation.
Physical incompatibility has been reported with ceftriaxone (see sections “Contraindications”, “Interactions” and “Adverse effects”).
Due to the presence of magnesium, the medicine is incompatible with solutions containing alcohol (at high concentrations), heavy metals, carbonates and bicarbonates, sodium hydrocortisone, succinates, phosphates, polymyxin B sulfate, procaine hydrochloride, calcium salicylate, clindamycin phosphate, tartrates, as precipitates may form.
Potential incompatibility is often influenced by changes in reactant concentrations and pH of solutions. The prescribing physician should refer to the scientific literature.

For further information, please consult the Summary of Product Characteristics.