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 may 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 ELETTROLITICA EQUILIBRATA ENTERICA FRESENIUS KABI ITALIA is and what it is used for
What you need to know before using ELETTROLITICA EQUILIBRATA ENTERICA FRESENIUS KABI ITALIA
How to use ELETTROLITICA EQUILIBRATA ENTERICA FRESENIUS KABI ITALIA
Possible side effects
How to store ELETTROLITICA EQUILIBRATA ENTERICA FRESENIUS KABI ITALIA
Contents of the pack and other information

1. What ELETTROLITICA EQUILIBRATA ENTERICA FRESENIUS KABI ITALIA is and what it is used for

ELETTROLITICA EQUILIBRATA ENTERICA FRESENIUS KABI ITALIA is a combination of sodium, potassium, magnesium, and calcium salts. These elements play a fundamental role in the proper functioning of the nervous system, heart, muscles, and in maintaining the balance of salts and other substances in the blood (electrolyte balance, acid-base equilibrium). In addition, calcium is a fundamental component of bones.
ELETTROLITICA EQUILIBRATA ENTERICA FRESENIUS KABI ITALIA is indicated for the treatment of deficiency of fluids and salts in the body (fluid and electrolyte replacement), and for the treatment of non-severe conditions in which there is an increase of acidic substances in the blood (mild to moderate metabolic acidosis).

2. What you must know before using ELETTROLITICA EQUILIBRATA ENTERICA FRESENIUS KABI

ITALY
Do not use ELETTROLITICA EQUILIBRATA ENTERICA FRESENIUS KABI ITALY

if you are allergic to sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, sodium acetate trihydrate, or to any of the other ingredients of this medicine (listed in section 6);
if you have high levels of calcium in your blood (hypercalcemia) or in your urine (hypercalciuria);
if you have kidney problems (severe renal failure, oliguric renal failure);
if your blood sodium levels are high (hypernatremia);
if you have an excessive amount of salts or fluids in your blood (hypervolemia);
if your blood potassium levels are high (hyperkalemia) or your body cannot eliminate potassium (potassium retention);
if you have a heart rhythm disorder (ventricular fibrillation);
if you have severe liver problems (severe hepatic insufficiency, inability to metabolize acetate ion);
if you have heart problems (severe myocardial disease);
if you have breathing difficulties (respiratory rate less than 16 breaths per minute);
if you have an accumulation of basic substances in the blood (metabolic and respiratory alkalosis);
if you have kidney stones;
if you have a disease called sarcoidosis, characterized by coughing with bleeding and breathing difficulties, because this medicine may excessively increase calcium levels in the blood;
if you have blood circulation problems (hypercoagulability);
if you are taking medicines used to treat certain heart conditions (cardiac glycosides);
if you have a disease characterized by insufficient hormone production by the adrenal glands and are not receiving treatment for it (untreated Addison's disease);
if the patient is in a coma;
if you experience painful, short-duration muscle cramps (heat cramps);
if the patient is a newborn (≤ 28 days of age), ELETTROLITICA EQUILIBRATA ENTERICA FRESENIUS KABI ITALY (or other solutions containing calcium) must not be administered simultaneously with ceftriaxone (an antibiotic), even when using separate infusion lines. There is a fatal risk of particle formation in the newborn's bloodstream.

During blood transfusions, this solution must not be administered through the same infusion catheter as whole blood due to a possible risk of coagulation.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using ELETTROLITICA EQUILIBRATA ENTERICA FRESENIUS KABI ITALY.
This medicine must be administered via very slow infusion, as potassium intoxication may occur, which could lead to death due to loss of heart function (cardiac depression), heart rhythm disturbances (arrhythmias), up to complete cessation of heart activity (cardiac arrest) (See section “How to use ELETTROLITICA EQUILIBRATA ENTERICA FRESENIUS KABI ITALY”).
The medicine must be administered immediately after opening the container, in a single uninterrupted administration, and only if the solution is clear, colorless, and free of particles. Any leftover medicine must be discarded.
Due to the presence of sodium, this medicine must be administered with particular caution if:

you have severe heart problems (heart failure, congestive cardiac decompensation);
you have high blood pressure (hypertension);
you have severe kidney problems (reduced renal function, severe renal failure);
you have swelling due to fluid accumulation around the lungs (pulmonary edema), or around the ankles and legs (peripheral edema), with poor elimination of fluids and salts (water and salt retention);
you are taking medicines used to treat heart conditions (cardiac inotropic agents), inflammation and allergies (corticosteroids), or medicines that stimulate steroid hormone production (corticotropins) (See section “Other medicines and ELETTROLITICA EQUILIBRATA ENTERICA FRESENIUS KABI ITALY”);
you are pregnant and have a condition called pre-eclampsia, characterized by high blood pressure, swelling due to fluid accumulation, and protein in the urine.

Due to the presence of potassium, this medicine must be administered with particular caution if:

you have severe kidney problems (renal failure, adrenal insufficiency);
you have heart problems (heart failure);
you are taking medicines for certain heart conditions (digitalized patients). In this case, especially if the medicine is used for prolonged periods, serious heart rhythm disturbances may occur;
you have liver problems (hepatic insufficiency);
someone in your family suffers from a disorder characterized by sudden episodes of muscle weakness (familial periodic paralysis);
you have been born with a serious condition characterized by prolonged muscle contraction (congenital myotonia);
you have recently undergone surgery (early post-operative phase).

Due to the presence of calcium, this medicine must be administered with caution if:

you have kidney problems (renal diseases);
you have heart problems (cardiac diseases), as this increases the risk of heart rhythm disturbances and may cause a drop in blood pressure (vasodilation-induced hypotension);
you have received a blood transfusion;
you have lung problems that may cause heart enlargement (cor pulmonale);
you have an increased level of blood acidity (respiratory acidosis);
you have severe breathing difficulties (respiratory failure); since calcium is a substance that increases blood acidity, be cautious, as all these conditions may worsen;
you are at risk of high calcium levels in the blood (hypercalcemia), for example, if you have severe kidney problems (chronic renal failure), significant fluid loss (dehydration), or an imbalance of salts and other substances in the blood (electrolyte imbalance).

ELETTROLITICA EQUILIBRATA ENTERICA FRESENIUS KABI ITALY must be administered directly into a vein via infusion (intravenous infusion) and not via other routes (intramuscular, subcutaneous, or perivascular tissues), as complications (tissue necrosis) may occur.
Due to the presence of magnesium, this medicine must be administered with caution if:

you have a severe muscle disease (severe myasthenia gravis);
you have kidney problems (renal failure);
you have heart problems (heart failure);
you are taking medicines for certain heart conditions (digitalized patients);
you are being treated with medicines that reduce brain activity (central nervous system depressants) or reduce muscle contraction (neuromuscular blockers).

Due to the presence of acetate, this medicine must be administered with caution if:

you have an increase in basic substances in the blood (metabolic and respiratory alkalosis);
you have liver problems (mild or moderate hepatic insufficiency).

During treatment with ELETTROLITICA EQUILIBRATA ENTERICA FRESENIUS KABI ITALY, your doctor must monitor:

heart activity through specific tests (serial electrocardiograms);
fluid levels (fluid balance), salts (electrolytes), and other substances (plasma osmolarity, acid-base balance) in the body;
blood pressure (arterial pressure);
your muscle reflexes (osteotendinous reflexes), as respiratory paralysis (respiratory arrest) may occur;
calcium and magnesium levels in the blood;
calcium levels in the urine, to prevent high calcium levels in the urine (hypercalciuria), which could lead to high calcium levels in the blood (hypercalcemia).

Children
There are insufficient data to establish the safety and efficacy of this medicine in children.
Other medicines and ELETTROLITICA EQUILIBRATA ENTERICA FRESENIUS KABI ITALY
Inform your doctor, pharmacist, or nurse if you are using, have recently used, or might use any other medicine.
Use caution and inform your doctor, who should carefully monitor your blood potassium levels, if you are taking:

medicines that promote urine elimination and reduce potassium loss (potassium-sparing diuretics). These medicines, when taken together with ELETTROLITICA EQUILIBRATA ENTERICA FRESENIUS KABI ITALY, especially if you have kidney problems (renal dysfunction), may cause an increase in blood potassium levels (hyperkalemia);
medicines used to lower blood pressure (ACE inhibitors), as they may reduce potassium excretion.

Additionally, use extreme caution and inform your doctor if you are being treated with:

corticosteroids, used for allergies and inflammation, as fluid retention (edema) and increased blood pressure (hypertension) may occur;
thiazide diuretics, which promote fluid elimination, as excessive increase in blood calcium levels (hypercalcemia) may occur;
cardiac glycosides (digoxin and digitoxin), used to treat heart conditions, as the risk of heart rhythm disturbances (arrhythmias) is higher (See section “Do not use ELETTROLITICA EQUILIBRATA ENTERICA FRESENIUS KABI ITALY”);
calcium channel blockers (verapamil), for treating high blood pressure, because ELETTROLITICA EQUILIBRATA ENTERICA FRESENIUS KABI ITALY may reduce their effectiveness;
neuromuscular blockers (tubocurarine), used to reduce muscle contractions, as ELETTROLITICA EQUILIBRATA ENTERICA FRESENIUS KABI ITALY may increase or decrease their effectiveness;
medicines that reduce brain activity (barbiturates, narcotics, hypnotics, and systemic anesthetics), because ELETTROLITICA EQUILIBRATA ENTERICA FRESENIUS KABI ITALY may alter their effectiveness;
aminoglycoside antibiotics, for treating bacterial infections, as a marked reduction in voluntary muscle contraction (neuromuscular blockade) may occur;
eltrombopag, used for circulation disorders, as ELETTROLITICA EQUILIBRATA ENTERICA FRESENIUS KABI ITALY may reduce its effectiveness;
rocuronium, used for anesthesia during surgery, as excessive reduction in voluntary muscle contraction (neuromuscular blockade) and severe breathing problems (respiratory depression, apnea) may occur;
labetalol, used for heart rhythm disorders, as reduced heart activity (cardiac output), shortness of breath, dizziness, and temporary loss of consciousness (fainting) may occur;
calcium antagonists (isradipine, felodipina, nicardipine, and nifedipine), for treating high blood pressure, as excessive lowering of blood pressure (hypotension) may occur;
ceftriaxone (an antibiotic) due to the risk of particle formation.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor, pharmacist, or nurse before using this medicine, as it should only be used if your doctor considers it strictly necessary.
This medicine must not be administered within 2 hours before delivery.
If you are pregnant and have a condition called eclampsia, characterized by high blood pressure, fluid retention, protein in the urine, and seizures, administration of this medicine may cause serious harm to your baby (neuromuscular depression, respiratory depression).
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.

3. How to use ELETTROLITICA EQUILIBRATA ENTERICA FRESENIUS KABI ITALIA

This medicinal product must be administered to you exactly as instructed by your doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, pharmacist, or nurse.
ELETTROLITICA EQUILIBRATA ENTERICA FRESENIUS KABI ITALIA will be prepared by a doctor, pharmacist, or nurse and must not be mixed with, nor administered simultaneously to, injections containing ceftriaxone.
The medicine must be shaken well before administration.
ELETTROLITICA EQUILIBRATA ENTERICA FRESENIUS KABI ITALIA must be administered directly into a vein by infusion (intravenous infusion), and not by any other route (intramuscular, subcutaneous, or into perivascular tissues). This medicinal product must be administered at a controlled rate (not exceeding 10 mEq potassium/hour) and with great caution (see section “Warnings and precautions”).

Use in adults
The dose will be determined by your doctor according to your age, body weight, and health condition.
Generally, the recommended dose for adults is 20 ml per kg of body weight per day.
After the infusion of this medicinal product, remain lying down.
Inform your doctor or nurse immediately if you experience pain or redness at the injection site, as leakage of the infused solution from the vein (extravasation) may occur (see section “Possible side effects”).

Use in patients with kidney problems
If you have kidney problems, the use of this medicinal product is not recommended for you.

If you use more ELETTROLITICA EQUILIBRATA ENTERICA FRESENIUS KABI ITALIA than you should
Following administration of an excessive dose of this medicinal product, the following may occur:

Increased sodium levels in the blood (hypernatraemia) and/or circulatory disturbances (hypervolaemia), which may cause dehydration of certain internal organs, particularly the brain, and fluid accumulation leading to swelling (oedema) affecting the lungs (pulmonary oedema), cerebral circulation, or legs and ankles (peripheral oedema);
Increased potassium levels in the blood (hyperkalaemia), which may lead to death due to reduced heart function (cardiac depression), disturbances in heart rhythm (arrhythmias), and cessation of heart activity (cardiac arrest);
Increased magnesium levels in the blood (hypermagnesaemia), with symptoms such as sudden sensation of warmth (flushing), sweating, lowered blood pressure (hypotension), loss of voluntary movement (flaccid paralysis), reduced body temperature (hypothermia), severe disturbances of the heart, circulation, and brain (circulatory collapse, cardiac and central nervous system depression), and, in the most severe cases, respiratory arrest (respiratory paralysis);
Increased calcium levels (hypercalcaemia), especially in patients with kidney problems (renal disease), with symptoms such as thirst, nausea, vomiting, constipation, excessive need to urinate (polyuria), abdominal pain, muscle weakness, mental disturbances, and, in more severe cases, disturbances in heart rhythm (cardiac arrhythmia) and deep unconsciousness (coma).

If you have taken or received an excessive amount of this medicinal product, stop treatment immediately and contact your doctor or go to the nearest hospital without delay.

If you forget to use ELETTROLITICA EQUILIBRATA ENTERICA FRESENIUS KABI ITALIA
Do not take a double dose to make up for a forgotten dose.
If you have any doubts about the use of this medicinal product, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The side effects that may occur are listed below:

Gastrointestinal disorders, thirst, reduced salivation, nausea, vomiting, diarrhoea, abdominal pain, constipation (stasis, delayed intestinal transit, paralytic ileus), taste disturbances (metallic taste, chalky taste);
Neuromuscular disorders, muscle stiffness, altered sensation in arms and legs (paraesthesia), loss of muscle tone (flaccid paralysis), weakness, confusion, headache (cephalalgia), dizziness, restlessness, irritability, seizures, coma, death;
Drowsiness, confusion, mental disorders;
Severe heart problems (arrhythmias, tachycardia, bradycardia, conduction disorders, disappearance of the P wave, widening of the QRS complex on the electrocardiogram, ventricular fibrillation, cardiac arrest);
Fainting associated with loss of consciousness (syncope);
Low or high blood pressure (hypotension, hypertension), swelling due to fluid retention affecting legs and ankles (peripheral oedema), dilation of blood vessels (vasodilatation), sudden sensation of warmth (flushing), sweating, severe circulatory problems (shock);
Increased levels of sodium (hypernatraemia), chloride (hyperchloraemia), and blood volume (hypervolaemia);
Severe breathing problems (dyspnoea, pneumothorax), respiratory arrest, swelling due to fluid accumulation around the lungs (pulmonary oedema);
Reduced tear production;
Kidney problems (renal failure), increased need to urinate (polyuria);
Increased levels of calcium and/or increased blood acidity (hypercalcaemia, Burnett's syndrome, metabolic acidosis);
Muscle weakness;
Fever, redness, skin irritations (rash), pain and infection at the infusion site, calcium deposits in tissues (cutaneous calcification), inflammation due to pus accumulation (abscesses), blood clots in veins (venous thrombosis), inflammation of veins (venous phlebitis), even in areas near the infusion site, leakage of the injected solution from the vein (extravasation), tissue damage and tissue death (tissue necrosis);
Kidney problems caused by calcium-ceftriaxone deposits. Pain during urination or reduced urine output may occur.

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
http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ELETTROLITICA EQUILIBRATA ENTERICA FRESENIUS KABI ITALIA

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.
Store in the original packaging. 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 no longer in use. This will help protect the environment.

6. Package contents and other information

What ELETTROLITICA EQUILIBRATA ENTERICA FRESENIUS KABI ITALIA contains

The active substances are sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, and sodium acetate trihydrate.
1 litre of solution (1000 ml) contains 5 g of sodium chloride, 0.75 g of potassium chloride, 0.35 g of calcium chloride dihydrate, 0.31 g of magnesium chloride hexahydrate, and 6.40 g of sodium acetate trihydrate.
Each litre of solution contains 133 mEq of sodium, 10 mEq of potassium, 5 mEq of calcium, 3 mEq of magnesium, 103 mEq of chloride, and 47 mEq of acetate.
pH: 5.0 - 7.0.
The other components are water for injections, hydrochloric acid (as pH regulator).

Description of the appearance of ELETTROLITICA EQUILIBRATA ENTERICA FRESENIUS KABI ITALIA and
contents of the pack
Glass bottle of 250 ml, 500 ml, 20x500 ml and 1000 ml of infusion solution.
Plastic bottle of 500 ml and 1000 ml of infusion solution.
Plastic bag of 500 ml and 1000 ml of infusion solution.

Marketing Authorization Holder and Manufacturer:
Marketing Authorization Holder:
FRESENIUS KABI ITALIA S.r.l.
Via Camagre, 41
37063 Isola della Scala (VR)

Manufacturer:
Fresenius Kabi Italia S.r.l. – Via Camagre, 41 – 37063 Isola della Scala (VR)
Fresenius Kabi France – 6, rue du Rempart BP611 – 27400 Louviers Cedex (France)
S.M. Farmaceutici S.r.l. – Zona Industriale – 85050 Tito (PZ)

The following information is intended exclusively for healthcare professionals:

Management of overdose
Immediately discontinue the infusion and initiate corrective therapy to reduce plasma levels of ions in excess and, if necessary, restore acid-base balance (see Precautions for use).
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.
In case of severe hypernatremia, loop diuretics may be used.
In case of hyperkalemia, intravenous glucose (with or without insulin) or sodium bicarbonate may be administered.
In case of mild calcium chloride overdose, treatment involves immediate discontinuation of the infusion and of any other calcium-containing medications. In case of severe overdose (plasma concentrations >2.9 mmol/l), the following measures should be taken:

Rehydration with administration of 0.9% sodium chloride solution;
Use of non-thiazide diuretics to enhance calcium excretion;
Monitoring of plasma potassium and magnesium levels, with immediate correction to normal values;
Monitoring of cardiac function, and use of beta-blockers to reduce the risk of cardiac arrhythmia;
Hemodialysis, if necessary.

In case of magnesium overdose, artificial ventilation may be required. To counteract the effects of hypermagnesemia, intravenous calcium should be administered (10–20 ml of a 5% solution). Subcutaneous administration of 0.5–1 mg of physostigmine may be helpful. Elevated plasma electrolyte levels may require dialysis.

Incompatibilities with Elettrolitica equilibrata enterica FRESENIUS KABI ITALIA
Due to the presence of calcium chloride, the medicinal product is incompatible with:

Magnesium sulfate: formation of a precipitate;
Medicinal products containing phosphate: formation of calcium phosphate precipitate;
Medicinal products containing carbonate: formation of calcium carbonate precipitate;
Medicinal products containing tartrate: formation of calcium tartrate precipitate.

Incompatibilities of calcium chloride have been observed with:

Aminophylline: due to precipitate formation;
Amphotericin B: due to development of turbidity;
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 development of turbidity;
Fat emulsion: due to presence of flocculate;
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.

Due to the presence of magnesium, the medicinal product 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, and tartrates, as precipitates may form. Potential incompatibility is often influenced by changes in reagent concentrations and solution pH. The prescribing physician should consult the scientific literature.

Special precautions for disposal and handling
Shake well before administration. Do not use the medicinal product if the solution is not clear and colorless or if it contains particles.
Use immediately after opening the container. The container is intended for single, uninterrupted administration; any residual solution must not be used.
Adopt all usual precautions to maintain sterility before and during intravenous infusion.
Unused medicinal product and waste materials derived from such medicinal product must be disposed of in accordance with local applicable regulations.
For further information, refer to the Summary of Product Characteristics.

Balanced electrolyte enteric solution FKI

Package leaflet: Information for the user

ELETTROLITICA EQUILIBRATA ENTERICA FRESENIUS KABI ITALIA infusion solution