Electrolyte rehydration solution Bioindustria L.I.M.

Package leaflet: Information for the user

ELETTROLITICA REIDRATANTE Bioindustria L.I.M.

Infusion solution I
Sodium chloride, potassium chloride, sodium lactate 60%
Equivalent medicine
Please read all of this leaflet carefully before you start using 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, 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:

1. What ELETTROLITICA REIDRATANTE Bioindustria L.I.M. is and what it is used for
2. What you need to know before using ELETTROLITICA REIDRATANTE Bioindustria L.I.M.
3. How to use ELETTROLITICA REIDRATANTE Bioindustria L.I.M.
4. Possible side effects
5. How to store ELETTROLITICA REIDRATANTE Bioindustria L.I.M.
6. Contents of the pack and other information

1. What ELETTROLITICA REIDRATANTE Bioindustria L.I.M. is and what it is used for

ELETTROLITICA REIDRATANTE Bioindustria L.I.M. is a combination of three active substances: sodium chloride, potassium chloride and sodium lactate, which are sodium and potassium salts. These components 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 balance).
ELETTROLITICA REIDRATANTE Bioindustria L.I.M. is indicated for the treatment of deficiency of fluids and salts in the body (fluid and electrolyte replenishment), and for the treatment of non-severe conditions characterized by an increase in acidic substances in the blood (mild to moderate metabolic acidosis).

2. What you need to know before using ELETTROLITICA REIDRATANTE Bioindustria L.I.M.

Do not use ELETTROLITICA REIDRATANTE Bioindustria L.I.M.

• if you are allergic (hypersensitive) to sodium chloride, potassium chloride, sodium lactate, or any of the other components of this medicine (listed in section 6);
• if you have severe kidney problems (severe renal insufficiency);
• if your blood sodium levels are high (hypernatremia);
• if you have an excessive amount of salts or fluids in your blood (hypersaline hypervolemia);
• if your blood potassium levels are high (hyperkalemia) or your body is unable to eliminate potassium (potassium retention);
• if you have a disease characterized by insufficient hormone production from the adrenal gland and are not receiving treatment for it (untreated Addison's disease);
• if you have severe fluid loss (acute dehydration);
• if you experience painful, brief muscle cramps (heat cramps);
• if your blood is more acidic than normal due to lactic acid buildup (lactic acidosis);
• if you have severe heart and circulatory problems (shock, hypoxemia, impaired oxidative processes preventing lactate utilization);
• if you have an accumulation of basic substances in the blood (metabolic and respiratory alkalosis).

Warnings and precautions
Consult your doctor, pharmacist, or nurse before using ELETTROLITICA REIDRATANTE Bioindustria L.I.M.
This medicine must be administered immediately after opening the vial, via a single uninterrupted administration, and only if the solution is clear, colorless, and free from particles.
Any unused medicine must be discarded.
Due to its sodium content, 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 insufficiency);
• you experience swelling due to fluid accumulation around the lungs (pulmonary edema), or in the ankles and legs (peripheral edema), with poor elimination of fluids and salts (water-salt retention);
• you are taking medicines used to treat heart conditions (cardiotonic inotropic drugs), for inflammation and allergies (corticosteroids), or medicines that stimulate steroid hormone production (corticotropics) (See section “Other medicines and ELETTROLITICA REIDRATANTE Bioindustria L.I.M.”);
• you are pregnant and have a condition called pre-eclampsia, characterized by high blood pressure, swelling due to fluid retention, and protein in the urine.

This medicine must be administered via very slow infusion, as potassium intoxication may occur, potentially leading to death due to loss of heart function (cardiac depression), heart rhythm disturbances (arrhythmias), or even cessation of heart activity (cardiac arrest) (See section “How to use ELETTROLITICA REIDRATANTE Bioindustria L.I.M.”).
Due to its potassium content, this medicine must be administered with particular caution if:

• you have severe kidney problems (renal insufficiency);
• you have adrenal insufficiency;
• you have heart problems (heart failure), especially if you are taking medicines for certain heart conditions (digitalized patients);
• you have liver problems (hepatic insufficiency);
• a member of your family has a disorder characterized by sudden episodes of muscle weakness (familial periodic paralysis);
• you have been born with a serious condition causing prolonged muscle contractions (congenital myotonia);
• you have recently undergone surgery (early post-operative phase).

This medicine must be administered cautiously and under specific monitoring due to the risk of reduced sodium concentration in the blood (hyponatremia) if:

• you have heart (heart failure) or lung problems (pulmonary insufficiency);
• you have liver and/or kidney disease (hepatopathies and/or nephropathies);
• you have non-osmotic release of antidiuretic hormone (vasopressin), including the syndrome of inappropriate antidiuretic hormone secretion (SIADH), or are undergoing treatment with vasopressin agonists. Sudden reduction in blood sodium concentration (acute hyponatremia) may cause acute hyponatremic encephalopathy (cerebral edema), characterized by headache, nausea, seizures, drowsiness (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 bleeding, and cerebral contusion) are particularly at risk of dangerous, life-threatening fluid accumulation in the brain (severe cerebral edema) caused by acute hyponatremia.

During treatment with this medicine, your doctor should monitor:

• your heart activity through specific tests (serial electrocardiograms);
• your fluid levels (fluid balance), salts (electrolytes), and substances (plasma osmolarity, acid-base balance) in your body.

Children
There are insufficient data to establish the safety and efficacy of this medicine in children.
Other medicines and ELETTROLITICA REIDRATANTE Bioindustria L.I.M.
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicine.
This medicine must be administered with caution if you are taking:

• medicines that promote urine elimination while reducing potassium loss (potassium-sparing diuretics). These medicines, when taken together with ELETTROLITICA REIDRATANTE Bioindustria L.I.M., especially if you have kidney problems (renal dysfunction), may cause increased blood potassium levels (hyperkalemia);
• medicines used to lower blood pressure (ACE inhibitors), as they may reduce potassium excretion;
• medicines that stimulate vasopressin release, e.g.: chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics;
• medicines that enhance the action of vasopressin, e.g.: chlorpropamide, NSAIDs, cyclophosphamide;
• vasopressin analogues, e.g.: desmopressin, oxytocin, vasopressin, terlipressin;
• other medicines that increase the risk of hyponatremia (reduced blood sodium concentration), such as diuretics in general and antiepileptic drugs like oxcarbazepine.

Additionally, use extreme caution and inform your doctor if you are being treated with corticosteroid medicines (cortisone and similar) used for treating allergies and inflammation, as swelling (edema) due to fluid and salt retention may occur, leading to increased blood pressure (hypertension) (See section “Possible side effects”).
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.
If you are pregnant, this medicine must be administered with particular caution during labor, especially regarding serum sodium levels, when administered in combination with a medicine inducing labor (oxytocin).
Driving and using machines
This medicine does not affect the ability to drive vehicles or operate machinery.

3. How to use ELETTROLITICA REIDRATANTE Bioindustria L.I.M.

This medicine must be administered to you exactly as prescribed by your doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, pharmacist, or nurse.
It may be necessary to monitor the electrolyte balance, serum electrolytes, and acid-base balance before and during administration, with particular attention to serum sodium if you suffer from the syndrome of inappropriate antidiuretic hormone secretion (vasopressin), SIADH, or if you are receiving concomitant therapy with vasopressin agonists, due to the risk of reduced plasma sodium concentration (hospital-acquired hyponatremia).
Monitoring of serum sodium is particularly important for hypotonic solutions.
Before administration, this medicine must be shaken well.
ELETTROLITICA REIDRATANTE Bioindustria L.I.M. must be administered via intravenous infusion (into a vein) at a controlled rate (not exceeding 10 mEq potassium/hour) and with great caution (see section “Warnings and precautions”).
The dose will be determined by your doctor based on your age, body weight, and clinical condition.
Generally, the recommended dose is 2 litres per day, administered at a rate of 300 ml per hour.

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

If you use more ELETTROLITICA REIDRATANTE Bioindustria L.I.M. than you should
If an excessive dose of this medicine is administered, the following adverse effects may occur, depending on your condition:

• increased levels of sodium in the blood (hypernatremia) and/or circulatory disturbances (hypervolemia), which, if you have kidney problems, may lead to dehydration of certain internal organs, particularly the brain, and fluid retention causing swelling (edema) that may affect the lungs (pulmonary edema), the brain, or the legs and ankles (peripheral edema);
• increased levels of potassium in the blood (hyperkalemia), which may result in death due to reduced heart function (cardiac depression), disturbances in heart rhythm (arrhythmias), and loss of heart activity (cardiac arrest).

In case of administration of an excessive amount of this medicine, stop treatment immediately and contact your doctor or go to the nearest hospital without delay.

If you forget to use ELETTROLITICA REIDRATANTE Bioindustria L.I.M.
Do not use a double dose to make up for the forgotten dose.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects that may occur are listed below:
Frequency not known (frequency cannot be estimated from the available data)

• stomach and intestinal (gastrointestinal) disturbances, thirst, reduced salivation, nausea, vomiting, diarrhoea, abdominal pain;
• nerve and muscle (neuromuscular) disturbances, altered sensation in arms and legs (paraesthesia), loss of muscle tone (flaccid paralysis), weakness, confusion, headache (cephalalgia), dizziness, restlessness, fever, irritability, weakness, muscle rigidity, seizures, coma, death;
• severe heart problems (arrhythmias, conduction disorders, disappearance of the P wave, widening of the QRS complex on the electrocardiogram, cardiac arrest, tachycardia);
• drowsiness, confusional states;
• breathing difficulties (dyspnoea), respiratory blockage (respiratory arrest), swelling due to fluid accumulation around the lungs (pulmonary oedema);
• reduced tear production;
• kidney problems (renal failure);
• low or high blood pressure (hypotension, hypertension), swelling due to fluid accumulation affecting the legs and ankles (peripheral oedema);
• increased levels of sodium (hypernatraemia), chloride (hyperchloraemia), or acidic substances (metabolic acidosis) in the blood, increased blood volume (hypervolaemia), changes in the levels of certain substances in the blood (hyperosmolarity), reduced levels of calcium in the blood (hypocalcaemia);
• reduced concentration of sodium in the blood (hospital-acquired hyponatraemia), which may cause irreversible brain damage and death;
• brain damage caused by reduced concentration of sodium in the blood (hyponatraemic encephalopathy);
• fever, infection at the infusion site, pain or allergic reactions near the injection site, vein irritation, formation of blood clots in the veins (venous thrombosis), inflammation of the veins (venous phlebitis), leakage of the injected solution from the vein (extravasation), tissue damage and tissue death (tissue necrosis).

Reporting of side effects
If you experience any side effects, 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 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 ELETTROLITICA REIDRATANTE 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.
Store this medicine in the original packaging and in a tightly closed container. Take all usual precautions to maintain sterility before and during intravenous infusion.
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. Contents of the pack and other information

What ELETTROLITICA REIDRATANTE Bioindustria L.I.M. contains
The active substances are sodium chloride, potassium chloride, and sodium lactate 60%. One litre of solution (1000 ml) contains 9.66 g of 60% sodium lactate solution, 4 g of sodium chloride, and 2.7 g of potassium chloride. One litre of solution contains 120 mEq of sodium, 36 mEq of potassium, 104 mEq of chloride, and 52 mEq of lactate.

• The other component is water for injections.

Description of the appearance of ELETTROLITICA REIDRATANTE Bioindustria L.I.M. and contents of the pack
Glass vials of 50 ml, 100 ml, 250 ml, 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 – 15067 Novi Ligure (AL) - Italy

The following information is intended exclusively for physicians or healthcare professionals

Instructions for the physician

Instructions for the physician

ELECTROLYTE REHYDRATION Bioindustria L.I.M. infusion solution I

Sodium chloride, potassium chloride, sodium lactate 60%
Clinical information
Overdose
Treatment
Immediately discontinue the infusion and initiate corrective therapy to reduce plasma levels of ions in excess and, if necessary, restore acid-base balance (see section 4.4 of the SmPC).
The patient should be closely monitored for the appearance of any signs and symptoms related to the administered drug, providing appropriate symptomatic and supportive measures as needed.
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.
Markedly elevated plasma electrolyte levels may require dialysis.
Incompatibilities
If used to dilute medicinal products, consult a pharmacist, if available, before adding any additive drugs; always consider the characteristics of the products to be added; use aseptic techniques.
Shelf life
36 months
Use the solution immediately after opening the container. It is intended for single, uninterrupted administration; any remaining solution must not be reused.
For further information, consult the Summary of Product Characteristics.

Patient Information Leaflet: Information for the User

ELETTROLITICA REIDRATANTE Bioindustria L.I.M. infusion solution III

Sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, sodium acetate
trihydrate, sodium citrate
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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What ELETTROLITICA REIDRATANTE Bioindustria L.I.M. is and what it is used for
2. What you need to know before using ELETTROLITICA REIDRATANTE Bioindustria L.I.M.
3. How to use ELETTROLITICA REIDRATANTE Bioindustria L.I.M.
4. Possible side effects
5. How to store ELETTROLITICA REIDRATANTE Bioindustria L.I.M.
6. Contents of the pack and other information

1. What ELETTROLITICA REIDRATANTE Bioindustria L.I.M. is and what it is used for

ELETTROLITICA REIDRATANTE Bioindustria L.I.M. is a combination of sodium, potassium, magnesium, and calcium salts. These components play a fundamental role in the proper functioning of the nervous system (nerve signal transmission), heart and muscle contraction, kidney function, respiration, and in maintaining the balance of salts and other substances in the blood (electrolyte balance, acid-base balance). In addition, calcium is a key component of bones.
ELETTROLITICA REIDRATANTE Bioindustria L.I.M. is indicated for the treatment of fluid and electrolyte deficiency in the body (fluid and electrolyte repletion), and for the treatment of non-severe conditions characterized by an increase in acidic substances in the blood (mild to moderate metabolic acidosis).

2. What you should know before using ELETTROLITICA REIDRATANTE Bioindustria L.I.M.

Do not use ELETTROLITICA REIDRATANTE Bioindustria L.I.M.

• if you are allergic (hypersensitive) to sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, sodium acetate trihydrate, sodium citrate, 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 suffer from severe kidney problems (severe renal failure);
• if your blood sodium levels are high (hypernatremia);
• if you have excessive amounts of salts or fluids in your blood (hypersaline 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), because calcium may worsen this condition;
• if you suffer from severe liver problems (severe hepatic insufficiency, inability to metabolize acetate ion);
• if you have an accumulation of alkaline substances in your blood (metabolic or respiratory alkalosis);
• if you suffer from kidney stones;
• if you have a disease called sarcoidosis, characterized by coughing, bleeding, and difficulty breathing;
• if you have blood circulation problems (hypercoagulability);
• if you are taking medicines used to treat certain heart conditions (cardiotonic glycosides);
• if you suffer from a disease characterized by insufficient hormone production by the adrenal gland and are not receiving treatment for it (untreated Addison's disease);
• if you have severe fluid loss (acute dehydration);
• if you experience painful, brief muscle cramps (heat cramps);
• if the patient is a newborn (≤ 28 days of age), ELETTROLITICA REIDRATANTE Bioindustria L.I.M. (or other solutions containing calcium) must not be administered simultaneously with ceftriaxone (an antibiotic), even if separate infusion lines are used, due to the risk of forming particles (calcium-ceftriaxone salt) in the newborn's bloodstream, which may be fatal.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using ELETTROLITICA REIDRATANTE Bioindustria L.I.M.
The medicine must be administered immediately after opening the container, in a single, uninterrupted infusion, and only if the solution is clear, colorless, and free from particles.
Any remaining medicine must be discarded.
Due to the presence of sodium, this medicine must be administered with particular caution if:

• you suffer from severe heart problems (heart failure, congestive cardiac decompensation);
• you have high blood pressure (hypertension);
• you suffer from severe kidney problems (reduced renal function, severe renal failure);
• you experience 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 (hydro-saline retention);
• you are taking medicines used to treat heart conditions (cardiotropic drugs), inflammation and allergies (corticosteroids), or medicines that stimulate steroid hormone production (corticotropins) (See section “Other medicines and ELETTROLITICA REIDRATANTE Bioindustria L.I.M.”);
• you are pregnant and suffer from a condition called pre-eclampsia, characterized by high blood pressure, swelling due to fluid accumulation, and protein in the urine.

This medicine must be administered via very slow infusion, as it may cause potassium intoxication, which can lead to death due to loss of heart function (cardiac depression), heart rhythm disturbances (arrhythmias), or even cessation of heart activity (cardiac arrest) (See section “How to use ELETTROLITICA REIDRATANTE Bioindustria L.I.M.”).
Due to the presence of potassium, this medicine must be administered with particular caution if:

• you suffer from severe kidney problems (renal failure);
• you suffer from adrenal insufficiency;
• you suffer from heart problems (heart failure), especially if you are taking medicines for certain heart conditions (digitalized patients);
• you suffer from liver problems (hepatic insufficiency);
• a family member suffers from a disorder characterized by sudden episodes of muscle weakness (familial periodic paralysis);
• you were born with a severe condition characterized by prolonged muscle contractions (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 suffer from kidney problems (renal diseases);
• you suffer from 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 suffer from lung problems that may cause heart enlargement (pulmonary heart disease);
• you have increased blood acidity (respiratory acidosis) or experience severe breathing difficulties (respiratory failure); since calcium is a substance that increases blood acidity, be cautious, as these conditions may worsen;
• you are predisposed to high calcium levels in the blood (hypercalcemia), for example, if you suffer from severe kidney problems (chronic renal failure), severe fluid loss (dehydration), or an imbalance of salts and other substances in the blood (electrolyte imbalance).

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

• you suffer from a severe muscle disease (myasthenia gravis);
• you suffer from kidney problems (renal failure);
• you suffer from heart problems (heart failure), especially if 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 or respiratory alkalosis);
• you suffer from mild or moderate liver insufficiency, as this may lead to increased acetate levels or inadequate utilization of acetate.

During treatment with ELETTROLITICA REIDRATANTE Bioindustria L.I.M., your doctor should monitor:

• heart activity through specific tests (serial electrocardiograms);
• fluid levels (fluid balance), salts (electrolytes), and other substances (plasma osmolarity, acid-base balance) in your body;
• blood pressure (arterial pressure);
• your muscle reflexes (osteotendinous reflexes), as respiratory paralysis may occur;
• calcium and magnesium levels in your blood;
• calcium levels in your urine, to prevent high calcium levels in the urine (hypercalciuria), which may 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 REIDRATANTE Bioindustria L.I.M.
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take 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 REIDRATANTE Bioindustria L.I.M., especially if you have kidney problems (renal dysfunction), may cause increased blood potassium levels (hyperkalemia);
• medicines used to lower blood pressure (ACE inhibitors), as they may reduce potassium elimination.

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

• corticosteroids, medicines used to treat allergies and inflammation, as you may experience swelling due to fluid and electrolyte accumulation (edema), leading to increased blood pressure (hypertension);
• thiazide diuretics, which promote fluid elimination, as they may cause excessive increases in blood calcium levels (hypercalcemia);
• cardiotonic glycosides (digoxin and digitoxin), used to treat heart problems, as the risk of heart rhythm disturbances (arrhythmias) is higher (See section “Do not use ELETTROLITICA REIDRATANTE Bioindustria L.I.M.”);
• calcium channel blockers (verapamil), used to treat high blood pressure, because ELETTROLITICA REIDRATANTE Bioindustria L.I.M. may reduce their effectiveness;
• medicines containing magnesium, as this may lead to increased calcium (hypercalcemia) and magnesium (hypermagnesemia) levels in the blood, especially if you have kidney problems (renal disorders);
• neuromuscular blockers (tubocurarine), used to reduce muscle contractions, as ELETTROLITICA REIDRATANTE Bioindustria L.I.M. may increase or decrease their effectiveness;
• medicines that reduce brain activity (barbiturates, narcotics, hypnotics, and systemic anesthetics), because ELETTROLITICA REIDRATANTE Bioindustria L.I.M. may alter their effectiveness;
• aminoglycoside antibiotics, used to treat bacterial infections, as they may cause a marked reduction in voluntary muscle contraction (neuromuscular blockade);
• eltrombopag, used for circulation disorders, as ELETTROLITICA REIDRATANTE Bioindustria L.I.M. 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, felodipine, nicardipina, and nifedipine), used to treat high blood pressure, as excessive lowering of blood pressure (hypotension) may occur;
• ceftriaxone (an antibiotic), due to the risk of particle formation (calcium-ceftriaxone salt).
  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 suffer from a condition called toxemia of pregnancy, characterized by high blood pressure, swelling due to fluid accumulation, protein in the urine, and seizures, administration of this medicine may cause serious harm to your baby (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 Bioindustria L.I.M.

This medicine must be administered to you exactly as prescribed by your doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, pharmacist, or nurse.
ELETTROLITICA REIDRATANTE Bioindustria L.I.M. will be prepared by a doctor, pharmacist, or nurse and must not be mixed with, nor administered simultaneously to, injections containing ceftriaxone.
Before administration, this medicine must be shaken well.
ELETTROLITICA REIDRATANTE Bioindustria L.I.M. must be administered directly into a vein by infusion (intravenous infusion), and not via other routes of administration (intramuscular, subcutaneous, or into perivascular tissues). This medicine must be administered at a controlled rate (not exceeding 10 mEq potassium/hour) and with great caution (see section “Warnings and precautions”).

Adults:
The dose will be determined by your doctor based on your age, weight, and health condition.
Generally, the recommended dose for adults is 3 litres per day, administered at a rate of 1 litre per hour.
After the infusion of this medicine, remain lying down for a short period of time, as calcium chloride solution may cause vasodilation leading to a drop in blood pressure.
Immediately inform your doctor or nurse if you experience pain or redness at the injection site, as leakage of the injected 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 medicine is not recommended for you.

If you use more ELETTROLITICA REIDRATANTE Bioindustria L.I.M. than you should
If an excessive dose of this medicine is administered, the following side effects 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), which may affect 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 loss of heart activity (cardiac arrest);
• increased magnesium levels in the blood (hypermagnesaemia), with symptoms such as sudden sensation of warmth (flushing), sweating, low blood pressure (hypotension), loss of voluntary movement (flaccid paralysis), reduced body temperature (hypothermia), severe heart, circulatory, and brain problems (circulatory collapse, cardiac and central nervous system depression), and, in the most severe cases, respiratory paralysis (respiratory arrest);
• increased calcium levels (hypercalcaemia: plasma calcium concentrations greater than 2.6 mmol/l), 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 medicine, stop treatment immediately and contact your doctor or go to the nearest hospital without delay.

If you forget to use ELETTROLITICA REIDRATANTE Bioindustria L.I.M.
Do not administer a double dose to make up for a missed dose.
If you have any doubts 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 everyone experiences them.
The side effects that may occur are listed below:
Frequency not known (frequency cannot be estimated from the available data)

• Stomach and intestinal (gastrointestinal) disorders and irritation, thirst, reduced salivation, nausea, vomiting, diarrhoea, abdominal pain, constipation (stipsis, delayed intestinal transit, paralytic ileus), taste disturbances (metallic taste, chalky taste);
• Nerve and muscle (neuromuscular) disorders, muscle stiffness, altered sensation in arms and legs (paraesthesiae), 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 accumulation affecting legs and ankles (peripheral oedema), dilation of veins and arteries (vasodilation), sudden sensation of warmth (hot flushes), 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) and decreased levels of calcium in the blood (hypocalcaemia);
• Muscle weakness;
• Fever, redness, skin irritations (rash), pain or reaction and infection at the infusion site, formation of calcium deposits in tissues (cutaneous calcification), inflammation due to pus accumulation (abscesses), formation of blood clots in veins (venous thrombosis), venous irritation, 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 may occur, or the amount of urine produced may decrease.

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 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 ELETTROLITICA REIDRATANTE 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.
Store the bottles in their 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 you no longer use. This will help protect the environment.

6. Package contents and other information

What ELETTROLITICA REIDRATANTE Bioindustria L.I.M. contains

• The active substances are sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, sodium acetate trihydrate, sodium citrate. 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, 6.40 g of sodium acetate trihydrate and 0.75 g of sodium citrate.
• The other components are hydrochloric acid and water for injections.

Description of the appearance of ELETTROLITICA REIDRATANTE Bioindustria L.I.M. and contents of the
pack
Glass vial of 50 ml, 100 ml, 250 ml, 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 – 15067 Novi Ligure (AL) –
Italy

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Package leaflet: information for the physician

ELECTROLYTE REHYDRATION Bioindustria L.I.M. infusion solution III

Sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, sodium acetate trihydrate, sodium citrate
Equivalent medicine
The following information is intended exclusively for physicians or healthcare professionals

Incompatibilities
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 cloudiness;
• cefamandole: due to the presence of sodium carbonate in the cefamandole formulation;
• sodium ceftriaxone: due to precipitate formation; therefore, administration of calcium-containing solutions must not occur within 48 hours following ceftriaxone administration;
• cephalothin: due to physical incompatibility;
• cefradine: due to the presence of sodium carbonate in the cefradine formulation;
• chlorpheniramine: due to physical incompatibility;
• dobutamine: due to development of cloudiness;
• fat emulsion: due to presence of flocculation;
• sodium heparin;
• indomethacin: due to precipitate formation;
• sodium nitrofurantoin;
• promethazine: due to precipitate formation;
• propofol: due to precipitate formation;
• streptomycin: because 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 reactant concentrations and solution pH. Calcium salts may form complexes with many drugs, potentially leading to precipitate formation. Physical incompatibility has been reported with ceftriaxone.

Overdose
Treatment
Immediately discontinue the infusion and initiate corrective therapy to reduce plasma levels of the excess ions and, if necessary, restore acid-base balance (see Precautions for use).

The patient should be closely monitored for the appearance of any signs and symptoms related to the administered drug, ensuring appropriate symptomatic and supportive measures are provided as needed.

In case of severe hypernatremia, loop diuretics may be used.

In case of hyperkalemia, intravenous infusion of glucose (with or without insulin) or sodium bicarbonate may be administered.

In case of mild calcium chloride overdose, treatment includes immediate discontinuation of the infusion and of any other calcium-containing medication. In case of severe overdose (plasma concentrations >2.9 mmol/L), the following measures should be taken:

• rehydration by 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 (10–20 mL of a 5% solution) should be administered. Subcutaneous administration of 0.5–1 mg of physostigmine may be helpful. Elevated plasma electrolyte levels may require dialysis.

Special precautions for disposal and handling
Use immediately after opening the container. The container is intended for single, uninterrupted administration; any remaining solution must not be used.

Shake well before administration. Do not use the medicinal product if the solution is not clear and colourless or if it contains particles.

Observe all standard precautions to maintain sterility before and during intravenous infusion.

Special storage precautions
Vials: store in the original packaging and in a tightly closed container. Do not refrigerate or freeze.

For further information, consult the Summary of Product Characteristics.