Electrolyte rehydrating solution S.A.L.F.

Package leaflet: Information for the user

ELETTROLITICA REIDRATANTE S.A.L.F. infusion solution I

Sodium chloride, potassium chloride and sodium lactate
Equivalent medicine
Please read this leaflet carefully before 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 others, 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 S.A.L.F. is and what it is used for
2. What you need to know before using ELETTROLITICA REIDRATANTE S.A.L.F.
3. How to use ELETTROLITICA REIDRATANTE S.A.L.F.
4. Possible side effects
5. How to store ELETTROLITICA REIDRATANTE S.A.L.F.
6. Contents of the pack and other information

1. What ELETTROLITICA REIDRATANTE S.A.L.F. is and what it is used for

ELETTROLITICA REIDRATANTE S.A.L.F. 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 S.A.L.F. 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
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 S.A.L.F.

Do not use ELETTROLITICA REIDRATANTE S.A.L.F.

• if you are allergic to sodium chloride, potassium chloride, sodium lactate, or any of the other ingredients of this medicine (listed in section 6);
• if you suffer from 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 volume overload);
• if your blood potassium levels are high (hyperkalemia) or if 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, short-lived muscle cramps (heat cramps);
• if your blood is more acidic than normal due to lactic acid buildup (lactic acidosis);
• if you suffer from severe heart and circulatory problems (shock, hypoxia, oxidative metabolic disturbances preventing lactate utilization);
• if you have an accumulation of basic substances in your blood (metabolic and respiratory alkalosis).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using ELETTROLITICA REIDRATANTE S.A.L.F.
This medicine should be administered to you with particular caution if:

• you suffer from severe heart problems (heart failure, congestive cardiac decompensation), especially if you are taking medicines for certain heart conditions (digitalized patients);
• you suffer from severe kidney problems (reduced renal function, severe renal insufficiency);
• you have 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 (hydro-saline retention);
• you are taking medicines used to treat heart conditions (cardiac inotropic agents), inflammation and allergies (corticosteroids), or medicines that stimulate steroid hormone production (corticotropics) (See section “Other medicines and ELETTROLITICA REIDRATANTE S.A.L.F.”);
• you suffer from high blood pressure (hypertension);
• you are pregnant and have a condition called pre-eclampsia, characterized by high blood pressure, fluid retention-related swelling, and presence of protein in the urine;
• you are in a condition characterized by poor sodium excretion from the body (sodium retention) (See section “Other medicines and ELETTROLITICA REIDRATANTE S.A.L.F.”);
• you suffer from severe adrenal gland (adrenal insufficiency) or liver problems (hepatic insufficiency);
• a member of your family suffers from a disorder characterized by sudden episodes of muscle weakness (familial periodic paralysis);
• you have had from birth a serious condition characterized by prolonged muscle contractions (congenital myotonia);
• you have recently undergone surgery (early post-operative phase).

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 of particles. Any unused medicine must be discarded.
This medicine must be administered via very slow infusion, as potassium intoxication may occur, potentially leading to death due to loss of heart function (respiratory depression), heart rhythm disturbances (arrhythmias), up to complete cessation of heart activity (cardiac arrest) (See section “How to use ELETTROLITICA REIDRATANTE S.A.L.F.”).
During treatment with this medicine, your doctor should monitor:

• your heart activity through specific tests (serial electrocardiograms);
• your fluid balance (fluid balance), electrolyte levels, particularly sodium, as hospital-acquired hyponatremia may develop, and other substances in your body (plasma osmolarity, acid-base balance).

This medicine must be administered cautiously and under specific monitoring conditions due to the risk of reduced sodium concentration in plasma (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 syndrome of inappropriate antidiuretic hormone secretion (SIADH), or are undergoing treatment with vasopressin agonists. Acute hyponatremia can cause acute hyponatremic encephalopathy (cerebral edema), characterized by headache, nausea, seizures, lethargy, and vomiting. Patients with cerebral edema are at particularly high risk of severe, irreversible, and life-threatening brain damage. Children, women of childbearing age, and patients with reduced cerebral compliance (e.g., meningitis, intracranial hemorrhage, cerebral contusion) are particularly at risk of severe, life-threatening cerebral fluid accumulation (cerebral edema) caused by acute hyponatremia.

Children
There are insufficient data to establish the safety and efficacy of this medicine in children.
Other medicines and ELETTROLITICA REIDRATANTE S.A.L.F.
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
Use caution and inform your doctor, who should closely monitor your blood potassium levels, if you are taking:

• medicines that increase urine output while reducing potassium loss (potassium-sparing diuretics). These medicines, when taken together with ELETTROLITICA REIDRATANTE S.A.L.F., 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.

This medicine should be administered cautiously if you are taking:

• medicines that enhance the effect of vasopressin hormone, for example: chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics, chlorpropamide, NSAIDs, cyclophosphamide, desmopressin, oxytocin, vasopressin, terlipressin;
• diuretics in general and antiepileptic drugs (e.g., oxcarbazepine), as they may increase the risk of hyponatremia.

Additionally, use extreme caution and inform your doctor if you are being treated with medicines for allergies and inflammation (corticosteroids), as fluid retention-related swelling (edema) and increased blood pressure (hypertension) may occur (See section “Possible side effects”).
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor, pharmacist, or nurse before using this medicine.
If you are pregnant or breastfeeding, do not use this medicine unless absolutely necessary and under strict medical supervision.
ELETTROLITICA REIDRATANTE S.A.L.F. should be administered cautiously to pregnant women during labor, particularly regarding serum sodium levels, especially when administered concomitantly with oxytocin.
Driving and using machines
This medicine does not affect your ability to drive or operate machinery.

3. How to use ELETTROLITICA REIDRATANTE S.A.L.F.

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.
Monitoring of electrolyte balance, serum electrolytes, and acid-base balance may be required before and during administration, with particular attention to serum sodium levels if you suffer from syndrome of inappropriate antidiuretic hormone secretion (SIADH), or if you are receiving concomitant therapy with vasopressin agonists, due to the risk of hospital-acquired hyponatremia.
Monitoring of serum sodium is particularly important when hypotonic solutions are administered.
Before administration, this medicinal product must be shaken well.
ELETTROLITICA REIDRATANTE S.A.L.F. must be administered via intravenous infusion 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 according to 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, the use of this medicinal product is not recommended.

If you use more ELETTROLITICA REIDRATANTE S.A.L.F. than you should
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.
Following administration of an excessive dose of this medicinal product, the following may occur:

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

If you forget to use ELETTROLITICA REIDRATANTE S.A.L.F.
Do not use a double dose to make up for the forgotten dose.
If you have any doubts about how to use this medicinal product, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

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

• Gastrointestinal disorders, thirst, reduced salivation, nausea, vomiting, diarrhea, abdominal pain;
• Neuromuscular disorders, altered sensation in arms and legs (paresthesia), loss of muscle tone (flaccid paralysis), weakness, confusion, headache (cephalalgia), dizziness, restlessness, fever, irritability, weakness, muscle rigidity, seizures, coma, death, cerebral edema (acute hyponatremic encephalopathy*);
• Severe heart problems (arrhythmias, conduction disturbances, disappearance of the P wave, widening of the QRS complex on the electrocardiogram, cardiac arrest, tachycardia);
• Drowsiness, confusion;
• Breathing difficulties (dyspnea), respiratory arrest, fluid accumulation around the lungs causing swelling (pulmonary edema);
• Decreased tear production;
• Kidney problems (renal failure);
• Low or high blood pressure (hypotension, hypertension), swelling due to fluid accumulation in legs and ankles (peripheral edema);
• Increased levels of sodium (hypernatremia), chloride (hyperchloremia), and acidic substances (metabolic acidosis) in the blood, increased blood volume (hypervolemia), changes in certain blood parameters (hyperosmolarity), reduced levels of calcium in the blood (hypocalcemia), reduced levels of sodium in the blood (hospital-acquired hyponatremia*);
• Fever (febrile episodes), infection at the infusion site, pain or allergic reactions near the injection site, vein irritation, formation of blood clots in veins (venous thrombosis), inflammation of veins (venous phlebitis), leakage of the injected solution from the vein (extravasation), tissue damage and tissue death (tissue necrosis).

* Hospital-acquired hyponatremia can cause irreversible brain damage and death due to the development of acute hyponatremic encephalopathy.
Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You may also report adverse effects directly via the national reporting system at the following address:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. How to store ELETTROLITICA REIDRATANTE S.A.L.F.

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.
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. Contents of the pack and other information

What ELETTROLITICA REIDRATANTE S.A.L.F. contains

• The active substances are sodium chloride, potassium chloride, sodium lactate. 1 litre of solution (1000 ml) contains 9.66 g of 60% sodium lactate solution, 4 g of sodium chloride, 2.7 g of potassium chloride.
• The other component is water for injections.

Description of the appearance of ELETTROLITICA REIDRATANTE S.A.L.F. and contents of the
pack
Sterile, pyrogen-free infusion solution
Glass bottle of 500 ml.

Marketing Authorization Holder and Manufacturer:
S.A.L.F. S.p.A. Laboratorio Farmacologico – Via Marconi, 2 - Cenate Sotto (BG) - Tel. 035 -

The following information is intended exclusively for physicians or healthcare professionals

CLINICAL INFORMATION
Dosage and method of administration
The solution is isotonic with blood and must be administered by intravenous infusion with caution and at a controlled infusion rate.
Shake well before administration.
The dose depends on the patient's age, weight and clinical condition.
The medicinal product must be administered with caution only in patients with intact renal function and at a rate not exceeding 10 mEq of potassium per hour.
Adults
Generally, the dose is 2 litres/day, administered at an infusion rate of approximately 300 ml/hour.
Children
In children, the safety and efficacy of the medicinal product have not been established.
Special warnings and precautions for use
Due to the presence of sodium, use with caution in patients with congestive heart failure, severe renal failure and clinical conditions associated with edema and salt retention; in patients receiving cardiac inotropic drugs or corticosteroid or corticotropin drugs.
Sodium salts must be administered with caution in patients with hypertension, cardiac failure, peripheral or pulmonary edema, reduced renal function, pre-eclampsia or other conditions associated with sodium retention (see section 4.5 of the Summary of Product Characteristics).
Due to the presence of potassium, administration should be guided by serial electrocardiograms; serum potassium levels do not reflect intracellular potassium concentrations.
High plasma potassium concentrations may cause death due to cardiac depression, arrhythmias or arrest. To avoid potassium intoxication, the infusion must be slow.
The medicinal product must be administered with caution in patients:

• with renal impairment (administration of potassium-containing solutions in patients with reduced renal function may cause potassium retention);
• with cardiac failure, especially if digitalized;
• with adrenal insufficiency;
• with hepatic insufficiency;
• with familial periodic paralysis;
• with congenital myotonia;
• in the early postoperative phase.

Continuous monitoring of the electrocardiogram is essential during infusion. It is good practice to monitor fluid balance, electrolytes—particularly sodium, as hyponatremia acquired in hospital may develop—plasma osmolarity, and acid-base balance.
Use immediately after opening the container. The solution must be clear, colourless and free from visible particles. It is intended for single, uninterrupted administration; any residual solution must not be used.
Serum sodium monitoring is particularly important for physiologically hypotonic solutions. Elettrolitica reidratante S.A.L.F. solution for infusion I may become extremely hypotonic after administration.
Patients with non-osmotic vasopressin release (e.g. during acute illness, pain, postoperative stress, infections, burns and central nervous system disorders), patients with cardiac, hepatic or renal diseases, and patients treated with vasopressin agonists are particularly at risk of acute hyponatremia following infusion of hypotonic solutions.
Acute hyponatremia may cause acute hyponatremic encephalopathy (cerebral edema), characterized by headache, nausea, seizures, lethargy and vomiting. Patients with cerebral edema are particularly at risk of severe, irreversible and life-threatening brain injury.
Children, women of reproductive age and patients with reduced cerebral compliance (e.g. meningitis, intracranial haemorrhage and cerebral contusion) are particularly at risk of severe, life-threatening cerebral edema caused by acute hyponatremia.
Pregnancy
Elettrolitica reidratante S.A.L.F. solution for infusion I must be administered with particular caution in pregnant women during labour, especially if administered concomitantly with oxytocin, due to the risk of hyponatremia.
Overdose
Symptoms
Excessive administration of Elettrolitica reidratante may lead, depending on the patient's clinical condition, to hypernatraemia and/or hypervolemia and hyperkalaemia.
Hypernatraemia and excessive sodium retention, when impaired renal sodium excretion exists, lead to dehydration of internal organs, particularly the brain, and accumulation of extracellular fluid with edema affecting the cerebral, pulmonary and peripheral circulation, resulting in pulmonary and peripheral edema.
High plasma potassium concentrations may cause death due to cardiac depression, arrhythmias or arrest.
Treatment
Immediately discontinue the infusion and initiate corrective therapy to reduce plasma levels of the excess ions and restore, if necessary, acid-base balance (see section 4.4 of the Summary of Product Characteristics).
The patient should be closely monitored for the appearance of any signs and symptoms related to the administered medicinal product, with appropriate symptomatic and supportive measures provided as needed.
In cases of marked hypernatraemia, loop diuretics may be used.
In cases of hyperkalaemia, intravenous glucose (with or without insulin) or sodium bicarbonate may be administered.
Markedly elevated plasma electrolyte levels may require dialysis.
Incompatibilities
The prescribing physician should refer to the scientific literature.
Interactions
Medicinal products that may increase the risk of hospital-acquired hyponatremia following inadequately balanced intravenous fluid therapy include:

• drugs stimulating vasopressin release, e.g.: chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics;
• drugs potentiating vasopressin action, e.g.: chlorpropamide, NSAIDs, cyclophosphamide;
• vasopressin analogues: desmopressin, oxytocin, vasopressin, terlipressin. Other drugs increasing the risk of hyponatremia include diuretics in general and antiepileptic drugs such as oxcarbazepine.

Shelf life
Glass vials: 24 months
Use the solution immediately after opening the container. It is intended for single, uninterrupted administration; any residual solution must not be used.
Special precautions for storage
Store in the original packaging and in a tightly closed container. Do not refrigerate or freeze.
The expiry date refers to the product stored in its original, undamaged packaging under recommended conditions. Do not use after this date.
Special precautions for disposal and handling
Shake well before administration. Do not use the medicinal product if the solution is not clear and colourless or if it contains particles.
Adopt all standard precautions to maintain sterility before and during intravenous infusion.
Unused medicinal product and waste materials derived from this medicinal product must be disposed of in accordance with local regulations.
For further information, consult the Summary of Product Characteristics.

Package leaflet: Information for the user

ELECTROLYTE REHYDRATION S.A.L.F. infusion solution III

sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, sodium acetate
trihydrate, sodium citrate dihydrate
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 may 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 S.A.L.F. is and what it is used for
2. What you need to know before using ELETTROLITICA REIDRATANTE S.A.L.F.
3. How to use ELETTROLITICA REIDRATANTE S.A.L.F.
4. Possible side effects
5. How to store ELETTROLITICA REIDRATANTE S.A.L.F.
6. Package contents and other information

1. What ELETTROLITICA REIDRATANTE S.A.L.F. is and what it is used for

ELETTROLITICA REIDRATANTE S.A.L.F. 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). Additionally, calcium is a key component of bones.
ELETTROLITICA REIDRATANTE S.A.L.F. is indicated for the treatment of fluid and electrolyte deficiency in the body (fluid and electrolyte replacement) 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 S.A.L.F.

Do not use ELETTROLITICA REIDRATANTE S.A.L.F.

• if you are allergic 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 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 heart rhythm disorder (ventricular fibrillation), as calcium may worsen this condition;
• if you suffer from severe liver problems (severe hepatic insufficiency, inability to metabolize acetate ions);
• if you have an accumulation of alkaline substances in your blood (metabolic and 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 (cardiac glycosides);
• if you suffer from a disease characterized by insufficient hormone production by the adrenal glands and are not receiving treatment for it (untreated Addison's disease);
• if you have severe fluid loss (acute dehydration);
• if you experience painful, short-lasting muscle cramps (heat cramps);
• if the patient is a newborn (≤ 28 days of age), ELETTROLITICA REIDRATANTE S.A.L.F. (or other solutions containing calcium) must not be administered simultaneously with ceftriaxone (an antibiotic), even if separate infusion lines are used. There is a fatal risk of particle formation in the newborn's bloodstream.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using ELETTROLITICA REIDRATANTE S.A.L.F.
This medicine must be administered via a 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 REIDRATANTE S.A.L.F.").
The medicine must be administered immediately after opening the container, through a single, uninterrupted administration, and only if the solution is clear, colorless, and free of particles. Any unused 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 suffer from high blood pressure (hypertension);
• you suffer from severe kidney problems (reduced renal function, severe renal insufficiency);
• 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 (hydrosaline retention);
• you are taking medicines used to treat heart conditions (cardiotonic inotropic drugs), inflammation, and allergies (corticosteroids), or medicines that stimulate steroid hormone production (corticotropins) (See section "Other medicines and ELETTROLITICA REIDRATANTE S.A.L.F.");
• you are pregnant and suffer from a condition called pre-eclampsia, characterized by high blood pressure, swelling due to fluid accumulation, and presence of proteins in the urine;
• you suffer from conditions associated with sodium retention.

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

• you suffer from severe kidney problems (renal insufficiency, adrenal insufficiency);
• you suffer from heart problems (heart failure);
• you are taking medicines for the treatment of certain heart conditions (digitalized patients). In this case, especially if the medicine is used for prolonged periods, serious heart rhythm disturbances may occur;
• you suffer from liver problems (hepatic insufficiency);
• a member of your family 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 low 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 an increased blood acidity (respiratory acidosis);
• you experience severe difficulty breathing (respiratory failure), as calcium is a substance that increases blood acidity; be cautious, as all 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 insufficiency), severe fluid loss (dehydration), or an imbalance of electrolytes 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 (severe myasthenia gravis);
• you suffer from kidney problems (renal insufficiency);
• you suffer from heart problems (heart failure);
• you are taking medicines for the treatment of 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).

During treatment with ELETTROLITICA REIDRATANTE S.A.L.F., 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;
• blood levels of calcium and magnesium;
• calcium levels in the urine, to prevent high urinary calcium levels (hypercalciuria), which may lead to high blood calcium levels (hypercalcemia).

Children
There are insufficient data to establish the safety and efficacy of this medicine in children.
Other medicines and ELETTROLITICA REIDRATANTE S.A.L.F.
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 S.A.L.F., 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, 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 (See section "Do not use ELETTROLITICA REIDRATANTE S.A.L.F.") as the risk of heart rhythm disturbances (arrhythmias) is higher (See section "Do not use ELETTROLITICA REIDRATANTE S.A.L.F.");
• calcium channel blockers (verapamil), used to treat high blood pressure, as ELETTROLITICA REIDRATANTE S.A.L.F. may reduce their effectiveness;
• medicines containing magnesium, as increased blood levels of calcium (hypercalcemia) and magnesium (hypermagnesemia) may occur, especially if you have kidney problems (renal disorders);
• neuromuscular blockers (tubocurarine), used to reduce muscle contractions, as ELETTROLITICA REIDRATANTE S.A.L.F. may increase or reduce their effectiveness;
• medicines that reduce brain activity (barbiturates, narcotics, hypnotics, and systemic anesthetics), as ELETTROLITICA REIDRATANTE S.A.L.F. may alter their effectiveness;
• aminoglycoside antibiotics, used to treat bacterial infections, as marked reduction in voluntary muscle contraction (neuromuscular blockade) may occur;
• eltrombopag, used for circulation disorders, as ELETTROLITICA REIDRATANTE S.A.L.F. may reduce its effectiveness;
• rocuronium, used for anesthesia during surgical procedures, 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 in the blood.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor, pharmacist, or nurse before using this medicine.
If you are pregnant or breastfeeding, do not use this medicine unless absolutely necessary and under strict medical supervision.
Driving and using machines
This medicine does not impair the ability to drive or operate machinery.

3. How to use ELETTROLITICA REIDRATANTE S.A.L.F.

This medicine must be administered to you exactly as directed by your
doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, pharmacist, or
nurse.
ELETTROLITICA REIDRATANTE S.A.L.F. 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 REIDRATANTE S.A.L.F. must be administered directly into a vein via intravenous infusion, and not by any other route 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 infusion of this medicine, remain lying down.
Immediately inform your doctor or nurse 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 medicine is not recommended for you.
If you use more ELETTROLITICA REIDRATANTE S.A.L.F. than you should
If you accidentally receive an excessive amount of this medicine, stop treatment immediately and contact your doctor or go to the nearest hospital without delay.
Following administration of an excessive dose of this medicine, the following may occur:

• increased levels of sodium in the blood (hypernatraemia) and/or circulatory disturbances (hypervolaemia), which may cause dehydration of certain internal organs, particularly the brain, and swelling due to fluid accumulation (oedema), which may affect the lungs (pulmonary oedema), cerebral circulation, or legs and ankles (peripheral oedema);
• increased levels of potassium 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 levels of magnesium in the blood (hypermagnesaemia), with symptoms such as sudden sensation of warmth (flushing), sweating, low blood pressure (hypotension), loss of voluntary muscle movement (flaccid paralysis), decreased 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 paralysis (respiratory arrest);
• increased levels of calcium (hypercalcaemia), particularly 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 the most severe cases, disturbances in heart rhythm (cardiac arrhythmia) and profound unconsciousness (coma).

If you forget to use ELETTROLITICA REIDRATANTE S.A.L.F.
Do not use a double dose to make up for a 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 will experience them.
The side effects that may occur are listed below:
Frequency not known (frequency cannot be estimated from the available data)

• Gastrointestinal disorders, thirst, reduced salivation, nausea, vomiting, diarrhoea, abdominal pain, constipation (stipsis, 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 accumulation affecting legs and ankles (peripheral oedema), dilation of blood vessels (vasodilation), sudden sensation of heat (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), formation of blood clots in veins (venous thrombosis), inflammation of veins (venous phlebitis), also in areas near the infusion site, leakage of the injected solution from the vein (extravasation), tissue damage and tissue death (tissue necrosis);

• If this medicine is administered together with ceftriaxone, it may cause formation of calcium-ceftriaxone deposits in the kidneys and gallbladder. This can lead to: kidney problems (renal failure, pain when urinating, reduced urine output), pain, nausea and vomiting.

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
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 REIDRATANTE S.A.L.F.

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 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 S.A.L.F. contains

• The active substances are: sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, sodium acetate trihydrate, sodium citrate dihydrate. Each liter (1000 ml) of solution contains: 5 g sodium chloride, 0.75 g potassium chloride, 0.35 g calcium chloride dihydrate, 0.31 g magnesium chloride hexahydrate, 6.40 g sodium acetate trihydrate, and 0.75 g sodium citrate dihydrate.
• The other components are: hydrochloric acid and water for injections.

Description of the appearance of ELETTROLITICA REIDRATANTE S.A.L.F. and contents of the
package
Sterile, pyrogen-free infusion solution.
Glass vial of 250 ml and 500 ml.
Polypropylene vial of 500 ml.
Bag of 500 ml.
15 plastic bags of 500 ml.
10 plastic bags of 1000 ml.

Marketing Authorization Holder and Manufacturer
S.A.L.F. S.p.A. Laboratorio Farmacologico – Via Marconi, 2 - Cenate Sotto (BG) - Italy

The following information is intended exclusively for physicians or healthcare professionals

Dosage and administration
The solution is isotonic with blood and must be administered by intravenous infusion with caution and at a controlled infusion rate.
Shake well before administration.
The dose depends on the patient's age, weight, and clinical condition.
The medicinal product must be administered only in the presence of intact renal function and at a rate not exceeding 10 mEq of potassium per hour.
Adults
Generally, the dose is 3 liters/day, administered at an infusion rate of approximately 1 liter per hour.
Children
In children, the safety and efficacy of the medicinal product have not been established.
Do not inject intramuscularly, subcutaneously, or into perivascular tissues.
Administration must be discontinued if the patient experiences pain or redness at the injection site, as this may indicate drug extravasation.
Excessively rapid infusions may cause local pain, and the infusion rate should be adjusted according to tolerance.
It is advisable for the patient to remain lying down for a short period after administration.

Special warnings and precautions for use
Due to the presence of sodium, use with caution in patients with congestive heart failure, severe renal insufficiency, and clinical conditions associated with edema and salt retention; in patients receiving cardiac inotropic drugs or corticosteroid or corticotropin drugs.
Sodium salts should be administered cautiously in patients with hypertension, cardiac failure, peripheral or pulmonary edema, reduced renal function, pre-eclampsia, or other conditions associated with sodium retention (see section 4.5 of the Summary of Product Characteristics).
Due to the presence of potassium, administration should be guided by serial electrocardiograms; serum potassium levels do not reflect intracellular potassium concentrations.
High plasma potassium concentrations may cause death due to cardiac depression, arrhythmias, or cardiac arrest. To avoid potassium intoxication, the infusion must be slow.
The medicinal product must be administered with caution in patients:

• with renal insufficiency (administration of potassium-containing solutions in patients with impaired renal function may cause potassium retention);
• with cardiac insufficiency, especially if digitalized;
• with adrenal insufficiency;
• with hepatic insufficiency;
• with familial periodic paralysis;
• with congenital myotonia;
• in the early postoperative period.

Due to the presence of calcium, the medicinal product must be used with great caution in patients:

• with renal diseases;
• with cardiac diseases;
• who have received blood transfusions, as calcium ion concentrations may differ from expected values.

Since calcium chloride is an acidifying agent, caution is required when administering it in conditions such as renal disease, cor pulmonale, respiratory acidosis, or respiratory failure, where acidification may worsen the clinical picture. Administration of calcium chloride may cause vasodilation leading to a drop in blood pressure.
Calcium chloride solution is irritating and therefore must not be administered intramuscularly, subcutaneously, or into perivascular tissue, as tissue necrosis may occur.
Plasma calcium concentrations and urinary calcium levels should be monitored frequently to avoid hypercalciuria, as hypercalciuria may progress to hypercalcemia.
Due to the presence of magnesium, the medicinal product must be administered with caution in patients:

• with renal insufficiency;
• with cardiac insufficiency, especially if digitalized;
• with myasthenia gravis;
• receiving central nervous system depressants or neuromuscular blocking agents.

Due to the presence of acetate, use with caution in patients with metabolic or respiratory alkalosis and in conditions where there is increased level or inadequate utilization of this ion, such as in mild to moderate hepatic insufficiency.
During infusion of the medicinal product, it is essential to monitor:

• Electrocardiographic tracing;
• fluid balance and electrolytes;
• plasma osmolarity;
• blood pressure;
• acid-base balance;
• osteotendinous reflexes (to monitor for possible respiratory paralysis);
• serum magnesium levels (ensuring they do not exceed normal values).

Pregnancy and lactation
The medicinal product must not be used during pregnancy or lactation unless absolutely necessary and only after careful assessment of the risk/benefit ratio.
Avoid use of magnesium within 2 hours before delivery. If magnesium chloride is administered (particularly for more than 24 hours before delivery) to control seizures in mothers with toxemia of pregnancy, newborns may show signs of magnesium toxicity, including neuromuscular and respiratory depression.

Overdose
Symptoms
High plasma potassium concentrations may cause death due to cardiac depression, arrhythmias, or cardiac arrest.
Excessive administration of sodium chloride may lead, depending on the patient's clinical condition, to hypernatremia and/or hypervolemia. Hypernatremia and excessive sodium retention, when renal excretion of sodium is impaired, result in dehydration of internal organs, particularly the brain, and accumulation of extracellular fluid with edema affecting the cerebral, pulmonary, and peripheral circulation, potentially causing pulmonary and peripheral edema.
In case of excessive administration of magnesium chloride, the following symptoms of intoxication may occur: flushing, sweating, hypotension, flaccid paralysis, hypothermia, circulatory collapse, cardiac and central nervous system depression, which may progress to respiratory paralysis.
Magnesium intoxication manifests with a transient rise in blood pressure and respiratory paralysis. Disappearance of the patellar reflex is a useful clinical sign indicating the onset of intoxication.
In case of excessive administration of calcium chloride, hypercalcemia may occur, especially in patients with renal disease. Typical symptoms of hypercalcemia include thirst, nausea, vomiting, constipation, polyuria, abdominal pain, muscle weakness, mental disturbances, and in severe cases, cardiac arrhythmias and coma. Hypercalcemia is defined as plasma calcium concentrations exceeding 2.6 mmol/L; therefore, such concentrations must be monitored continuously.

Treatment
Immediately discontinue the infusion and initiate corrective therapy to reduce plasma levels of excess ions and, if necessary, restore acid-base balance (see section 4.4 of the Summary of Product Characteristics).
The patient should be kept under observation for the appearance of any signs and symptoms related to the administered drug, providing symptomatic and supportive measures as required.
In case of elevated natremia, loop diuretics may be used.
In case of hyperkalemia, glucose (with or without insulin) or sodium bicarbonate may be administered by intravenous infusion.
In case of mild overdose of calcium chloride, treatment involves immediate discontinuation of the infusion and any other calcium-containing medication. In case of severe overdose (plasma concentrations >2.9 mmol/L), the following measures should be taken:

• rehydration with 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 arrhythmias;
• hemodialysis if necessary.

In case of magnesium overdose, artificial ventilation is required. To counteract the effects of hypermagnesemia, calcium must be administered intravenously (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
Due to the presence of calcium chloride, the medicinal product is incompatible with:

• magnesium sulfate: formation of a precipitate;
• phosphate-containing drugs: formation of calcium phosphate precipitate;
• carbonate-containing drugs: formation of calcium carbonate precipitate;
• tartrate-containing drugs: formation of calcium tartrate precipitate.

Incompatibilities of calcium chloride have been reported with:

• aminophylline: due to precipitate formation;
• amphotericin B: due to development of cloudiness;
• cefamandole: due to presence of sodium carbonate in cefamandole formulation;
• sodium ceftriaxone: due to precipitate formation; therefore, calcium-containing solutions must not be administered within 48 hours after ceftriaxone;
• cephalothin: due to physical incompatibility;
• cefradine: due to presence of sodium carbonate in cefradine formulation;
• chlorpheniramine: due to physical incompatibility;
• dobutamine: due to development of cloudiness;
• 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: as 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 4.3, 4.5, and 4.8 of the Summary of Product Characteristics).
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, tartrates, as precipitates may form. Potential incompatibility is often influenced by changes in reagent concentration and solution pH.

Shelf life
Use the solution immediately after opening the container. It is intended for single, uninterrupted administration; any remaining solution must not be reused.

Special precautions for storage
Store in the original packaging and in a tightly closed container. Do not refrigerate or freeze.
The expiry date refers to the product in intact packaging and properly stored. Do not use after this date.

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 contains particles.
Adopt all standard precautions to maintain sterility before and during intravenous infusion.
Unused medicinal product and waste materials derived from it must be disposed of in accordance with local regulations.

For further information, consult the Summary of Product Characteristics.