Electrolyte balanced enteral solution Monico

PACKAGE LEAFLET: INFORMATION FOR THE USER

ELETTROLITICA EQUILIBRATA ENTERICA MONICO

Infusion solution
Sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, sodium acetate trihydrate
Equivalent medicine
Please read all of 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 pass it on 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 EQUILIBRATA ENTERICA MONICO is and what it is used for
2. What you need to know before using ELETTROLITICA EQUILIBRATA ENTERICA MONICO
3. How to use ELETTROLITICA EQUILIBRATA ENTERICA MONICO
4. Possible side effects
5. How to store ELETTROLITICA EQUILIBRATA ENTERICA MONICO
6. Contents of the pack and other information

1. What ELETTROLITICA EQUILIBRATA ENTERICA MONICO is and what it is used for

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

2. What you need to know before using ELETTROLITICA EQUILIBRATA ENTERICA MONICO

Do not use ELETTROLITICA EQUILIBRATA ENTERICA MONICO

• if you are allergic to sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, sodium acetate trihydrate, or 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 kidney problems (severe renal failure, oliguric renal failure);
• if your sodium levels in the blood are high (hypernatremia);
• if you have excessive amounts of salts or fluids in your blood (hydro-saline plethora);
• if your potassium levels in the blood are high (hyperkalemia) or your body cannot eliminate potassium (potassium retention);
• if you have a heart rhythm disorder (ventricular fibrillation);
• if you suffer from severe liver problems (severe hepatic insufficiency, inability to metabolize the acetate ion);
• if you suffer from heart problems (severe myocardial disease);
• if you suffer from breathing problems (respiratory rate less than 16 breaths per minute);
• if you have an accumulation of basic substances in the blood (metabolic and respiratory alkalosis);
• if you suffer from kidney stones;
• if you suffer from a disease called sarcoidosis, characterized by coughing, bleeding, and difficulty breathing;
• if you have blood clotting 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 the patient is in a coma;
• if you experience painful, short-term muscle cramps (heat cramps);
• if the patient is a newborn (≤ 28 days of age), ELETTROLITICA EQUILIBRATA ENTERICA MONICO (or other calcium-containing solutions) 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.

If you have recently received blood transfusions, this solution must not be administered through the same infusion catheter as whole blood due to the possible risk of coagulation.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before using ELETTROLITICA EQUILIBRATA ENTERICA MONICO.

This medicine must be administered via very slow intravenous infusion, as potassium intoxication may occur, which could lead to death due to loss of heart function (cardiac depression), irregular heartbeat (arrhythmias), up to complete cessation of heart activity (cardiac arrest) (see section “How to use ELETTROLITICA EQUILIBRATA ENTERICA MONICO”).

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 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 heart failure);
• you suffer from high blood pressure (hypertension);
• you suffer from severe kidney problems (reduced kidney 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 cardiac drugs), inflammation and allergies (corticosteroids), or medicines that stimulate the production of steroid hormones (corticotropic agents) (see section “Other medicines and ELETTROLITICA EQUILIBRATA ENTERICA MONICO”);
• you are pregnant and suffer from a condition called pre-eclampsia (gestosis), characterized by high blood pressure, swelling due to fluid accumulation, and presence of proteins in the urine.

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

• you suffer from severe kidney problems (renal failure, adrenal insufficiency), as this may reduce your ability to eliminate potassium (potassium retention);
• you suffer from heart problems (heart failure);
• you are taking medicines for certain heart conditions (digitalized patients). In this case, especially if the medicine is used for long periods, serious heart rhythm problems may occur;
• you suffer from adrenal insufficiency;
• you suffer from liver problems (hepatic insufficiency);
• a member of your family suffers from a disorder characterized by sudden attacks of muscle weakness (familial periodic paralysis);
• you were born with a severe condition characterized by prolonged muscle contraction (congenital myotonia);
• you have recently undergone surgery (early post-operative phase).

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

• you suffer from kidney problems (renal diseases);
• you suffer from heart problems (cardiac diseases), as this increases the risk of irregular heartbeat 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 an increased level of acidity in the blood (respiratory acidosis);
• you experience severe difficulty breathing (respiratory failure); since 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 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);
• you are taking medicines for certain heart conditions (digitalized patients);
• you are being treated with medicines that reduce brain activity (central nervous system depressants) or reduce muscle contraction (neuromuscular blockers).

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

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

During treatment with ELETTROLITICA EQUILIBRATA ENTERICA MONICO, 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 the body;
• blood pressure (arterial pressure);
• your muscle reflexes (osteotendinous reflexes), as respiratory arrest (respiratory paralysis) may occur;
• calcium and magnesium levels in the blood;
• calcium levels in the 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 EQUILIBRATA ENTERICA MONICO
Inform your doctor, pharmacist, or nurse if you are using, have recently used, or might use any other medicines.

Use caution and inform your doctor, who should closely monitor your blood potassium levels, if you are taking:

• medicines that promote urine elimination and reduce potassium loss (potassium-sparing diuretics). These medicines, if taken together with ELETTROLITICA EQUILIBRATA ENTERICA MONICO, especially if you have kidney problems (renal dysfunction), may cause an increase in blood potassium levels (hyperkalemia);
• medicines used to lower blood pressure (ACE inhibitors), as they may reduce potassium elimination (potassium retention). Frequent monitoring of blood potassium levels is necessary.

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 they may cause reduced calcium excretion through the kidneys, leading to excessive calcium levels in the blood (hypercalcemia);
• cardiotonic glycosides (digoxin and digitoxin), used to treat heart conditions (see section “Do not use ELETTROLITICA EQUILIBRATA ENTERICA MONICO”) as the risk of heart rhythm disorders (arrhythmias) is higher (see section “Do not use ELETTROLITICA EQUILIBRATA ENTERICA MONICO”);
• calcium channel blockers (verapamil), used to treat high blood pressure, as ELETTROLITICA EQUILIBRATA ENTERICA MONICO may reduce their effectiveness;
• neuromuscular blockers (tubocurarine), used to reduce muscle contractions, as ELETTROLITICA EQUILIBRATA ENTERICA MONICO may increase or decrease their effectiveness;
• medicines that reduce brain activity (barbiturates, narcotics, hypnotics, and systemic anesthetics), as ELETTROLITICA EQUILIBRATA ENTERICA MONICO may alter their effectiveness, since magnesium may enhance the depressant effect on the central nervous system;
• aminoglycoside antibiotics, used to treat bacterial infections, as a marked reduction in voluntary muscle contraction (neuromuscular blockade) may occur;
• eltrombopag, used for circulation disorders, as ELETTROLITICA EQUILIBRATA ENTERICA MONICO 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 a decrease in heart rate (bradycardia), reduced heart activity (cardiac output), shortness of breath, dizziness, and temporary loss of consciousness (fainting) may occur;
• calcium antagonists (isradipine, felodipina, 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.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor, pharmacist, or nurse before using this medicine, as it should only be used if your doctor considers it truly necessary.

This medicine must not be administered within 2 hours before delivery.

If you are pregnant and suffer from a condition called gestational toxemia, characterized by high blood pressure, fluid retention, protein in the urine, and seizures, administration of this medicine may cause serious harm to your baby (neuromuscular depression, respiratory depression).

Driving and using machines
This medicine does not affect the ability to drive or operate machinery.

3. How to use ELETTROLITICA EQUILIBRATA ENTERICA MONICO

You must be given this medicine exactly as directed by your doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, pharmacist, or nurse.
ELETTROLITICA EQUILIBRATA ENTERICA MONICO will be prepared by a doctor, pharmacist, or nurse and must not be mixed with, nor administered simultaneously to, injections containing ceftriaxone.
The medicine must be shaken well before administration.
ELETTROLITICA EQUILIBRATA ENTERICA MONICO must be administered directly into a vein by infusion (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. Too rapid infusions may cause local pain, and the infusion rate should be adjusted according to your tolerance.
Adults
The dose will be determined by your doctor based on your age, body weight, and health condition.
Generally, the recommended dose for adults is 20 ml of solution per kg of body weight per day.
After receiving this medicine, remain lying down for a short period of time.
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; in such case, administration must be stopped (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 EQUILIBRATA ENTERICA MONICO than you should
Following an overdose of this medicine, the following may occur:

• increased levels of sodium in the blood (hypernatremia) and/or circulatory disturbances due to increased volume of circulating blood (hypervolemia). Elevated sodium levels (hypernatremia) and reduced ability to excrete sodium from the body may cause dehydration of certain internal organs, particularly the brain, and fluid accumulation leading to swelling (edema), which may affect the lungs (pulmonary edema), cerebral circulation, or legs and ankles (peripheral edema);
• increased levels of potassium in the blood (hyperkalemia), which may lead to death due to reduced heart function (cardiac depression), irregular heartbeat (arrhythmias), and loss of heart activity (cardiac arrest);
• increased levels of magnesium in the blood (hypermagnesemia), with symptoms such as sudden sensation of warmth (flushing), sweating, low blood pressure (hypotension), loss of voluntary muscle movement (flaccid paralysis), lowered body temperature (hypothermia), severe problems affecting the heart, circulation, and brain (circulatory collapse, cardiac and central nervous system depression), and, in the most severe cases, respiratory failure (respiratory paralysis);
• increased levels of calcium (hypercalcemia), 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 the most severe cases, irregular heartbeat (cardiac arrhythmia) and profound 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 EQUILIBRATA ENTERICA MONICO
Do not take a double dose to make up for the missed 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, ELETTROLITICA EQUILIBRATA ENTERICA MONICO can cause side effects, although not everybody experiences 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 (stasis, delayed intestinal transit, paralytic ileus), taste disturbances (metallic taste, chalky taste);
• Neuromuscular disorders, muscle stiffness, altered sensation in arms and legs (paraesthesia), loss of muscle tone (flaccid paralysis), weakness, mental confusion, headache (cephalalgia), dizziness, restlessness, irritability, seizures, coma, death;
• Drowsiness, mental disorders;
• Serious 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 heat (hot flushes), sweating, serious circulatory problems (shock);
• Increased levels of sodium (hypernatraemia), chloride (hyperchloraemia), and blood volume (hypervolaemia);
• Serious 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);
• Decreased levels of calcium in the blood (hypocalcaemia), 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 forming in tissues (cutaneous calcification), inflammation due to pus accumulation (abscesses), formation of blood clots in veins (venous thrombosis), inflammation and irritation of veins (venous phlebitis), even in areas near the infusion site, leakage of the infused solution from the vein (extravasation), tissue damage and tissue death (tissue necrosis);
• Kidney problems caused by calcium-ceftriaxone deposits. Pain during urination or reduced urine output may occur.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ELETTROLITICA EQUILIBRATA ENTERICA MONICO

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after "EXP.".
The expiry date refers to the last day of that month.
Store the bottles 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 EQUILIBRATA ENTERICA MONICO contains

• The active substances are: sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, sodium acetate trihydrate. Each litre of solution (1000 ml) contains: 5.0 g of sodium chloride, 0.75 g of potassium chloride, 0.35 g of calcium chloride dihydrate, 0.31 g of magnesium chloride hexahydrate, 6.4 g of sodium acetate trihydrate. Each litre of solution contains 133 mEq/litre of sodium, 10 mEq/litre of potassium, 5 mEq/litre of calcium, 3 mEq/litre of magnesium, 103 mEq/litre of chloride, 47 mEq/litre of acetate. pH 5.0 ÷ 7.0.
• The other components are hydrochloric acid and water for injections.

Description of the appearance of ELETTROLITICA EQUILIBRATA ENTERICA MONICO and contents of the
packaging
Glass flasks of 50 ml, 100 ml, 250 ml, 500 ml, 1000 ml.
Plastic bags of 50 ml, 100 ml, 250 ml, 500 ml, 1000 ml.
Marketing Authorization Holder and Manufacturer
MONICO SPA – Via Ponte di Pietra 7, 30173 – VENEZIA/MESTRE - Italy

The following information is intended for healthcare professionals only

Warnings and precautions
Due to the risk of hospital-acquired hyponatremia, monitoring of electrolyte balance, serum electrolytes, and acid-base balance should be considered before and during administration, with particular attention to serum sodium levels, in patients with non-osmotic release of vasopressin (syndrome of inappropriate antidiuretic hormone secretion, SIADH) and in patients receiving concomitant therapy with vasopressin agonists.
Monitoring of serum sodium is especially important when administering hypotonic solutions.
The infusion rate and volume depend on the patient's age, weight, and clinical condition (e.g., burns, surgical procedures, head injuries, infections), and concomitant therapy must be determined by a physician experienced in pediatric intravenous fluid therapy.
Infusion of large volumes should be used with specific monitoring in patients with cardiac or pulmonary insufficiency and in patients with non-osmotic vasopressin release (including SIADH), due to the risk of hospital-acquired hyponatremia.
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 disease, and patients treated with vasopressin agonists are particularly at risk of acute hyponatremia following infusion of hypotonic solutions.
Acute hyponatremia may lead to 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 reproductive age, and patients with reduced cerebral compliance (e.g., meningitis, intracranial hemorrhage, cerebral contusion, and cerebral edema) are particularly at risk of severe, life-threatening cerebral edema caused by acute hyponatremia.

Interactions
Medicinal products that may reduce renal electrolyte-free water excretion and increase the risk of hospital-acquired hyponatremia during 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 the action of vasopressin, e.g.: chlorpropamide, NSAIDs, cyclophosphamide;
• vasopressin analogs, e.g.: desmopressin, oxytocin, vasopressin, terlipressin.
  Other medicinal products that increase the risk of hyponatremia also include diuretics in general and antiepileptic drugs such as oxcarbazepine.

Pregnancy
Elettrolitica Equilibrata Enterica MONICO should be administered with particular caution to pregnant women during labor, especially with regard to serum sodium levels, when administered concomitantly with oxytocin.