Balanced electrolyte solution pediatric Monico

Package leaflet: Information for the user

ELETTROLITICA EQUILIBRATA PEDIATRICA MONICO

Infusion solution
Sodium acetate trihydrate, potassium chloride, magnesium chloride hexahydrate,
dipotassium phosphate, glucose monohydrate
Equivalent medicine
Please read all of this leaflet carefully before this medicine is administered to your child, because it contains important information for your child.

• 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 only for your child. Do not give it to other people, even if their symptoms are the same, as it may be harmful.
• If any adverse reaction occurs, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

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

ELETTROLITICA EQUILIBRATA PEDIATRICA MONICO is an infusion solution intended for direct intravenous injection (intravenous infusion), containing a combination of active substances: sodium acetate trihydrate, potassium chloride, magnesium chloride hexahydrate, potassium dibasic phosphate, glucose monohydrate.
This medicinal product is indicated to provide water and electrolytes to the body in situations where a caloric intake must be ensured, and for the treatment of mild states of metabolic acidosis, a condition characterized by increased blood acidity.

2. What you need to know before using ELETTROLITICA EQUILIBRATA PEDIATRICA

MONICO
ELETTROLITICA EQUILIBRATA PEDIATRICA MONICO must not be
administered to your child:

• if he or she is allergic to the active substances or to any of the other components of this medicine (listed in section 6);
• if he or she has high levels of potassium in the blood (hyperkalemia) or reduced ability to eliminate potassium from the body (potassium retention);
• if he or she has severe liver problems (severe hepatic insufficiency) leading to inability to metabolize the acetate ion;
• if he or she has severe kidney problems (severe renal insufficiency);
• if he or she has difficulty urinating (oliguric renal failure, anuria);
• if he or she has severe heart problems;
• if he or she has an increased blood pH (metabolic and respiratory alkalosis);
• if he or she has breathing difficulties (respiratory rate lower than the physiological rate expected for the specific age group);
• if he or she has circulatory problems due to a high tendency of blood to clot (hypercoagulability);
• if he or she is taking cardiac glycosides, medicines used to treat heart problems;
• if he or she has bleeding into the tissues forming the brain or spinal cord (intracranial or spinal hemorrhage);
• if he or she suffers from mental disorders characterized by hallucinations, tremors, sweating (delirium tremens), especially if dehydrated;
• if he or she has low levels of fluids in the body (severe dehydration);
• if the patient is in a coma;
• if he or she suffers from a disease of the adrenal glands (Addison's disease) and is not undergoing treatment for it;
• if he or she experiences painful, brief muscle cramps (heat cramps).

During blood transfusions, this medicine must not be administered through the same infusion catheter as whole blood due to the possible risk of red blood cell aggregation (pseudoagglutination).
Warnings and precautions
Consult your child’s treating physician, pharmacist, or nurse before administering ELETTROLITICA EQUILIBRATA PEDIATRICA MONICO.
This medicine must be administered with extreme caution in newborns and children with low body weight, as it may increase blood glucose levels (hyperglycemia). Additionally, in children with low body weight, rapid or excessive intravenous infusion may cause increased concentration of mineral salts in the blood (serum osmolarity) and cerebral hemorrhage due to rupture of blood vessels (intracerebral hemorrhage).
This medicine must be administered via a very slow intravenous infusion (endovenous infusion), as potassium intoxication may occur, potentially leading to cardiac arrest due to loss of heart function (cardiac depression), irregular heartbeat (arrhythmias), up to cardiac arrest (see section “How to use ELETTROLITICA EQUILIBRATA PEDIATRICA MONICO”).
Due to the presence of sodium, this medicine must be administered with caution to your child in the following cases:

• if he or she has heart problems (congestive heart failure, cardiac insufficiency) or kidney problems (severe renal insufficiency, reduced renal function);
• if he or she has fluid accumulation (edema with salt retention), either in the lungs (pulmonary edema) or associated with swelling of the legs and ankles (peripheral edema);
• if he or she is taking heart medications (cardiotonic inotropic drugs);
• corticosteroid anti-inflammatory drugs or corticotropin hormonal medicines;
• if he or she has high blood pressure (hypertension).

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

• if he or she has kidney problems (renal insufficiency), as this may cause inability to eliminate potassium from the body (potassium retention);
• if he or she has heart problems (cardiac insufficiency) and is taking other heart medications (digitalis);
• if he or she has adrenal gland problems (adrenal insufficiency);
• if he or she has liver problems (hepatic insufficiency);
• if someone in the family suffers from a disorder characterized by sudden attacks of muscle weakness (familial periodic paralysis);
• if he or she suffers from a disease characterized by muscle stiffness (congenital myotonia);
• if he or she has recently undergone surgery (early postoperative phase).

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

• if he or she has kidney problems (renal insufficiency);
• if he or she has heart problems (cardiac insufficiency) and is taking other heart medications (digitalis);
• if he or she has a muscle disease (myasthenia gravis);
• if he or she is being treated with sedatives, hypnotics (central nervous system depressants), or drugs used to block muscles during surgical procedures (neuromuscular blockers). Frequent monitoring of magnesium blood levels is required to ensure they do not become too high.

Due to the presence of phosphates, infusion of the medicine may cause reduced calcium levels in the blood (hypocalcemia).
Due to the presence of acetate, the medicine must be used with caution in children who have increased pH (metabolic and respiratory alkalosis) or elevated acetate levels in the blood, such as in children with liver problems (mild or moderate hepatic insufficiency).
Due to the presence of glucose, the medicine must be administered with caution in children suffering from diabetes mellitus or glucose intolerance, and in children taking corticosteroid anti-inflammatory drugs (corticosteroids) or corticotropin.
During treatment, glucose levels in blood and urine must be monitored, and insulin administered if required to minimize the risk of increased glucose levels in blood (hyperglycemia) and urine (glycosuria). Prolonged use of glucose solutions may lead to fluid accumulation (water overload, congestive state) and deficiency of mineral salts in the blood (electrolyte deficit).
Intravenous infusions containing glucose may cause electrolyte imbalances in the blood, particularly of sodium (hyponatremia).
Patients at highest risk of acute hyponatremia are:

• patients with non-osmotic release of a hormone called vasopressin (a condition occurring, for example, during the acute phase of illness, in the presence of pain, after surgery, following infections, burns, and diseases of the central nervous system);
• patients with heart, liver, or kidney diseases and those treated with drugs that enhance the effect of vasopressin (see section “Other medicines and ELETTROLITICA EQUILIBRATA PEDIATRICA MONICO”).

Acute hyponatremia may cause severe brain damage, especially in children, women of childbearing age, and patients with certain brain disorders (reduced cerebral compliance).
Other medicines and ELETTROLITICA EQUILIBRATA PEDIATRICA MONICO
Inform the doctor or nurse if your child is taking, has recently taken, or might take any other medicine.
This medicine must be administered with caution if your child is taking:

• medicines used to lower blood pressure such as potassium-sparing diuretics, ACE inhibitors, or other medicines causing decreased levels of the hormone aldosterone, as they may lead to increased potassium levels in the blood (hyperkalemia) and reduced ability to eliminate potassium (potassium retention), especially in patients with kidney problems (renal dysfunction); in such cases, blood potassium levels must be closely monitored;
• steroid anti-inflammatory medicines (corticosteroids) which may cause sodium and water retention, leading to fluid accumulation (edema) and increased blood pressure (hypertension); these drugs are associated with reduced sugar tolerance, potentially unmasking latent diabetes mellitus; blood glucose levels will be monitored during treatment;
• medicines that increase the effect of vasopressin (antidiuretic hormone), e.g., chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics, NSAIDs, cyclophosphamide, desmopressin, oxytocin, terlipressin, as they may increase the risk of decreased sodium concentration in plasma (hyponatremia); other medicines increasing the risk of hyponatremia include diuretics and antiepileptics such as oxcarbazepine.

Due to the presence of magnesium, pay special attention if your child is taking the following medicines:

• central nervous system depressants such as barbiturates, narcotics, or other hypnotics (or systemic anesthetics); in this case, dosage must be carefully adjusted, as magnesium potentiates the central nervous system depressant effect; the central nervous system depressant effect of magnesium can be counteracted by calcium administration;
• medicines used for heart problems (cardiac glycosides, digoxin and digitoxin); if calcium administration becomes necessary to treat potential magnesium intoxication, disturbances in cardiac conduction may occur, potentially leading to irregular heartbeat (arrhythmias);
• medicines used to block muscles during surgical procedures (competitive and depolarizing neuromuscular blockers), such as rocuronium, as their effect may be enhanced by magnesium chloride;
• aminoglycoside antibiotics, used against bacterial infections, as their effect may be additive to that of magnesium;
• eltrombopag, a medicine used to treat low platelet levels in the blood, as eltrombopag levels may decrease;
• labetalol, a medicine used to treat irregular heartbeat (arrhythmias), as co-administration with magnesium may cause reduced heart rate (bradycardia) and reduced volume of blood pumped by the heart (cardiac output);
• medicines used to treat high blood pressure (isradipine, felodipine, nicardipina and nifedipine), as concomitant use with magnesium may cause a significant drop in blood pressure (hypotension).

3. How to use ELETTROLITICA EQUILIBRATA PEDIATRICA MONICO

This medicine will be prepared by a doctor, pharmacist, or nurse and must not be mixed or administered simultaneously with other incompatible medicines.
This medicine must be administered directly into a vein (intravenous infusion) by specialized medical personnel. It must not be injected via other routes of administration (intramuscular, subcutaneous, or into perivascular tissues).
The dose will be adjusted according to the child's age, weight, blood electrolyte levels, and overall health condition, taking into account that the daily potassium requirement for children is 2–3 mEq per kilogram of body weight per day.
Particular caution is required in newborns and underweight children (see section “Warnings and precautions”).
Generally, the recommended dose is approximately 500 ml per day, administered at an infusion rate of about 500 ml of solution per hour. The medicine should be administered only if the child has intact renal function and at a rate not exceeding 10 mEq of potassium per hour and 0.4–0.8 g of glucose per kilogram of body weight per hour.
After administration of the medicine, the child should remain lying down for a short period of time.
Infusions that are too rapid may cause local pain, and the infusion rate must be adjusted according to the child's needs.
Administration must be stopped if the child experiences pain or redness at the injection site, as this may be due to leakage of the medicine from the vein (drug extravasation).

Preparation of the medicine: Use the solution immediately after opening the container.
It is intended for single and uninterrupted administration, and any remaining residue must not be used.
Shake well before administration. Do not use the medicine if the solution is not clear and colorless or slightly yellowish, or if it contains particles.
Take all usual precautions to maintain sterility before and during intravenous infusion.

If you use more ELETTROLITICA EQUILIBRATA PEDIATRICA MONICO than you should
Since this medicine will be administered by a doctor or trained healthcare professional, it is unlikely that an excessive dose will be given. However, if you think your child has been given an excessive dose of ELETTROLITICA EQUILIBRATA PEDIATRICA MONICO, inform the doctor or another healthcare provider immediately.

Following administration of an excessive dose of this medicine, the following may occur:

• Increased blood potassium levels (hyperkalemia), which may lead to death due to heart damage (cardiac depression, arrhythmias, or arrest);
• Increased sodium levels (hypernatremia) and/or increased blood volume (hypervolemia); if blood sodium levels rise too much, loss of fluids from internal organs (dehydration), particularly from the brain, may occur, and fluid accumulation may affect the cerebral, pulmonary, and peripheral circulation, leading to fluid buildup around the lungs (pulmonary edema) or swelling in the legs and ankles (peripheral edema).

Following excessive administration of magnesium chloride, the following symptoms of intoxication may occur: flushing, sweating, reduced blood pressure (hypotension), paralysis of certain muscles such as respiratory muscles (flaccid paralysis), reduced body temperature (hypothermia), circulatory collapse, cardiac and central nervous system depression that may progress to respiratory paralysis.
Magnesium intoxication manifests as a sudden increase in blood pressure, difficulty breathing (respiratory paralysis), and loss of the leg extension response following a percussion stimulus (patellar reflex).

With prolonged administration of glucose, fluid accumulation (hyperhydration) and solute overload may occur.
In case of overdose, stop the infusion immediately; the doctor will promptly intervene using corrective therapy to reduce excess blood sugar and ion levels and restore acid-base balance.

If you have any doubts about using 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 following side effects may occur:
Not known (frequency cannot be estimated from the available data):

• allergic reactions and urticaria;
• stomach and intestinal disorders (gastrointestinal disorders, delayed intestinal transit, and paralytic ileus), nausea, vomiting, diarrhoea, abdominal pain, constipation;
• thirst, reduced salivation, metallic taste, chalky taste;
• nerve and muscle disorders (neuromuscular disorders), muscle stiffness, altered sensitivity of limbs (paraesthesia), paralysis of certain muscles such as respiratory muscles (flaccid paralysis), weakness;
• mental confusion, headache, dizziness, restlessness, irritability;
• seizures, coma, death, hyponatraemic encephalopathy**;
• bleeding in the brain due to rupture of blood vessels (cerebral haemorrhage);
• brain damage caused by poor blood circulation to the brain (cerebral ischaemia);
• drowsiness, confusion, mental disorders;
• irregular heartbeat such as arrhythmias, increased heart rate (tachycardia), decreased heart rate (bradycardia), conduction disorders, disappearance of the P wave, widening of the QRS complex on electrocardiogram, syncope, ventricular fibrillation, cardiac arrest;
• decrease or increase in blood pressure (hypotension or hypertension), swelling of legs and ankles (peripheral oedema), hot flushes, sweating, and shock;
• increased levels of sodium (hypernatraemia) and chloride (hyperchloraemia) in the blood, increased blood volume (hypervolaemia) and osmolarity (hyperosmolarity);
• decreased levels of calcium in the blood (hypocalcaemia);
• breathing problems (dyspnoea, respiratory arrest);
• accumulation of fluid in the lungs (pulmonary oedema) and air in the membrane surrounding the lung (pneumothorax);
• reduced tear production;
• kidney problems (renal failure) and excessive urine production (polyuria);
• muscle weakness;
• increased metabolic rate, increased or decreased blood glucose levels (hyperglycaemia or hypoglycaemia), increased insulin levels, increased adrenaline levels;
• hospital-acquired hyponatraemia**;
• fever, infection at the infusion site, pain or local reaction, redness, skin irritation (rash);
• venous irritation, formation of blood clots in veins (venous thrombosis);
• inflammation of veins (venous phlebitis) extending from the infusion site;
• leakage of the injected solution from the vein (extravasation);
• tissue damage and tissue death (tissue necrosis);
• inflammation due to pus accumulation (abscess).

** Hospital-acquired hyponatraemia can cause irreversible brain damage and death due to the development of acute hyponatraemic encephalopathy.
Reporting of side effects
If your child experiences 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 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 EQUILIBRATA PEDIATRICA MONICO

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.
After opening the container, the solution may be used for a single, continuous
administration only, and any remaining residue must not be used.
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 PEDIATRICA MONICO contains

• The active substances are: sodium acetate trihydrate, potassium chloride, magnesium chloride hexahydrate, potassium dibasic phosphate, glucose monohydrate. 1000 ml of solution contain: 3.20 g of sodium acetate trihydrate, 1.30 g of potassium chloride, 0.31 g of magnesium chloride hexahydrate, 0.26 g of potassium dibasic phosphate, 55.0 g of glucose monohydrate (equivalent to 50 g of glucose). Each litre of solution contains: 23 mEq of sodium, 20 mEq of potassium, 3 mEq of magnesium, 20 mEq of chloride, 23 mEq of acetate, 3 mEq of phosphate and 277 mmol of glucose. pH: 5.0 ÷ 7.0.
• The other components are: water for injections, hydrochloric acid and acetic acid.

Description of the appearance of ELETTROLITICA EQUILIBRATA PEDIATRICA MONICO and contents of the pack
Glass flacons of 50 ml, 100 ml, 250 ml, 500 ml, 1000 ml of infusion solution.
Plastic bags of 50 ml, 100 ml, 250 ml, 500 ml, 1000 ml of infusion solution.

Marketing Authorization Holder and Manufacturer
Monico spa
Via Ponte di Pietra 7, 30173 Venezia Mestre – Italy

The following information is intended exclusively for healthcare professionals

Incompatibilities
If used to dilute medicinal products, consult the pharmacist, if available, before adding any
medicinal additives; always consider the characteristics of the products to be added; use
aseptic techniques.
Due to the presence of glucose, the medicinal product is incompatible with:

• cyanocobalamin;
• kanamycin sulfate;
• sodium novobiocin;
• sodium warfarin.
  Furthermore, there are conflicting opinions regarding the compatibility of glucose with hydroxyethyl starch (hetastarch).
  Ampicillin and amoxicillin remain stable in glucose solutions only for a short period.
  Due to the presence of 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 the concentration of reactants and the pH of the solutions.

Management of overdose
Immediately discontinue the infusion and initiate corrective therapy for hyperglycemia and to reduce plasma levels of ions in excess; restore acid-base balance if necessary.
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 required.
In case of severe hypernatremia, loop diuretics may be used.
In case of hyperkalemia, intravenous glucose (with or without insulin) or sodium bicarbonate may be administered.
In case of magnesium intoxication manifesting with respiratory paralysis, artificial ventilation must be initiated.
To counteract the effects of hypermagnesemia, intravenous calcium should be administered (10–20 mL of a 5% solution).
Subcutaneous administration of 0.5–1 mg of physostigmine may be helpful.
Markedly elevated plasma electrolyte levels may require dialysis.
In case of excessive glucose administration, reassess the patient's clinical condition and initiate appropriate corrective measures.
For further information, refer to the Summary of Product Characteristics.