Electrolyte balanced pediatric solution Bioindustria L.I.M.

Package leaflet: Information for the user

ELETTROLITICA EQUILIBRATA PEDIATRICA Bioindustria L.I.M. infusion solution

Sodium acetate trihydrate, potassium chloride, magnesium chloride hexahydrate, dipotassium phosphate, glucose monohydrate
Generic medicine
Please read this leaflet carefully before using this medicine 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 for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

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

ELETTROLITICA EQUILIBRATA PEDIATRICA Bioindustria L.I.M. is an infusion solution to be administered directly into a vein (intravenous infusion) containing a combination of active substances: Natrium 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 is required, and for the treatment of mild to moderate metabolic acidosis, a condition characterized by increased acidity of the blood.

2. What you should know before using ELETTROLITICA EQUILIBRATA PEDIATRICA Bioindustria

L.I.M.
ELETTROLITICA EQUILIBRATA PEDIATRICA Bioindustria L.I.M. must not be
administered to your child:

• if he/she is allergic to the active substances or to any of the other components of this medicine (listed in section 6);
• if he/she has high levels of potassium in the blood (hyperkalaemia) or reduced ability to eliminate potassium from the body (potassium retention);
• if he/she has severe liver problems (severe hepatic insufficiency) leading to inability to metabolize the acetate ion;
• if he/she has severe kidney problems (severe renal insufficiency);
• if he/she has difficulty urinating (oliguric renal insufficiency, anuria);
• if he/she has severe heart problems;
• if he/she has an increased blood pH (metabolic and respiratory alkalosis);
• if he/she has breathing difficulties (respiratory rate lower than the physiological rate expected for the specific age group);
• if he/she has circulatory problems due to increased tendency of blood to clot (hypercoagulability);
• if he/she is taking cardiac glycosides, medicines used to treat heart conditions;
• if he/she has bleeding in the spinal cord or brain (spinal or intracranial haemorrhage);
• if he/she has mental disorders characterized by hallucinations, tremors, sweating (delirium tremens), especially if dehydrated;
• if he/she has low fluid levels in the body (dehydration);
• if the patient is in a coma;
• if he/she has a disease of the adrenal glands (Addison's disease) and is not receiving treatment for it;
• if he/she experiences painful, brief muscle cramps (heat cramps).
  When administered concomitantly with blood transfusions, this medicine must not be given through the same infusion catheter as whole blood due to the possible risk of red blood cell aggregation (pseudoagglutination).

Warnings and precautions
Please consult your child’s doctor, pharmacist, or nurse before ELETTROLITICA EQUILIBRATA PEDIATRICA Bioindustria L.I.M. is administered.
This medicine must be administered with great caution in newborns and children with low body weight, as blood glucose levels may increase (hyperglycaemia). Additionally, in children with low body weight, rapid or excessive intravenous infusion may lead to increased concentration of mineral salts in the blood (serum osmolarity) and bleeding in the brain due to rupture of blood vessels (intracerebral haemorrhage).
This medicine must be administered via a very slow intravenous infusion (intravenous infusion), as potassium intoxication may occur, potentially leading to death due to loss of heart function (cardiac depression), irregular heartbeat (arrhythmias), up to cardiac arrest (see section “How to use ELETTROLITICA EQUILIBRATA PEDIATRICA Bioindustria L.I.M.”).
Due to the presence of sodium, this medicine must be administered with caution to your child in the following cases:

• if he/she has heart problems (congestive heart failure, cardiac insufficiency) or kidney problems (severe renal insufficiency, reduced renal function);
• if he/she has fluid accumulation (oedema with salt retention), either in the lungs (pulmonary oedema) or associated with swelling of the legs and ankles (peripheral oedema);
• if he/she is taking heart medications (cardiotropic inotropic drugs), corticosteroid anti-inflammatory drugs, or corticotropin hormonal medicines;
• if he/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/she has kidney problems (renal insufficiency), as it may cause potassium retention;
• if he/she has heart problems (cardiac insufficiency) and is taking other heart medications (digitalis);
• if he/she has a disease of the adrenal glands (adrenal insufficiency);
• if he/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/she has a condition characterized by muscle stiffness (congenital myotonia);
• if he/she has recently undergone surgery (early post-operative phase).

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

• if he/she has kidney problems (renal insufficiency);
• if he/she has heart problems (cardiac insufficiency) and is taking other heart medications (digitalis);
• if he/she has a muscle disease (myasthenia gravis);
• if he/she is being treated with central nervous system depressants (sedatives, hypnotics) or drugs used to block muscles during surgery (neuromuscular blockers).
  Serum magnesium levels should be monitored frequently to ensure they do not rise excessively.

Due to the presence of phosphates, infusion of the medicine may cause reduced calcium levels in the blood (hypocalcaemia).
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 with diabetes mellitus or glucose intolerance, and in children taking corticosteroid anti-inflammatory drugs (corticosteroids or corticotropin).
During treatment, blood and urine glucose levels must be monitored, and insulin administered if necessary to minimize the risk of increased blood glucose (hyperglycaemia) and glucose in the urine (glycosuria).
Prolonged use of glucose solutions may lead to fluid accumulation (fluid overload, congestive state) and deficiency of mineral salts in the blood (electrolyte deficit).
Intravenous glucose infusions may become extremely hypotonic after administration due to rapid glucose metabolism, causing a decrease in plasma sodium concentration (hyponatraemia). Acute hyponatraemia may cause acute hyponatraemic encephalopathy (cerebral oedema), characterized by headache, nausea, convulsions, lethargy, and vomiting. Patients with cerebral oedema are particularly at risk of severe, irreversible, and life-threatening brain damage.
Children, women of childbearing age, and patients with reduced cerebral compliance (e.g. meningitis, intracranial haemorrhage, and cerebral contusion) are particularly at risk of severe, life-threatening cerebral fluid accumulation (cerebral oedema) caused by acute hyponatraemia.
During treatment with this medicine, the doctor should periodically monitor heart function via serial electrocardiograms and blood levels of electrolytes (plasma osmolarity), glucose (glycaemia), fluids, and blood pH (acid-base balance). It is also advisable to monitor blood pressure and osteotendinous reflexes to detect any potential respiratory muscle paralysis.

Other medicines and ELETTROLITICA EQUILIBRATA PEDIATRICA Bioindustria L.I.M.
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 that reduce aldosterone hormone levels, as they may lead to increased potassium in the blood (hyperkalaemia) and reduced ability to eliminate potassium (potassium retention), especially in patients with kidney problems (renal dysfunction); in such cases, serum potassium levels must be closely monitored;
• steroid anti-inflammatory medicines (corticosteroids) that may cause sodium and water retention, leading to fluid accumulation (oedema) and increased blood pressure (hypertension). These drugs are associated with reduced sugar tolerance, potentially unmasking latent diabetes mellitus; patients should be carefully monitored when glucose is administered concurrently;
• medicines that increase the effect of the antidiuretic hormone (vasopressin), 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 plasma sodium concentration (hyponatraemia). Other medicines that increase the risk of hyponatraemia include diuretics in general and antiepileptic drugs such as oxcarbazepine.

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

• central nervous system depressants such as barbiturates, narcotics, or other hypnotics (or systemic anaesthetics). In this case, dosage should be carefully adjusted, as magnesium potentiates the central nervous system depressant effect;
• medicines used for heart conditions (cardiac glycosides, digoxin and digitoxin), as cardiac conduction disturbances may occur, potentially progressing to arrhythmia;
• medicines used to block muscles during surgery (competitive and depolarizing neuromuscular junction blockers), such as rocuronium, as their effect may be enhanced by magnesium chloride;
• aminoglycoside antibiotics, used to treat bacterial infections, as their neuromuscular blocking effect may be additive to that of magnesium;
• eltrombopag, a medicine used to treat low platelet levels in the blood, as its blood concentration may decrease;
• labetalol, a medicine used to treat heart rhythm disorders (arrhythmias), as administration with magnesium may cause decreased 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).

ELETTROLITICA EQUILIBRATA PEDIATRICA Bioindustria L.I.M. contains sodium metabisulphite.
This medicine contains sodium metabisulphite, which rarely may cause severe hypersensitivity reactions and bronchospasm, especially in sensitive individuals and/or those suffering from asthma.

3. How to use ELETTROLITICA EQUILIBRATA PEDIATRICA Bioindustria L.I.M.

This medicine will be prepared by a doctor, pharmacist, or nurse and will not be mixed with, nor 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 patient may need to be monitored for electrolyte balance, serum glucose, serum sodium, and other electrolytes before and during administration, particularly if suffering from the syndrome of inappropriate antidiuretic hormone secretion (antidiuretic hormone, ADH), also known as SIADH, or if undergoing concomitant therapy with vasopressin agonists, due to the risk of decreased plasma sodium concentration (hyponatremia).
The dose will be adjusted according to the child's age, weight, blood electrolyte levels, and overall health condition, bearing in mind that the daily potassium requirement for children is 2–3 mEq per kg of body weight.
Particular caution is required in neonates 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 only be administered if the child has intact renal function and at an infusion rate not exceeding 10 mEq of potassium per hour and 0.4–0.8 g of glucose per kg 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 should 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 indicate 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, uninterrupted administration, and any remaining solution must not be used.
Shake well before administration. The solution should be clear, colorless, or slightly straw-yellow, and free from visible particles.
All standard precautions should be taken to maintain sterility before and during intravenous infusion.

If you use more ELETTROLITICA EQUILIBRATA PEDIATRICA Bioindustria L.I.M. than you should
Since this medicine will be administered by a doctor or specialized personnel, 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 Bioindustria L.I.M., inform the doctor or another healthcare professional immediately.

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

• Increased potassium levels in the blood (hyperkalemia), which may lead to death due to heart damage (cardiac depression, arrhythmias, or cardiac arrest);
• Increased sodium levels (hypernatremia) and increased blood volume (hypervolemia). If sodium levels in the blood rise too much, fluid loss from internal organs (dehydration) may occur, especially in the brain, 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).

In case of 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, which may progress to respiratory paralysis.
Magnesium intoxication is characterized by a sudden increase in blood pressure, difficulty breathing (respiratory paralysis), and loss of the knee-jerk reflex (patellar reflex) following a percussion stimulus.

Prolonged administration of glucose may lead to accumulation of intracellular fluids (overhydration) and solute overload.

In case of overdose, immediately stop the infusion and initiate corrective therapy to reduce excess blood sugar and ion levels, and restore acid-base balance if necessary.

If you have any doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The following side effects may occur:
Not known (frequency cannot be established from available data):

• allergic reactions and urticaria;
• stomach and intestinal (gastrointestinal) disorders, nausea, vomiting, diarrhoea, abdominal pain, constipation, intestinal disturbances (delayed intestinal transit and paralytic ileus);
• thirst, reduced salivation, metallic taste, chalky taste;
• nerve and muscle disorders (neuromuscular disorders), muscle rigidity, altered limb sensation (paraesthesias), paralysis of certain muscles such as respiratory muscles (flaccid paralysis), weakness;
• mental confusion, headache, dizziness, restlessness, irritability;
• seizures, coma, death;
• bleeding into the brain (cerebral haemorrhage);
• brain damage caused by poor cerebral blood circulation (cerebral ischaemia);
• drowsiness, confusional states, mental disorders, hyponatraemic encephalopathy**;
• irregular heartbeat (arrhythmias), increased heart rate (tachycardia), decreased heart rate (bradycardia), conduction disturbances, disappearance of the P wave, widening of the QRS complex on electrocardiogram, syncope, ventricular fibrillation, cardiac arrest;
• reduction or increase in blood pressure (hypotension, hypertension), swelling of legs and ankles (peripheral oedema), hot flushes, vasodilation, sweating, and shock;
• increased levels of sodium (hypernatraemia) and chloride (hyperchloraemia) in the blood;
• increased blood volume (hypervolaemia) and blood osmolarity (hyperosmolarity);
• reduced calcium levels in the blood (hypocalcaemia);
• breathing difficulties (dyspnoea, respiratory arrest);
• fluid accumulation in the lungs (pulmonary oedema) and air around the lung (pneumothorax);
• reduced tear production;
• kidney problems (renal failure) and excessive urine production (polyuria);
• muscle weakness;
• increased metabolic rate, increased blood glucose levels (hyperglycaemia), decreased blood glucose levels (hypoglycaemia), increased insulin levels, increased adrenaline levels;
• reduced sodium levels in the blood (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 (abscesses).

** Hospital-acquired hyponatraemia may 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, consult your doctor or pharmacist. You may also report side effects directly via the national reporting system at 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 PEDIATRICA Bioindustria L.I.M.
Keep this medicine out of the reach and sight 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 no longer in use. This will help protect the environment.

6. Package contents and other information

What ELETTROLITICA EQUILIBRATA PEDIATRICA Bioindustria L.I.M. contains

• The active substances are: sodium acetate trihydrate, potassium chloride, magnesium chloride hexahydrate, dipotassium 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 dipotassium phosphate, 55.0 g of glucose monohydrate (equivalent to 50 g of glucose). Each liter 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: sodium metabisulfite, glacial acetic acid, water for injections.

Description of the appearance of ELETTROLITICA EQUILIBRATA PEDIATRICA Bioindustria L.I.M. and contents of the pack
Pack containing one vial of 50 ml, 100 ml, 250 ml, 500 ml of infusion solution
Pack containing 50 ml of solution in a 100 ml vial
Pack containing 100 ml of solution in a 250 ml vial
Pack containing 250 ml of solution in a 500 ml vial

Marketing Authorization Holder and Manufacturer
BIOINDUSTRIA Laboratorio Italiano Medicinali S.p.A.
Via De Ambrosiis, 2 – 15067 Novi Ligure (AL)

The following information is intended exclusively for physicians or healthcare professionals

ELETTROLITICA EQUILIBRATA PEDIATRICA Bioindustria L.I.M. infusion solution
The following information is intended exclusively for physicians or healthcare professionals

Incompatibilities
If used to dilute medications, consult the pharmacist, if available, before adding any additive drugs;
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.

Moreover, 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, and 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, and restore acid-base balance if necessary (see Precautions for use).
The patient should be closely monitored for the appearance of any signs and symptoms related to the administered drug, providing appropriate symptomatic and supportive measures as needed.
In case of severe hypernatremia, loop diuretics may be used.
In case of hyperkalemia, intravenous glucose (with or without insulin) or sodium bicarbonate may be administered.
In case of magnesium intoxication manifesting as 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 institute appropriate corrective measures.
For further information, refer to the Summary of Product Characteristics.