Balanced electrolyte solution for pediatric use FKI: detailed information

Package leaflet: Information for the user

ELETTROLITICA EQUILIBRATA PEDIATRICA FRESENIUS KABI ITALIA

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

Contents of this leaflet:

What ELETTROLITICA EQUILIBRATA PEDIATRICA FRESENIUS KABI ITALIA is and what it is used for
What you need to know before using ELETTROLITICA EQUILIBRATA PEDIATRICA FRESENIUS KABI ITALIA
How to use ELETTROLITICA EQUILIBRATA PEDIATRICA FRESENIUS KABI ITALIA
Possible side effects
How to store ELETTROLITICA EQUILIBRATA PEDIATRICA FRESENIUS KABI ITALIA
Contents of the pack and other information

1. What ELETTROLITICA EQUILIBRATA PEDIATRICA FRESENIUS KABI ITALIA is and what it is used for

What it is used for
ELETTROLITICA EQUILIBRATA PEDIATRICA FRESENIUS KABI ITALIA is an infusion solution 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 caloric intake must be ensured, and for the treatment of mild to moderate metabolic acidosis, a condition characterized by increased blood acidity.

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

KABI ITALIA
ELETTROLITICA EQUILIBRATA PEDIATRICA FRESENIUS KABI ITALIA must not be
administered to your child if:

he/she is allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
he/she has high levels of potassium in the blood (hyperkalemia) or reduced ability to excrete potassium from the body (potassium retention);
he/she has severe liver problems (severe hepatic insufficiency) leading to inability to metabolize the acetate ion;
he/she has severe kidney problems (severe renal insufficiency);
he/she has difficulty urinating (oliguric renal insufficiency, anuria);
he/she has severe heart problems;
he/she has an increased blood pH (metabolic and respiratory alkalosis);
he/she has breathing difficulties (respiratory rate lower than the physiological rate expected for the specific age group);
he/she has circulatory problems due to increased tendency of blood to clot (hypercoagulability);
he/she is taking cardiac glycosides, medicines used to treat heart problems;
he/she has bleeding in the spinal cord or brain (spinal or intracranial hemorrhage);
he/she suffers from mental disorders characterized by hallucinations, tremors, sweating (delirium tremens), especially if dehydrated;
he/she has low fluid levels in the body (dehydration);
the patient is in a coma;
he/she has a disease of the adrenal glands (Addison's disease) and is not receiving treatment for it;
he/she experiences painful, short-duration 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 doctor, pharmacist, or nurse before ELETTROLITICA EQUILIBRATA PEDIATRICA FRESENIUS KABI ITALIA is administered.
This medicine must be administered with great caution in neonates 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 lead to increased concentration of minerals in the blood (serum osmolarity) and bleeding in the brain due to rupture of blood vessels (intracerebral hemorrhage).
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 FRESENIUS KABI ITALIA”).
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 kidney function);
if he/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/she is taking heart medications (cardiotonic 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 episodes of muscle weakness (familial periodic paralysis);
if he/she has congenital myotonia, a disease characterized by muscle stiffness;
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 sedatives, hypnotics (central nervous system depressants), or drugs used to block muscles during surgery (neuromuscular blockers). Blood magnesium levels should be frequently monitored to ensure they do not become too high.

Due to the presence of phosphates, infusion of the medicine may cause a reduction in blood calcium levels (hypocalcemia).
Due to the presence of acetate, the medicine must be used with caution in children who have increased blood pH (metabolic and respiratory alkalosis) or elevated blood acetate levels, such as in children with liver problems (mild to 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, blood and urine glucose levels must be monitored, and insulin administered if necessary to minimize the risk of increased blood glucose (hyperglycemia) and glucose in urine (glucosuria). During prolonged use of glucose solutions, fluid accumulation (water overload, congestive state) and deficiency of minerals in the blood (electrolytes) may occur.
During treatment with this medicine, the doctor must periodically check heart function via serial electrocardiograms and monitor blood levels of electrolytes (plasma osmolarity), glucose (glycemia), fluids, and blood pH (acid-base balance). It is also advisable to monitor blood pressure and osteotendinous reflexes to detect possible respiratory muscle paralysis.
Special attention must be paid in cases of:

acute illness, pain, post-operative stress, infections, burns, diseases of the central nervous system;
heart, liver, or kidney diseases treated with a drug that enhances the effect of vasopressin (a hormone regulating water retention in the body), as this may increase the risk of hospital-acquired low blood sodium (hyponatremia) (See also section "Other medicines and ELETTROLITICA EQUILIBRATA PEDIATRICA FRESENIUS KABI ITALIA"). All patients must be closely monitored. In cases where normal regulation of blood water content is affected due to increased secretion of vasopressin (also known as antidiuretic hormone), infusion of fluids with low sodium chloride concentration (hypotonic fluids) may lead to low blood sodium (hyponatremia). This may result in headache, nausea, seizures, lethargy, coma, brain swelling (cerebral edema), and death. Therefore, these symptoms (acute symptomatic hyponatremic encephalopathy) are considered a medical emergency (see also section "Possible side effects"). Children with reduced cerebral compliance (e.g., meningitis, intracranial bleeding, cerebral contusion) are particularly at risk of severe, life-threatening cerebral edema caused by acute hyponatremia.

Other medicines and ELETTROLITICA EQUILIBRATA PEDIATRICA FRESENIUS KABI ITALIA
Inform the doctor or nurse if your child is taking, has recently taken, or might take any other medicine, especially if he/she is taking:
Medicines that increase the effect of vasopressin (see also section “Warnings and precautions”):

Medicines stimulating vasopressin release, e.g.: Chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics;
Medicines enhancing vasopressin action, e.g.: Chlorpropamide, NSAIDs, cyclophosphamide;
Vasopressin analogs, e.g.: Desmopressin, oxytocin, vasopressin, terlipressin;
Other medicines increasing the risk of hyponatremia also include diuretics in general and antiepileptic drugs such as oxcarbazepine.

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 aldosterone levels, as they may lead to increased potassium in the blood (hyperkalemia) and reduced potassium excretion (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, resulting in fluid accumulation (edema) and increased blood pressure (hypertension). These drugs are associated with reduced sugar tolerance, possibly unmasking latent diabetes mellitus; careful monitoring is required when glucose is administered concurrently.

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 anesthetics). In this case, dosage must be carefully adjusted, as magnesium enhances the CNS depressant effect;
medicines used for heart problems (cardiac glycosides, digoxin, digitoxin);
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;
eltrombopag, a medicine used to treat low platelet levels in the blood;
labetalol, a medicine used to treat heart rhythm disorders (arrhythmias);
medicines used to treat high blood pressure (isradipine, felodipina, nicardipine, and nifedipine), as concurrent use with magnesium may cause a significant drop in blood pressure (hypotension).

ELETTROLITICA EQUILIBRATA PEDIATRICA FRESENIUS KABI ITALIA contains sodium
metabisulfite
This medicine contains sodium metabisulfite, 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 FRESENIUS KABI ITALIA

This medicinal product will be prepared by a doctor, pharmacist, or nurse and must not be mixed with, nor administered simultaneously to, other incompatible medicinal products.
This medicine must be administered directly into a vein (intravenous infusion) by trained 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, body 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 newborns and underweight children (see section "Warnings and precautions").
The recommended dose is generally about 500 ml per day, administered at an infusion rate of approximately 500 ml of solution per hour. The medicine must 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 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 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, uninterrupted administration, and any remaining solution must not be used.
Shake well before administration. Do not use the medicine if the solution is not clear, colourless, or slightly yellowish straw-coloured, or if it contains particles.
Take all usual precautions to maintain sterility before and during intravenous infusion.

If you use more ELETTROLITICA EQUILIBRATA PEDIATRICA FRESENIUS KABI ITALIA 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 too much ELETTROLITICA EQUILIBRATA PEDIATRICA FRESENIUS KABI ITALIA, inform your doctor or another healthcare provider immediately.

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

Increased potassium levels in the blood (hyperkalaemia), which may lead to death due to heart damage (cardiac depression, arrhythmias, or arrest);
Increased sodium levels (hypernatraemia) and increased blood volume (hypervolaemia). If sodium levels in the blood rise too much, fluid loss from internal organs (dehydration), particularly from the brain, may occur, along with fluid accumulation affecting the cerebral, pulmonary, and peripheral circulation, leading to fluid buildup around the lungs (pulmonary oedema) or swelling in the legs and ankles (peripheral oedema).

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 the respiratory muscles (flaccid paralysis), reduced body temperature (hypothermia), circulatory collapse, cardiac and central nervous system depression, which 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).

In case of prolonged administration of glucose, accumulation of intracellular fluids (overhydration) and solute overload may occur.
In case of overdose, stop the infusion immediately and initiate corrective therapy to reduce excess blood glucose 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 will experience them.
The following side effects may occur:
Not known (frequency cannot be estimated from the available data):

allergic reactions and urticaria;
stomach and intestinal (gastrointestinal) disorders, nausea, vomiting, diarrhoea, abdominal pain, constipation, intestinal disorders (delayed intestinal transit and paralytic ileus);
thirst, reduced salivation, metallic taste, chalky taste;
nerve and muscle disorders (neuromuscular disorders), muscle rigidity, altered sensation in limbs (paraesthesia), paralysis of certain muscles such as respiratory muscles (flaccid paralysis), weakness;
mental confusion, headache, dizziness, restlessness, irritability;
seizures, coma, death;
bleeding in the brain (cerebral haemorrhage);
brain damage caused by poor blood circulation to the brain (cerebral ischaemia);
drowsiness, confusional states, mental disorders;
irregular heartbeat such as 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, sweating, and shock;
increased or decreased levels of sodium (hypernatraemia/hyponatraemia, hospital-acquired hyponatraemia**) and chloride (hyperchloraemia) in the blood;
increased blood volume (hypervolaemia) and blood osmolarity (hyperosmolarity);
reduced levels of calcium in the blood (hypocalcaemia);
breathing problems (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), reduced blood glucose levels (hypoglycaemia), increased insulin levels, increased adrenaline levels;
fever, infection at the infusion site, local pain or reaction, redness, skin irritation (rash);
venous irritation, formation of blood clots in veins (venous thrombosis);
inflammation of the 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);
brain damage and death caused by very low sodium levels in the blood (hyponatraemic encephalopathy**);
** When sodium levels in the blood become very low, water enters the brain cells and causes them to swell. This leads to increased pressure within the skull and results in hyponatraemic encephalopathy.

Reporting of side effects
If your child experiences any side effect, including those not listed in this leaflet,
please contact your doctor or pharmacist. You may also report side effects directly via the
national reporting system at 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 PEDIATRICA FRESENIUS KABI ITALIA

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 EQUILIBRATA PEDIATRICA FRESENIUS KABI ITALIA 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 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. (*) Ions from the stabilizer and those added to adjust pH are excluded. pH: 5.0 - 7.0.
The other components are: water for injections, sodium metabisulfite (as stabilizer), hydrochloric acid (as pH regulator).

Description of the appearance of ELETTROLITICA EQUILIBRATA PEDIATRICA FRESENIUS KABI ITALIA and package contents
50 ml, 100 ml, 250 ml, 24x250 ml, 500 ml, 20x500 ml, 1000 ml infusion vial of solution for infusion.
Flexible bag containing 500 ml, 1000 ml of solution for infusion.
Plastic infusion vial containing 500 ml, 1000 ml of solution for infusion.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Fresenius Kabi Italia S.r.l. – Via Camagre, 41 – 37063 Isola della Scala (VR) – Italy
Manufacturer
Fresenius Kabi Italia S.r.l. – Via Camagre, 41 – 37063 Isola della Scala (VR) – Italy
Fresenius Kabi France – 6, rue du Rempart BP611 – 27400 Louviers Cedex (France)
S.M. Farmaceutici S.r.l. – Zona Industriale – 85050 Tito (PZ)

The following information is intended exclusively for physicians or healthcare professionals

Dosage and method of administration
Monitoring of electrolyte balance, serum glucose, serum sodium and other electrolytes may be required before and during administration, particularly in patients with increased non-osmotic release of vasopressin (syndrome of inappropriate antidiuretic hormone secretion, SIADH) and in patients receiving concomitant therapy with vasopressin agonists, due to the risk of hyponatremia.
Monitoring of serum sodium is particularly important for physiologically hypotonic solutions.
Paediatric Balanced Electrolyte Solution for infusion may become extremely hypotonic after administration due to glucose metabolism in the body (see sections 4.4, 4.5 and 4.8 of the Summary of Product Characteristics).
Intravenous glucose infusions are generally isotonic solutions. However, in the body, glucose-containing solutions may become extremely hypotonic physiologically due to the rapid metabolism of glucose (see section 4.2 of the Summary of Product Characteristics).
Depending on the tonicity of the solution, volume and frequency of infusion, the patient's underlying clinical condition, and the capacity for glucose metabolism, intravenous administration of glucose may cause electrolyte disturbances, particularly hypo- or hyperosmolar hyponatremia.

Incompatibilities
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 are 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.
The prescribing physician should refer to the scientific literature.

Management of overdose
Immediately discontinue the infusion and initiate corrective therapy for hyperglycemia and reduce plasma levels of ions in excess; restore acid-base balance if necessary (see section Warnings and precautions).
The patient should be closely monitored for the appearance of any signs and symptoms related to the administered drug, ensuring appropriate symptomatic and supportive measures as required.

In cases of marked hypernatremia, loop diuretics may be used.
In cases of hyperkalemia, intravenous glucose (with or without insulin) or sodium bicarbonate may be administered.
In cases of magnesium intoxication presenting with respiratory paralysis, artificial ventilation is required. 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.
Elevated plasma levels of electrolytes may require dialysis.
In case of excessive glucose administration, the patient's clinical condition should be reassessed and appropriate corrective measures instituted.

For further information, consult the Summary of Product Characteristics.