Balanced electrolyte pediatric formulation Galenica Senese

PATIENT INFORMATION LEAFLET: information for the user

ELETTROLITICA EQUILIBRATA PEDIATRICA GALENICA SENESE solution for infusion

Sodium acetate trihydrate, potassium chloride, magnesium chloride hexahydrate, potassium phosphate dibasic anhydrous, glucose monohydrate
Equivalent medicinal product
Please read all of 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:

1. What ELETTROLITICA EQUILIBRATA PEDIATRICA GALENICA SENESE is and what it is used for
2. What you need to know before using ELETTROLITICA EQUILIBRATA PEDIATRICA GALENICA SENESE
3. How to use ELETTROLITICA EQUILIBRATA PEDIATRICA GALENICA SENESE
4. Possible side effects
5. How to store ELETTROLITICA EQUILIBRATA PEDIATRICA GALENICA SENESE
6. Package contents and other information

1. What ELETTROLITICA EQUILIBRATA PEDIATRICAGALENICA SENESE is and what it is used for

ELETTROLITICA EQUILIBRATA PEDIATRICAGALENICA SENESE 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 anhydrous, 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 blood acidity.

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

ELETTROLITICA EQUILIBRATA PEDIATRICA GALENICA SENESE must not be
administered to the 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 (hyperkalemia) or reduced ability to eliminate potassium from the body (potassium retention);
• if he/she has severe liver problems (severe hepatic insufficiency);
• if he/she has severe kidney problems (severe renal insufficiency);
• if he/she has problems urinating (oliguric renal failure, 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 a high tendency of the blood to clot (hypercoagulability);
• if he/she is taking cardiac glycosides, medicines used to treat heart conditions;
• if he/she has bleeding into the spinal cord or brain tissue (spinal or intracranial hemorrhage);
• if he/she suffers from 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, short-lasting 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 the doctor treating your child, the pharmacist, or the nurse before
ELETTROLITICA EQUILIBRATA PEDIATRICA GALENICA SENESE is administered.
This medicine must be administered with great caution in newborns and children with low body weight, as this may lead to increased glucose levels in the blood (hyperglycemia). Additionally, in children with low body weight, rapid or excessive intravenous infusion may cause an increase in mineral salt concentration in the blood (serum osmolarity) and bleeding into the brain due to rupture of blood vessels (intracerebral hemorrhage).
This medicine must be administered via 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 GALENICA SENESE”).
Due to the presence of sodium, this medicine must be administered cautiously to the 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 (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 (cardiac inotropic drugs) or corticosteroid or corticotropin drugs;
• if he/she has high blood pressure (hypertension);
• if pre-eclampsia or another condition associated with sodium retention is present.

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

• if he/she has kidney problems (renal insufficiency), as this 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 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 cautiously to the 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).
  The magnesium concentration in the blood must be monitored frequently to ensure it does not increase excessively.
  Due to the presence of phosphates, the infusion of the medicine may cause a reduction in calcium levels in the blood (hypocalcemia).

Due to the presence of acetate, the medicine must be used cautiously in children who have an 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 cautiously 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 the blood and urine must be monitored, and insulin administered if necessary to minimize the risk of increased glucose levels in the blood (hyperglycemia) and urine (glucosuria). During prolonged use of glucose solutions, fluid accumulation (fluid overload, congestive state) and deficiency of mineral salts in the blood (electrolytes) may occur.
During treatment with this medicine, the doctor must periodically monitor heart function using serial electrocardiograms and the concentration of mineral salts in the blood (plasma osmolarity), glucose (glycemia), fluids, and blood pH (acid-base balance). It is also good practice to monitor blood pressure and osteotendinous reflexes to detect any possible paralysis of respiratory muscles.

Other medicines and ELETTROLITICA EQUILIBRATA PEDIATRICA GALENICA SENESE
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 levels, as they may lead to increased potassium in the blood (hyperkalemia) and reduced ability to eliminate potassium (potassium retention), especially in people with kidney problems (renal dysfunction); in such cases, potassium levels in the blood must be closely monitored;
• corticosteroid anti-inflammatory drugs (corticosteroids) that may cause sodium and water retention, resulting in fluid accumulation (edema) and increased blood pressure (hypertension). These drugs are associated with reduced sugar tolerance, potentially triggering latent diabetes mellitus; therefore, careful monitoring of the child is required if glucose is administered concurrently.

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

• medicines that depress the central nervous system such as barbiturates, narcotics, or other hypnotics (or systemic anesthetics). In this case, the dosage must be carefully adjusted, as magnesium potentiates the depressant effect on the central nervous system;
• medicines used for heart problems (cardiac glycosides, digoxin and 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 against bacterial infections;
• eltrombopag, a medicine used to treat low platelet levels in the blood;
• labetalol, a medicine used to treat heart rhythm disorders (arrhythmias);
• calcium channel blockers used to treat high blood pressure (isradipine, felodipine, nicardipine, and nifedipine), as concurrent use with magnesium may cause a significant drop in blood pressure (hypotension).

ELETTROLITICA EQUILIBRATA PEDIATRICA GALENICA SENESE 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 GALENICA SENESE
This medicine will be prepared by a doctor, pharmacist, or nurse and will not be mixed or administered simultaneously with 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, mineral salt levels in the blood, and health condition, considering that the daily potassium requirement for children is 2–3 mEq per kg 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 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.
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, colorless, or slightly yellowish, or if it contains particles.
Adopt all standard precautions to maintain sterility before and during intravenous infusion.

If you use more ELETTROLITICA EQUILIBRATA PEDIATRICA GALENICA SENESE than you should
Since this medicine will be administered by a doctor or specialized personnel, it is unlikely that an excessive dose will be injected. However, if you think your child has been given an excessive dose of ELETTROLITICA EQUILIBRATA PEDIATRICA GALENICA SENESE, 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/or increased blood volume (hypervolemia). If sodium levels in the blood rise too much, loss of fluids 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 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 manifests as a sudden increase in blood pressure, difficulty breathing (respiratory paralysis), and disappearance of the leg extension response after a percussion stimulus (patellar reflex).

With prolonged administration of glucose, accumulation of intracellular fluids (hyperhydration) and solute overload may occur.
In case of overdose, immediately discontinue the infusion and initiate corrective therapy to reduce excess sugar and ion levels in the blood and, if necessary, restore acid-base balance.
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 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 (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 stiffness, altered sensation in limbs (paraesthesiae), paralysis of certain muscles such as respiratory muscles (flaccid paralysis), weakness;
• mental confusion, headache, dizziness, restlessness, irritability;
• seizures, coma, death;
• cerebral haemorrhage;
• inadequate blood flow 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 the electrocardiogram, syncope, ventricular fibrillation, cardiac arrest;
• reduction or increase in blood pressure (hypotension, hypertension), swelling of legs and ankles (peripheral oedema), vasodilation, flushing, sweating and shock;
• increased levels of sodium (hypernatraemia) and chloride (hyperchloraemia) in the blood;
• increased blood volume (hypervolaemia) and increased 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), decreased blood glucose levels (hypoglycaemia), increased insulin levels, increased adrenaline levels;
• 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).

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 can 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 PEDIATRICAGALENICA SENESE
Keep this medicine out of the reach and sight 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 below 30°C.
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 required. This will help protect the environment.

6. Package contents and other information

What ELETTROLITICA EQUILIBRATA PEDIATRICAGALENICA SENESE contains

• The active substances are: sodium acetate trihydrate, potassium chloride, magnesium chloride hexahydrate, potassium dibasic phosphate anhydrous, 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 anhydrous, 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, water for injections.

• Description of the appearance of ELETTROLITICA EQUILIBRATA PEDIATRICAGALENICA SENESE and contents of the pack
  Vial in glass of 50 ml, 100 ml, 250 ml, 500 ml and 1000 ml of infusion solution.
  Plastic bag containing 50 ml, 100 ml, 250 ml, 500 ml and 1000 ml of infusion solution.

Marketing Authorization Holder and Manufacturer
Industria Farmaceutica Galenica Senese S.r.l.
Via Cassia Nord, 351
53014 Monteroni D’Arbia (SI)
Italy

PACKAGE LEAFLET: Information for the physician

ELECTROLYTE PEDIATRIC BALANCED GALENICA SENESE infusion solution

Equivalent medicinal product
For further information, please refer to the Summary of Product Characteristics
The following information is intended exclusively for physicians or healthcare professionals

Incompatibilities
Due to the presence of glucose, this 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, this 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 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 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 electrolyte levels may require dialysis.

In case of excessive glucose administration, reassess the patient's clinical condition and institute appropriate corrective measures.

Shelf life
24 months from the date of preparation.

For further information, please refer to the Summary of Product Characteristics.