Package leaflet: Information for the user

ELETTROLITICA EQUILIBRATA PEDIATRICA BAXTER

Infusion solution
Generic medicine
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or nurse.
If you get any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

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

1. WHAT ELETTROLITICA EQUILIBRATA PEDIATRICA BAXTER IS AND WHAT IT IS USED FOR

PURPOSE
ELETTROLITICA EQUILIBRATA PEDIATRICA BAXTER belongs to the class of
solutions affecting electrolyte balance. It consists of electrolytes (substances
essential for all cells to maintain a condition allowing them to perform their functions optimally) combined with carbohydrates (sugars).
This medicinal product is used in children:

For the treatment of mild metabolic acidosis (increased blood acidity).
To rehydrate and replenish electrolytes in conditions requiring concomitant caloric intake.

2. WHAT YOU NEED TO KNOW BEFORE USING ELETTROLITICA EQUILIBRATA PEDIATRICA BAXTER

PEDIATRIC BAXTER ELECTROLYTE BALANCED
Do not use ELETTROLITICA EQUILIBRATA PEDIATRICA BAXTER

If you are allergic to the active substance or to any of the other components of this medicine (listed in section 6).
In case of hyperkalemia (increased potassium levels in the blood) or in cases of potassium retention.
If you suffer from severe hepatic insufficiency (reduced liver function).
If you suffer from severe renal insufficiency (reduced kidney function).
In case of metabolic and respiratory alkalosis (decreased blood acidity).
In case of hypercoagulability (abnormal blood clotting).
If you are concurrently being treated with cardioactive glycosides (see "Other medicines and ELETTROLITICA EQUILIBRATA PEDIATRICA BAXTER").
If you suffer from anuria (lack of urine production by the urinary system).
In case of spinal or intracranial hemorrhage (bleeding within the skull).
If you have delirium tremens (acute psychotic syndrome often associated with alcoholism, characterized by tremors, motor restlessness, hallucinations, attention disturbances, incoherence, and anxiety) and are already dehydrated.
If you are severely dehydrated (have lost excessive fluids).
If you have untreated Addison's disease (a condition caused by reduced adrenal cortex function).
In case of heat cramps.
If you are in a coma.
In case of oliguric renal failure (reduced urine output).
In case of severe myocardial disease.
If your respiratory rate is lower than the physiological rate expected for your specific age group.
If you have clinically significant hyperglycemia (elevated blood glucose levels). During blood transfusions, the solution must not be administered through the same infusion catheter as whole blood due to the potential risk of coagulation.

Warnings and precautions
Consult your doctor or nurse before using ELETTROLITICA EQUILIBRATA PEDIATRICA BAXTER.
The medicine must be administered with caution in patients:

With renal insufficiency (reduced kidney function) or adrenocortical insufficiency; administration of solutions containing potassium ions in patients with impaired renal function may cause potassium retention.
With cardiac insufficiency (reduced heart function), especially if being treated with digitalis drugs (medicines that enhance heart function).
With adrenal insufficiency (reduced adrenal gland function).
With hepatic insufficiency (reduced liver function).
With familial periodic paralysis (a neuromuscular disorder with functional disturbances).
With congenital myotonia (a pathological condition present from birth characterized by prolonged muscle contraction).
In the early postoperative phase.
With severe dehydration (excessive fluid loss) or severe tissue damage or burns.
With hypochloremic hypokalemic alkalosis (e.g., due to prolonged vomiting, pyloric stenosis, prolonged nasogastric aspiration).

Use in patients with hypervolemia or hyperhydration, or conditions causing sodium retention and edema
Due to the presence of sodium, administer the medicine with caution:

In hypervolemic or hyperhydrated patients (those with excessive fluid volume in the body).
In patients with congestive heart failure (a pathological condition caused by the heart's inability to pump adequate blood to meet the body's needs).
In cases of severe renal insufficiency (reduced kidney function).
In clinical conditions associated with edema (swelling) and hydrosaline retention (retention of water and salts).
In patients receiving inotropic cardiac drugs (which stimulate heart function) or corticosteroid (anti-inflammatory) or corticotropin drugs (used to assess adrenal gland function or treat diseases requiring corticosteroid therapy).
In patients with hypertension (high blood pressure).
In cases of cardiac insufficiency (reduced heart function).
In patients with peripheral or pulmonary edema.
In patients with reduced kidney function.
In cases of pre-eclampsia (a specific pregnancy condition characterized by edema, protein in urine, and high blood pressure), or other conditions associated with sodium retention such as primary or secondary hyperaldosteronism (increased aldosterone production, an important hormone regulating sodium and potassium levels and body fluid volume) (see "Other medicines and ELETTROLITICA EQUILIBRATA PEDIATRICA BAXTER").

Use in patients with or at risk of hyperkalemia (high potassium concentration in the blood)
Due to the presence of potassium, administration must be guided by serial electrocardiograms (repeated every 15–30 minutes); serum potassium levels (potassium concentration in the blood) do not reflect intracellular potassium concentrations. High potassium levels in the blood may cause death due to cardiac depression, arrhythmias (abnormal heart rhythms), or cardiac arrest. To avoid potassium intoxication, infusion must be administered at a controlled rate (see "How to use ELETTROLITICA EQUILIBRATA PEDIATRICA BAXTER").
The medicine is not indicated for use in patients with hyperkalemia.

Use in patients with or at risk of hypermagnesemia
Due to the presence of magnesium, the medicine must be administered with caution in patients:

With renal insufficiency.
With cardiac insufficiency, especially if receiving digitalis drugs.
With severe myasthenia gravis (a neuromuscular disease characterized by severe muscle weakness).
Receiving central nervous system depressants and neuromuscular blocking agents (medicines used to achieve muscle relaxation during surgical procedures).
With hypermagnesemia or conditions predisposing to hypermagnesemia such as severe renal impairment or magnesium therapy in cases of eclampsia (a syndrome characterized by seizures similar to epileptic seizures but not caused by brain disease).

The medicine is not indicated for the treatment of hypomagnesemia (decreased magnesium levels in the blood).

Use in patients with or at risk of alkalosis
Due to the presence of acetate, the medicine must be used with caution:

In patients with metabolic and respiratory alkalosis (a pathological condition characterized by decreased blood acidity).
In conditions where acetate levels are elevated or its utilization is insufficient, such as in mild to moderate hepatic insufficiency (reduced liver function). Excessive administration of the medicine may cause metabolic acidosis (see "If you use more ELETTROLITICA EQUILIBRATA PEDIATRICA BAXTER than you should").

The medicine is not indicated for the primary treatment of severe metabolic acidosis.

Use in patients with or at risk of hyperphosphatemia (excessive phosphate concentration in the blood)
Due to the presence of phosphates, infusion of the medicine may cause hypocalcemia (reduced calcium concentration in the blood); therefore, it must be administered with caution in patients with:

High blood phosphate levels and low calcium or magnesium levels;
Hyperphosphatemia or conditions predisposing to hyperphosphatemia such as patients with severe renal or adrenal damage.

The medicine is not indicated for the treatment of hypophosphatemia (decreased phosphate levels in the blood).

Use in patients with or at risk of hyperglycemia
Due to the presence of glucose, the medicine must be administered with caution in patients with overt or latent diabetes mellitus (a pathological condition characterized by high blood glucose levels) or with glucose intolerance of any kind. One gram of glucose provides approximately 3.74 kcal (about 15.6 kJ) of caloric energy.
To avoid hyperglycemia, the infusion rate must not exceed the patient's ability to utilize glucose.
Hyperglycemia has been considered a cause of increased ischemic brain injury (brain damage due to reduced blood flow) and impaired recovery after severe ischemic stroke. Caution is recommended when using glucose-containing solutions in these patients.
Early hyperglycemia has been associated with poor outcomes in patients with severe traumatic brain injury. Therefore, glucose-containing solutions should be used cautiously in head-injured patients, particularly within the first 24 hours after trauma.
To minimize the risk of hyperglycemia (increased blood glucose levels) and consequent glycosuria (presence of glucose in urine), blood and urine glucose levels must be monitored, and insulin should be administered or its dose adjusted if hyperglycemia occurs.
During prolonged use of glucose solutions, fluid overload, congestive state, and electrolyte deficits may occur. Particular attention should be paid when administering glucose to patients receiving corticosteroids or corticotropin (see "Other medicines and ELETTROLITICA EQUILIBRATA PEDIATRICA BAXTER").
During infusion of the medicine, continuous monitoring of the electrocardiographic trace is essential, and it is good practice to monitor fluid balance, electrolytes, plasma osmolarity (blood concentration), blood pressure, acid-base balance, osteotendinous reflexes (automatic and involuntary body responses caused by muscle stretching), and blood glucose. Osteotendinous reflexes should be monitored to detect possible respiratory muscle paralysis.
Serum magnesium levels must be closely monitored during therapy to ensure they do not exceed normal limits.

Administration of anticoagulant citrates preserving blood
The medicine must not be administered simultaneously with blood through the same administration set due to the risk of pseudo-agglutination (clumping of red blood cells, a type of blood cell) or hemolysis (destruction of red blood cells).

Risk of gas embolism
Do not use plastic containers connected in series, as they may cause gas embolism (formation of air bubbles in blood vessels) due to possible residual air from the primary container.
Pressurizing intravenous solutions contained in flexible plastic containers to increase flow rates may cause gas embolism if residual air in the container is not completely removed before administration.
Using an intravenous administration set with the vent in the open position may cause gas embolism. Intravenous administration sets with the vent open must not be used with flexible plastic containers.

Osmolarity
The medicine is a hyperosmotic solution, with an osmolarity of 390 mOsmol/liter.
Normal physiological serum osmolarity ranges from approximately 280 to 310 mOsmol/liter.
Administration of hypertonic solutions (with osmolarity higher than normal physiological levels) may cause venous irritation, including phlebitis (vein inflammation). Such solutions must be administered with caution in patients with hyperosmolar states.

Hypersensitivity reactions
Hypersensitivity/infusion reactions, including anaphylactoid reactions (rapid and severe allergic reactions), have been reported with this medicine.
Infusion of the medicine must be discontinued if any signs or symptoms of suspected hypersensitivity occur. Appropriate therapeutic countermeasures must be instituted as clinically indicated.
Glucose-containing solutions must be used with caution in patients with known allergy to corn or corn-derived products.

Risk of fluid and/or solute overload and electrolyte imbalances
Intravenous administration of the medicine, depending on volume and infusion rate, may cause:

Hyperhydration/hypervolemia and congestive states such as pulmonary congestion and edema due to fluid overload;
Clinically significant electrolyte imbalances and acid-base imbalance (see "Children and adolescents").

In case of prolonged therapy or if patient condition or infusion rate requires it, clinical evaluation and periodic laboratory tests may be necessary to monitor changes in body fluids, electrolyte concentrations, and acid-base balance.

Use in patients with hypocalcemia
The medicine must be used with particular caution in patients with hypocalcemia.

Use in patients with severe renal insufficiency
The medicine must be administered with particular caution in patients with severe renal insufficiency, as it may cause retention of sodium and/or potassium or magnesium.

Use in elderly patients
The choice of type, volume, and infusion rate will be decided by the physician, taking into account that elderly patients generally have a higher likelihood of cardiac, renal, hepatic, or other diseases or are receiving concomitant therapy.
Use immediately after opening the container. The container is intended for single, uninterrupted administration, and any remaining solution must not be used.
Do not use the medicine if the solution is not clear and colorless or contains particles.
Adopt all standard precautions to maintain sterility before and during intravenous infusion.

Children
In children, the safety and efficacy of the medicine have not been established.
Neonates, especially those born prematurely and with low birth weight, are at higher risk of developing hypo- or hyperglycemia; therefore, careful monitoring is required during treatment with intravenous glucose solutions to ensure adequate glycemic control (blood glucose concentration) and to avoid potential long-term adverse effects.
Hypoglycemia in neonates may cause seizures, coma, and brain damage.
Hyperglycemia has been associated with intraventricular hemorrhage, delayed onset of bacterial and fungal infections, retinopathy (a disease affecting the retina), necrotizing enterocolitis (a severe intestinal disease), bronchopulmonary dysplasia (a chronic lung disease), prolonged hospital stay, and death.
Plasma electrolyte concentrations must be closely monitored in the pediatric population, as this population may have a reduced capacity to regulate fluids and electrolytes.
Infusion of hypotonic fluids associated with non-osmotic ADH secretion may cause hyponatremia (decreased sodium levels in the blood), which may manifest as headache, nausea, seizures, lethargy (deep sleep state with muscle relaxation and complete loss of sensation), coma, cerebral edema, and death. Therefore, severe symptomatic hyponatremic encephalopathy (a brain disorder) is considered a medical emergency.
Furthermore, in children with low body weight, rapid or excessive infusion may cause increased serum osmolarity and intracerebral hemorrhage (bleeding in the brain).
Infusion rate and volume depend on age, weight, clinical and metabolic condition of the patient, and concomitant therapy, and must be determined by a physician experienced in pediatric intravenous therapy.

Other medicines and ELETTROLITICA EQUILIBRATA PEDIATRICA BAXTER
Inform your doctor if you are using, have recently used, or might use any other medicine. ELETTROLITICA EQUILIBRATA PEDIATRICA BAXTER must be used with caution in combination with:

Potassium-sparing diuretics (drugs that increase urine production, e.g., amiloride, spironolactone, triamterene); this combination may cause hyperkalemia (excessive potassium concentration in the blood) or increase its risk, especially in the presence of renal dysfunction. Therefore, serum potassium levels must be closely monitored in such cases.
Angiotensin II receptor antagonists (medicines used to treat hypertension) or immunosuppressants such as tacrolimus and cyclosporine. Administration of potassium in patients treated with these drugs may cause severe and potentially fatal hyperkalemia, especially in patients with severe renal insufficiency.
Drugs such as ACE inhibitors (medicines used to lower blood pressure); these drugs reduce aldosterone levels and may lead to potassium retention; therefore, serum potassium levels must be closely monitored.
Corticosteroid drugs (anti-inflammatory); these drugs are associated with sodium and water retention, leading to edema (fluid accumulation) and hypertension (see "Warnings and precautions") and with reduced sugar tolerance and possible onset of diabetes mellitus.
Drugs that depress the central nervous system. When barbiturates (drugs used to treat seizures), narcotics (pain-relieving drugs), or other hypnotics (or systemic anesthetics, i.e., those with whole-body effects) or other central nervous system depressants are administered concurrently with magnesium, their dosage must be carefully adjusted due to the additive central nervous system depressant effect of magnesium. Magnesium-induced depression of the central nervous system and peripheral transmission can be counteracted by calcium.
Cardioactive glycosides (digitalis), digoxin, and digitoxin (drugs that enhance heart function), due to changes in cardiac conduction that may lead to cardiac arrhythmia (abnormal heart rhythm) if calcium administration becomes necessary to treat magnesium intoxication.
Competitive and depolarizing neuromuscular blockers; their effects may be potentiated.
Aminoglycoside antibiotics; the effect on neuromuscular blockade of parenterally administered magnesium and aminoglycoside antibiotics may be additive.
Eltrombopag (a drug used to treat conditions with altered platelet count); administration of products containing aluminum, calcium, or magnesium may reduce eltrombopag blood concentrations.
Rocuronium (a drug used in modern anesthesia to facilitate intubation and provide adequate muscle relaxation during surgery or mechanical ventilation); concurrent administration of rocuronium and magnesium may increase the risk of rocuronium toxicity (prolonged neuromuscular blockade, respiratory depression, and apnea).
Labetalol (a drug used to correct heart rhythm abnormalities): concurrent administration of labetalol and magnesium may cause bradycardia (reduced heart rate) and reduced cardiac output, i.e., the volume of blood expelled by a heart ventricle per minute (shortness of breath, dizziness, or fainting).
Calcium antagonists (isradipine, felodipine, nicardipine, and nifedipine); concomitant administration of magnesium with a calcium antagonist may cause hypotension (reduced blood pressure).
Drugs whose renal elimination depends on pH. Due to its alkalinizing effect (bicarbonate formation), the medicine may interfere with the elimination of acidic drugs such as salicylates, barbiturates, and lithium, whose renal clearance may be increased, and alkaline drugs such as sympathomimetics (e.g., ephedrine, pseudoephedrine), quinidine, or dexamfetamine sulfate, whose renal clearance may be decreased.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Intravenous infusion of glucose-containing solutions during labor may cause fetal insulin production, with an associated risk of hyperglycemia, fetal metabolic acidosis, and subsequent neonatal hypoglycemia. The doctor must carefully evaluate the potential risks and benefits for each individual patient before administering the drug.

Driving and using machines
There is no information on the effects of the medicine on the ability to drive or use machinery.

ELETTROLITICA EQUILIBRATA PEDIATRICA BAXTER contains 10 mmol of potassium per daily dose. This should be considered in individuals with reduced renal function or those on a low-potassium diet.

ELETTROLITICA EQUILIBRATA PEDIATRICA BAXTER contains 12 mmol of sodium per daily dose. This should be considered in individuals with reduced renal function or those on a low-sodium diet.

This medicine contains 25.2 g of glucose per dose. This should be considered in individuals with diabetes mellitus.

3. HOW TO USE ELETTROLITICA EQUILIBRATA PEDIATRICA BAXTER

Treatment with ELETTROLITICA EQUILIBRATA PEDIATRICA BAXTER will be supervised by a physician. The physician will determine the amount of ELETTROLITICA EQUILIBRATA PEDIATRICA BAXTER to administer and will prepare the medicinal product.
The solution is hypertonic (has a higher concentration) compared to blood and must be administered by intravenous infusion (into the vein) with caution and at a controlled infusion rate.
Shake well during preparation and before use.
The dose depends on the child's age, weight, clinical condition, and electrolyte status, taking into account that the normal daily potassium requirement in children is 2–3 milliequivalents/kg body weight per day, concomitant treatments, and the child’s clinical and laboratory response to therapy.
Particular caution is required in neonates and children with low body weight (see "Children").
The medicinal product must be administered only if renal function is intact and at a rate not exceeding 10 milliequivalents of potassium per hour and 0.4–0.8 g of glucose per kg of body weight per hour.
Do not inject intramuscularly (into the muscle), subcutaneously (under the skin), or into perivascular tissues (around blood vessels).
Do not administer the solution if it is not clear or if the seal is broken; parenteral medicinal products must be visually inspected for the presence of particles and discoloration.
Administration must be discontinued if the child experiences pain or redness at the injection site, as this may indicate extravasation of the drug.
Infusions that are too rapid may cause local pain, and the infusion rate should be adjusted according to tolerance.
It is advisable for the patient to remain lying down for a short period after administration.
Generally, the dose is 500 ml per day, administered at an infusion rate of approximately 500 ml/hour.
If used to dilute medicinal products, consult the pharmacist, if possible, before adding additive drugs; always consider the characteristics of the products to be added; when adding additive drugs, use aseptic (sterile) techniques.
Additive drugs may be incompatible with the medicinal product. As with all parenteral solutions, compatibility of additive drugs with the solution must be evaluated before addition. The Instructions for Use of the additive drug and relevant literature should be consulted. Additive drugs known to be incompatible must not be used.
Before adding any substance or drug, verify that it is soluble and/or stable in water and that the pH range of ELETTROLITICA EQUILIBRATA PEDIATRICA BAXTER is appropriate. After addition, check for any change in color and/or formation of precipitates, insoluble complexes, or crystals.
Mix the solution thoroughly when additive drugs are added; do not store solutions containing additive drugs.

Incompatibilities with ELETTROLITICA EQUILIBRATA PEDIATRICA BAXTER
The medicinal product is incompatible with:

Cyanocobalamin
Kanamycin sulfate
Sodium novobiocin
Sodium warfarin

Additionally, there are conflicting opinions regarding the compatibility of glucose with hydroxyethyl starch (hetastarch).
Ampicillin and amoxicillin (antibiotics) 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 (formation of insoluble solids) may form.
Potential incompatibility is often influenced by changes in the concentration of reactants and the pH of the solutions.

Use immediately after opening the container. The container is intended for single, uninterrupted administration, and any residual solution must not be used.
Do not use the medicinal product if the solution is not clear and colorless or if it contains particles.
Take all usual precautions to maintain sterility before and during intravenous infusion.

If you use more ELETTROLITICA EQUILIBRATA PEDIATRICA BAXTER than you should
High concentrations of potassium in the blood can cause death due to cardiac depression, arrhythmias, or arrest.
Excessive administration of potassium may lead to hyperkalemia, especially in patients with severe renal insufficiency.
Excessive administration of the medicinal product may lead to metabolic alkalosis, which may be accompanied by hypokalemia and/or a decrease in ionized calcium and magnesium in the blood.
Excessive administration of sodium chloride may lead, depending on the patient’s clinical condition, to hypernatremia (elevated sodium concentration in the blood) and/or hypervolemia (increased blood volume). Hypernatremia and excessive sodium retention when renal sodium excretion is impaired may cause dehydration of internal organs, especially the brain, and accumulation of extracellular fluid (outside the cells), leading to edema that may affect the cerebral (brain), pulmonary, and peripheral circulation, resulting in pulmonary and peripheral edema.
Excessive volume of the medicinal product may lead to fluid overload with a risk of edema (peripheral and/or pulmonary), particularly when sodium excretion is impaired.
Excessive administration of magnesium may lead to hypermagnesemia.
In case of high-dose magnesium administration, the following signs of intoxication may occur: flushing, sweating, hypotension, flaccid paralysis (loss of voluntary movement accompanied by decreased muscle tone), hypothermia (decreased body temperature), circulatory collapse, cardiac and central nervous system depression, which may progress to respiratory paralysis. Magnesium intoxication may present with elevated blood pressure and respiratory paralysis. The disappearance of the patellar reflex (extension of the leg in response to a percussion stimulus below the knee) is a useful clinical sign indicating the onset of intoxication.
Prolonged administration of glucose may lead to hyperhydration (excessive fluid accumulation) and solute overload.
Excessive administration of a solution containing glucose may lead to hyperglycemia, hyperosmolarity, osmotic diuresis, and dehydration.
Excessive administration of phosphate may lead to hyperphosphatemia, hypocalcemia, and hypomagnesemia.
When assessing an overdose, any additives to the solution must also be considered.
The effects of an overdose may require immediate medical attention and treatment.
In case of excessive administration of ELETTROLITICA EQUILIBRATA PEDIATRICA BAXTER, immediately discontinue the infusion and initiate corrective therapy to reduce blood levels of excess ions and, if necessary, restore acid-base balance (see "Warnings and precautions").
The patient should be closely monitored for the appearance of any signs and symptoms related to the administered drug, to ensure appropriate symptomatic and supportive measures as needed.
In case of elevated natremia (excessive sodium in the blood), loop diuretics (medicinal products that increase urine production) may be used.
In case of hyperkalemia (excessive potassium concentration in the blood), intravenous glucose (with or without insulin) or sodium bicarbonate may be administered.
In case of magnesium intoxication presenting with respiratory paralysis, artificial ventilation is required. To counteract the effects of hypermagnesemia (excessive magnesium concentration in the blood), calcium must be administered intravenously (10–20 ml of a 5% solution). Subcutaneous administration of 0.5–1 mg of physostigmine may be helpful.
Elevated levels of electrolytes in the blood may require dialysis (a physical therapy replacing kidney function).
In case of excessive glucose administration, the patient’s clinical condition should be reassessed and appropriate corrective measures instituted.
If you have any questions about the use of this medicinal product, consult your doctor or nurse.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine may cause adverse reactions, although not everyone experiences them.
Possible adverse reactions include:

Hypersensitivity/infusion reactions including anaphylactoid reactions with the following manifestations: urticaria (skin disorder), hypotension, chest pain, dyspnea (difficulty breathing), rales (labored and noisy breathing due to fluid in the bronchi), flushing, hyperemia (increased blood flow in a tissue), asthenia (lack of energy), cold sweats, pyrexia (fever), chills, palpitations (rapid heartbeat), increased respiratory rate, feeling strange, piloerection (goosebumps), peripheral edema.
Gastrointestinal disturbances and irritation, thirst, reduced salivation, nausea, vomiting, diarrhea, abdominal pain, constipation, metallic taste, chalky taste.
Neuromuscular disorders, muscle rigidity, paresthesia (altered sensation in limbs or other body parts), flaccid paralysis (loss of voluntary movement associated with decreased muscle tone), weakness, mental confusion, headache, dizziness, restlessness, irritability, seizures, coma, death.
Drowsiness, confusional states, mental disorders.
Arrhythmias, tachycardia (increased heart rate), bradycardia (decreased heart rate), conduction disturbances, disappearance of the P wave, widening of the QRS complex on the electrocardiogram, syncope (transient loss of consciousness), ventricular fibrillation (severe cardiac decompensation), cardiac arrest.
Hypotension, hypertension, peripheral edema, vasodilation, hot flushes, sweating, shock.
Hypernatremia, hypervolemia, hyperchloremia (increased blood chloride levels), hyperkalemia (increased blood potassium levels), hyperosmolarity (high blood concentration), hypocalcemia (decreased blood calcium levels), alkalosis (reduced blood acidity).
Dyspnea (difficulty breathing), respiratory arrest, pulmonary edema, pneumothorax (a condition with sudden onset characterized by accumulation of air in the space between the lung and the chest wall).
Reduced lacrimation.
Renal failure, polyuria (excessive urine production).
Increased metabolic rate, hyperglycemia (increased blood sugar levels), hypoglycemia (decreased blood sugar levels), increased insulin levels, increased adrenaline levels, hyperkalemia.
Muscle weakness.
Febrile reactions, infection/pain at the infusion site, local pain or reaction, redness, rash (sudden reddening of the skin), venous irritation, thrombosis (a pathological process involving formation of blood clots within blood vessels, obstructing or preventing normal blood circulation), or venous phlebitis (vein inflammation) extending from the infusion site, extravasation, tissue necrosis, abscess formation (collection of pus within a tissue), infusion site reactions (e.g., burning sensation).

If you experience any of the following potentially serious adverse reactions:

If you are in hospital: inform your doctor or nurse immediately.
After leaving the hospital: go immediately to the Emergency Department of the nearest hospital.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at the website
http://www.agenziafarmaco.gov.it/it/responsabili.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE ELETTROLITICA EQUILIBRATED PEDIATRIC

BAXTER
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 and to the product in
intact packaging, properly stored.
The solution must be clear, colourless, and free from visible particles.
This medicine is intended for single, uninterrupted administration; any residual solution must not be used. After opening the container, the contents must be used
immediately and must not be stored for subsequent infusion. Do not reconnect
partially used containers.
Use immediately after opening the container.
Store in the original packaging and in a tightly closed container.
Do not refrigerate or freeze.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What ELETTROLITICA EQUILIBRATA PEDIATRICA BAXTER contains
1000 ml of solution contain:
Active substances:
Sodium Acetate trihydrate 3.2 g
Potassium Chloride 1.3 g
Magnesium Chloride hexahydrate 0.31 g
Dipotassium Phosphate 0.26 g
Glucose monohydrate 55 g (equivalent to 50 g of glucose)
milliequivalents/litre: Na 23
K 20
Mg 3
Cl 20
Acetate 23
HPO 3
mMol/L Glucose 277
Theoretical osmolarity: (mOsm/litre) 369
pH: 5.0 – 7.0
Other components:
Water for injections q.s. to 1000 ml
Hydrochloric acid q.s. to pH 5.0 – 7.0

Description of the appearance of ELETTROLITICA EQUILIBRATA PEDIATRICA BAXTER and contents of the package
Infusion solution, sterile and free from bacterial endotoxins.
Clear, colourless solution free from visible particles.

Glass vials: 250 ml
Packaging: 30 units
Flexible bags: 100, 250, 500 and 1000 ml
Single packaging
Glass vials: 50, 100, 250 and 500 ml
Single packaging

Marketing Authorization Holder
BAXTER S.p.A. - Piazzale dell’Industria 20 – 00144 Rome, Italy.

Manufacturer
BIEFFE MEDITAL S.p.A. - Via Nuova Provinciale - 23034 Grosotto (SO), Italy.
BIEFFE MEDITAL S.A. Ctra de Biescas - 22666 Sabiñánigo (Spain).

Balanced electrolyte pediatric Baxter