Electrolyte solution for replenishment with sodium gluconate Baxter

Patient Information Leaflet

ELETTROLITICA DI REINTEGRAZIONE CON SODIO GLUCONATO BAXTER

Infusion solution
Sodium chloride, Potassium chloride, Magnesium chloride, Sodium acetate, Sodium gluconate
BIOLOGICAL EQUIVALENT MEDICINE
Please read this leaflet carefully before you are given 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, pharmacist, or nurse.
• If you get any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Elettrolitica di Reintegrazione con Sodio Gluconato Baxter is and what it is used for
2. What you need to know before you are given Elettrolitica di Reintegrazione con Sodio Gluconato Baxter
3. How you will be given Elettrolitica di Reintegrazione con Sodio Gluconato Baxter
4. Possible side effects
5. How to store Elettrolitica di Reintegrazione con Sodio Gluconato Baxter
6. Contents of the pack and other information

1. What Elettrolitica di Reintegrazione con Sodio Gluconato Baxter is and what it is used for

Elettrolitica di Reintegrazione con Sodio Gluconato Baxter contains electrolytes, substances
naturally present in the blood that are essential for the body's proper functioning.
Elettrolitica di Reintegrazione con Sodio Gluconato Baxter is indicated in adults for
replacing fluids and electrolytes after their loss and for treating mild levels of acid in the
blood (metabolic acidosis).

2. What you should know before being administered Elettrolitica di Reintegrazione

with Sodium Gluconate Baxter
You will not be administered Elettrolitica di Reintegrazione with Sodium Gluconate Baxter

• if you are allergic to one or more of the electrolytes or to any of the components of this medicine (listed in section 6);
• if you have high levels of sodium in the blood (hypernatremia);
• if you have high levels of water and salts in the blood;
• if you have high levels of potassium in the blood (hyperkalemia) or if your body retains potassium;
• if you have severe liver disease (inability to metabolize the acetate ion);
• if you have severe kidney disease;
• if you have kidney disease and produce little urine;
• if you have severe heart disease;
• if you have fewer than 16 breaths per minute;
• if you have low levels of acid in the blood (respiratory and metabolic alkalosis);
• if you have excess coagulation factors promoting blood clot formation (hypercoagulability);
• if you are taking medicines to treat heart conditions (cardiac glycosides - see section "Other medicines and Elettrolitica di Reintegrazione with Sodium Gluconate Baxter");
• if you have lost large amounts of fluids;
• if you are in a coma;
• if you have adrenal gland disease (glands located above the kidneys) and are not receiving treatment for it (untreated Addison's disease);
• if you experience cramps after physical activity.

Warnings and precautions
Consult your doctor or nurse before receiving Elettrolitica di Reintegrazione with Sodium Gluconate Baxter.
Inform your doctor:

• if you have heart disease (congestive heart failure);
• if you have severe kidney disease with fluid and salt retention causing swelling;
• if you are taking medicines to treat heart conditions or inflammation (see section "Other medicines and Elettrolitica di Reintegrazione with Sodium Gluconate Baxter");
• if you have high blood pressure;
• if you have a weak heart (heart failure), especially if you are taking digitalis-based medicines (see section "Other medicines and Elettrolitica di Reintegrazione with Sodium Gluconate Baxter");
• if you have swelling in your ankles, hands, or feet (peripheral edema);
• if you have fluid accumulation around the lungs;
• if you have kidney disease;
• if you are pregnant and have high blood pressure (pre-eclampsia);
• if you have adrenal gland disease;
• if you or a family member has a condition causing paralysis (familial periodic paralysis);
• if you or a family member has a condition preventing muscles from relaxing after contraction (congenital myotonia);
• if you have recently undergone surgery;
• if you have severe muscle disease that may lead to paralysis (myasthenia gravis);
• if you are taking medicines that inhibit the central nervous system and neuromuscular blockers (see section "Other medicines and Elettrolitica di Reintegrazione with Sodium Gluconate Baxter");
• if you have liver disease, even mild or moderate;
• if you have high levels of magnesium in the blood (hypermagnesemia) or are taking magnesium (see section "Other medicines and Elettrolitica di Reintegrazione with Sodium Gluconate Baxter");
• if you have low levels of acid in the blood (alkalosis);
• if you have increased blood volume or have received large amounts of fluids;
• if you have low levels of calcium in the blood;
• if you have high levels of potassium in the blood;
• if you have lost large amounts of fluids;
• if you have a burn;
• if you are in a condition that may cause high levels of vasopressin, a hormone regulating fluids in your body. You may have excessive vasopressin in your body, for example, if:
• you have a sudden, severe illness;
• you have pain;
• you have undergone surgery;
• you have infections, burns, or brain diseases;
• you have conditions related to your heart, liver, kidneys, or central nervous system due to taking certain medications (also see below "Other medicines and Elettrolitica di Reintegrazione with Sodium Gluconate Baxter").

This may increase the risk of low sodium levels in your blood and may lead to headache, seizures, lethargy, coma, and cerebral edema. Cerebral edema increases the risk of severe, irreversible, and life-threatening brain injury. People at higher risk of cerebral edema include:

• children;
• women (especially those of childbearing age);
• individuals with conditions affecting cerebral fluid levels, such as meningitis, intracranial hemorrhage, or brain injury.

Elettrolitica di Reintegrazione with Sodium Gluconate Baxter may interfere with blood tests for detecting the fungus Aspergillus. Inform your doctor or laboratory technician that you are receiving Elettrolitica di Reintegrazione with Sodium Gluconate Baxter.

Other medicines and Elettrolitica di Reintegrazione with Sodium Gluconate Baxter
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicine.
Some drugs affect the vasopressin hormone. These may include:

• antidiabetic drugs (chlorpropamide);
• cholesterol-lowering drugs (clofibrate);
• anticonvulsants (carbamazepine);
• certain cancer drugs (vincristine, ifosfamide, cyclophosphamide);
• selective serotonin reuptake inhibitors (used to treat depression);
• 3,4-methylenedioxy-N-methamphetamine;
• antipsychotics;
• narcotics;
• painkillers and/or anti-inflammatory drugs (also known as NSAIDs);
• drugs that mimic or enhance the effect of vasopressin, such as desmopressin, oxytocin, terlipressin, vasopressin.

Other medicines increasing the risk of hyponatremia also include diuretics in general and antiepileptic drugs such as oxcarbazepine.

In particular, inform your doctor if you are taking any of the following medicines, as concomitant administration with Elettrolitica di Reintegrazione with Sodium Gluconate Baxter is not recommended:

• medicines for high blood pressure such as potassium-sparing diuretics (amiloride, spironolactone, triamterene), ACE inhibitors (Angiotensin-Converting Enzyme inhibitors), and angiotensin II receptor antagonists;
• tacrolimus or cyclosporine, if you have undergone an organ transplant.

Your doctor will perform blood tests since these medicines may increase potassium levels in the blood.
Additionally, inform your doctor if you are taking:

• corticosteroids and salicylates, medicines used to treat inflammation (see section "Warnings and precautions");
• barbiturates, narcotics, or other hypnotics, medicines used to treat mental disorders or induce sleep;
• drugs that depress the central nervous system;
• cardiac glycosides (digitalis), digoxin and digitoxin, quinidine, medicines used to treat heart conditions (see section 2. You will not be administered Elettrolitica di Reintegrazione with Sodium Gluconate Baxter);
• calcium channel blockers (isradipine, felodipine, nicardipina, and nifedipine), medicines used to treat high blood pressure;
• neuromuscular blockers or systemic anesthetics such as rocuronium, medicines administered during surgery (see section "Warnings and precautions");
• aminoglycoside antibiotics, medicines used to treat infections;
• eltrombopag, a medicine used to help increase platelet count in the blood;
• labetalol, a medicine used to treat heart conditions (see section "Warnings and precautions"). If you take Elettrolitica di Reintegrazione with Sodium Gluconate Baxter and labetalol, you may experience shortness of breath, dizziness, or fainting;
• lithium, a medicine used to treat mental disorders;
• sympathomimetics (e.g., ephedrine, pseudoephedrine), medicines that stimulate nerves;
• dextroamphetamine sulfate, a medicine used to treat excessive sleepiness.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Elettrolitica di Reintegrazione with Sodium Gluconate Baxter should be administered with particular caution in pregnant women during labor, especially regarding serum sodium levels, when administered concomitantly with oxytocin.
Elettrolitica di Reintegrazione with Sodium Gluconate Baxter will be administered during pregnancy or breastfeeding only if clearly needed.
Avoid the use of magnesium 2 hours before delivery. If magnesium chloride is administered (especially for more than 24 hours before delivery) to control seizures in mothers with pregnancy toxemia, it may cause magnesium toxicity in newborns, including neuromuscular and respiratory depression.

Driving and using machines
This medicine does not impair your ability to drive vehicles or operate machinery.

3. How Elettrolitica di Reintegrazione con Sodio Gluconato Baxter will be administered to you

Baxter
This medicine will be given to you through a vein, and you must always follow exactly the
instructions provided by your doctor or nurse. If you have any doubts, consult your doctor.
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The dose will be determined by your doctor based on your age, weight, health condition, and any other ongoing treatments with medicines.

If you are given more Elettrolitica di Reintegrazione con Sodio Gluconato Baxter than you should

It is very unlikely that you will be given more Elettrolitica di Reintegrazione con Sodio Gluconato Baxter than required, as your doctor or nurse will monitor you during treatment.

Symptoms
High blood levels of the substances contained in Elettrolitica di Reintegrazione con Sodio Gluconato Baxter may cause:

• death due to reduced activity, heart rhythm disturbances, or cardiac arrest;
• increased sodium levels and reduced fluid in the blood, which may lead to internal organ dehydration and fluid accumulation in organs (e.g. brain and lungs);
• hot flushes, sweating, low blood pressure, paralysis, reduced body temperature, inability of the heart to pump sufficient blood to meet the body's needs, reduced activity of the heart and central nervous system, possibly leading to respiratory arrest;
• reduction in blood acidity (alkalosis), which may cause low levels of potassium, calcium, and magnesium in the blood.

Treatment
Your doctor will immediately stop the infusion and initiate corrective therapy to reduce the blood levels of substances that are in excess. You may also undergo blood filtration (dialysis).

If you stop treatment with Elettrolitica di Reintegrazione con Sodio Gluconato Baxter

Your doctor will decide when treatment should be stopped.
If you have any doubts about using this medicine, consult your doctor or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If any of the following adverse reactions occur during administration of Elettrolitica di Reintegrazione con Sodio Gluconato Baxter, the doctor will IMMEDIATELY STOP the administration at the first sign of warning, and will provide, whenever possible, appropriate treatment to manage these symptoms, which may be life-threatening:

• allergic reactions, which in some cases may progress to severe allergic reactions (anaphylaxis). Allergic reactions may include the following symptoms:
• very fast heart rate (tachycardia)
• awareness of heart beat (palpitations)
• chest pain and discomfort
• difficulty breathing (dyspnea), increased breathing rate
• flushing, warmth, weakness
• feeling of uneasiness, goosebumps (piloerection)
• swelling of the ankles (peripheral edema), fever, urticaria
• low blood pressure (hypotension), shortness of breath, cold sweats, chills, high levels of potassium in the blood (hyperkalemia)
• pain or redness at the injection site, as this may indicate leakage of the medicine from blood vessels. 5 of 12

Additionally, your doctor may ask you to undergo periodic check-ups and laboratory tests.
Below are listed the adverse reactions associated with Elettrolitica di Reintegrazione con Sodio Gluconato Baxter. There are insufficient data available to determine the frequency of individual listed reactions:

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* Hospital-acquired hyponatremia may cause irreversible brain damage and death due to the development of acute hyponatremic encephalopathy, with unknown frequency (see also section “Warnings and Precautions”).

Reporting of adverse reactions
If you experience any adverse reactions, including those not listed in this leaflet, please contact your doctor, pharmacist, or nurse. You may also report adverse reactions directly via the website https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store Elettrolitica di Reintegrazione con Sodio Gluconato Baxter

Store in the original packaging and keep the container tightly closed.
Do not refrigerate or freeze.
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Keep this medicine out of 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.
Do not use this medicine if you notice any leaks.
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 di Reintegrazione con Sodio Gluconato Baxter contains

• The active substances are: sodium chloride, potassium chloride, magnesium chloride, sodium acetate, sodium gluconate.
• The other components are: water for injections; hydrochloric acid

Description of the appearance of Elettrolitica di Reintegrazione con Sodio Gluconato Baxter and contents of the pack
Elettrolitica di Reintegrazione con Sodio Gluconato Baxter is a solution.
It is available in the following pack sizes:
Glass bottles 100 ml, pack size: 1 unit
Glass bottles 250 ml, pack size: 1 unit
Glass bottles 500 ml, pack size: 20 units
Flexible bags ClearFlex 100 ml, pack size: 1 unit
Flexible bags ClearFlex 250 ml, pack size: 1 unit
Flexible bags ClearFlex and Viaflo 500 ml, pack size: 20 units
Flexible bags ClearFlex 1000 ml, pack size: 1 unit
Flexible bags Viaflo 500 ml, pack size: 24 units
Flexible bags Viaflo 1000 ml, pack size: 10 units
Flexible bags Viaflo 1000 ml, pack size: 12 units
Not all pack sizes may be marketed.

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

Manufacturer
Glass bottles and ClearFlex bags:
BIEFFE MEDITAL S.p.A. Via Nuova Provinciale - 23034 Grosotto (SO), Italy
ClearFlex and Viaflo bags may also be manufactured by:
BIEFFE MEDITAL S.A. Ctra de Biescas - 22666 Sabiñánigo (Spain)

The following information is intended exclusively for physicians or healthcare professionals:
Dosage, method and duration of administration
Electrolyte balance, serum electrolytes, and acid-base balance may need to be monitored before and during administration, with particular attention to serum sodium in patients with 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 hospital-acquired hyponatremia (see sections Warnings and Precautions, Interactions, and Undesirable Effects).
Monitoring of serum sodium is particularly important when hypotonic solutions are used.
Tonicity of Elettrolitica di Reintegrazione con Sodio Gluconato Baxter: 296 mOsm/L
The infusion rate and volume depend on age, body weight, clinical condition (e.g., burns, surgery, head injuries, infections), and concomitant therapy, and must be determined by a physician experienced in pediatric intravenous therapy (see sections Warnings and Precautions and Undesirable Effects).
The solution is isotonic with blood and must be administered by intravenous infusion with caution and at a controlled infusion rate.
Use immediately after opening the container. The solution must be clear, colorless or slightly yellowish and free from visible particles. It is intended for single, uninterrupted administration; any unused portion must not be retained.
Shake well during preparation and before use.
Administer only with intact renal function and at a perfusion rate not exceeding 10 mEq potassium/hour.
Adults
The usual dose is approximately 2 liters/day, administered at an infusion rate of about 2 liters/hour.
Children
In children, the safety and efficacy of this medicinal product have not been established.
Do not inject intramuscularly, subcutaneously, or into perivascular tissues.
Infusion must be stopped if the patient experiences pain or redness at the injection site, as this may indicate extravasation. Excessively rapid infusions 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.
When selecting the type of solution and volume/infusion rate for elderly patients, consider that elderly patients generally have a higher likelihood of various problems (e.g., cardiac, renal, hepatic), and also consider concomitant pharmacological therapies.
Do not connect flexible plastic containers in series, to avoid gas embolism due to possible residual air in 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 in the open position must not be used with flexible plastic containers.

Warnings
Infusion of large volumes should be used with specific monitoring in patients with cardiac or pulmonary insufficiency and in patients with non-osmotic vasopressin release (including SIADH), due to the risk of hospital-acquired hyponatremia (see below).

Hyponatremia
Patients with non-osmotic vasopressin release (e.g., during acute illness, pain, postoperative stress, infections, burns, and central nervous system disorders), patients with cardiac, hepatic, or renal diseases, and patients treated with vasopressin agonists (see section Interactions) are particularly at risk of acute hyponatremia following infusion of hypotonic solutions.
Acute hyponatremia may cause acute hyponatremic encephalopathy (cerebral edema), characterized by headache, nausea, seizures, lethargy, and vomiting. Patients with cerebral edema are particularly at risk of severe, irreversible, and life-threatening brain injury.
Children, women of childbearing age, and patients with reduced cerebral compliance (e.g., meningitis, intracranial hemorrhage, contusion, and cerebral edema) are particularly at risk of severe, life-threatening cerebral edema due to acute hyponatremia.
Due to the presence of potassium, administration should be guided by serial electrocardiograms; serum potassium levels do not reflect intracellular potassium concentrations.
High plasma potassium concentrations may cause death due to cardiac depression, arrhythmias, or arrest. To avoid potassium intoxication, infusion must be slow.
Continuous monitoring of the electrocardiographic trace is essential during infusion. It is good practice to monitor fluid balance, electrolytes, plasma osmolarity, blood pressure, acid-base balance, and osteotendinous reflexes, the latter to monitor for possible respiratory paralysis.
Serum magnesium levels should be closely monitored during therapy to ensure they do not exceed normal levels.
Do not administer to patients in coma.
The solution is not indicated for the treatment of hypochloremic-hypokalemic alkalosis.
Although the solution contains potassium at a concentration similar to plasma levels, it is insufficient to produce beneficial effects in cases of severe potassium deficiency; therefore, it should not be used for correction of severe potassium deficiency.
The solution is not indicated for the primary treatment of severe metabolic acidosis or for the treatment of hypomagnesemia.
Infusion/hypersensitivity reactions, including anaphylactoid reactions, have been reported.
Infusion must be stopped immediately if signs or symptoms of a suspected hypersensitivity reaction occur. Appropriate therapeutic countermeasures should be initiated as clinically indicated.
Depending on volume and infusion rate, intravenous administration of the solution may cause:

• fluid and/or solute overload leading to hyperhydration/hypervolemia and, for example, congestive states, including pulmonary congestion and edema
• clinically significant electrolyte disturbances and acid-base imbalances

Clinical evaluation and periodic laboratory tests may be necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or when the patient's condition or rate of administration requires such monitoring.

Incompatibilities with Elettrolitica di Reintegrazione con Sodio Gluconato Baxter:
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 reactant concentrations and solution pH.
Use immediately after opening the container. The container is intended for single, uninterrupted administration; any unused portion must not be retained.
Shake well before administration. Do not use the medicinal product if the solution is not clear, colorless or slightly yellowish, or if it contains particles.
Take all usual precautions to maintain sterility before and during intravenous infusion.
If used to dilute medicinal products, consult a pharmacist, if available, before adding additives; always consider the characteristics of the products to be added; use aseptic techniques. Mix the solution thoroughly when additives are introduced. Do not store solutions containing additives.
As with all parenteral solutions, compatibility of additive medicinal products with the solution must be evaluated before addition. Before adding any substance or medicinal product, verify its solubility and/or stability in water and that its pH range is appropriate. After addition, check for any color change and/or formation of precipitates, insoluble complexes, or crystals.
Additive medicinal products that are known to be incompatible or have been shown to be incompatible must not be used.

Overdose
Symptoms
High plasma potassium concentrations may cause death due to cardiac depression, arrhythmias, or arrest.
Excessive administration of sodium chloride may lead, depending on the patient's clinical condition, to hypernatremia and/or hypervolemia. Hypernatremia and excessive sodium retention when renal sodium excretion is impaired lead to dehydration of internal organs, especially the brain, and accumulation of extracellular fluids with edema affecting the cerebral, pulmonary, and peripheral circulation, including pulmonary and peripheral edema.
Excessive administration of magnesium may cause the following signs of intoxication: flushing, sweating, hypotension, flaccid paralysis, hypothermia, circulatory collapse, cardiac and central nervous system depression, potentially progressing to respiratory paralysis. Magnesium intoxication may present with elevated blood pressure and respiratory paralysis. Disappearance of the patellar reflex is a useful clinical sign indicating the onset of intoxication.
Excessive administration of the solution may cause metabolic alkalosis, which may be accompanied by hypokalemia as well as decreased ionized serum calcium and ionized serum magnesium.
Excessive volume of solution may cause fluid and sodium overload, with risk of edema (peripheral and/or pulmonary), particularly when renal sodium excretion is impaired.
Excessive potassium administration may lead to hyperkalemia, especially in patients with severe renal impairment.
Excessive magnesium administration may cause hypermagnesemia.
When overdose is suspected, any additives to the solution must also be considered.
The effects of overdose may require immediate medical attention and immediate treatment.

Treatment
Immediately discontinue the infusion and initiate corrective therapy to reduce plasma levels of excess ions and restore, if necessary, 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 medicinal product, and appropriate symptomatic and supportive measures should be provided 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 presenting with respiratory paralysis, artificial ventilation is required. To counteract the effects of hypermagnesemia, intravenous calcium must 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.
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