Balanced electrolyte solution for maintenance with glucose Baxter: detailed information

Package leaflet: Information for the user

MAINTENANCE BALANCED ELECTROLYTE WITH GLUCOSE

BAXTER
II Infusion Solution
Sodium Chloride, Potassium Acetate, Magnesium Acetate, Glucose monohydrate
Generic medicinal product
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.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful to them.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

What ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO BAXTER II infusion solution is and what it is used for
What you need to know before using ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO BAXTER II infusion solution
How to use ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO BAXTER II infusion solution
Possible side effects
How to store ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO BAXTER II infusion solution
Contents of the pack and other information

1. What ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO BAXTER is and what it is used for

II Infusion solution and what it is for
ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO BAXTER II infusion solution is an infusion solution administered directly into a vein (intravenous infusion) containing a combination of active substances: sodium chloride, potassium acetate, magnesium acetate, 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 states of metabolic acidosis, a condition characterized by increased blood acidity.

2. What you should know before using ELETTROLITICA BILANCIATA DI MANTENIMENTO

WITH GLUCOSE BAXTER II infusion solution
Do not use ELETTROLITICA BILANCIATA DI MANTENIMENTO WITH GLUCOSE BAXTER II
infusion solution

if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
if you have higher than normal levels of potassium in the blood (hyperkalemia) (or reduced ability to excrete potassium (potassium retention);
if you suffer from severe liver disease (severe hepatic insufficiency);
if you suffer from severe kidney disease (severe renal insufficiency);
if you have an increased blood pH (metabolic and respiratory alkalosis);
in case of abnormal blood coagulation (hypercoagulability);
if you are taking cardiac glycosides, medicines used to treat heart problems (see "Other medicines and ELETTROLITICA BILANCIATA DI MANTENIMENTO WITH GLUCOSE BAXTER II infusion solution");
if you have difficulty urinating (oliguric renal failure, anuria);
in case of bleeding into the spinal cord or brain tissue (spinal or intracranial hemorrhage);
if you suffer from mental disorders characterized by hallucinations, tremors, sweating (delirium tremens), especially if you are dehydrated;
if you have low fluid levels in the body (dehydration);
if you have a disease of the adrenal glands (Addison's disease) and are not receiving treatment for it;
if you experience painful, brief muscle cramps (heat cramps);
if the patient is in a coma;
if you have serious heart problems (severe myocardial disease);
if you have breathing difficulties (respiratory rate less than 16 breaths per minute);
if you have higher than normal blood sugar levels (hyperglycemia).

During blood transfusions, this solution 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
Talk to your doctor or nurse before being administered ELETTROLITICA BILANCIATA DI MANTENIMENTO WITH GLUCOSE BAXTER II infusion solution.
Due to the presence of potassium, this medicine must be administered with caution in the following cases:

if you have kidney problems (renal or adrenocortical insufficiency), as this may worsen potassium retention;
if you have heart problems (heart failure) and/or are taking other heart medications (digitalis drugs);
if you have an adrenal gland disease (adrenal insufficiency); if you have liver problems (hepatic insufficiency);
if someone in your family suffers from a disorder characterized by sudden attacks of muscle weakness (familial periodic paralysis);
if you have a condition characterized by muscle stiffness (congenital myotonia);
if you have recently undergone surgery (early postoperative phase);
if you have 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).

Due to the presence of sodium, this medicine must be administered with caution in the following cases:

if you have heart problems (congestive heart failure, cardiac insufficiency) or kidney problems (severe renal insufficiency, reduced renal function);
if you have fluid accumulation (edema with salt retention), either in the lungs (pulmonary edema) or associated with leg and ankle swelling (peripheral edema);
if you are taking heart medications (cardiotonic drugs), steroid anti-inflammatory drugs (corticosteroids), or hormonal medications (corticotropins);
if you have high blood pressure (hypertension);
if you suffer from a condition called pre-eclampsia, characterized by high blood pressure, swelling due to fluid accumulation, and protein in the urine, or other conditions associated with sodium retention, such as primary or secondary hyperaldosteronism (increased production of aldosterone, an important hormone regulating sodium and potassium levels and body fluid volume), for example associated with hypertension, congestive heart failure, renal artery stenosis, or nephrosclerosis;
if you have excessive fluid in the body (hypervolemia or hyperhydration).

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

if you have kidney problems (renal insufficiency);
if you have heart problems (cardiac insufficiency) and are taking other heart medications (digitalis);
if you have a muscle disease (myasthenia gravis);
if you are being treated with central nervous system depressants and drugs used to block muscles during surgery (neuromuscular blockers);
if you have hypermagnesemia or are in conditions predisposing to hypermagnesemia, such as severe renal impairment or magnesium therapy in eclampsia (a syndrome characterized by seizures similar to epileptic seizures but not caused by brain disease). Magnesium blood levels must be monitored frequently to prevent excessive increases.

Due to the presence of acetate, this medicine must be used with caution:

if you have or are at risk of increased blood pH (metabolic and respiratory alkalosis);
if you have elevated blood acetate levels or inadequate utilization of this ion, as in patients with liver problems (mild or moderate hepatic insufficiency). Excessive administration of this medicine may cause metabolic alkalosis.

Due to the presence of glucose, this medicine must be administered with caution in the following cases:

if you have overt or latent diabetes mellitus (a pathological condition characterized by high blood glucose levels);
if you have any type of glucose intolerance;
if you suffer from corn allergy or allergy to corn-derived products;
if you are taking corticosteroid anti-inflammatory drugs (corticosteroids or corticotropin);
if you have suffered head trauma, particularly within the last 24 hours. During treatment, your doctor will monitor your blood and urine glucose levels and, if necessary, administer insulin or adjust the dose to reduce the risk of increased blood glucose (hyperglycemia) and glucose in urine (glycosuria). Prolonged use of glucose solutions may lead to fluid accumulation (fluid overload, congestive state) and deficiency of minerals in the blood (electrolytes).

Additionally, talk to your doctor or nurse before being administered ELETTROLITICA BILANCIATA DI MANTENIMENTO WITH GLUCOSE BAXTER II infusion solution if you suffer from low calcium levels.
During treatment with this medicine, your doctor must periodically monitor heart function via serial electrocardiograms and blood electrolyte concentrations (plasma osmolarity), particularly sodium levels, as hyponatremia (sodium deficiency) may develop, glucose levels (glycemia), fluids, and blood pH (acid-base balance). Additionally, your blood pressure and osteotendinous reflexes (automatic, involuntary response of the body to muscle stretching) will be monitored to detect possible respiratory muscle paralysis.
Children
In children, the safety and efficacy of this medicine have not been established.
In children, BILANCIATA DI MANTENIMENTO CON GLUCOSIO BAXTER II infusion solution must be administered with particular caution and careful monitoring is required.
Newborns, especially those born prematurely and with low birth weight, are at increased risk of developing blood sugar levels that are too low or too high due to glucose solution infusions. In newborns, low blood sugar may cause seizures, coma, and brain damage. High blood sugar has been associated with intraventricular hemorrhage, late-onset bacterial and fungal infections, retinopathy (a disease affecting the retina), necrotizing enterocolitis (a severe intestinal disease), bronchopulmonary dysplasia (a chronic lung disease), prolonged hospitalization, and death.
Plasma electrolyte concentrations must be carefully monitored in the pediatric population, as this group may have a reduced capacity to regulate fluids and electrolytes.
In cases where increased secretion of antidiuretic hormone (ADH) disrupts normal regulation of blood water content, infusion of fluids with low sodium chloride concentration may result in low sodium levels in the blood (hyponatremia). This may lead to headache, nausea, convulsions, lethargy, coma, brain swelling (cerebral edema), and death; these symptoms of brain disease (symptomatic hyponatremic encephalopathy) are therefore considered a medical emergency.
Furthermore, in children with low body weight, rapid or excessive intravenous infusion may cause increased blood mineral concentration (serum osmolarity) and cerebral hemorrhage due to rupture of blood vessels (intracerebral hemorrhage).
Other medicines and ELETTROLITICA BILANCIATA DI MANTENIMENTO WITH GLUCOSE BAXTER II infusion solution
Inform your doctor if you are using, have recently used, or might use any other medicines.
ELETTROLITICA BILANCIATA DI MANTENIMENTO WITH GLUCOSE BAXTER II infusion solution must be administered with caution if you are taking:

medicines used to lower blood pressure such as potassium-sparing diuretics (amiloride, spironolactone, triamterene), ACE inhibitors, angiotensin II receptor antagonists, or other medicines, as they may lead to increased potassium in the blood (hyperkalemia) and reduced ability to excrete potassium (potassium retention), especially if you have kidney problems (renal dysfunction). Therefore, potassium levels in the blood must be closely monitored in such cases;
immunosuppressants such as tacrolimus and cyclosporine, as potassium administration in patients treated with these drugs may lead to severe and potentially fatal hyperkalemia, particularly in patients with severe renal insufficiency;
steroid anti-inflammatory drugs (corticosteroids) which may cause sodium and water retention, leading to fluid accumulation (edema) and increased blood pressure (hypertension). These drugs are associated with reduced glucose tolerance and possible onset of diabetes mellitus;
medicines that depress the central nervous system (barbiturates, narcotics, hypnotics, or systemic anesthetics), as magnesium enhances their depressant effect on the central nervous system;
medicines used for heart problems (cardiac glycosides, digoxin, and digitoxin), as altered cardiac conduction may occur, potentially progressing to arrhythmia if calcium administration becomes necessary to treat magnesium intoxication;
medicines used to achieve muscle relaxation during surgery (competitive and depolarizing neuromuscular blockers), such as rocuronium, as their effect may be enhanced by magnesium;
aminoglycoside antibiotics, used against bacterial infections, as their neuromuscular blocking effect may be additive to that of magnesium;
eltrombopag, a medicine used to treat low platelet levels in the blood, as its blood concentration may decrease;
rocuronium, as magnesium may increase the risk of rocuronium-induced toxicity;
labetalol, a medicine used to treat heart rhythm disorders (arrhythmias), as co-administration with magnesium may cause decreased heart rate (bradycardia) and reduced blood volume pumped by the heart (cardiac output);
calcium antagonists (isradipine, felodipine, nicardipina, and nifedipine), as concomitant administration with magnesium may lead to decreased blood pressure (hypotension);
acidic drugs such as salicylates (used to treat inflammation), barbiturates (used for sleep disorders), and lithium (used to treat psychiatric conditions);
alkaline drugs such as sympathomimetics (e.g., ephedrine, pseudoephedrine, used in cough preparations), stimulants such as dextroamphetamine sulfate (dexamfetamine used to treat ADHD), and phenfluramine hydrochloride (used for epileptic seizures).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before this medicine is administered.
During pregnancy and breastfeeding, this medicine will be administered only if clearly needed.
The doctor will carefully evaluate the potential risks and benefits for each individual patient before administering the medicine.
Due to the presence of magnesium, this medicine must not be administered within 2 hours before delivery. If magnesium chloride is administered (especially for more than 24 hours before delivery), newborns may show signs of magnesium toxicity, including neuromuscular and respiratory depression.
Intravenous infusion of glucose-containing solutions during labor may cause fetal insulin production, with an associated risk of fetal hyperglycemia, metabolic acidosis, and subsequent rebound hyperglycemia in the newborn.
Driving and using machines
There is no information available on the effects of this medicine on the ability to drive or use machines.

3. How to use ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO

BAXTER II infusion solution
ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO BAXTER II infusion solution will be administered to you by a doctor or nurse.
The doctor will decide the required amount and timing of administration.
This will depend on your age, weight, clinical condition, and concomitant treatments.
The doctor may monitor the levels of salts (electrolytes) and sugar (glucose) in your blood.
ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO BAXTER II infusion solution must not be administered if the solution is not clear, colourless or slightly yellowish, if particles are present, or if the packaging is damaged in any way.
ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO BAXTER II infusion solution must not be administered into a muscle (intramuscularly), into the skin (subcutaneously), or into perivascular tissues (around blood vessels).
Any unused solution must be discarded.
After administration of the medicine, remain lying down for a short period of time.

If you receive more ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO BAXTER II
infusion solution than you should
Since this medicine will be administered by a doctor or trained healthcare professional, it is unlikely that you will receive an excessive dose. However, if you think that you have been given an excessive dose of ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO BAXTER II infusion solution, inform your doctor or another healthcare professional immediately.

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

Increased levels of potassium in the blood (hyperkalaemia), which may lead to death due to heart damage (cardiac depression, arrhythmias or arrest);
Increased levels of sodium (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 administration of high doses of magnesium, the following symptoms of intoxication may occur: flushing, sweating, reduced blood pressure (hypotension), loss of voluntary motor function accompanied by reduced muscle tone (flaccid paralysis), decreased body temperature (hypothermia), severe drop in blood pressure (circulatory collapse), reduced heart function (cardiac depression), and depression of the central nervous system, which may progress to respiratory muscle paralysis (respiratory paralysis). Magnesium intoxication may present with a sudden increase in blood pressure, difficulty breathing (respiratory paralysis), and loss of the leg extension response after a percussive stimulus below the knee (patellar reflex); the absence of the patellar reflex is a useful clinical sign to identify the onset of intoxication.

With prolonged administration of glucose, accumulation of intracellular fluid (overhydration) and solute overload may occur.
Excessive administration of a glucose-containing solution may lead to hyperglycaemia, hyperosmolarity, osmotic diuresis, and dehydration.

In case of overdose, administration of the medicine must be immediately stopped, and corrective therapy will be initiated to reduce elevated glucose and electrolyte 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 or nurse.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions may occur:

allergic reactions, including severe ones (anaphylactoid reactions), urticaria, reduced blood pressure (hypotension), chest pain, difficulty breathing (dyspnea), labored and noisy breathing (rales), flushing, increased blood flow to a specific tissue (hyperemia), lack of strength (asthenia), cold sweats, pyrexia (fever), chills, rapid heartbeat (palpitations), increased respiratory rate, feeling strange, goosebumps (piloerection), peripheral edema;
stomach and intestinal disorders (gastrointestinal disturbances), thirst, reduced salivation, nausea, vomiting, diarrhea, abdominal pain, constipation, intestinal disturbances (delayed intestinal transit), metallic taste, chalky taste;
nervous and muscular system disorders (neuromuscular disturbances), muscle stiffness, altered sensation in limbs or other body parts (paresthesia), loss of voluntary movement associated with reduced muscle tone (flaccid paralysis), weakness;
mental confusion, headache, dizziness, restlessness, irritability;
brain damage due to poor blood circulation to brain tissues (cerebral ischemia);
seizures, coma, death;
drowsiness, confusional states, psychiatric disorders;
irregular heartbeat (arrhythmias), increased heart rate (tachycardia), decreased heart rate (bradycardia), conduction disturbances, disappearance of the P wave, widening of the QRS complex on electrocardiogram, fainting associated with loss of consciousness (syncope), severe heart failure (ventricular fibrillation), cardiac arrest;
reduced or increased blood pressure (hypotension, hypertension), swelling of legs and ankles (peripheral edema), vasodilation, hot flushes, sweating, shock;
increased levels of sodium (hypernatremia), chloride (hyperchloremia), and potassium (hyperkalemia) in blood;
increased blood volume (hypervolemia);
increased concentration of substances in blood (hyperosmolarity);
reduced level of calcium in blood (hypocalcemia);
increased blood pH (alkalosis);
difficulty breathing (dyspnea), respiratory arrest;
fluid accumulation in the lungs (pulmonary edema) and air accumulation within the space between the lung and chest wall (pneumothorax);
reduced tear production;
kidney problems (renal failure), excessive urine production (polyuria);
increased metabolic rate, increased blood glucose level (hyperglycemia), decreased blood glucose level (hypoglycemia), increased insulin level, increased adrenaline level;
increased potassium levels in blood (hyperkalemia);
muscle weakness;
febrile responses, infection/pain at infusion site, local pain or 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 death (tissue necrosis);
inflammation due to pus accumulation (abscesses);
reactions at the infusion site (e.g., burning sensation).

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 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 BILANCIATA DI MANTENIMENTO CON GLUCOSIO

BAXTER II infusion solution
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack 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 BILANCIATA DI MANTENIMENTO CON GLUCOSIO BAXTERII infusion solution contains
Active substances: sodium chloride, potassium acetate, magnesium acetate, glucose monohydrate.
1000 ml of solution contains: 2.34 g of sodium chloride, 1.28 g of potassium acetate, 0.21 g of magnesium acetate, 55 g of glucose monohydrate (equivalent to 50 g of glucose).
Each litre of solution contains: 40 mEq of sodium, 13 mEq of potassium, 3 mEq of magnesium, 40 mEq of chloride, 16 mEq of acetate, 278 mmol of glucose.
pH: 5.0 – 6.0.
Other components: hydrochloric acid (pH adjuster) and water for injections.

Description of the appearance of ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO BAXTERII infusion solution and package contents
Clear, colourless or slightly straw-coloured solution, free from visible particles, in glass bottles or bags.
Glass bottles of 50, 100, 250 and 500 ml.
Pack sizes of 1 bottle or 20 bottles (only for 500 ml).
Bags containing 100, 250, 500 and 1000 ml.
Pack sizes of 1 bag or 20 bags (only for 500 ml).

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
BAXTER S.p.A. - Via del Serafico 89 – 00142 Rome, Italy.
Manufacturers:
BIEFFE MEDITAL S.p.A. - Via Nuova Provinciale - 23034 Grosotto (SO), Italy.
BIEFFE MEDITAL S.A. - Ctra de Biescas - 22666 Sabiñánigo (Spain).

The following information is intended exclusively for healthcare professionals:

Special warnings and precautions for use
Risk of fluid and/or solute overload and electrolyte imbalances
Depending on the volume and rate of infusion, intravenous administration of the medicinal product may cause:

fluid overload leading to hyperhydration/hypervolemia and, for example, congestive states, including pulmonary congestion and edema
clinically significant electrolyte imbalances and acid-base disturbances (see also Use in pediatric patients)

In general, the risk of dilutional states is inversely proportional to the electrolyte concentrations in the medicinal product. The risk of solute overload leading to congestive states is directly proportional to the electrolyte concentrations in the medicinal product. Clinical evaluation and periodic laboratory tests may be necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base equilibrium during prolonged parenteral therapy or whenever the patient's condition or rate of administration so requires.

Administration of anticoagulant citrates used to preserve blood
The medicinal product must not be administered simultaneously with blood through the same administration set due to the risk of pseudoagglutination or hemolysis.

Risk of gas embolism
Do not use plastic containers connected in series, as they may cause gas embolism 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 expelled 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.

Use in patients with or at risk of hyperglycemia
Due to the presence of glucose, the medicinal product must be administered with caution in patients with overt or subclinical diabetes mellitus or with any type of glucose intolerance. 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 capacity to utilize glucose.
Hyperglycemia has been considered a contributing factor to increased ischemic brain injury and impaired recovery after severe ischemic stroke. Caution is recommended when using glucose-containing solutions in such patients.
Early hyperglycemia has been associated with poor outcomes in patients with severe traumatic brain injury. Therefore, glucose-containing solutions should be used with caution in patients with head injuries, particularly within the first 24 hours after trauma.

Osmolarity
The medicinal product 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 may cause venous irritation, including phlebitis.
Hyperosmolar solutions must be administered with caution in patients with existing hyperosmolar states.

Use in elderly patients
When selecting the type of infusion and the volume/infusion rate for elderly patients, consider that elderly patients are more likely to have cardiac, renal, hepatic, or other diseases, or to be receiving concomitant therapy.

Handling
Shake well before administration.
Do not use the medicinal product if the solution is not clear, colorless or slightly straw-colored, or if it contains particles.
After opening the container, the contents must be used immediately and must not be stored for subsequent infusion. Do not reconnect partially used containers.
Observe all standard precautions to maintain sterility before and during intravenous infusion.

Method and time of administration
The solution is hypertonic relative to blood and must be administered by intravenous infusion with caution and at a controlled infusion rate.
The dose depends on the patient's age, weight, clinical condition, and electrolyte status.
The medicinal product must be administered only in patients with intact renal function and at a rate not exceeding 10 mEq potassium per hour and 0.4–0.8 g of glucose per kg of body weight per hour.

Adults
The usual infusion rate is approximately 500 ml/hour.

Children
The safety and efficacy of the medicinal product in children have not been established.
Glucose dosage and infusion rate must be selected based on the patient's age, weight, clinical condition, concomitant therapy, and clinical and laboratory response to treatment. Particular caution is required in pediatric patients, especially neonates or children with low body weight.
Do not inject intramuscularly, subcutaneously, or into perivascular tissues.
Infusion must be discontinued if the patient experiences pain or redness at the injection site, as this may indicate extravasation.
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.

Incompatibilities
Due to the presence of glucose, the medicinal product is incompatible with:

cyanocobalamin;
kanamycin sulfate;
novobiocin sodium;
warfarin sodium.

Furthermore, 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 reagent concentrations and solution pH.
If used to dilute medicinal products, consult a pharmacist, if available, before adding additive drugs; always consider the characteristics of the products to be added; use aseptic 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. Before adding any substance or drug, verify that it is soluble and/or stable in water and that the pH range of Balanced Maintenance Electrolytes with Glucose is suitable. After addition, check for possible color changes and/or formation of precipitates, insoluble complexes, or crystals. Consult the package insert and relevant literature of the additive drug. Additive drugs known to be incompatible must not be used. Mix the solution thoroughly after adding additive drugs; do not store solutions containing additive drugs.

Overdose
Treatment
Immediately discontinue the infusion and initiate corrective therapy for hyperglycemia to reduce plasma levels of excess ions and restore acid-base balance if necessary.
The patient should be closely monitored for any signs and symptoms related to the administered drug, 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 cases of magnesium intoxication presenting with respiratory paralysis, artificial ventilation is required. To counteract the effects of hypermagnesemia, calcium must be administered intravenously (10–20 ml of a 5% solution). Subcutaneous administration of 0.5–1 mg of physostigmine may be helpful.
Markedly elevated plasma electrolyte levels may require dialysis.
In case of excessive glucose administration, reassess the patient's clinical condition and implement appropriate corrective measures.

Balanced electrolyte solution for maintenance with glucose Baxter