Electrolyte solution for maintenance with glucose Bioindustria L.I.M.

Package leaflet: Information for the user

ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO Bioindustria L.I.M.

Infusion solution I
ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO Bioindustria L.I.M.
Infusion solution II
Sodium chloride, potassium acetate, magnesium acetate tetrahydrate, glucose monohydrate
Generic medicine

Please read all of this leaflet carefully before you start using this medicine, as 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.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO Bioindustria L.I.M. is and what it is used for
2. What you need to know before using ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO Bioindustria L.I.M.
3. How to use ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO Bioindustria L.I.M.
4. Possible side effects
5. How to store ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO Bioindustria L.I.M.
6. Contents of the pack and other information

1. What ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO Bioindustria L.I.M. is and what it is used for

ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO Bioindustria L.I.M. is an intravenous infusion solution intended for direct injection into the vein (intravenous infusion) containing a combination of active substances: Natrium chloridum, Kalii acetas, Magnesii acetas tetrahydricus, Glucosum monohydricum.
This medicinal product is indicated to provide water and electrolytes to the body in situations where a caloric intake must be ensured, and for the treatment of mild to moderate metabolic acidosis, a condition characterized by increased acidity of the blood.

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

GLUCOSIO Bioindustria L.I.M.
Do not use ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO Bioindustria
L.I.M.

• 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 high levels of potassium in the blood (hyperkalemia) or reduced ability to excrete potassium (potassium retention);
• if you have severe liver problems (severe hepatic insufficiency) leading to inability to metabolize the acetate ion;
• if you have severe kidney problems (severe renal insufficiency);
• if you have difficulty urinating (oliguric renal failure, anuria);
• if you have severe heart problems (severe myocardial disease);
• if you have an increased blood pH (metabolic and respiratory alkalosis);
• if you have breathing difficulties (respiratory rate less than 16 breaths per minute);
• if you have circulatory problems due to a high tendency of blood to clot (hypercoagulability);
• if you are taking cardiac glycosides, medicines used to treat heart conditions;
• if you have 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 body fluid levels (dehydration);
• if the patient is in a coma;
• if you have a disease of the adrenal glands (Addison's disease) and are not receiving treatment for it;
• if you experience painful, short-duration muscle cramps (heat cramps). If you have recently received blood transfusions, this medicine must not be administered through the same infusion catheter as whole blood due to the possible risk of red blood cell aggregation (pseudoagglutination).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before ELETTROLITICA
BILANCIATA DI MANTENIMENTO CON GLUCOSIO Bioindustria L.I.M. is administered to you.
Due to the presence of sodium, this medicine should 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 swelling of the legs and ankles (peripheral edema);
• if you are taking heart medications (cardiotonic inotropic drugs), anti-inflammatory drugs (corticosteroids), or hormonal drugs (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 caused by sodium retention.

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

• if you have kidney problems (renal insufficiency), as this may worsen potassium retention;
• if you have heart problems (cardiac insufficiency) and/or are taking other heart medications (digitalis);
• if you have a disease of the adrenal glands (adrenal insufficiency);
• if you have liver problems (hepatic insufficiency);
• if a member of your family suffers from a disorder characterized by sudden episodes of muscle weakness (familial periodic paralysis);
• if you suffer from a condition characterized by muscle stiffness (congenital myotonia);
• if you have recently undergone surgery (early post-operative phase).

Due to the presence of magnesium, this medicine should 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).
  Serum magnesium concentration should be monitored frequently to prevent excessive accumulation.

Due to the presence of acetate, this medicine should be administered with caution if you have increased
pH (metabolic and respiratory alkalosis) or elevated acetate levels in the blood, or inadequate utilization of
this ion, as may occur in individuals with liver problems (mild or moderate hepatic insufficiency).
Due to the presence of glucose, this medicine should be administered with caution if you have
diabetes mellitus or glucose intolerance, or if you are taking corticosteroid anti-inflammatory drugs (corticosteroids or corticotropin).
During treatment, your doctor will monitor glucose levels in your blood and urine and, if necessary,
administer insulin to reduce the risk of increased blood glucose levels (hyperglycemia) and glucose in the urine (glycosuria).
Prolonged use of glucose solutions may lead to fluid accumulation (water overload, congestive state) and deficiency of mineral salts in the blood (electrolytes).
Talk to your doctor, pharmacist, or nurse before ELETTROLITICA
BILANCIATA DI MANTENIMENTO CON GLUCOSIO Bioindustria L.I.M. is administered to you if you are in any of the following
conditions that may cause elevated levels of vasopressin, a hormone that regulates your body fluids:

• acute illness
• pain
• recent surgery
• infections, burns
• brain diseases
• liver, heart, or kidney diseases
• taking certain medications (see also Other medicines and ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO Bioindustria L.I.M.)

This may increase the risk of low sodium levels in the blood (hyponatremia) and may lead to headache,
nausea, seizures, lethargy, vomiting, and cerebral edema. Cerebral edema increases the risk of dangerous
brain damage. Individuals at higher risk of cerebral edema include:

• children
• women (especially those of childbearing age)
• individuals with altered fluid levels in the brain (e.g., due to meningitis, intracranial bleeding, or cerebral contusion).

During treatment with this medicine, your doctor should periodically monitor heart function using serial electrocardiograms and blood electrolyte concentrations (plasma osmolarity), particularly sodium levels, as hyponatremia may develop, as well as glucose levels (glycemia), fluid balance, and blood pH (acid-base balance). Additionally, your blood pressure and osteotendinous reflexes will be monitored to detect any potential respiratory muscle paralysis.
Children
This medicine should be administered with caution in children, particularly neonates and low-birth-weight infants, as blood glucose levels may increase (hyperglycemia). Furthermore, in low-birth-weight children, rapid or excessive intravenous infusion may cause increased serum electrolyte concentration (serum osmolarity) and intracerebral hemorrhage due to rupture of blood vessels.
Other medicines and ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO
Bioindustria L.I.M.
Inform your doctor or nurse if you are using, have recently used, or might use any other
medicines.
This medicine should be administered with caution if you are taking:

• medicines used to lower blood pressure such as potassium-sparing diuretics, ACE inhibitors, or other drugs, as they may lead to increased potassium levels in the blood (hyperkalemia) and reduced potassium excretion (potassium retention), especially if you have kidney problems (renal dysfunction);
• steroid anti-inflammatory drugs (corticosteroids), which may cause sodium and water retention, leading to fluid accumulation (edema) and increased blood pressure (hypertension). Corticosteroids and corticotropin are also associated with reduced sugar tolerance, potentially unmasking latent diabetes mellitus;
• medicines that increase the effect of the antidiuretic hormone (vasopressin), e.g., chlorpropamide, clofibrate, carbamazepine, oxcarbazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics, NSAIDs, cyclophosphamide, desmopressin, oxytocin, vasopressin, terlipressin, and diuretics in general, as they may increase the risk of decreased plasma sodium concentration (hyponatremia).

Due to the presence of magnesium, pay special attention if you are taking the following medicines:

• central nervous system depressants (barbiturates, narcotics, hypnotics, or systemic anesthetics), as magnesium may enhance their depressant effect on the central nervous system;
• medicines used for heart conditions (cardiac glycosides, digoxin, and digitoxin), as they may alter cardiac conduction, potentially leading to arrhythmias;
• medicines used to block muscles during surgery (competitive and depolarizing neuromuscular junction blockers), such as rocuronium, as their effects may be enhanced by magnesium chloride;
• aminoglycoside antibiotics, used to treat bacterial infections, as their neuromuscular blocking effect may be additive to that of magnesium;
• eltrombopag, a medicine used to treat low platelet counts, 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 cardiac output;
• medicines used to treat high blood pressure (isradipine, felodipina, nicardipine, and nifedipine), as concurrent use with magnesium may cause a significant drop in blood pressure (hypotension).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning pregnancy, or breastfeeding, consult your doctor before this medicine is administered.
This medicine should not be used during pregnancy or breastfeeding unless absolutely necessary.
Due to the presence of magnesium, this medicine should 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.
If you are pregnant, this medicine should be administered with particular caution during labor due to the risk of hyponatremia, especially if administered in combination with a labor-inducing medicine (oxytocin).
Driving and use of machines
This medicine does not affect the ability to drive or operate machinery.

3. How to use ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO

Bioindustria L.I.M.
This medicine will be prepared by a doctor, pharmacist, or nurse and must not be mixed or administered simultaneously with other incompatible medicines.
This medicine must be administered as a very slow intravenous infusion (intravenous infusion) by a specialist doctor, as potassium intoxication may occur, which could lead to death due to loss of heart function (cardiac depression), irregular heartbeat (arrhythmias), up to cardiac arrest (see section “How to use ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO Bioindustria L.I.M.”). It must not be injected via other routes of administration (intramuscular, subcutaneous, or into perivascular tissues).
The dose will be adjusted according to age, body weight, blood electrolyte levels, and your overall health condition.
After administration of the medicine, remain lying down for a short period of time.
Infusions that are too rapid may cause local pain, and the infusion rate must be adjusted according to your needs.
Administration must be stopped if you experience pain or redness at the injection site, as this could be due to leakage of the medicine from the vein (drug extravasation).

Use in children
In children, the safety and efficacy of this medicine have not been established.
The dosage and rate of glucose administration must be determined based on the patient's age, weight, and clinical condition. Particular caution is required in newborns and underweight children (see section “Children”).

Preparation of the medicine: the solution must be used immediately after opening the container. Administration must be single and uninterrupted; any remaining solution must not be reused.
The solution must be thoroughly shaken before administration. Do not use the medicine if the solution is not clear and colourless or slightly yellowish, or if it contains particles.
The healthcare personnel performing the infusion will take all standard precautions to maintain sterility before and during the intravenous infusion.

If you use more ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO Bioindustria L.I.M. than you should
Since this medicine will be administered by a doctor or trained healthcare professional, it is unlikely that you will receive an overdose. However, if you think you have been given too much ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO Bioindustria L.I.M., inform your doctor or another healthcare provider immediately.

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

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

In case of excessive magnesium administration, the following symptoms of intoxication may occur: flushing, sweating, reduced blood pressure (hypotension), paralysis of certain muscles including respiratory muscles (flaccid paralysis), reduced body temperature (hypothermia), severe drop in blood pressure (circulatory collapse), reduced heart function (cardiac depression), and reduced central nervous system function, which may progress to respiratory muscle paralysis (respiratory paralysis).
Magnesium intoxication manifests as a sudden increase in blood pressure, difficulty breathing (respiratory paralysis), and loss of the leg extension response following a percussion stimulus (patellar reflex).

Prolonged administration of high doses of glucose may lead to accumulation of intracellular fluids (overhydration) and solute overload.

In case of overdose, administration of the medicine must be immediately discontinued, and corrective therapy will be initiated to reduce blood glucose and excess electrolyte levels, and to restore, if necessary, acid-base balance.

If you have any doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
The following adverse effects may occur:
Not known (frequency cannot be estimated from the available data):

• allergic reactions and urticaria;
• stomach and intestinal (gastrointestinal) disorders, nausea, vomiting, diarrhoea, abdominal pain, constipation, intestinal disturbances (delayed intestinal transit and paralytic ileus);
• thirst, reduced salivation, metallic taste, chalky taste;
• nerve and muscle disorders (neuromuscular disorders), muscle stiffness, altered limb sensation (paraesthesiae), paralysis of certain muscles such as respiratory muscles (flaccid paralysis), weakness;
• mental confusion, headache, dizziness, restlessness, irritability;
• seizures, coma, death;
• bleeding in the brain (cerebral haemorrhage);
• brain damage caused by poor blood circulation to brain tissues (cerebral ischemia);
• drowsiness, confusional states, psychiatric disorders, cerebral edema;
• 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), ventricular fibrillation, cardiac arrest;
• reduction or increase in blood pressure (hypotension, hypertension), swelling of legs and ankles (peripheral edema), vasodilation, hot flushes, sweating, and shock;
• increased levels of sodium (hypernatremia), potassium (hyperkalemia), and chloride (hyperchloremia) in the blood;
• increased blood volume (hypervolemia);
• increased concentration of substances in the blood (hyperosmolarity);
• reduced levels of calcium in the blood (hypocalcemia);
• increased blood pH (alkalosis);
• breathing problems (dyspnoea, respiratory arrest);
• fluid accumulation in the lungs (pulmonary edema) and air accumulation around the membrane surrounding the lung (pneumothorax);
• reduced tear production;
• kidney problems (renal failure) and excessive urine production (polyuria);
• muscle weakness;
• increased metabolic rate, increased blood glucose levels (hyperglycemia), reduced blood glucose levels (hypoglycemia), increased insulin levels, increased adrenaline levels;
• decreased sodium levels (hyponatremia)**;
• fever, infection at the infusion site, local pain or reaction, redness, skin irritation (rash), venous irritation, formation of blood clots in veins (venous thrombosis);
• inflammation of veins (venous phlebitis) extending from the infusion site;
• leakage of the infused solution from the vein (extravasation);
• tissue damage and tissue death (tissue necrosis);
• inflammation due to pus accumulation (abscesses).

**Hospital-acquired hyponatremia which may cause irreversible brain damage and death due to the development of acute hyponatremic encephalopathy.

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. How to store ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO Bioindustria L.I.M.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “EXP.”.
The expiry date refers to the last day of that month.
Store 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 no longer required. This will help protect the environment.

6. Package contents and other information

What ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO contains
Bioindustria L.I.M.
Infusion solution I

• Active substances: sodium chloride, potassium acetate, magnesium acetate tetrahydrate, glucose monohydrate.
  1000 ml of solution contain 2.34 g of sodium chloride, 0.98 g of potassium acetate, 0.32 g of magnesium acetate tetrahydrate, 55 g of glucose monohydrate (equivalent to 50 g of glucose).
  Each liter of solution contains 40 mEq of sodium, 10 mEq of potassium, 3 mEq of magnesium, 40 mEq of chloride, 13 mEq of acetate, and 278 mmol of glucose.
  pH: 5.0 – 7.0.
• Other components: hydrochloric acid, water for injections.

Infusion solution II

• Active substances: sodium chloride, potassium acetate, magnesium acetate tetrahydrate, glucose monohydrate.
  1000 ml of solution contain 2.34 g of sodium chloride, 1.28 g of potassium acetate, 0.32 g of magnesium acetate tetrahydrate, 55 g of glucose monohydrate (equivalent to 50 g of glucose).
  Each liter of solution contains 40 mEq of sodium, 13 mEq of potassium, 3 mEq of magnesium, 40 mEq of chloride, 16 mEq of acetate, and 278 mmol of glucose.
  pH: 5.0 – 7.0.
• Other components: hydrochloric acid, water for injections.

Description of the appearance of ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO Bioindustria L.I.M. and package contents
Glass vial containing 50 ml, 100 ml, 250 ml, 500 ml of infusion solution.
Pack containing 50 ml of solution in a 100 ml vial.
Pack containing 100 ml of solution in a 250 ml vial.
Pack containing 250 ml of solution in a 500 ml vial.

Marketing Authorization Holder and Manufacturer
Bioindustria Laboratorio Italiano Medicinali S.p.A.
Via De Ambrosiis, 2 – 15067 Novi Ligure (AL)

Package leaflet: information for the physician

The following information is intended exclusively for physicians or healthcare professionals
Incompatibilities
If used to dilute drugs, consult the pharmacist, if available, before adding any drug;
always consider the characteristics of the products to be added; use aseptic techniques.
Due to the presence of glucose, the medicinal product is incompatible with:

• cyanocobalamin;
• kanamycin sulfate;
• novobiocin sodium;
• sodium warfarin.
  Furthermore, there are conflicting opinions regarding the compatibility of glucose with hydroxyethyl starch (hetastarch). Ampicillin and amoxicillin remain stable in glucose solutions only for a short period.
  Due to the presence of magnesium, 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 precipitation may occur.
  Potential incompatibility is often influenced by changes in the concentration of reactants and the pH of the solutions.

Dosage
Generally, the infusion rate is approximately 500 ml of solution per hour. The medicinal product must be
administered only in the presence of intact renal function and at a rate not exceeding 10 mEq of potassium per hour,
and 0.4–0.8 g of glucose per kilogram of body weight per hour should be administered.
It may be necessary to monitor electrolyte balance, serum glucose, serum sodium, and other electrolytes before and during administration, particularly in patients with increased non-osmotic release of vasopressin (syndrome of inappropriate antidiuretic hormone secretion, SIADH) and in patients receiving concomitant therapy with vasopressin agonists, due to the risk of hyponatremia. Monitoring of serum sodium is particularly important for physiologically hypotonic solutions.
Depending on the tonicity of the solution, the volume and frequency of infusion, the patient's underlying clinical conditions, and the capacity for glucose metabolism, intravenous administration of glucose may cause electrolyte disturbances, particularly hypo- or hyperosmolar hyponatremia.

Management of overdose
Immediately discontinue the infusion and initiate corrective therapy for hyperglycemia and to reduce plasma levels of ions in excess, and restore acid-base balance if necessary (see section 4.4).
The patient should be closely monitored for the appearance of any signs and symptoms related to the administered drug, ensuring appropriate symptomatic and supportive measures as required.
In case of severe hypernatremia, loop diuretics may be used.
In case of hyperkalemia, intravenous glucose (with or without insulin) or sodium bicarbonate may be administered.
In case of magnesium intoxication manifesting with respiratory paralysis, artificial ventilation is required.
To counteract the effects of hypermagnesemia, 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.

For further information, consult the Summary of Product Characteristics.