Balanced electrolyte solution for maintenance with glucose Monico

Package leaflet: Information for the user

MAINTENANCE BALANCED ELECTROLYTE WITH MONOHYDRATE GLUCOSE

Infusion solution I
Infusion solution II
Sodium chloride, potassium acetate, magnesium acetate, 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 pass it on to others, even if they have the same symptoms as you, because it may be harmful.
• If you experience 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 BILANCIATA DI MANTENIMENTO CON GLUCOSIO MONICO is and what it is used for
2. What you need to know before using ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO MONICO
3. How to use ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO MONICO
4. Possible side effects
5. How to store ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO MONICO
6. Contents of the pack and other information

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

ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO MONICO is an infusion solution for direct intravenous injection (intravenous infusion), containing a combination of active substances: sodium chloride, potassium acetate, magnesium acetate and glucose monohydrate.
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 blood acidity.

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

GLUCOSIO MONICO
Do not use ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO MONICO

• 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 insufficiency, 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 increased 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 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, brief muscle cramps (heat cramps).

If you have recently received blood transfusions, this medicine must not be administered through the same infusion catheter used for whole blood, due to the potential risk of red blood cell aggregation (pseudoagglutination).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before this medicine is administered to you.
This medicine must be administered by slow intravenous infusion, as rapid administration may cause potassium intoxication, which can lead to cardiac depression, cardiac arrhythmias, and even cardiac arrest (see section “How to use ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO MONICO”).

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 (cardiotropic inotropic drugs), corticosteroid anti-inflammatory drugs, or corticotropin medications;
• if you have high blood pressure (hypertension);
• if you have a disease characterized by high blood pressure, fluid retention, and protein in the urine (pre-eclampsia), or other conditions associated with 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 potassium retention may worsen;
• if you have heart problems (cardiac insufficiency) and are taking other heart medications (digitalis glycosides);
• if you have adrenal gland problems (adrenal insufficiency);
• if you have liver problems (hepatic insufficiency);
• if any family member suffers from a disorder characterized by sudden episodes of muscle weakness (familial periodic paralysis);
• if you have a condition causing muscle stiffness (congenital myotonia);
• if you have recently undergone surgery (early postoperative 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 sedatives and hypnotics (central nervous system depressants) or drugs used to block muscles during surgery (neuromuscular blockers).
  Serum magnesium levels should be monitored frequently to prevent excessive accumulation.

Due to the presence of acetate, this medicine should be used with caution in individuals with increased pH (metabolic and respiratory alkalosis) or elevated blood acetate levels, such as in those with mild to moderate liver problems (hepatic insufficiency).
Due to the presence of glucose, this medicine should be administered with caution in individuals with diabetes mellitus or glucose intolerance, and in those taking corticosteroid anti-inflammatory drugs (corticosteroids) or corticotropin.
During treatment, blood and urine glucose levels should be monitored, and insulin administered if necessary to minimize the risk of elevated blood glucose (hyperglycemia) and glucose in the urine (glycosuria). Prolonged use of glucose solutions may lead to fluid overload (hypervolemia, congestive state) and deficiency of minerals in the blood (electrolyte deficit).

Talk to your doctor, pharmacist, or nurse before receiving ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO MONICO if you are in any of the following conditions, which may cause elevated levels of vasopressin, a hormone that regulates body fluids:

• acute illness;
• pain;
• recent surgery;
• infections or burns;
• brain diseases;
• liver, heart, or kidney diseases.

These conditions may increase the risk of low sodium levels in the blood (hyponatremia), potentially causing 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 via serial electrocardiograms and check serum electrolyte levels (plasma osmolarity), blood glucose (glycemia), fluid balance, and blood pH (acid-base balance). It is also advisable to monitor blood pressure and osteotendinous reflexes to detect any potential respiratory muscle paralysis.

Use immediately after opening the container. The solution should be clear, colorless or slightly straw-yellow, and free from visible particles. It is intended for single, uninterrupted administration; any unused portion must not be reused.

Children
This medicine should be administered with caution in children, particularly in neonates and low-birth-weight infants, as it may cause elevated blood glucose levels (hyperglycemia). Additionally, in low-birth-weight children, rapid or excessive intravenous infusion may increase serum osmolarity and cause intracerebral hemorrhage due to rupture of blood vessels.

Other medicines and ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO MONICO
Inform your doctor or nurse if you are using, have recently used, or might use any other medicines.
This medicine, containing sodium salts, 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 that reduce aldosterone levels, as they may increase potassium levels in the blood (hyperkalemia) and impair potassium excretion (potassium retention), especially in patients with kidney dysfunction; in such cases, serum potassium levels must be closely monitored;
• corticosteroid anti-inflammatory drugs (corticosteroids), which may cause sodium and water retention, leading to fluid accumulation (edema) and increased blood pressure (hypertension); corticosteroids and corticotropin may reduce glucose tolerance, potentially unmasking latent diabetes mellitus, so careful monitoring is required when glucose is administered concurrently;
• medicines affecting vasopressin, e.g., chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics, NSAIDs, cyclophosphamide, desmopressin, oxytocin, vasopressin, terlipressin, diuretics in general, and oxcarbazepine, as they may increase the risk of hyponatremia.

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

• central nervous system depressants such as barbiturates, narcotics, or other hypnotics (or systemic anesthetics); in such cases, dosage adjustments must be carefully considered, as magnesium potentiates central nervous system depression; this depressant effect of magnesium can be counteracted by calcium;
• heart medications (cardiac glycosides, digoxin, digitoxin); if calcium is administered to treat magnesium intoxication, disturbances in cardiac conduction may occur, potentially leading to arrhythmias;
• neuromuscular blocking agents used during surgery (competitive and depolarizing neuromuscular blockers), such as rocuronium, as their effects may be enhanced by magnesium chloride;
• aminoglycoside antibiotics, used to treat bacterial infections, as their effects may be additive with those of magnesium;
• eltrombopag, a medicine used to treat low platelet counts, as eltrombopag levels may decrease;
• labetalol, a medicine used to treat heart rhythm disorders (arrhythmias), as co-administration with magnesium may cause bradycardia and reduced cardiac output;
• medicines used to treat high blood pressure (isradipine, felodipina, nicardipine, 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 receiving this medicine.
This medicine should not be used during pregnancy or breastfeeding unless absolutely necessary.
If you are pregnant, this medicine should be administered with particular caution during labor due to the risk of hyponatremia, especially if used in combination with a labor-inducing medicine (oxytocin).
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.

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

3. How to use ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO MONICO

This medicinal product will be prepared by a doctor, pharmacist, or nurse and will not be mixed or administered simultaneously with other incompatible medicinal products.
Before and during administration, your doctor will monitor your body fluid levels, glucose levels, and electrolyte levels, particularly sodium in the blood.
This medicine must be administered directly into a vein (intravenous infusion) by trained medical personnel. It must not be injected via other routes of administration (intramuscular, subcutaneous, or into perivascular tissues).
Shake well before administration.
The dose will be adjusted according to age, body weight, blood electrolyte levels, and your overall health condition.
Generally, the infusion rate is approximately 500 ml of solution per hour. The medicine must be administered only if kidney function is normal, and the infusion rate must not exceed 10 mEq of potassium per hour and 0.4–0.8 g of glucose per kilogram of body weight per hour.
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 should be adjusted according to your individual needs.
Administration must be stopped if you experience pain or redness at the injection site, as this may indicate 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 neonates and children with low body weight (see section “Children”).

Preparation of the medicine: use the solution immediately after opening the container. It is intended for single, uninterrupted administration, and any remaining solution must not be reused.
Shake well before administration. Do not use the medicine if the solution is not clear and colorless or slightly yellowish, or if it contains particles.
Take all usual precautions to maintain sterility before and during intravenous infusion.

If you use more ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO MONICO 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 you have been given too much ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO MONICO, 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 (hyperkalemia), which may lead to death due to heart damage (cardiac depression, arrhythmias, or cardiac arrest);
• Increased sodium levels (hypernatremia) and increased blood volume (hypervolemia); if sodium levels in the blood rise too much, fluid loss from internal organs (dehydration), particularly from the brain, may occur, and fluid accumulation may affect the cerebral, pulmonary, and peripheral circulation, leading to fluid buildup around the lungs (pulmonary edema) or swelling in the legs and ankles (peripheral edema).

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

With prolonged administration of glucose, fluid accumulation (overhydration) and solute overload may occur.

In case of overdose, stop administration of the medicine immediately and initiate corrective therapy 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, pharmacist, or nurse.

4. Possible side effects

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

• allergic reactions and urticaria;
• stomach and intestinal disorders (gastrointestinal disturbances, delayed intestinal transit, and paralytic ileus), nausea, vomiting, diarrhoea, abdominal pain, constipation;
• thirst, reduced salivation, metallic taste, chalky taste;
• nerve and muscle disorders (neuromuscular disturbances), muscle stiffness, altered limb sensation (paraesthesia), paralysis of certain muscles such as respiratory muscles (flaccid paralysis), weakness;
• confusion, headache, dizziness, restlessness, irritability;
• seizures, coma, death;
• bleeding in the brain due to rupture of blood vessels (cerebral haemorrhage);
• brain damage caused by poor blood circulation to brain tissues (cerebral ischaemia);
• drowsiness, confusional states, mental disorders, brain swelling (hyponatraemic encephalopathy)*;
• 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, syncope, ventricular fibrillation, cardiac arrest;
• decreased or increased blood pressure (hypotension or hypertension), swelling of the legs and ankles (peripheral oedema), hot flushes, sweating, shock, dilation of blood vessels;
• increased levels of sodium (hypernatraemia), potassium (hyperkalaemia), and chloride (hyperchloraemia) in the blood;
• increased blood volume (hypervolaemia) and osmolarity (hyperosmolarity);
• reduced levels of calcium in the blood (hypocalcaemia);
• reduced levels of sodium in the blood (hospital-acquired hyponatraemia)*;
• increased blood pH (alkalosis);
• breathing problems (dyspnoea, respiratory arrest);
• fluid accumulation in the lungs (pulmonary oedema) and air in the membrane surrounding the lung (pneumothorax);
• reduced tear production;
• kidney problems (renal failure) and excessive urine production (polyuria);
• muscle weakness;
• increased metabolic rate, increased or decreased blood glucose levels (hyperglycaemia or hypoglycaemia), increased insulin levels, increased adrenaline levels;
• fever, infection at the infusion site, pain or local reaction, redness, skin irritation (rash), venous irritation, formation of blood clots in veins (venous thrombosis);
• inflammation of veins (venous phlebitis) extending from the infusion site;
• leakage of the infused solution from the vein (extravasation);
• tissue damage and death (tissue necrosis);
• inflammation due to pus accumulation (abscess).
  *Hospital-acquired hyponatraemia may cause irreversible brain damage and death due to the development of acute hyponatraemic encephalopathy.

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

5. How to store ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO MONICO

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. Contents of the Pack and Other Information

What ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO MONICO Contains
Infusion Solution I

• The active substances are: sodium chloride, potassium acetate, magnesium acetate, glucose monohydrate. 1000 ml of solution contains: 2.34 g of sodium chloride, 0.98 g of potassium acetate, 0.21 g of magnesium acetate, 55.0 g of glucose monohydrate (equivalent to 50 g of glucose). Each litre 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.
• The other components are water for injections and hydrochloric acid.

Infusion Solution II

• The active substances are: 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, 55.0 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 and 278 mmol of glucose. pH: 5.0 ÷ 7.0.
• The other components are water for injections and hydrochloric acid.

Description of the Appearance of ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO and Contents of the Pack
ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO – Infusion Solution I
Glass flacons of 50, 100, 250, 500, 1000 ml.
Plastic bags of 50, 100, 250, 500, 1000 ml.
ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO – Infusion Solution II
Glass flacons of 50, 100, 250, 500, 1000 ml.
Plastic bags of 50, 100, 250, 500, 1000 ml.

Marketing Authorization Holder and Manufacturer
Monico spa
Via Ponte di Pietra 7, 30173 Venezia Mestre - Italy

The following information is intended for healthcare professionals only

Warnings and precautions
Monitoring of serum sodium is particularly important for physiologically hypotonic solutions.
ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO MONICO may become
extremely hypotonic after administration due to glucose metabolism in the body.
Patients with non-osmotic release of vasopressin (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 are at particularly high risk of developing 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 at particular 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, and cerebral contusion) are especially vulnerable to severe and life-threatening cerebral edema caused by acute hyponatremia.

Interactions
The following list includes medications that enhance the effect of vasopressin, leading to reduced renal excretion of electrolyte-free water and an increased risk of hospital-acquired hyponatremia when intravenous fluid therapy is not appropriately balanced.

• Medications stimulating vasopressin release, for example: chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics.
• Medications potentiating the action of vasopressin, for example: chlorpropamide, NSAIDs, cyclophosphamide.
• Vasopressin analogs: desmopressin, oxytocin, vasopressin, terlipressin. Other medications that also increase the risk of hyponatremia include diuretics in general and antiepileptic drugs such as oxcarbazepine.

Pregnancy
ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO MONICO should be administered with particular caution to pregnant women during labor, especially when administered concomitantly with oxytocin, due to the risk of hyponatremia.