Balanced electrolyte maintenance solution with glucose S.A.L.F.

Package leaflet: Information for the user

ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO S.A.L.F.

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 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.
• 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 may be harmful.
• If you experience any side effect, 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 S.A.L.F. is and what it is used for
2. What you need to know before using ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO S.A.L.F.
3. How to use ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO S.A.L.F.
4. Possible side effects
5. How to store ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO S.A.L.F.
6. Contents of the pack and other information

1. What ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO S.A.L.F. is and what it is used for

ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO S.A.L.F. is an infusion solution intended for direct intravenous injection (intravenous infusion) containing a combination of active substances: sodium chloride, potassium acetate, magnesium acetate tetrahydrate, 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 to moderate states of metabolic acidosis, a condition characterized by increased acidity of the blood.

2. What you should know before using ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO S.A.L.F.

Do not use ELETTROLITICA BILANCIATA DI MANTENEMENTO CON GLUCOSIO S.A.L.F.

• if you are allergic to the active substances or to any of the other components of this medicine (listed in section 6);
• if you have high levels of potassium in the blood (hyperkalemia) or reduced ability to eliminate potassium (potassium retention);
• if you have severe liver problems (severe hepatic insufficiency) leading to inability to metabolize the acetate ion;
• if you suffer from severe kidney problems (severe renal insufficiency);
• if you have problems with urination (oliguric renal failure, anuria);
• if you suffer from 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 you are dehydrated;
• if you have low fluid levels in the body (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 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 being administered ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO S.A.L.F.

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) or anti-inflammatory corticosteroid or corticotropin drugs;
• if you have high blood pressure (hypertension);
• if you have a condition called pre-eclampsia, characterized by high blood pressure, swelling due to fluid accumulation, and presence of protein in the urine, or other conditions caused by sodium accumulation.

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 an adrenal gland disorder (adrenal insufficiency);
• if you have liver problems (hepatic insufficiency);
• if any member of 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).

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 disorder (myasthenia gravis);
• if you are being treated with sedatives, hypnotics (central nervous system depressants), or drugs used to block muscles during surgery (neuromuscular blockers). Magnesium blood concentration should be monitored frequently to prevent excessive increases.

Due to the presence of acetate, this medicine should be administered with caution if you have increased blood pH (metabolic and respiratory alkalosis) or elevated blood acetate levels, such as in mild or moderate liver problems (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 anti-inflammatory drugs (corticosteroids) or hormonal drugs (corticotropins).

During treatment, your doctor will monitor your blood and urine glucose levels and, if necessary, administer insulin to minimize the risk of increased blood glucose (hyperglycemia) and glucose in the urine (glycosuria).

Talk to your doctor, pharmacist, or nurse before being administered ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO S.A.L.F. if you are in any of the following conditions, which may cause high 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 S.A.L.F.)

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

People 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 your heart function via electrocardiograms and blood electrolyte concentrations (plasma osmolarity), particularly sodium levels, as hyponatremia may develop, as well as blood glucose (glycemia), fluid balance, and blood pH (acid-base balance). Blood pressure and osteotendinous reflexes should also be monitored to detect any potential respiratory muscle paralysis.

Children

This medicine should be administered with caution in children, especially neonates and low-birth-weight infants, as blood glucose levels may increase (hyperglycemia). Additionally, in children with low body weight, 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 S.A.L.F.

Inform your doctor or nurse if you are using, have recently used, or might use any other medicine.

This medicine, which contains 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, as they may lead to increased potassium levels in the blood (hyperkalemia) and reduced ability to eliminate potassium (potassium retention), especially if you have kidney problems (renal dysfunction);
• anti-inflammatory steroid drugs (corticosteroids), which may cause sodium and water retention, leading to fluid accumulation (edema) and increased blood pressure (hypertension). Since corticosteroids and corticotropin are associated with reduced sugar tolerance and possible manifestation of latent diabetes mellitus, your doctor will monitor you closely if glucose is administered concurrently;
• drugs affecting the vasopressin hormone, e.g., chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics, chlorpropamide, 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);
• heart medications (cardiac glycosides, digoxin, and digitoxin);
• drugs 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;
• eltrombopag, a medicine used to treat low platelet levels in the blood;
• labetalol, a medicine used to treat heart rhythm disorders (arrhythmias);
• medicines used to treat high blood pressure (isradipine, felodipina, nicardipine, and nifedipine), as concomitant use with magnesium may cause a significant drop in blood pressure (hypotension).

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, planning pregnancy, or breastfeeding, consult your doctor or nurse before this medicine is administered.

This medicine will not be administered during pregnancy or breastfeeding unless absolutely necessary.

If you are pregnant, ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO S.A.L.F. should be administered with particular caution during labor due to the risk of hyponatremia, especially if administered together with a drug inducing labor (oxytocin).

Due to the presence of magnesium, this medicine must not be administered within 2 hours before delivery, as newborns may show signs of magnesium toxicity, including neuromuscular and respiratory depression.

Driving and using machines

This medicine does not affect the ability to drive vehicles or operate machinery.

ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO S.A.L.F. contains sodium metabisulfite.

This medicine contains sodium metabisulfite, which may rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to use ELETTROLITICA BILANCIATA DI MANTENIMENTO CON

GLUCOSIO S.A.L.F.
This medicine will be prepared by a doctor, pharmacist, or nurse and will not be mixed or
administered simultaneously with other incompatible medicines.
This medicine must be administered by specialized medical personnel via
a very slow intravenous infusion (intravenous infusion), as it could cause potassium intoxication leading to death due to loss of heart function (cardiac depression), irregular heartbeat (arrhythmias), up to cardiac arrest.
It must not be injected via other routes of administration (intramuscular, subcutaneous, or into perivascular tissues).
Too rapid infusions may cause local pain, and the infusion rate will be adjusted according to your needs.
Administration will 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 the solution immediately after opening the container. The solution must be clear, colorless or slightly yellowish and free from visible particles. The administration must consist of a single, uninterrupted infusion, and any remaining solution must not be used.
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.
Use in children
In children, the safety and efficacy of this medicine have not been established.
The dosage and infusion rate of glucose must be chosen based on the patient's age, weight, and clinical condition. Particular caution is required in neonates and underweight children (see section “Children”).
Preparation of the medicine: use the solution immediately after opening the container.
It is intended for single, uninterrupted administration only, and any leftover solution must not be used.
Shake well before administration. Do not use the medicine if the solution is not clear, colorless or slightly yellowish, or if it contains particles.
If you use more ELETTROLITICA BILANCIATA DI MANTENIMENTO CON
GLUCOSIO S.A.L.F. 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 too much ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO S.A.L.F., inform your doctor or another healthcare professional 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) may occur, especially in the brain, 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, decreased blood pressure (hypotension), paralysis of certain muscles such as respiratory muscles (flaccid paralysis), reduced body temperature (hypothermia), circulatory collapse, cardiac and central nervous system depression, which may progress to respiratory paralysis.
Magnesium intoxication manifests as a sudden increase in blood pressure, difficulty breathing (respiratory paralysis), and loss of knee reflex response (patellar reflex) following a percussion stimulus.
With prolonged administration of glucose, accumulation of intracellular fluids (overhydration) and solute overload may occur.
In case of overdose, administration of the medicine will be immediately discontinued, and corrective therapy will be initiated to reduce glucose and excess 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 will experience them.
The following side 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 disorders (delayed intestinal transit and paralytic ileus);
• thirst, reduced salivation, metallic taste, chalky taste;
• nerve and muscle disorders (neuromuscular disorders), muscle stiffness, altered sensation in the limbs (paraesthesiae), paralysis of certain muscles such as those involved in respiration (flaccid paralysis), weakness;
• confusion, headache, dizziness, restlessness, irritability;
• seizures, coma, death;
• bleeding in the brain (cerebral haemorrhage);
• brain damage caused by poor blood circulation to the tissues (cerebral ischaemia);
• drowsiness, confusional states, mental disorders, brain swelling (hyponatraemic encephalopathy)*;
• irregular heartbeat (arrhythmias), increased heart rate (tachycardia), decreased heart rate (bradycardia), conduction disorders, disappearance of the P wave, widening of the QRS complex on the electrocardiogram, syncope, ventricular fibrillation, cardiac arrest;
• reduction or increase in blood pressure (hypotension, hypertension), swelling of the legs and ankles (peripheral oedema), hot flushes, sweating and shock, dilation of blood vessels;
• increased levels of sodium (hypernatraemia), potassium (hyperkalaemia) and chloride (hyperchloraemia) in the blood;
• increased blood volume (hypervolaemia) and blood osmolarity (hyperosmolarity);
• reduced levels of calcium in the blood (hypocalcaemia);
• reduced levels of sodium in the blood (hyponatraemia)*;
• increased blood pH (alkalosis);
• breathing difficulties (dyspnoea, respiratory arrest);
• fluid accumulation in the lungs (pulmonary oedema) and air 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 (hyperglycaemia), reduced blood glucose levels (hypoglycaemia), increased insulin levels, increased adrenaline levels;
• fever, infection at the infusion site, pain or local reaction, skin redness (rash), venous irritation, formation of blood clots in veins (venous thrombosis);
• inflammation of the 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).
  *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 the following website:
http://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 S.A.L.F.
Keep this medicine out of the reach and sight 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 any medicine 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 S.A.L.F. contains

• The active substances are: 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, 0.316 g of magnesium acetate tetrahydrate, 55.0 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.
• The other components are: water for injections, sodium metabisulfite.

Description of the appearance of ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO S.A.L.F. and package contents
Glass bottle of 500 ml.
Marketing Authorization Holder and Manufacturer
S.A.L.F. S.p.A. Laboratorio Farmacologico – Via Marconi, 2 - Cenate Sotto (BG)

Package leaflet: information for the physician

BALANCED MAINTENANCE ELECTROLYTE SOLUTION WITH GLUCOSE S.A.L.F.

Infusion solution II
The following information is intended exclusively for physicians or healthcare professionals
Dosage and method of administration
The solution is hypertonic with respect to blood and must be administered by intravenous infusion with caution and at a controlled infusion rate.
Shake well before administration.
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 OF POTASSIUM PER HOUR AND 0.4–0.8 G OF GLUCOSE PER KG OF BODY WEIGHT PER HOUR.
ADULTS
GENERALLY, THE INFUSION RATE IS APPROXIMATELY 500 ML/HOUR.
Children
In children, the safety and efficacy of this medicinal product have not been established.
The dosage and rate of glucose administration must be selected according to the patient’s age, weight, and clinical condition. Particular caution is required in pediatric patients, especially neonates or children with low body weight (see section 4.4).
Do not inject intramuscularly, subcutaneously, or into perivascular tissues.
Administration must be discontinued if the patient experiences pain or redness at the injection site, as this may indicate drug 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.
Hyponatremia
Monitoring of electrolyte balance, serum glucose, serum sodium, and other electrolytes may be necessary before and during administration, particularly in patients with non-osmotic vasopressin release (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 especially important with physiologically hypotonic solutions.
Depending on the tonicity of the solution, volume and frequency of infusion, underlying clinical conditions of the patient, and the capacity for glucose metabolism, intravenous administration of glucose may cause electrolyte disturbances, particularly hypo- or hyperosmolar hyponatremia.
Incompatibilities
If used to dilute medicinal products, consult a pharmacist, if available, before adding any additive drugs; 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;
• sodium novobiocin;
• sodium warfarin.
  Additionally, 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, and tartrates, as precipitates may form. Potential incompatibility is often influenced by changes in the concentration of reactants and the pH of solutions.
  Management of overdose
  Immediately discontinue the infusion and initiate corrective therapy for hyperglycemia and to reduce plasma levels of ions in excess; restore acid-base balance if necessary (see section 4.4).
  The patient should be closely monitored for any signs and symptoms related to the administered drug, ensuring appropriate symptomatic and supportive measures as needed.
  In cases of marked hypernatremia, loop diuretics may be used.
  In cases 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, intravenous calcium must be administered (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 cases of excessive glucose administration, reassess the patient's clinical condition and implement appropriate corrective measures.
  Shelf life
  24 months.
  Use the solution immediately after opening the container; it is intended for single, uninterrupted administration, and any unused residue must not be retained.
  Special storage precautions
  Store in the original packaging and in a tightly closed container. Do not refrigerate or freeze.
  For further information, please consult the Summary of Product Characteristics.