Electrolyte solution for replenishment with sodium gluconate Bioindustria L.I.M.

Package leaflet: Information for the user

ELETTROLITICA DI REINTEGRAZIONE CON SODIO GLUCONATO Bioindustria

L.I.M. infusion solution
Sodium chloride, potassium chloride, magnesium chloride hexahydrate, sodium acetate trihydrate, sodium gluconate
Generic medicine
Please read all of this leaflet carefully before you use 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 could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

What is in this leaflet:

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

1. What ELETTROLITICA DI REINTEGRAZIONE CON SODIO GLUCONATO Bioindustria L.I.M. is and what it is used for

ELETTROLITICA DI REINTEGRAZIONE CON SODIO GLUCONATO Bioindustria L.I.M. is an infusion solution intended for direct intravenous injection (intravenous infusion), containing a combination of active substances: sodium chloride, potassium chloride, magnesium chloride hexahydrate, sodium acetate trihydrate, sodium gluconate.

This medicinal product is indicated to provide water and electrolytes to the body and for the treatment of mild states of metabolic acidosis, a condition characterized by increased blood acidity.

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

SODIO GLUCONATO Bioindustria L.I.M.
Do not use ELETTROLITICA DI REINTEGRAZIONE CON SODIO GLUCONATO
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 sodium in the blood (hypernatraemia) or other mineral salts (hydrosaline overload);
• if you have high levels of potassium in the blood (hyperkalaemia) 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);
• if you have severe heart problems;
• if you have breathing difficulties (respiratory rate less than 16 breaths per minute);
• if you have an increased blood pH (metabolic and respiratory alkalosis);
• if you have circulatory problems due to increased tendency of blood to clot (hypercoagulability);
• if you are taking medicines for heart diseases called cardioactive glycosides;
• if you have low fluid levels in the body (severe dehydration);
• if you suffer from a disease of the adrenal glands (Addison's disease) and are not undergoing treatment for it;
• if you are in a state of coma;
• if you experience painful, short-duration muscle cramps (heat cramps).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using ELETTROLITICA DI
REINTEGRAZIONE CON SODIO GLUCONATO Bioindustria L.I.M.
This medicine must be administered by very slow intravenous infusion
directly into a vein, as it may cause potassium intoxication which can
lead to death due to loss of heart function (cardiac depression), alteration of
heart rhythm (arrhythmias), up to cardiac arrest (see section “How to use
ELETTROLITICA DI REINTEGRAZIONE CON SODIO GLUCONATO Bioindustria
L.I.M.”).
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 kidney function);
• if you have fluid accumulation (oedema with saline retention), either in the lung (pulmonary oedema) or associated with swelling of the legs and ankles (peripheral oedema);
• if you are taking heart medications (cardiotonic drugs), corticosteroid anti-inflammatory medicines, or corticotropin medicines;
• 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 presence of proteins in urine, or other conditions caused by sodium accumulation.

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

• if you have severe kidney problems (renal insufficiency), as potassium retention may worsen;
• if you have heart problems (cardiac insufficiency) and are taking other heart medications (digitalis);
• if you have a disease of the adrenal glands (adrenal insufficiency);
• if you have severe 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 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, the medicine must be administered with caution in the
following cases:

• if you have severe 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) and medicines used to block muscles during surgery (neuromuscular blockers). Serum magnesium levels must be closely monitored during therapy to ensure they do not exceed safe limits.

Due to the presence of acetate, the medicine must be used with caution in individuals who
have increased pH (metabolic and respiratory alkalosis) or elevated acetate levels in
the blood, such as in individuals with liver problems (mild or moderate hepatic insufficiency).
During treatment with this medicine, your doctor must periodically monitor heart function
through serial electrocardiograms and the concentration of mineral salts in the blood (electrolytes and plasma osmolarity), fluids, and blood pH (acid-base balance). Additionally, it is advisable to monitor blood pressure and osteotendinous reflexes to detect any possible respiratory muscle paralysis.
This medicine must be used immediately after opening the container. The solution must
be clear, colourless, and free of visible particles and is intended for single, uninterrupted
administration. Any remaining solution must not be used.
Children
In children, the safety and efficacy of this medicine have not been established.
Other medicines and ELETTROLITICA DI REINTEGRAZIONE CON SODIO
GLUCONATO Bioindustria L.I.M.
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might
take any other medicines.
This medicine must be administered with caution if you are taking:

• medicines used to lower blood pressure such as potassium-sparing diuretics, ACE inhibitors which cause a decrease in aldosterone hormone levels, as they may lead to increased potassium levels in the blood (hyperkalaemia) and reduced ability to excrete potassium (potassium retention), especially in individuals with kidney problems (renal dysfunction); in such cases, potassium levels in the blood must be closely monitored;
• steroid anti-inflammatory medicines (corticosteroids) which may cause sodium and water retention, resulting in fluid accumulation (oedema) and increased blood pressure (hypertension).

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

• medicines that depress the central nervous system (barbiturates, narcotics, other hypnotics or systemic anesthetics). In this case, dosage must be carefully adjusted because magnesium potentiates the central nervous system depressant effect;
• medicines used for heart problems (cardioactive glycosides, digoxin and digitoxin), due to changes in cardiac conduction;
• medicines used to block muscles during surgery (competitive and depolarizing neuromuscular junction blockers), such as rocuronium, because their effect may be enhanced by magnesium chloride;
• aminoglycoside antibiotics, used against bacterial infections, due to their additive effect on neuromuscular blockade induced by magnesium;
• eltrombopag, a medicine used to treat low platelet levels in the blood, because magnesium may reduce the amount of this medicine in the blood;
• labetalol, a medicine used to treat heart rhythm disorders (arrhythmias); when administered together with magnesium, bradycardia (slowed heart rate) may occur;
• medicines used to treat high blood pressure (isradipine, felodipine, nicardipina and nifedipine), because concomitant 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 to you.
This medicine must not be administered during pregnancy or breastfeeding,
unless absolutely necessary.
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.
Driving and using machines
This medicine does not affect the ability to drive vehicles or use machinery.

3. How to use ELETTROLITICA DI REINTEGRAZIONE CON SODIO GLUCONATO Bioindustria L.I.M.

This medicinal product will be prepared by a physician, pharmacist, or nurse and will not be mixed or administered simultaneously with other incompatible medicinal products.
This medicinal product must be administered directly into a vein (intravenous infusion) by specialized medical personnel. It must not be injected via other routes of administration (intramuscular, subcutaneous, or into perivascular tissues).
This medicinal product must be administered only when kidney function is normal and at a rate not exceeding 10 mEq of potassium per hour.
After administration of the medicinal product, remain lying down for a short period of time.
The dose will be adjusted according to age, body weight, and your health condition.
The recommended dose in adults is 2 litres per day, administered at an infusion rate of approximately 2 litres per hour.
Infusions that are too rapid may cause local pain; 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 may be due to leakage of the medicinal product from the vein (drug extravasation).

Preparation of the medicinal product: Use immediately after opening the container. The container is intended for single and uninterrupted administration, and any remaining solution must not be used.
Shake well before administration. Do not use the medicinal product if the solution is not clear and colourless or if it contains particles. Do not mix with incompatible solutions.
All usual precautions must be taken to maintain sterility before and during intravenous infusion.

If you use more ELETTROLITICA DI REINTEGRAZIONE CON SODIO GLUCONATO Bioindustria L.I.M. than you should
Since this medicinal product will be administered by a physician or trained medical personnel, it is unlikely that you will receive an excessive dose. However, if you think that you have been given an excessive dose of ELETTROLITICA DI REINTEGRAZIONE CON SODIO GLUCONATO Bioindustria L.I.M., inform your doctor or another healthcare professional immediately.

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

• Increased blood potassium levels (hyperkalaemia), which may lead to death due to heart damage (cardiac depression, arrhythmias, or cardiac arrest);
• Increased sodium levels (hypernatraemia) and increased blood volume (hypervolaemia). If blood sodium levels 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).

Following administration of high doses of magnesium, the following symptoms of intoxication may occur: flushing, sweating, reduced arterial pressure (hypotension), paralysis of certain muscles such as the 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, breathing difficulties (respiratory paralysis), and loss of the leg extension response following a percussion stimulus (patellar reflex).

In case of overdose, stop the infusion immediately and initiate corrective therapy to reduce blood levels of excess ions and, if necessary, restore acid-base balance.
If you have any doubts about the use of this medicinal product, 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):

• Gastrointestinal disorders and irritation of the stomach and intestines, nausea, vomiting, diarrhoea, abdominal pain, constipation, intestinal disorders (delayed intestinal transit and paralytic ileus);
• Thirst, reduced salivation, metallic taste, chalky taste;
• Neuromuscular disturbances, muscular rigidity, altered sensation in the limbs (paraesthesiae), paralysis of certain muscles such as respiratory muscles (flaccid paralysis), weakness;
• Mental confusion, headache (cephalaea), dizziness, restlessness, irritability;
• Seizures, coma, death;
• Drowsiness, confusional states, mental disorders;
• 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, feeling of fainting (syncope), ventricular fibrillation, cardiac arrest;
• Decrease or increase in blood pressure (hypotension, hypertension), swelling of legs and ankles (peripheral oedema), hot flushes, sweating, vasodilation and shock;
• Increased levels of sodium (hypernatraemia), chloride (hyperchloraemia), blood volume (hypervolaemia), and blood solutes (hyperosmolarity);
• Decreased levels of calcium in the blood (hypocalcaemia);
• Breathing difficulties (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;
• Fever, infection at the infusion site, pain or local reaction, redness, skin irritation (rash);
• Venous irritation, formation of blood clots in the 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 tissue death (tissue necrosis);
• Inflammation due to accumulation of pus (abscesses).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform 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/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ELETTROLITICA DI REINTEGRAZIONE CON SODIO GLUCONATO Bioindustria L.I.M.
Keep this medicine out of the sight and reach of children.
Medical personnel know how to store this medicine.
Do not use this medicine after the expiry date stated on the packaging after "EXP.".
The expiry date refers to the last day of that month.
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 DI REINTEGRAZIONE CON SODIO GLUCONATO Bioindustria L.I.M. contains

• The active substances are: sodium chloride, potassium chloride, magnesium chloride hexahydrate, sodium acetate trihydrate, sodium gluconate.
  1000 ml of solution contain 5.26 g of sodium chloride, 0.37 g of potassium chloride, 0.31 g of magnesium chloride hexahydrate, 3.67 g of sodium acetate trihydrate, and 5.02 g of sodium gluconate.
  Each litre of solution contains 140 mEq of sodium, 5 mEq of potassium, 3 mEq of magnesium, 98 mEq of chloride, 27 mEq of acetate, and 23 mEq of gluconate.
  pH: 5.5 - 7.0.
• Other components: water for injections, hydrochloric acid (as pH regulator).

Description of the appearance of ELETTROLITICA DI REINTEGRAZIONE CON SODIO GLUCONATO Bioindustria L.I.M. and package contents
Vial containing 50 ml, 100 ml, 250 ml or 500 ml of infusion solution.
50 ml of infusion solution in a 100 ml vial.
100 ml of infusion solution in a 250 ml vial.
250 ml of infusion 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) – Italy.

ELETTROLITICA DI REINTEGRAZIONE CON SODIO GLUCONATO Bioindustria L.I.M. infusion solution
The following information is intended exclusively for physicians or healthcare professionals

Incompatibilities
Due to the presence of magnesium, this 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 the concentration of reactants and the pH of solutions.

Management of overdose
Immediately discontinue the infusion and initiate corrective therapy to reduce plasma levels of ions in excess and restore, if necessary, acid-base balance (see section 4.4).
The patient should be closely monitored for the appearance of any signs and symptoms related to the administered drug, providing appropriate symptomatic and supportive measures as needed.

In case of severe hypernatraemia, loop diuretics may be used.
In case of hyperkalaemia, 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 hypermagnesaemia, 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.

For further information, please refer to the Summary of Product Characteristics