Electrolyte solution for replenishment with sodium gluconate S.A.L.F.

Italy
Brand name Electrolyte solution for replenishment with sodium gluconate S.A.L.F.
Form solution for infusion
Active substance / Dosage
SODIUM CHLORIDE
POTASSIUM CHLORIDE
MAGNESIUM CHLORIDE HEXAHYDRATE
SODIUM ACETATE TRIHYDRATE
SODIUM GLUCONATE
Prescription type Prescription only
ATC code
B05BB01
Registration number 031342
Manufacturer S.A.L.F. SPA LABORATORIO FARMACOLOGICO

Table of Contents

Package leaflet: Information for the user

REHYDRATION ELECTROLYTE WITH SODIUM GLUCONATE S.A.L.F.

infusion solution pH 7.4
Sodium chloride, potassium chloride, magnesium chloride hexahydrate, sodium acetate trihydrate, sodium gluconate
Generic medicine
Read this leaflet carefully before 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, because 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.

Contents of this leaflet:

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

1. What ELETTROLITICA DI REINTEGRAZIONE CON SODIO GLUCONATO S.A.L.F. is and

what it is used for
ELETTROLITICA DI REINTEGRAZIONE CON SODIO GLUCONATO S.A.L.F. is a solution for
infusion 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 acidity of the blood.

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

GLUCONATO S.A.L.F.
Do not use ELETTROLITICA DI REINTEGRAZIONE CON SODIO GLUCONATO S.A.L.F.

  • 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 of other electrolytes (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 problems urinating (oliguric renal insufficiency);
  • if you have severe heart problems;
  • if you have difficulty breathing (respiratory rate less than 16 breaths per minute);
  • if you have an increased blood pH (metabolic and respiratory alkalosis);
  • if you have a high tendency for blood to clot (hypercoagulability);
  • if you are taking medicines for heart conditions called cardioactive glycosides;
  • if you have severe dehydration (low fluid levels in the body);
  • if you suffer from untreated adrenal gland disease (Addison's disease);
  • in coma;
  • if you experience painful, short-lasting muscle cramps (heat cramps).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using ELETTROLITICA DI REINTEGRAZIONE CON SODIO GLUCONATO S.A.L.F.
This medicine must be administered by slow intravenous infusion (intravenous infusion), as potassium intoxication may occur, which could lead to death due to loss of heart function (cardiac depression), disturbances in heart rhythm (arrhythmias), up to cardiac arrest (see section “How to use ELETTROLITICA DI REINTEGRAZIONE CON SODIO GLUCONATO S.A.L.F.”).
Due to the presence of sodium, this medicine must be administered with caution in the following cases:

  • if you have heart problems (congestive heart failure, cardiac insufficiency) or kidney problems (severe renal insufficiency, reduced renal function);
  • if you have fluid accumulation (oedema with salt retention), either in the lungs (pulmonary oedema) or associated with swelling of the legs and ankles (peripheral oedema);
  • if you are taking medicines for the heart (cardiotonic agents), anti-inflammatory corticosteroids, or hormonal medicines (corticotropins);
  • if you have high blood pressure (hypertension);
  • if during pregnancy you suffered from a condition called pre-eclampsia, characterized by high blood pressure, swelling due to fluid retention, and presence of proteins in the urine, or other conditions associated with sodium retention.

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

  • if you have kidney problems (renal insufficiency), as potassium retention may occur;
  • if you have heart problems (cardiac insufficiency) and are taking other heart medicines (digitalis);
  • if you have adrenal gland problems (adrenal insufficiency);
  • if you have liver problems (hepatic insufficiency);
  • if you have periodic familial paralysis (episodes of sudden muscle weakness);
  • 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 kidney problems (renal insufficiency);
  • if you have heart problems (cardiac insufficiency) and are taking other heart medicines (digitalis);
  • if you suffer from a muscle disease (severe myasthenia gravis);
  • if you are being treated with medicines that depress the central nervous system (such as sedatives and hypnotics) 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 normal limits.

Due to the presence of acetate, the medicine must be used with caution in the following cases:

  • if you have an increased pH (metabolic and respiratory alkalosis), or high levels of acetate in the blood, as may occur in liver problems (mild or moderate hepatic insufficiency).

During treatment with this medicine, your doctor must periodically monitor heart function through serial electrocardiograms and check levels of electrolytes and plasma osmolarity, fluid balance, and blood pH (acid-base balance). It is also advisable to monitor blood pressure and osteotendinous reflexes (involuntary muscle contraction) to detect any potential respiratory muscle paralysis.
This medicine must be used immediately after opening the container. The solution must be clear, colourless, and free from visible particles, and is intended for single, uninterrupted administration.
Any unused portion must not be reused.

Children
In children, the safety and efficacy of this medicine have not been established.

Other medicines and ELETTROLITICA DI REINTEGRAZIONE CON SODIO GLUCONATO S.A.L.F.
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicine.
This medicine must be administered with caution if you are taking:

  • medicines used to lower blood pressure such as potassium-sparing diuretics, ACE inhibitors, or other medicines that reduce aldosterone levels, as they may lead to increased potassium in the blood (hyperkalaemia) and reduced ability to excrete potassium (potassium retention), especially in patients with kidney problems (renal dysfunction); in such cases, close monitoring of blood potassium levels is required;
  • anti-inflammatory steroid medicines (corticosteroids), which may cause sodium and water retention, leading to fluid accumulation (oedema) and increased blood pressure (hypertension).

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

  • medicines that depress the central nervous system such as barbiturates, narcotics, or other hypnotics (or systemic anaesthetics); in this case, dosage must be carefully adjusted, as magnesium enhances the central nervous system depressant effect;
  • medicines used for heart problems (cardioactive glycosides, digoxin, and digitoxin), due to risk of irregular heartbeat (arrhythmias);
  • medicines used to block muscles during surgery (competitive and depolarizing neuromuscular junction blockers), such as rocuronium, as their effect may be enhanced by magnesium;
  • aminoglycoside antibiotics, used to treat bacterial infections;
  • eltrombopag, a medicine used to treat low platelet levels in the blood, as magnesium may reduce the blood concentration of this medicine;
  • labetalol, a medicine used to treat irregular heartbeat (arrhythmias);
  • medicines used to treat high blood pressure (isradipine, felodipine, 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 to become pregnant, or are breastfeeding, consult your doctor before this medicine is administered.
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 is administered to control seizures in cases of pregnancy-related toxemia (pre-eclampsia), 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 or operate machinery.

3. How to use ELETTROLITICA DI REINTEGRAZIONE CON SODIO GLUCONATO S.A.L.F.

This medicine will be prepared by a doctor, pharmacist, or nurse and must not be mixed with or administered simultaneously to other incompatible medicines.
This medicine must be administered directly into a vein (intravenous infusion) at a controlled rate by trained medical personnel. It must not be injected via other routes of administration (intramuscular, subcutaneous, or into perivascular tissues).
The medicine must be administered only if kidney function is normal and at a rate not exceeding 10 mEq of potassium per hour.
After receiving the medicine, remain lying down for a short period of time.
The dose will be adjusted according to age, body weight, and your overall health condition.
The recommended dose in adults is approximately 2 liters per day, administered at an infusion rate of about 2 liters per hour.
Infusions that are too rapid may cause local pain; the infusion rate should be adjusted according to your 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).

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

If you use more ELETTROLITICA DI REINTEGRAZIONE CON SODIO GLUCONATO 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 you have been given too much ELETTROLITICA DI REINTEGRAZIONE CON SODIO GLUCONATO S.A.L.F., inform your doctor or another healthcare provider immediately.
Following administration of an excessive dose of this medicine, the following may occur:

  • Increased blood potassium levels (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 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 edema) or swelling in the legs and ankles (peripheral edema).

Following 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), circulatory collapse, cardiac and central nervous system depression, which may progress to respiratory paralysis.
Magnesium intoxication may present with a sudden increase in blood pressure and breathing difficulties (respiratory paralysis). The disappearance of the leg extension response following a stimulus below the knee (patellar reflex) is a clinical sign of the onset of intoxication.
In case of overdose, the infusion must be stopped immediately and appropriate therapy initiated.
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):

  • stomach and intestinal disorders and irritation (gastrointestinal disturbances, delayed intestinal transit, and paralytic ileus), nausea, vomiting, diarrhoea, abdominal pain, constipation;
  • thirst, reduced salivation, metallic taste, chalky taste;
  • muscle and nerve disorders (neuromuscular disturbances), muscle stiffness, altered sensation in limbs (paraesthesiae), paralysis of certain muscles such as respiratory muscles (flaccid paralysis), weakness;
  • confusion, headache, dizziness, restlessness, irritability;
  • seizures, coma, death;
  • drowsiness, confusional states, mental disorders;
  • irregular heartbeat (arrhythmias), increased heart rate (tachycardia), decreased heart rate (bradycardia), conduction disturbances, disappearance of the P wave, widening of the QRS complex on electrocardiogram, syncope, ventricular fibrillation, cardiac arrest;
  • reduction or increase in blood pressure (hypotension or hypertension), swelling of legs and ankles (peripheral oedema), vasodilation, flushing, sweating, and shock;
  • increased levels of sodium (hypernatraemia), chloride (hyperchloraemia), blood volume (hypervolaemia), and blood solutes (hyperosmolarity);
  • reduced 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 infusion site, pain or local reaction, redness, skin irritation, venous irritation;
  • formation of blood clots in veins (venous thrombosis);
  • inflammation of veins (venous phlebitis) extending from the infusion site;
  • leakage of the injected solution from the vein (extravasation), tissue damage and tissue death (tissue necrosis);
  • inflammation due to pus accumulation (abscess).

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/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

S.A.L.F.
Keep this medicine out of the sight and reach of children.
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 you no longer use. This will help protect the environment.

6. Package contents and other information

What ELETTROLITICA DI REINTEGRAZIONE CON SODIO GLUCONATO S.A.L.F. 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, 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: 7.2 - 7.6.

  • The other component is water for injections.

Description of the appearance of ELETTROLITICA DI REINTEGRAZIONE CON SODIO GLUCONATO S.A.L.F. and contents of the pack

ELETTROLITICA DI REINTEGRAZIONE CON SODIO GLUCONATO S.A.L.F. pH 7.4 is a sterile, pyrogen-free infusion solution (with physiological pH).
Glass bottles containing 500 ml of infusion solution.

Marketing Authorisation Holder and Manufacturer
S.A.L.F. S.p.A. Laboratorio Farmacologico – Via Marconi, 2 - Cenate Sotto (BG) – Italy.

The following information is intended exclusively for physicians or healthcare professionals

Incompatibilities
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 to reduce plasma levels of ions in excess and restore, if necessary, acid-base balance.
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 hypernatremia, loop diuretics may be used.
In case of hyperkalemia, glucose (with or without insulin) or sodium bicarbonate may be administered by intravenous infusion.
In case of magnesium intoxication manifesting with respiratory paralysis, artificial respiration must be employed. 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.
For further information, refer to the Summary of Product Characteristics.

Package leaflet: information for the user

ELECTROLYTE REHYDRATION SOLUTION WITH SODIUM GLUCONATE S.A.L.F.

infusion solution
Sodium chloride, potassium chloride, magnesium chloride hexahydrate, sodium acetate trihydrate, sodium gluconate
Equivalent medicine
Please read this leaflet carefully before 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 other people, even if their symptoms are the same as yours, as it may be harmful.
  • If you experience any side effects, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What ELETTROLITICA DI REINTEGRAZIONE CON SODIO GLUCONATO S.A.L.F. is and

what it is used for
ELETTROLITICA DI REINTEGRAZIONE CON SODIO GLUCONATO S.A.L.F. is an infusion solution to be injected directly into a vein (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 S.A.L.F.
Do not use ELETTROLITICA DI REINTEGRAZIONE CON SODIO GLUCONATO S.A.L.F.

  • 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 problems urinating (oliguric renal insufficiency);
  • if you have severe heart problems;
  • if you have difficulty breathing (respiratory rate less than 16 breaths per minute);
  • if you have an increased blood pH (metabolic and respiratory alkalosis);
  • if you have a high tendency for blood to clot (hypercoagulability);
  • if you are taking medicines for heart conditions called cardioactive glycosides;
  • if you have severe dehydration (low fluid levels in the body);
  • if you suffer from untreated adrenal gland disease (Addison's disease);
  • in case of coma;
  • if you experience muscle cramps that are painful and short-lived (heat cramps).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using ELETTROLITICA DI REINTEGRAZIONE CON SODIO GLUCONATO S.A.L.F.
This medicine must be administered by slow intravenous infusion (intravenous infusion), as potassium intoxication may occur, potentially leading to death due to loss of heart function (cardiac depression), disturbances in heart rhythm (arrhythmias), up to cardiac arrest (see section “How to use ELETTROLITICA DI REINTEGRAZIONE CON SODIO GLUCONATO S.A.L.F.”).
Due to the presence of sodium, this medicine must be administered cautiously 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 (oedema with salt retention), either in the lungs (pulmonary oedema) or associated with swelling of the legs and ankles (peripheral oedema);
  • if you are taking heart medications (cardiotonic agents), anti-inflammatory drugs (corticosteroids), or hormonal medicines (corticotropins);
  • if you have high blood pressure (hypertension);
  • if during pregnancy you suffered from a condition called pre-eclampsia, characterized by high blood pressure, swelling due to fluid retention, and presence of protein in urine, or other conditions associated with sodium retention.

Due to the presence of potassium, this medicine must be administered cautiously 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);
  • if you have adrenal gland problems (adrenal insufficiency);
  • if you have liver problems (hepatic insufficiency);
  • if you have familial periodic paralysis (episodes of sudden muscle weakness);
  • if you suffer from a disease characterized by muscle stiffness (congenital myotonia);
  • if you have recently undergone surgery (early post-operative phase).

Due to the presence of magnesium, this medicine must be administered cautiously 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 medicines that depress the central nervous system (such as sedatives and hypnotics) or medicines used to block muscles during surgery (neuromuscular blockers). Serum magnesium levels must be closely monitored during therapy to ensure they do not exceed normal limits.

Due to the presence of acetate, this medicine must be used cautiously in the following cases:

  • if you have an increased pH (metabolic and respiratory alkalosis);
  • if you have high levels of acetate in the blood, as may occur in liver problems (mild or moderate hepatic insufficiency).

During treatment with this medicine, your doctor must periodically monitor heart function through serial electrocardiograms and check blood levels of mineral salts (electrolytes and plasma osmolarity), fluid balance, and blood pH (acid-base balance). It is also advisable to monitor blood pressure and osteotendinous reflexes (involuntary muscle contraction) to detect any potential respiratory muscle paralysis.
This medicine must be used immediately after opening the container. The solution must be clear, colourless, and free from visible particles, and is intended for single, uninterrupted administration only.
Any remaining solution must not be reused.
Children
The safety and efficacy of this medicine in children have not been established.
Other medicines and ELETTROLITICA DI REINTEGRAZIONE CON SODIO GLUCONATO S.A.L.F.
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicine.
This medicine must be administered with caution if you are taking:

  • medicines used to lower blood pressure such as potassium-sparing diuretics, ACE inhibitors, or other medicines that reduce aldosterone levels, as they may lead to increased potassium in the blood (hyperkalaemia) and reduced ability to excrete potassium (potassium retention), especially in people with kidney problems (renal dysfunction); in such cases, close monitoring of blood potassium levels is required;
  • anti-inflammatory steroid 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, such as barbiturates, narcotics, or other hypnotics (or systemic anaesthetics). In this case, dosage must be carefully adjusted, as magnesium potentiates the depressant effect on the central nervous system;
  • medicines used for heart problems (cardioactive glycosides, digoxin, and digitoxin), due to risk of irregular heart rhythm (arrhythmias);
  • medicines used to block muscles during surgery (competitive and depolarizing neuromuscular junction blockers), such as rocuronium, as their effect may be enhanced by magnesium;
  • aminoglycoside antibiotics, used to treat bacterial infections;
  • eltrombopag, a medicine used to treat low platelet levels in the blood, as magnesium may reduce the blood concentration of this medicine;
  • labetalol, a medicine used to treat heart rhythm disturbances (arrhythmias);
  • medicines used to treat high blood pressure (isradipine, felodipine, nicardipine, and nifedipine), as concomitant use with magnesium may cause a marked drop in blood pressure (hypotension).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before this medicine is administered.
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 is administered to control seizures in cases of pregnancy toxemia (pre-eclampsia), particularly 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 or operate machinery.

3. How to use ELETTROLITICA DI REINTEGRAZIONE CON SODIO GLUCONATO S.A.L.F.

This medicinal product will be prepared by a physician, pharmacist, or nurse and must not be mixed or administered simultaneously with other incompatible medicinal products.
This medicine must be administered directly into a vein (intravenous infusion) at a controlled rate by trained medical personnel. It must not be injected via other routes of administration (intramuscular, subcutaneous, or into perivascular tissues).
The medicine must be administered only if kidney function is normal and at a rate not exceeding 10 mEq of potassium per hour.
After administration of the medicine, 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 approximately 2 liters per day, administered at an infusion rate of about 2 liters 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 could be due to leakage of the medicine from the vein (drug extravasation).
Preparation of the medicine: Use immediately after opening the container. The container is intended for single, uninterrupted administration and any residual solution must not be used.
Shake well before administration. Do not use the medicine if the solution is not clear and colorless or if it contains particles. Do not mix with incompatible solutions.
Take all usual precautions to maintain sterility before and during intravenous infusion.
If you use more ELETTROLITICA DI REINTEGRAZIONE CON SODIO GLUCONATO S.A.L.F. than you should
Since this medicine 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 too much ELETTROLITICA DI REINTEGRAZIONE CON SODIO GLUCONATO 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 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, along with fluid accumulation affecting the cerebral, pulmonary, and peripheral circulation, leading to fluid buildup around the lungs (pulmonary edema) or swelling in the legs and ankles (peripheral edema).

Following administration of high doses of magnesium, the following symptoms of intoxication may occur: flushing, sweating, decreased arterial pressure (hypotension), paralysis of certain muscles such as respiratory muscles (flaccid paralysis), reduced body temperature (hypothermia), circulatory collapse, cardiac and central nervous system depression that may progress to respiratory paralysis.
Magnesium intoxication manifests as a sudden increase in blood pressure and difficulty breathing (respiratory paralysis). The disappearance of the leg extension response following a stimulus below the knee (patellar reflex) is a clinical sign of the onset of intoxication.
In case of overdose, the infusion must be stopped immediately and appropriate therapy initiated.
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):

  • Stomach and intestinal disturbances and irritation (gastrointestinal disorders, delayed intestinal transit, and paralytic ileus), nausea, vomiting, diarrhoea, abdominal pain, constipation;
  • Thirst, reduced salivation, metallic taste, chalky taste;
  • Muscle and nerve disturbances (neuromuscular disorders), muscle stiffness, altered sensation in limbs (paraesthesiae), paralysis of certain muscles such as respiratory muscles (flaccid paralysis), weakness;
  • Mental confusion, headache, dizziness, restlessness, irritability;
  • Seizures, coma, death;
  • Drowsiness, confusional states, mental disorders;
  • Irregular heartbeat (arrhythmias), increased heart rate (tachycardia), decreased heart rate (bradycardia), conduction disturbances, disappearance of the P wave, widening of the QRS complex on electrocardiogram, syncope, ventricular fibrillation, cardiac arrest;
  • Decreased or increased blood pressure (hypotension, hypertension), swelling of legs and ankles (peripheral oedema), vasodilation, hot flushes, sweating, and shock;
  • Increased levels of sodium (hypernatraemia), chloride (hyperchloraemia), blood volume (hypervolaemia), and solutes (hyperosmolarity) in the blood;
  • 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, venous irritation;
  • Formation of blood clots in veins (venous thrombosis);
  • Inflammation of veins (venous phlebitis) extending from the infusion site;
  • Leakage of the injected solution from the vein (extravasation), tissue damage and tissue death (tissue necrosis);
  • Inflammation due to pus accumulation (abscess).

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/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

S.A.L.F.
Keep this medicine out of the sight and reach of children.
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 in use. This will help protect the environment.

6. Package contents and other information

What ELETTROLITICA DI REINTEGRAZIONE CON SODIO GLUCONATO S.A.L.F. 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, 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.
  • The other components are: water for injections, hydrochloric acid (as pH regulator).

Description of the appearance of ELETTROLITICA DI REINTEGRAZIONE CON SODIO GLUCONATO S.A.L.F. and contents of the package
ELETTROLITICA DI REINTEGRAZIONE CON SODIO GLUCONATO S.A.L.F. is a sterile, pyrogen-free solution for infusion.
Glass bottle containing 500 ml of infusion solution.

Marketing Authorisation Holder and Manufacturer
S.A.L.F. S.p.A. Laboratorio Farmacologico – Via Marconi, 2 – Cenate Sotto (BG) – Italy.

The following information is intended exclusively for physicians or healthcare professionals

Incompatibilities
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 to reduce plasma levels of excess ions and, if necessary, restore acid-base balance.
The patient should be closely monitored for the onset of any signs and symptoms related to the administered drug, providing appropriate symptomatic and supportive measures as needed.
In case of severe hypernatremia, loop diuretics may be used.
In case of hyperkalemia, intravenous glucose (with or without insulin) or sodium bicarbonate may be administered.
In case of magnesium intoxication manifesting with respiratory paralysis, artificial ventilation is required. To counteract the effects of hypermagnesemia, intravenous calcium should be administered (10–20 mL of a 5% solution). Subcutaneous administration of 0.5–1 mg of physostigmine may be helpful.
Elevated plasma electrolyte levels may require dialysis.

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