Electrolyte solution for replenishment with sodium gluconate Monico

Italy
Brand name Electrolyte solution for replenishment with sodium gluconate Monico
Form solution for infusion
Active substance / Dosage
SODIUM CHLORIDE
POTASSIUM CHLORIDE
MAGNESIUM CHLORIDE
SODIUM ACETATE
SODIUM GLUCONATE
Prescription type Prescription only
ATC code
B05BB01
Registration number 030862
Manufacturer MONICO S.P.A.

ELECTROLYTE REPLETION SOLUTION WITH SODIUM GLUCONATE
ELECTROLYTE REPLETION SOLUTION WITH SODIUM GLUCONATE MONICO – infusion solution

PHARMACOTHERAPEUTIC CATEGORY
Electrolytes.

THERAPEUTIC INDICATIONS
Replenishment of fluids and electrolytes.
Treatment of mild metabolic acidosis.

CONTRAINDICATIONS

  • Hypersensitivity to the active substances or to any of the excipients;
  • hypernatraemia;
  • hypervolaemia;
  • hyperkalaemia or conditions involving potassium retention;
  • severe hepatic insufficiency (inability to metabolize the acetate ion);
  • severe renal insufficiency;
  • oliguric renal failure;
  • severe myocardial disease;
  • respiratory rate below 16 breaths per minute;
  • metabolic and respiratory alkalosis;
  • hypercoagulability;
  • concomitant therapy with cardioactive glycosides (see Interactions);
  • severe dehydration;
  • coma;
  • untreated Addison's disease;
  • heat cramps.

PRECAUTIONS FOR USE
Due to the presence of sodium, use with caution in patients with congestive heart failure, severe renal
insufficiency, and in clinical conditions associated with oedema and salt retention; in patients receiving
cardiotonic inotropic drugs or corticosteroid or corticotropin drugs.
Sodium salts should be administered cautiously in patients with hypertension, cardiac failure, peripheral or pulmonary oedema, reduced renal function, pre-eclampsia, or other conditions associated with sodium retention (see Interactions).
Due to the presence of potassium, administration must be guided by serial electrocardiograms; serum potassium levels do not reflect intracellular potassium concentrations.
High plasma potassium concentrations may cause death due to cardiac depression, arrhythmias, or arrest. To prevent potassium intoxication, the infusion must be administered slowly.
The medicinal product must be administered with caution in patients:

  • with renal insufficiency (administration of solutions containing potassium ions in patients with reduced renal function may cause potassium retention);
  • with cardiac failure, particularly if digitalized;
  • with adrenal insufficiency;
  • with hepatic insufficiency;
  • with familial periodic paralysis;
  • with congenital myotonia;
  • in the early postoperative phase.

Due to the presence of magnesium, the medicinal product must be administered with caution in patients:

  • with renal insufficiency;
  • with cardiac failure, particularly if digitalized;
  • with severe myasthenia gravis;
  • undergoing treatment with central nervous system depressants or neuromuscular blocking agents.

Due to the presence of acetate, use with caution in patients with metabolic or respiratory alkalosis and in conditions where acetate levels are elevated or its utilization is impaired, such as in mild to moderate hepatic insufficiency.
During infusion, continuous monitoring of the electrocardiographic trace is essential. It is good practice to monitor fluid balance, electrolytes, plasma osmolarity, blood pressure, acid-base balance, and osteotendinous reflexes, the latter to detect possible respiratory paralysis. Serum magnesium levels must be closely monitored during therapy to ensure they do not exceed normal values.

INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicines, including those
obtained without a prescription.
The use of potassium-sparing diuretics may increase the risk of hyperkalaemia, especially in the presence of renal dysfunction. Therefore, in such cases, serum potassium levels must be closely monitored.
The use of drugs such as ACE inhibitors, which reduce aldosterone levels, may lead to potassium retention. Therefore, serum potassium levels must be closely monitored.
Corticosteroids are associated with sodium and water retention, leading to oedema and hypertension: therefore, caution is required when administering sodium salts concomitantly with corticosteroids (see Precautions for Use).
Magnesium may interact with the following medicines:

  • central nervous system depressants: when barbiturates, narcotics, or other hypnotics (or systemic anaesthetics) or other central nervous system depressants are administered concomitantly with magnesium, their dosage must be carefully adjusted due to the additive central nervous system depressant effect of magnesium. Central nervous system and peripheral transmission depression caused by magnesium can be antagonized by calcium;
  • cardioactive glycosides (digitalis), digoxin and digitoxin: magnesium chloride must be administered with extreme caution in patients taking cardiac glycosides due to changes in cardiac conduction that may progress to cardiac arrhythmias, especially if calcium administration becomes necessary to treat magnesium intoxication;
  • competitive and depolarizing neuromuscular blockers: parenteral administration of magnesium chloride potentiates the effect of competitive and depolarizing neuromuscular junction blockers;
  • aminoglycoside antibiotics: the effect on neuromuscular blockade of parenterally administered magnesium and aminoglycoside antibiotics may be additive;
  • eltrombopag: administration of products containing aluminium, calcium or magnesium may decrease plasma concentrations of eltrombopag;
  • rocuronium: concomitant administration of rocuronium and magnesium may increase the risk of rocuronium toxicity (prolonged neuromuscular blockade, respiratory depression and apnoea);
  • labetalol: concomitant administration of labetalol and magnesium may cause bradycardia and reduced cardiac output (shortness of breath, dizziness or fainting);
  • calcium antagonists (isradipine, felodipine, nicardipina and nifedipine): concomitant administration of magnesium with a calcium antagonist may lead to hypotension.

SPECIAL WARNINGS
Use immediately after opening the container. The solution must be clear, colourless and free from visible particles. It is intended for single, uninterrupted administration; any residual solution must not be used.

Pregnancy and breastfeeding
Consult your doctor or pharmacist before taking any medicine.
There are no available data on possible adverse effects of the medicinal product when administered during pregnancy or breastfeeding or on reproductive capacity.
Therefore, the medicinal product must not be used during pregnancy or breastfeeding unless strictly necessary and only after careful assessment of the risk/benefit ratio.
Avoid using magnesium within 2 hours before delivery. If magnesium is administered (especially for more than 24 hours before delivery) to control seizures in mothers with pregnancy toxemia, newborns may show signs of magnesium toxicity, including neuromuscular and respiratory depression.

Effects on ability to drive and use machines
The medicinal product does not impair the ability to drive vehicles or operate machinery.

DOSAGE, ADMINISTRATION AND DURATION OF TREATMENT
The solution is isotonic with blood and must be administered cautiously by intravenous infusion at a controlled infusion rate.
Shake well before administration.
Dosage 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 potassium/hour.

Adults
Generally, the dose is approximately 2 litres/day, administered at an infusion rate of about 2 litres/hour.

Children
In children, the safety and efficacy of the medicinal product have not been established.

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.
Infusions that are too rapid may cause local pain; the infusion rate must be adjusted according to tolerance.
It is advisable for the patient to remain lying down for a short period after administration.

Incompatibilities with Electrolyte Repletion Solution with Sodium Gluconate MONICO:
Due to the presence of magnesium, the medicinal product is incompatible with solutions containing alcohol (at high concentrations), heavy metals, carbonates and bicarbonates, sodium hydrocortisone, succinates, phosphates, polymyxin B sulfate, procaine hydrochloride, calcium salicylate, clindamycin phosphate, tartrates, as precipitates may form.
Potential incompatibility is often influenced by changes in reagent concentration and solution pH.

Use the solution immediately after opening the container; it is intended for single, uninterrupted administration and any residual 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.
Adopt all standard precautions to maintain sterility before and during intravenous infusion.

OVERDOSE
Symptoms
High plasma potassium concentrations may cause death due to cardiac depression, arrhythmias or arrest.
Excessive administration of sodium chloride may lead, depending on the patient's clinical condition, to hypernatraemia and/or hypervolaemia. Hypernatraemia and excessive sodium retention, particularly when renal sodium excretion is impaired, may cause dehydration of internal organs, especially the brain, and accumulation of extracellular fluid with oedema affecting the cerebral, pulmonary and peripheral circulation, potentially leading to pulmonary and peripheral oedema.
In case of excessive magnesium administration, the following symptoms of intoxication may occur: flushing, sweating, hypotension, flaccid paralysis, hypothermia, circulatory collapse, cardiac and central nervous system depression, potentially progressing to respiratory paralysis.
Magnesium intoxication manifests with a peak in arterial pressure and respiratory paralysis. Disappearance of the patellar reflex is a useful clinical sign indicating the onset of intoxication.

Treatment
Immediately discontinue the infusion and initiate corrective therapy to reduce plasma levels of excess ions and, if necessary, restore acid-base balance (see Precautions for Use).
The patient must be closely monitored for the appearance of any signs or symptoms related to the administered drug, ensuring 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 as respiratory paralysis, artificial ventilation is required. To counteract the effects of hypermagnesaemia, intravenous calcium must 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.
In case of accidental ingestion/overdose of Electrolyte Repletion Solution with Sodium Gluconate MONICO, contact a doctor immediately or go to the nearest hospital.
If you have any doubts about the use of Electrolyte Repletion Solution with Sodium Gluconate MONICO, consult your doctor or pharmacist.

UNDESIRABLE EFFECTS
Like all medicines, Electrolyte Repletion Solution with Sodium Gluconate may cause adverse effects, although not everyone experiences them.
The following adverse effects of Electrolyte Repletion Solution with Sodium Gluconate are listed below. There are insufficient data to establish the frequency of individual listed effects.

Gastrointestinal disorders: gastrointestinal disturbances and irritation, thirst, reduced salivation, nausea, vomiting, diarrhoea, abdominal pain, constipation, metallic taste, chalky taste, delayed intestinal transit, paralytic ileus.
Nervous system disorders: neuromuscular disturbances, muscle stiffness, paraesthesias, flaccid paralysis, weakness, mental confusion, headache, dizziness, restlessness, irritability, seizures, coma, death.
Psychiatric disorders: somnolence, confusion, mental disturbances.
Cardiac disorders: arrhythmias, tachycardia, bradycardia, conduction disturbances, disappearance of the P wave, widening of the QRS complex on the electrocardiogram, syncope, ventricular fibrillation, cardiac arrest.
Vascular disorders: hypotension, hypertension, peripheral oedema, vasodilation, flushing, sweating, shock.
Disorders of fluid and electrolyte balance: hypernatraemia, hypervolaemia, hyperchloraemia, hyperosmolarity, hypocalcaemia.
Respiratory, thoracic and mediastinal disorders: dyspnoea, respiratory arrest, pulmonary oedema, pneumothorax.
Eye disorders: reduced lacrimation.
Renal and urinary disorders: renal failure, polyuria.
Musculoskeletal and connective tissue disorders: muscle weakness.
General disorders and administration site conditions: fever, infusion site infection, pain or local reaction, redness, rash, venous irritation, thrombosis or phlebitis extending from the infusion site, extravasation, tissue necrosis, abscess formation.

Following the instructions in the package leaflet reduces the risk of adverse effects.
If any of the adverse effects worsens, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

EXPIRY DATE AND STORAGE
Expiry date: see the date on the packaging.
The expiry date refers to the product in intact packaging, stored correctly.
Warning: do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions
Store in the original packaging and in a tightly closed container. Do not refrigerate or freeze.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
Keep the medicinal product out of the reach and sight of children.

COMPOSITION
1000 ml contains:
Active substances: sodium chloride 5.26 g
potassium chloride 0.37 g
magnesium chloride 0.31 g
sodium acetate 3.67 g
sodium gluconate 5.02 g
mEq/litre Na 140
K 5
Mg 3
Cl 98
acetate 27
gluconate 23
Theoretical osmolarity (mOsm/litre) 294
pH 5.5 ÷ 7.0
Excipients: water for injections, hydrochloric acid

PHARMACEUTICAL FORM AND CONTENT
Infusion solution, sterile and pyrogen-free.
Glass vials (pharmaceutical glass) of 50 – 100 – 250 – 500 – 1000 ml.
Plastic bags (polypropylene) of 50 – 100 – 250 – 500 – 1000 ml.

MARKETING AUTHORIZATION HOLDER
MONICO SPA, Via Ponte di Pietra 7 – VENEZIA / MESTRE

MANUFACTURER
MONICO SPA, Via Ponte di Pietra 7 – VENEZIA / MESTRE
8 March 2013