Electrolyte solution for replenishment ph 7.4 with sodium gluconate Monico

Italy
Brand name Electrolyte solution for replenishment ph 7.4 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 031398
Manufacturer MONICO S.P.A.

ELECTROLYTE REPLETION SOLUTION pH 7.4 WITH MONIC SODIUM GLUCONATE – 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;
  • Hypernatremia;
  • Hydro-saline plethoras;
  • Hyperkalemia or conditions with potassium retention;
  • Severe hepatic insufficiency (inability to metabolize acetate ion);
  • Severe renal insufficiency;
  • Oliguric renal failure;
  • Severe myocardial pathology;
  • Respiratory rate below 16 breaths per minute;
  • Metabolic and respiratory alkalosis;
  • Hypercoagulability;
  • Concomitant therapy with cardiac 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 clinical conditions associated with edema and salt retention; in patients receiving
cardiotonic inotropic drugs or corticosteroid or corticotropin therapy.
Sodium salts must be administered cautiously in patients with hypertension, heart failure, peripheral or
pulmonary edema, reduced renal function, pre-eclampsia, or other conditions associated with sodium
retention (see Interactions).
Due to the presence of potassium, administration should be guided by serial electrocardiograms; serum
potassium levels do not necessarily reflect intracellular potassium concentrations.
High plasma potassium concentrations may cause death due to cardiac depression, arrhythmias, or
arrest. To avoid 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 heart failure, especially 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 heart failure, especially if digitalized;

  • with severe myasthenia gravis;

  • receiving central nervous system depressants and neuromuscular blocking agents.

Due to the presence of acetate, use with caution in patients with metabolic and respiratory alkalosis and in
conditions associated with increased levels or inadequate utilization of this ion, such as mild or moderate
hepatic insufficiency.
During infusion of the medicinal product, continuous monitoring of the electrocardiographic trace is
essential, and 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 should be closely monitored during therapy to ensure they do not exceed normal
limits.
INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicines, including those
without a prescription.
The use of potassium-sparing diuretics may increase the risk of hyperkalemia, particularly 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 edema and hypertension:
therefore, caution is required when administering sodium salts concomitantly with corticosteroids (see
Precautions for Use).
Magnesium may interact with the following medicinal products:

  • central nervous system depressants: when barbiturates, narcotics, or other hypnotics (or systemic anesthetics) or other drugs that depress the central nervous system are administered concurrently 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 receiving digitalis due to potential alterations in cardiac conduction that may lead 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 aluminum, calcium, or magnesium may reduce plasma concentrations of eltrombopag;
  • rocuronium: concomitant administration of rocuronium and magnesium may increase the risk of rocuronium toxicity (prolonged neuromuscular blockade, respiratory depression, and apnea);
  • labetalol: concomitant administration of labetalol and magnesium may cause bradycardia and reduced cardiac output (shortness of breath, dizziness, or fainting);
  • calcium antagonists (isradipine, felodipine, nicardipine, and nifedipine): concomitant administration of magnesium with a calcium antagonist may result in hypotension.

SPECIAL WARNINGS
Use immediately after opening the container. The solution must be clear, colorless, and free from visible
particles. It is intended for single, uninterrupted administration; any residual solution must not be used.
Pregnancy and lactation
Consult your doctor or pharmacist before taking any medicine.
There are no available data on potential adverse effects of the medicinal product when administered during
pregnancy or lactation, or on reproductive capacity.
Therefore, the medicinal product should not be used during pregnancy or lactation unless absolutely
necessary and only after careful assessment of the risk/benefit ratio.
Avoid the use of magnesium 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 vehicles and use machinery
The medicinal product does not impair the ability to drive vehicles or operate machinery.
Important information about certain excipients:
DOSAGE, METHOD AND DURATION OF ADMINISTRATION
The solution is isotonic with blood and must be administered with caution by intravenous infusion at a
controlled infusion rate.
Shake well before administration.
The dosage depends on age, weight, clinical condition, and the patient's 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 liters/day, administered at an infusion rate of about 2 liters/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, 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.
Incompatibilities with Electrolyte Repletion Solution pH 7.4 with Monic Sodium Gluconate:
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 colorless 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.
Administration of excessive doses of sodium chloride may lead, depending on the patient's clinical
condition, to hypernatremia and/or hypervolemia. Hypernatremia and excessive sodium retention where
renal sodium excretion is impaired lead to dehydration of internal organs, especially the brain, and
accumulation of extracellular fluid with edema affecting the cerebral, pulmonary, and peripheral circulation,
potentially resulting in pulmonary and peripheral edema.
In case of administration of high doses of magnesium, 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 blood pressure and respiratory paralysis. The disappearance
of the patellar reflex is a useful clinical sign to identify the onset of intoxication.
Treatment
Immediately discontinue the infusion and initiate corrective therapy to reduce plasma levels of the ions in
excess and, if necessary, restore acid-base balance (see Precautions for Use).
The patient should be kept under observation for the appearance of any signs and symptoms related to the
administered drug, ensuring appropriate symptomatic and supportive measures as needed.
In case of high natremia, 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 as respiratory paralysis, artificial respiration must be
initiated. 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.
Elevated plasma electrolyte levels may require dialysis.
In case of accidental ingestion/absorption of an excessive dose of Electrolyte Repletion Solution pH 7.4 with
Monic Sodium Gluconate, immediately contact a doctor or go to the nearest hospital.
If you have any doubts about the use of Electrolyte Repletion Solution pH 7.4 with Monic Sodium Gluconate,
consult your doctor or pharmacist.
UNDESIRABLE EFFECTS
Like all medicinal products, Electrolyte Repletion Solution pH 7.4 with Sodium Gluconate may cause
undesirable effects, although not all individuals experience them.
The following undesirable effects of Electrolyte Repletion Solution pH 7.4 with Sodium Gluconate are listed
below.
There are insufficient data to determine the frequency of individual listed effects.
Gastrointestinal disorders: gastrointestinal disturbances and irritation, thirst, reduced salivation, nausea,
vomiting, diarrhea, abdominal pain, constipation, metallic taste, chalky taste, delayed intestinal transit,
paralytic ileus.
Nervous system disorders: neuromuscular disturbances, muscle rigidity, paresthesia, flaccid paralysis,
weakness, mental confusion, headache, dizziness, restlessness, irritability, convulsions, 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 edema, vasodilation, flushing, sweating, shock.
Disorders of water and electrolyte balance: hypernatremia, hypervolemia, hyperchloremia, hyperosmolarity,
hypocalcemia.
Respiratory, thoracic and mediastinal disorders: dyspnea, respiratory arrest, pulmonary edema,
pneumothorax.
Eye disorders: reduced lacrimation.
Renal and urinary disorders: renal failure, polyuria.
Musculoskeletal and connective tissue disorders: muscle weakness.
Systemic disorders and administration site conditions: febrile reactions, 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 this leaflet reduces the risk of undesirable effects.
If any of the undesirable effects worsens, or if you notice any undesirable 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, correctly stored.
Caution: 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/liter: Na 140
K 5
Mg 3
Cl 98
Acetate 27
gluconate 23
Theoretical osmolarity: (mOsm/liter) 295
pH: 7.2 ÷ 7.6
Excipients: water for injections, sodium hydroxide, hydrochloric acid.
PHARMACEUTICAL FORM AND CONTENT
Sterile, pyrogen-free infusion solution (at physiological pH).
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