Electrolyte solution for replenishment with potassium, glucose and sodium gluconate Monico

PACKAGE LEAFLET – ELECTROLYTE REPLETION WITH POTASSIUM, GLUCOSE AND SODIUM

GLUCONATE
ELECTROLYTE REPLETION WITH POTASSIUM, GLUCOSE AND SODIUM MONICO GLUCONATE
Infusion Solution
PHARMACOTHERAPEUTIC CATEGORY
Solutions affecting electrolyte balance, electrolytes associated with carbohydrates.
THERAPEUTIC INDICATIONS
Replenishment of fluids and electrolytes in conditions where a caloric intake is also required.
Treatment of mild metabolic acidosis.
CONTRAINDICATIONS

• Hypersensitivity to the active substances or to any of the excipients;
• hypernatremia;
• hydro-saline plethora;
• hyperkalemia or in cases of potassium retention;
• severe hepatic insufficiency (inability to metabolize the acetate ion);
• severe renal insufficiency;
• oliguric renal insufficiency;
• severe myocardial pathology;
• respiratory rate below 16 breaths per minute;
• metabolic and respiratory alkalosis;
• hypercoagulability;
• concomitant therapy with cardioactive glycosides (see section on interactions);
• anuria;
• spinal or intracranial hemorrhage;
• delirium tremens (especially if these patients are already dehydrated);
• severe dehydration;
• coma;
• untreated Addison's disease;
• heat cramps.
  When administered concomitantly with blood transfusions, this solution must not be administered through the same infusion catheter as whole blood due to the possible risk of pseudoagglutination.

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 edema and salt retention; in patients receiving
cardiotonic inotropic drugs or corticosteroid or corticotropin drugs.
Sodium salts should 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 section on interactions).
Due to the presence of potassium, administration should be guided by serial electrocardiograms;
serum potassium levels are not indicative of intracellular potassium concentrations.
High plasma potassium concentrations may cause death due to cardiac depression, arrhythmias, or
cardiac arrest. To avoid potassium intoxication, the infusion must be slow.
The medicinal product must be administered with caution in patients:

• with renal insufficiency (administration of potassium-containing solutions in patients with impaired renal function may cause potassium retention);
• with heart 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 heart failure, particularly if digitalized;
• with severe myasthenia gravis;
• receiving central nervous system depressants or neuromuscular blocking agents.
  Due to the presence of acetate, use with caution in patients with metabolic and respiratory alkalosis and in conditions where there is an increase in or inadequate utilization of this ion, such as in mild or moderate hepatic insufficiency.
  Due to the presence of glucose, the medicinal product must be administered with caution in patients with overt or subclinical diabetes mellitus or with any form of glucose intolerance. One gram of glucose provides approximately 3.74 kcal (about 15.6 kJ). To minimize the risk of hyperglycemia and consequent glycosuria, blood and urine glucose levels should be monitored, and insulin administered if required. During prolonged use of glucose solutions, fluid overload, congestive state, and electrolyte deficiencies may occur. Special attention should be paid when administering glucose to patients receiving corticosteroids or corticotropin (see Interactions). In pediatric patients, particularly neonates and low-birth-weight infants, glucose administration may increase the risk of hyperglycemia. Furthermore, in low-birth-weight children, rapid or excessive infusion may cause an increase in serum osmolarity and intracerebral hemorrhage. 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, osteotendinous reflexes (to detect possible respiratory paralysis), and blood glucose. 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 medicinal products, including those
obtained without a prescription.
The use of potassium-sparing diuretics may increase the risk of hyperkalemia, especially in the presence of renal dysfunction. Therefore, serum potassium levels should be closely monitored in such cases.
The use of ACE inhibitors, which reduce aldosterone levels, may lead to potassium retention. Therefore, serum potassium levels should 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).
Since corticosteroids and corticotropin are associated with reduced carbohydrate tolerance and possible manifestation of latent diabetes mellitus, careful monitoring of the patient is necessary when glucose is administered concomitantly.
Magnesium may interact with the following medicinal products:

• central nervous system depressants: when barbiturates, narcotics, or other hypnotics (or systemic anesthetics) 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. CNS 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 possible alterations 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 blockers;
• aminoglycoside antibiotics: the neuromuscular blocking effect of parenterally administered magnesium and aminoglycoside antibiotics may be additive;
• eltrombopag: administration of products containing aluminum, calcium, or magnesium may reduce eltrombopag plasma concentrations;
• 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 (labored breathing, dizziness, and fainting);
• calcium channel antagonists (isradipine, felodipine, nicardipine, and nifedipine): concomitant administration of magnesium with a calcium channel blocker may result in hypotension.

SPECIAL WARNINGS
Use immediately after opening the container. The solution must be clear, colorless, or slightly straw-yellow and free from visible particles. It is intended for single, uninterrupted administration, and any residual solution must not be used.
Pregnancy and breastfeeding
Consult your doctor or pharmacist before taking any medicinal product.
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 should not be used during pregnancy or breastfeeding unless absolutely necessary and only after careful assessment of the risk/benefit ratio.
Avoid the use of 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.
Important information about certain excipients: the product contains sodium metabisulfite. Rarely, this may cause severe hypersensitivity reactions and bronchospasm.
DOSAGE, METHOD AND DURATION OF ADMINISTRATION
The solution is hypertonic relative to blood and must be administered by intravenous infusion with caution and 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 of potassium per hour and 0.4–0.8 g of glucose per kg of body weight per hour.
Adults:
Generally, the dose is approximately 2 liters/day, administered at an infusion rate of about 300 ml/hour.
Children:
In children, the safety and efficacy of the medicinal product have not been established.
The dosage and infusion rate of glucose should be adjusted according to the patient's age, weight, and clinical condition. Particular caution is required in pediatric patients, especially neonates and low-birth-weight children (see Precautions for Use).
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 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 with Potassium, Glucose and Sodium Gluconate
Due to the presence of glucose, the medicinal product is incompatible with:

• cyanocobalamin;
• kanamycin sulfate;
• novobiocin sodium;
• 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 reactant concentration and solution pH.

Use the solution 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 medicinal product if the solution is not clear, colorless, or slightly straw-yellow, 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
cardiac arrest.
Excessive administration of sodium chloride may lead, depending on the patient's clinical condition, to hypernatremia and/or hypervolemia. Hypernatremia and excessive sodium retention, especially when renal sodium excretion is impaired, cause dehydration of internal organs, particularly the brain, and accumulation of extracellular fluid leading to edema affecting the cerebral, pulmonary, and peripheral circulation, including pulmonary and peripheral edema.
In case of excessive magnesium administration, the following signs of intoxication may occur: flushing, sweating, hypotension, flaccid paralysis, hypothermia, circulatory collapse, cardiac depression, and central nervous system depression, which may progress to respiratory paralysis.
Magnesium intoxication manifests with a peak in arterial pressure and respiratory paralysis. The disappearance of the patellar reflex is a useful clinical sign indicating the onset of intoxication.
Prolonged administration of glucose may lead to hyperhydration and solute overload.
Treatment
Immediately discontinue the infusion and initiate corrective therapy for hyperglycemia and reduce plasma levels of excess ions, restoring acid-base balance if necessary (see Precautions for Use).
The patient should be closely observed for the appearance of any signs and symptoms related to the administered medicinal product, with appropriate symptomatic and supportive measures provided 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 with respiratory paralysis, artificial respiration is required. 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 excessive glucose administration, reassess the patient's clinical condition and implement appropriate corrective measures.
In case of accidental ingestion/overdose of Electrolyte Repletion with Potassium, Glucose and Sodium Gluconate MONICO, contact a doctor immediately or go to the nearest hospital.
If you have any doubts about the use of Electrolyte Repletion with Potassium, Glucose and Sodium Gluconate MONICO, consult your doctor or pharmacist.
UNDESIRABLE EFFECTS
Like all medicinal products, Electrolyte Repletion with Potassium, Glucose and Sodium Gluconate may cause adverse effects, although not everyone experiences them.
The following are the adverse effects associated with Electrolyte Repletion with Potassium, Glucose and Sodium Gluconate. There are insufficient data to determine the frequency of individual listed effects.
Immune system disorders
Hypersensitivity reactions, urticaria.
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, cerebral hemorrhage, cerebral ischemia, coma, death.
Psychiatric disorders
Somnolence, confusion, mental disorders.
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.
Metabolism and nutrition disorders
Increased metabolic rate, hyperglycemia, hypoglycemia, increased insulin levels, increased adrenaline levels.
Musculoskeletal and connective tissue disorders
Muscle weakness.
Systemic disorders and administration site conditions
Fever, infusion site infection, local pain or 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 adverse effects.
Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, contact your doctor or pharmacist. Adverse effects can also be reported directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili”. Reporting adverse effects helps provide more information on the safety of this medicinal product.
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.
Store in the original packaging and in a tightly closed container. Do not refrigerate or freeze.
Medicinal products must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This helps protect the environment.
Keep the medicinal product out of the sight and reach of children.
COMPOSITION
1000 ml contains:
Active substances: sodium chloride 5.26 g
potassium chloride 0.37 g
magnesium chloride 0.31 g
potassium acetate 2.45 g
sodium acetate 3.67 g
sodium gluconate 5.02 g
monohydrate glucose 55.0 g
(equivalent to glucose 50 g)
mEq/liter: Na 140
K 30
Mg 3
Cl 98
acetate 52
gluconate 23
mMol/liter: glucose 277
Theoretical osmolarity (mOsm/liter): 622
pH: 5.5 – 7.0
Excipients: water for injections, sodium metabisulfite, hydrochloric acid.
PHARMACEUTICAL FORM AND CONTENT
Sterile, pyrogen-free infusion solution.
Glass vials (pharmaceutical glass) of 50 – 100 – 250 – 500 – 1000 ml.
Plastic bags (polypropylene) of 50 – 100 – 250 – 500 – 1000 ml.
MARKETING AUTHORIZATION HOLDER AND MANUFACTURER
MONICO SPA, Via Ponte di Pietra 7, VENEZIA/MESTRE.