Electrolyte solution for replenishment with glucose and sodium gluconate Monico

PACKAGE LEAFLET – REHYDRATION ELECTROLYTE SOLUTION WITH GLUCOSE AND SODIUM GLUCONATE

REHYDRATION ELECTROLYTE SOLUTION WITH GLUCOSE AND SODIUM GLUCONATE MONICO

Infusion Solution
PHARMACOTHERAPEUTIC CATEGORY
Solutions affecting electrolyte balance, electrolytes associated with carbohydrates.
THERAPEUTIC INDICATIONS
Rehydration and electrolyte replacement in conditions where caloric intake is also required.
Treatment of mild metabolic acidosis.
CONTRAINDICATIONS

• Hypersensitivity to the active substances or to any of the excipients;
• Hypernatraemia;
• Hydro-saline plethory;
• Hyperkalaemia or in cases of potassium retention;
• Severe hepatic insufficiency (inability to metabolize acetate ion);
• Severe renal insufficiency;
• Oliguric renal insufficiency;
• Severe myocardial disease;
• Respiratory rate below 16 breaths per minute;
• Metabolic and respiratory alkalosis;
• Hypercoagulability;
• Concomitant therapy with cardioactive glycosides (see Interactions);
• Anuria;
• Spinal or intracranial haemorrhage;
• Delirium tremens (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 infused through the same 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 oedema and salt retention; in patients receiving
cardiac inotropic drugs or corticosteroid or corticotropin medications.
Sodium salts must be administered cautiously in patients with hypertension, heart 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 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 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 potassium-containing solutions in patients with impaired 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 period.
  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 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 insufficient 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 hyperglycaemia and consequent glycosuria, blood and urine glucose levels must be monitored and, if required, insulin administered.
  Prolonged use of glucose solutions may lead to fluid overload, congestive state, and electrolyte deficits.
  Particular attention should be paid when administering glucose to patients receiving corticosteroids or corticotropin (see Interactions).
  In paediatric patients, particularly neonates and children with low body weight, glucose administration may increase the risk of hyperglycaemia. Moreover, in low-weight children, rapid or excessive infusion may cause an increase in serum osmolarity and intracerebral haemorrhage.
  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 glycaemia. Serum magnesium levels must 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
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 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).
Since corticosteroids and corticotropin are associated with reduced carbohydrate tolerance and possible manifestation of latent diabetes mellitus, careful monitoring of the patient is required 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 anaesthetics) or other CNS depressants are administered concomitantly with magnesium, their dosage must be carefully adjusted due to the additive CNS depressant effect of magnesium. CNS and peripheral transmission depression caused by magnesium may be antagonized by calcium;
• Cardioactive glycosides (digitalis), digoxin and digitoxin: magnesium chloride must be administered with extreme caution in patients receiving digitalis due to changes 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 neuromuscular blocking effect of parenterally administered magnesium and aminoglycoside antibiotics may be additive;
• Eltrombopag: administration of products containing aluminium, 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 apnoea);
• Labetalol: concomitant administration of labetalol and magnesium may cause bradycardia and reduced cardiac output (dyspnoea, 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, colourless or slightly yellowish 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 must not be used during pregnancy or breastfeeding unless absolutely necessary and only after careful assessment of the risk/benefit ratio.
Avoid magnesium use within 2 hours before delivery. If magnesium is administered (especially for more than 24 hours before delivery) to control seizures in mothers with pregnancy-related toxaemia, 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 use machinery.
Important information about certain excipients: the medicinal product contains sodium metabisulphite. This substance may cause allergic-type reactions and severe asthma attacks in sensitive individuals, particularly asthmatics.
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 potassium/hour and 0.4–0.8 g glucose per kg body weight per hour.
Adults
The usual dosage is approximately 2 litres/day, administered at an infusion rate of about 1 litre/hour.
Children
In children, the safety and efficacy of the medicinal product have not been established.
Glucose dosage and infusion rate must be adjusted according to the patient's age, weight and clinical condition. Particular caution is required in paediatric patients, especially neonates or children with low body weight (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 must be adjusted according to tolerance.
It is advisable for the patient to remain lying down for a short period after administration.
Incompatibilities with Rehydration Electrolyte Solution with Glucose and Sodium Gluconate MONICO:
Due to the presence of glucose, the medicinal product is incompatible with:

• Cyanocobalamin;
• Kanamycin sulphate;
• Novobiocin sodium;
• Warfarin sodium.
  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 sulphate, procaine hydrochloride, calcium salicylate, clindamycin phosphate, tartrates, as precipitates may form.
  Potential incompatibility is often influenced by changes in reactant concentrations 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, colourless or slightly yellowish, 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, especially when renal sodium excretion is impaired, may cause internal organ dehydration, particularly of the brain, and extracellular fluid accumulation with oedema affecting the cerebral, pulmonary and peripheral circulation, leading to pulmonary and peripheral oedema.
In case of excessive magnesium administration, the following signs of intoxication may occur: flushing, sweating, hypotension, flaccid paralysis, hypothermia, circulatory collapse, cardiac and central nervous system depression, which may progress to respiratory paralysis.
Magnesium intoxication manifests with a peak in arterial pressure followed by respiratory paralysis. 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 hyperglycaemia and reduce plasma levels of excess ions, restoring acid-base balance if necessary (see Precautions for Use).
The patient must be closely monitored 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 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, 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 Rehydration Electrolyte Solution with Glucose and Sodium Gluconate MONICO, contact a doctor immediately or go to the nearest hospital.
If you have any doubts about the use of Rehydration Electrolyte Solution with Glucose and Sodium Gluconate MONICO, consult your doctor or pharmacist.
UNDESIRABLE EFFECTS
Like all medicinal products, Rehydration Electrolyte Solution with Glucose and Sodium Gluconate may cause adverse effects, although not everyone experiences them.
The following are the adverse effects of Rehydration Electrolyte Solution with 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, diarrhoea, abdominal pain, constipation, metallic taste, chalky taste, delayed intestinal transit, paralytic ileus.
Nervous system disorders: neuromuscular disturbances, muscle rigidity, paraesthesia, flaccid paralysis, weakness, mental confusion, headache, dizziness, restlessness, irritability, convulsions, cerebral haemorrhage, cerebral ischaemia, coma, death.
Psychiatric disorders: somnolence, confusion, mental disorders.
Cardiac disorders: arrhythmias, tachycardia, bradycardia, conduction disturbances, disappearance of P wave, widening of QRS complex on electrocardiogram, syncope, ventricular fibrillation, cardiac arrest.
Vascular disorders: hypotension, hypertension, peripheral oedema, vasodilation, flushing, sweating, shock.
Fluid and electrolyte balance disorders: 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.
Metabolism and nutrition disorders: increased metabolic rate, hyperglycaemia, hypoglycaemia, increased insulin levels, increased adrenaline levels.
Musculoskeletal and connective tissue disorders: muscle weakness.
General 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 adverse effects.
If any of the adverse effects worsen, or if you notice any adverse effects 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 its original, undamaged 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.
Medicinal products must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused medicinal products. 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
glucose monohydrate 55.0 g
equivalent to glucose 50 g
mEq/litre Na 140
K 5
Mg 3
Cl 98
Acetate 27
gluconate 23
mMol/litre glucose 277
Theoretical osmolarity (mOsm/litre) 572
pH 4.0 ÷ 6.0
Excipients: water for injections, hydrochloric acid, sodium metabisulphite.
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 AUTHORISATION HOLDER
MONICO SPA, Via Ponte di Pietra 7 – VENEZIA / MESTRE.
MANUFACTURER
MONICO SPA, Via Ponte di Pietra 7 – VENEZIA / MESTRE.
8 March 2013