ELETTROLITICA 50 ML Infusion solution

Зміст інструкції

1. ELECTROLYTIC REHYDRATION WITH GLUCOSE AND SODIUM GLUCONATE MONIC

ELECTROLYTIC REHYDRATION WITH GLUCOSE AND SODIUM GLUCONATE MONIC

Solution for Infusion
PHARMACOTHERAPEUTIC CATEGORY
Solutions that influence electrolyte balance, electrolytes associated with carbohydrates.

THERAPEUTIC INDICATIONS
Rehydration of fluids and electrolytes in situations where it is necessary to ensure a caloric intake.
Treatment of mild metabolic acidosis.

CONTRAINDICATIONS

• Hypersensitivity to the active ingredients or to any of the excipients;
• Hypernatremia;
• hydrosaline 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 disease;
• respiratory rate less than 16 breaths per minute;
• metabolic and respiratory alkalosis;
• hypercoagulability;
• concomitant therapy with cardiac glycosides (see Interactions);
• anuria;
• spinal or intracranial hemorrhage;
• delirium tremens (if such subjects already present in a state of dehydration);
• severe dehydration;
• coma;
• untreated Addison's disease;
• heat cramps. In conjunction with blood transfusions, the solution should not be administered through the same infusion catheter with 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 where edema with salt retention exists; in patients undergoing treatment with drugs with inotropic cardiac action or with corticosteroids or corticotropins.
Sodium salts should be administered with caution 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; potassium levels are not indicative of intracellular potassium concentrations.
High plasma potassium concentrations can cause death from cardiac depression, arrhythmias, or arrest. To avoid potassium intoxication, infusion must be slow.
The medicine should be administered with caution in patients:

• with renal insufficiency (administration of solutions containing potassium ions in patients with decreased 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 medicine must be administered with caution in patients:
• with renal insufficiency;
• with heart failure, especially if digitalized;
• with myasthenia gravis;
• receiving drugs that depress the central nervous system and neuromuscular blockers. Due to the presence of acetate, use with caution in patients with metabolic and respiratory alkalosis and in those conditions where there is an increase in the level or insufficient utilization of this ion, such as in mild or moderate hepatic insufficiency. Due to the presence of glucose, the medicine must be administered with caution in patients with overt or subclinical diabetes mellitus or with glucose intolerance of any kind. One gram of glucose provides a caloric contribution equal to 3.74 Kcal (approximately 15.6 Kjoules) To minimize the risk of hyperglycemia and subsequent glycosuria, blood and urine glucose must be monitored and, if necessary, insulin must be administered. During prolonged use of glucose solutions, fluid overload, congestion and electrolyte deficits may occur. Particular care should be taken when administering glucose to patients receiving corticosteroids or corticotropin (see Interactions). In pediatric patients, especially in neonates and children with low body weight, the administration of glucose may increase the risk of hyperglycemia. In addition, in children with low body weight, a rapid or excessive infusion may cause an increase in serum osmolarity and intracranial hemorrhage. During the infusion of the medicine, monitoring of the electrocardiographic tracing is essential and it is good practice to monitor fluid balance, electrolytes, plasma osmolarity, blood pressure, acid-base balance, osteotendinous reflexes, the latter in order to monitor any respiratory paralysis and blood glucose. Serum magnesium levels should be carefully monitored during therapy to ensure they do not exceed.

INTERACTIONS
Tell your doctor or pharmacist if you have recently taken any other medicines, even those
without a prescription.
The use of potassium-sparing diuretics may increase the risk of hyperkalemia, in
particular 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 that cause a decrease in aldosterone levels can lead to
potassium retention. Therefore, serum potassium levels must be closely monitored.
Corticosteroids are associated with sodium and water retention, resulting in edema and hypertension:
therefore, caution should be used in the concomitant administration of sodium salts and
corticosteroids (see Precautions for Use).
Since corticosteroids and corticotropin are associated with decreased carbohydrate tolerance and possible
manifestation of latent diabetes mellitus, the patient should be carefully monitored in case of
concomitant administration of glucose.
Magnesium may interact with the following medicines:

• drugs that depress the central nervous system: when barbiturates, narcotics or other hypnotics (or systemic anesthetics) or other drugs that depress the central nervous system are administered simultaneously with magnesium, their dosage must be carefully modified due to the additive depressive effect of magnesium on the central nervous system. The central nervous system and peripheral transmission depression caused by magnesium can be antagonized by calcium;
• cardiac glycosides (digitalis), digoxin and digitoxin: magnesium chloride should be administered with extreme caution in patients taking digitalis due to changes in

cardiac conduction that may evolve into cardiac arrhythmia in the event that 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 plaque blockers;
• aminoglycoside antibiotics: the effect on neuromuscular blockade of parenterally administered magnesium and aminoglycoside antibiotics may be additive;
• eltrombopag: the administration of products containing aluminum, calcium or magnesium may decrease plasma concentrations of eltrombopag;
• rocuronium: the concomitant administration of rocuronium and magnesium may increase the risk of rocuronium toxicity (prolongation of neuromuscular blockade, respiratory depression and apnea);
• labetalol: the concomitant administration of labetalol and magnesium may cause bradycardia and decreased cardiac output (difficulty breathing, dizziness or fainting);
• calcium antagonists (isradipine, felodipine, nicardipine and nifedipine): the concomitant administration of magnesium with a calcium antagonist drug may determine hypotension.

SPECIAL WARNINGS
Use immediately after opening the container. The solution must be clear, colorless or slightly straw-yellow in color and free of visible particles. It is for single and uninterrupted
administration and any residue cannot be used.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
No data are available on possible adverse effects of the medicine when administered during
pregnancy or breastfeeding or on reproductive capacity.
Therefore, the medicine should not be used during pregnancy and breastfeeding unless
absolutely necessary and only after assessing 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 and operate machinery
The medicine does not impair the ability to drive vehicles or operate machinery.
Important information on some excipients: the medicine contains sodium metabisulfite. This substance may
cause allergic reactions and severe asthma attacks in sensitive subjects, and especially in asthmatics.

DOSAGE, ADMINISTRATION AND DURATION OF TREATMENT
The solution is hypertonic with blood and must be administered by intravenous infusion with
caution, at a controlled infusion rate.

Shake well before administration.
The dose depends on the age, weight and clinical conditions and the electrolyte profile of the patient.
The medicine should be administered only with intact renal function and at a rate not exceeding
10 mEq potassium/hour and 0.4-0.8 g of glucose per kg of body weight per hour.

Adults
Generally the dose is about 2 liters/day, administered at an infusion rate of about 1 liter/hour.

Children
In children, the safety and efficacy of the medicine have not been established.
The dosage and rate of glucose administration must be chosen based on the age, weight
and clinical condition of the patient. Particular caution is required in pediatric patients and especially in
neonates or children with low body weight (see Precautions for Use).
Do not inject intramuscularly, subcutaneously or into perivascular tissues.
Administration should be discontinued if the patient experiences pain or redness at the injection site, as this may indicate extravasation of the drug.
Infusions that are too rapid can cause local pain and the infusion rate must be adjusted in
relation to tolerance.
It is recommended that the patient remain lying down for a short period after administration.
Incompatibilities with Electrolytic Rehydration with Glucose and Sodium Gluconate MONIC:
Due to the presence of glucose, the medicine is incompatible with:

• cyanocobalamin;
• kanamycin sulfate;
• novobiocin sodium;
• warfarin sodium; In addition, there are conflicting opinions regarding the compatibility of glucose with hydroxyethyl starch (hetastarch). Ampicillin and amoxicillin are stable in glucose solutions only for a short period. Due to the presence of magnesium, the medicine 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. The potential incompatibility is often influenced by the modification of the concentration of the reagents and the pH of the solutions.

Use the solution immediately after opening the container; it is for single and uninterrupted
administration and any residue cannot be used.
Shake well before administration. Do not use the medicine if the solution does not appear clear,
colorless or slightly straw-yellow or if it contains particles.

Take all usual precautions to maintain sterility before and during intravenous infusion.

OVERDOSAGE

Symptoms
High plasma concentrations of potassium can cause death due to cardiac depression, arrhythmias or
arrest.
Administration of excessive doses of sodium chloride can lead, depending on the patient's clinical conditions, to hypernatremia and/or hypervolemia. Hypernatremia and excessive sodium retention where
there is impaired sodium excretion at the renal level determines dehydration of internal organs, in
particular the brain, and the accumulation of extracellular fluids with edema that can affect the
cerebral, pulmonary and peripheral circulation with the appearance of 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 which can evolve into 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.
In case of prolonged administration of glucose, it is possible that overhydration and
solute overload occur.

Treatment
Immediately stop the infusion and institute corrective therapy for hyperglycemia and to reduce the
plasma levels of ions that are in excess and restore, if necessary, the acid-base balance (see
Precautions for use).
The patient should be kept under observation to assess the appearance of any signs and symptoms
related to the administered drug, ensuring the patient with appropriate symptomatic and supportive measures
as needed.
In case of high natremia, loop diuretics can be used.
In case of hyperkalemia, glucose (with or without
insulin) or sodium bicarbonate can be administered by intravenous infusion.
In case of magnesium intoxication that manifests with respiratory paralysis ,it is necessary to resort to
artificial respiration. To counteract the effects of hypermagnesemia, calcium must be administered
intravenously (10-20 ml of a 5% solution). The administration of 0.5-1 mg of physostigmine
subcutaneously may be helpful.
High values of plasma electrolyte levels may require dialysis.
In case of excessive administration of glucose, the patient's clinical condition must be reassessed and
appropriate corrective measures must be instituted.
In case of accidental ingestion/administration of an excessive dose of Electrolytic Rehydration with
Glucose and Sodium Gluconate MONICO, immediately notify a doctor or go to the nearest
hospital.
If you have any doubts about the use of Electrolytic Rehydration with Glucose and Sodium Gluconate MONICO,
consult your doctor or pharmacist.

UNDESIRABLE EFFECTS
Like all medicines, Electrolytic rehydration with glucose and sodium gluconate can cause adverse
effects, although not all people experience them.
The following are the undesirable effects of Electrolytic rehydration with glucose and sodium
gluconate. Sufficient data are not available to establish the frequency of the individual effects listed.

Immune system disorders:hypersensitivity reactions, urticaria.

Gastrointestinal disorders: disturbances and gastrointestinal irritation, thirst, reduced salivation, nausea, vomiting,
diarrhea, abdominal pain, constipation, metallic taste, chalky taste, delayed intestinal transit, paralytic ileus.

Nervous system disorders:neuromuscular disorders, muscle rigidity, paresthesia, flaccid paralysis,
weakness, mental confusion, headache, dizziness, restlessness, irritability, convulsions, cerebral hemorrhage,
cerebral ischemia, coma, death.

Psychiatric disorders:drowsiness, confused states, mental disorders.

Cardiac disorders:arrhythmias, tachycardia, bradycardia, conduction disturbances, disappearance of the P wave,
widening of the QRS complex in the electrocardiogram, syncope, ventricular fibrillation, cardiac arrest.

Vascular disorders:hypotension, hypertension, peripheral edema, vasodilation, flushing, sweating,
shock.

Fluid and electrolyte balance disorders:hypernatremia, hypervolemia, hyperchloremia, hyperosmolarity,
hypocalcemia.

Respiratory, thoracic and mediastinal disorders:dyspnea, respiratory arrest, pulmonary edema,
pneumothorax.

Eye disorders: reducedlacrimation.

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 conditions related to the site of administration:febrile reactions, infection at the infusion site,
pain or local reaction, redness, rash, venous irritation, thrombosis or phlebitis extending from the infusion site,
extravasation, tissue necrosis, abscess formation.

If any of these side effects worsen, or if you notice any side effect

SHELF LIFE AND STORAGE
Shelf life: see the expiration date printed on the packaging.
The expiration date refers to the product in intact packaging, stored correctly.

Warning: do not use the medicine after the expiration date printed on the packaging.
Storage conditions
Store in the original packaging and in a tightly closed container. Do not refrigerate or freeze.
Medicines should not be disposed of via drains or household waste. Ask your pharmacist
how to dispose of medicines that are no longer used. This will help protect the environment.

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.
COMPOSITION
1000 ml contain:
Active ingredients: 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
corresponding to glucose 50 g
mEq/liter Na 140
K 5
Mg 3
Cl 98
Acetate 27
gluconate 23
mMol/liter glucose 277
Theoretical osmolarity (mOsm/liter) 572
pH 4.0 ÷ 6.0
Excipients: water for injections, hydrochloric acid, sodium metabisulfite.

PHARMACEUTICAL FORM AND CONTENT
Solution for infusion, sterile and apyrogenic.
Glass bottles 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 – VENICE / MESTRE.

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