Electrolyte rehydration solution with glucose and calcium gluconate S.A.L.F.: detailed information

PACKAGE LEAFLET: Information for the user

ELETTROLITICA REIDRATANTE CON GLUCOSIO E CALCIO GLUCONATO S.A.L.F. infusion solution

Sodium chloride, potassium acetate, dibasic potassium phosphate anhydrous, calcium gluconate monohydrate, magnesium sulfate heptahydrate,
glucose monohydrate
Generic medicinal product
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor or nurse.
If you experience any side effects, including those not listed in this leaflet, inform your doctor or nurse. See section 4.
Contents of this leaflet:

What ELETTROLITICA REIDRATANTE CON GLUCOSIO E CALCIO GLUCONATO S.A.L.F. is and what it is used for
What you need to know before using ELETTROLITICA REIDRATANTE CON GLUCOSIO E CALCIO GLUCONATO S.A.L.F.
How to use ELETTROLITICA REIDRATANTE CON GLUCOSIO E CALCIO GLUCONATO S.A.L.F.
Possible side effects
How to store ELETTROLITICA REIDRATANTE CON GLUCOSIO E CALCIO GLUCONATO S.A.L.F.
Contents of the pack and other information

1. What ELETTROLITICA REIDRATANTE CON GLUCOSIO E CALCIO GLUCONATO S.A.L.F. is and what it is used for

ELETTROLITICA REIDRATANTE CON GLUCOSIO E CALCIO GLUCONATO S.A.L.F. is an infusion solution to be injected directly into a vein, containing a combination of active substances: sodium chloride, potassium acetate, anhydrous dibasic potassium phosphate, calcium gluconate monohydrate, magnesium sulfate heptahydrate, and monohydrate glucose.
This medicine is indicated to provide water and electrolytes to the body in situations where a caloric intake is required, and for the treatment of mild states of metabolic acidosis, a condition characterized by increased acidity of the blood.

2. What you need to know before using ELETTROLITICA REIDRATANTE CON GLUCOSIO E CALCIO

GLUCONATO S.A.L.F.
Do not use ELETTROLITICA REIDRATANTE CON GLUCOSIO E CALCIO GLUCONATO S.A.L.F.
if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
if you have high levels of calcium in the blood (hypercalcemia) or in the urine (hypercalciuria);
if you have severe kidney problems (severe renal failure);
if you have high levels of potassium in the blood (hyperkalemia) or reduced ability to eliminate potassium and phosphates (potassium or phosphate retention);
if you have a heart rhythm disorder called ventricular fibrillation, as calcium chloride may increase the risk of heart rhythm irregularities (arrhythmias);
if you have severe liver problems (severe hepatic insufficiency) leading to inability to metabolize the acetate ion;
if you have difficulty urinating (oliguric renal failure, anuria);
if you have severe heart problems;
if you have breathing difficulties (respiratory rate less than 16 breaths per minute);
if you have an increased blood pH (metabolic and respiratory alkalosis);
if you have kidney stones, which may worsen with calcium administration;
if you have a chronic systemic disease called sarcoidosis, which may enhance increased calcium levels in the blood (hypercalcemia);
if you have circulatory problems due to a high tendency of blood to clot (hypercoagulability);
if you are taking, or have taken in excess, heart medications called cardiac glycosides (digitalis toxicity);
if you have bleeding (hemorrhages) occurring in the spinal area or within brain tissues (intracranial hemorrhage);
if you have low body fluid levels (dehydration);
if you suffer from mental disorders characterized by hallucinations, tremors, sweating (delirium tremens), especially if you are dehydrated;
if you have a disease of the adrenal glands (Addison's disease) and are not receiving treatment for it;
if you are in a coma;
if you experience painful, brief muscle cramps (heat cramps);
if the patient is a newborn (under 28 days of age), ELETTROLITICA REIDRATANTE CON GLUCOSIO E CALCIO GLUCONATO S.A.L.F. (or other solutions containing calcium) must not be administered simultaneously with ceftriaxone (an antibiotic), even if separate infusion lines are used. There is a fatal risk of particle formation in the newborn's bloodstream.
Glucose solutions must not be administered through the same infusion catheter as whole blood, due to the possible risk of red blood cell aggregation (pseudoagglutination and coagulation).

Warnings and precautions
Talk to your doctor or nurse before using ELETTROLITICA REIDRATANTE CON GLUCOSIO E CALCIO GLUCONATO S.A.L.F.
This medicine must be administered by very slow intravenous infusion, as rapid administration may cause potassium intoxication, potentially leading to cardiac dysfunction (cardiac depression), heart rhythm disturbances (arrhythmias), and even cardiac arrest (see section “How to use ELETTROLITICA REIDRATANTE CON GLUCOSIO E CALCIO GLUCONATO S.A.L.F.”).

Due to the presence of sodium, this medicine should be administered with caution in the following cases:
if you have heart problems (congestive heart failure, cardiac insufficiency) or kidney problems (severe renal failure, reduced kidney function);
if you have fluid accumulation (edema with salt retention), either in the lungs (pulmonary edema) or associated with leg and ankle swelling (peripheral edema);
if you are taking heart medications (cardiotonic drugs), anti-inflammatory steroid drugs (corticosteroids), or hormonal drugs (corticotropins);
if you have high blood pressure (hypertension);
if you have a condition called pre-eclampsia, characterized by high blood pressure, swelling due to fluid retention, and protein in the urine, or other conditions caused by sodium accumulation.

Due to the presence of potassium, this medicine should be administered with caution in the following cases:
if you have kidney problems (renal failure), as this may worsen potassium retention;
if you have heart problems (cardiac insufficiency) and are taking other heart medications (digitalis);
if you have a disease of the adrenal glands (adrenal insufficiency);
if you have liver problems (hepatic insufficiency);
if someone in your family suffers from a disorder characterized by sudden episodes of muscle weakness (familial periodic paralysis);
if you have a condition characterized by muscle stiffness (congenital myotonia);
if you have recently undergone surgery (early post-operative phase).

Due to the presence of calcium, this medicine should be administered with caution in the following cases:
if you have kidney (renal failure, kidney diseases) or heart problems (cardiac diseases), as this may increase the risk of heart rhythm irregularities (arrhythmias);
if you have received a blood transfusion, as calcium ion concentrations may differ from expected levels;
if you have kidney problems (kidney diseases) or lung problems causing heart enlargement (pulmonary heart disease), breathing difficulties (respiratory failure), or decreased blood pH due to respiratory issues (respiratory acidosis); these conditions may promote increased calcium levels in the blood (hypercalcemia), worsening your clinical condition;
if you have chronic renal failure, low body water levels (dehydration), or an imbalance in mineral levels (electrolyte imbalance);
if you have low blood pressure, as calcium chloride administration may cause vasodilation and further decrease blood pressure.

Calcium chloride solution is irritating and must not be administered by intramuscular, subcutaneous, or perivascular injection, as tissue damage and tissue death (necrosis) may occur. Urinary calcium levels should be monitored frequently to prevent excessive increase (hypercalciuria), as high urinary calcium levels may lead to increased blood calcium levels (hypercalcemia).

Due to the presence of magnesium, this medicine should be administered with caution in the following cases:
if you have kidney problems (renal failure);
if you have heart problems (cardiac insufficiency) and are taking other heart medications (digitalis);
if you have a muscle disease (myasthenia gravis);
if you are being treated with sedatives, hypnotics (central nervous system depressants), or drugs used to block muscles during surgery (neuromuscular blockers).

Serum magnesium concentration should be monitored frequently to prevent excessive increase.

Due to the presence of phosphates, the infusion of this medicine may cause a reduction in blood calcium levels (hypocalcemia).

Due to the presence of glucose, this medicine should be administered with caution in people with diabetes mellitus or glucose intolerance, and in those taking corticosteroid anti-inflammatory drugs (corticosteroids) or hormonal drugs (corticotropin). During treatment, blood and urine glucose levels must be monitored, and insulin may be administered if needed to minimize the risk of increased blood glucose (hyperglycemia) and glucose in urine (glycosuria). Prolonged use of glucose solutions may lead to fluid accumulation (fluid overload, congestive state) and deficiency of minerals in the blood (electrolytes).

Due to the presence of acetate, this medicine should be used with caution in people with increased pH (metabolic and respiratory alkalosis) or elevated blood acetate levels, such as in individuals with liver problems (mild or moderate hepatic insufficiency).

Talk to your doctor, pharmacist, or nurse before ELETTROLITICA REIDRATANTE CON GLUCOSIO E CALCIO GLUCONATO S.A.L.F. is administered to a child if the child is in any of the following conditions that may cause high levels of vasopressin, a hormone regulating body fluids:

has an acute illness;
has pain;
has undergone surgery;
has infections or burns;
has brain diseases;
has liver, heart, or kidney diseases;
is taking certain medications (see also Other medicines and ELETTROLITICA REIDRATANTE CON GLUCOSIO E CALCIO GLUCONATO S.A.L.F.).
This may increase the risk of low sodium levels in the blood (hyponatremia), leading to headache, nausea, seizures, lethargy, vomiting, and cerebral edema. Cerebral edema increases the risk of dangerous brain damage. People at higher risk of cerebral edema include:
children;
women (especially those of childbearing age);
people with altered fluid levels in the brain (e.g., due to meningitis, intracranial bleeding, or brain contusion).

During treatment with this medicine, your doctor should periodically monitor heart function (via serial electrocardiograms) and blood electrolyte concentrations (plasma osmolarity), particularly sodium levels, as hospital-acquired hyponatremia may develop, as well as glucose (blood sugar), fluid balance, and blood pH (acid-base balance). Additionally, it is advisable to monitor blood pressure and osteotendinous reflexes to detect any potential respiratory muscle paralysis.

This medicine should be used immediately after opening the container. The solution should be clear, colorless or slightly yellowish, and free of visible particles. It is intended for single, uninterrupted administration. Any remaining solution must not be reused.

Children
This medicine should be administered with caution in children, especially in newborns and low-body-weight infants, as blood glucose levels may increase (hyperglycemia). Moreover, in low-body-weight children, rapid or excessive intravenous infusion may increase serum electrolyte concentration (serum osmolarity) and cause intracerebral hemorrhage due to blood vessel rupture.

As with other calcium-containing solutions, concomitant treatment with ceftriaxone is contraindicated in neonates (under 28 days of age) due to the fatal risk of ceftriaxone-calcium salt precipitation in the newborn's bloodstream (see section “Possible side effects”).

Other medicines and ELETTROLITICA REIDRATANTE CON GLUCOSIO E CALCIO GLUCONATO S.A.L.F.
Inform your doctor if you are taking, have recently taken, or might take any other medicines.

This medicine should be administered with caution if you are taking:
medicines used to lower blood pressure such as potassium-sparing diuretics, ACE inhibitors, or other drugs that reduce aldosterone levels, as they may cause increased potassium in the blood (hyperkalemia) and reduced potassium elimination (potassium retention), especially in people with kidney problems (renal dysfunction); in such cases, blood potassium levels must be closely monitored;
steroidal anti-inflammatory drugs (corticosteroids), which may cause sodium and water retention, leading to fluid accumulation (edema) and increased blood pressure (hypertension). These drugs may also reduce sugar tolerance, potentially unmasking latent diabetes mellitus; therefore, careful monitoring is required when glucose is administered concurrently;
medicines acting on vasopressin hormone, e.g., chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics, chlorpropamide, NSAIDs, cyclophosphamide, desmopressin, oxytocin, vasopressin, terlipressin, diuretics in general, and antiepileptics (such as oxcarbazepine), as they may increase the risk of hyponatremia.

Due to the presence of calcium chloride, be cautious if you are taking the following medicines:
thiazide diuretics, used to treat high blood pressure, as they may increase blood calcium levels by reducing calcium excretion;
heart medications (cardiac glycosides, digoxin, digitoxin), as their effects are additive to those of calcium, increasing the risk of heart rhythm irregularities;
verapamil (and other calcium channel blockers), used to treat high blood pressure, as concomitant use may reduce the antihypertensive effect of this medicine;
medicines containing magnesium, as they may increase the risk of elevated calcium (hypercalcemia) or magnesium (hypermagnesemia), especially in patients with kidney disorders;
medicines used to block muscles during surgery (neuromuscular blockers), as calcium salts may counteract their effects;
ceftriaxone (an antibiotic), due to the risk of particle formation.

Due to the presence of magnesium chloride, pay special attention if you are taking the following medicines:
central nervous system depressants such as barbiturates, narcotics, or other hypnotics (or systemic anesthetics). In such cases, dosage should be carefully adjusted, as magnesium enhances the depressant effect on the central nervous system;
heart medications (cardiac glycosides, digoxin, digitoxin);
medicines used to block muscles during surgery (competitive and depolarizing neuromuscular junction blockers), such as rocuronium, as their effects may be enhanced by magnesium chloride;
aminoglycoside antibiotics, used to treat bacterial infections;
eltrombopag, a medicine used to treat low platelet levels in the blood;
labetalol, a medicine used to treat heart rhythm disorders (arrhythmias);
medicines used to treat high blood pressure (isradipine, felodipina, nicardipine, nifedipine), as concomitant use with magnesium may cause a significant drop in blood pressure (hypotension).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before this medicine is administered.

This medicine should not be administered during pregnancy or breastfeeding unless absolutely necessary.

If required, ELETTROLITICA REIDRATANTE CON GLUCOSIO E CALCIO GLUCONATO S.A.L.F. should be administered with caution to pregnant women during labor, particularly regarding serum sodium levels, if administered together with oxytocin.

Due to the presence of magnesium, this medicine should not be administered within 2 hours before delivery. If magnesium chloride is administered (especially for more than 24 hours before delivery), newborns may show signs of magnesium toxicity, including neuromuscular and respiratory depression.

Driving and using machines
This medicine does not affect the ability to drive or operate machinery.

3. How to use ELETTROLITICA REIDRATANTE CON GLUCOSIO E CALCIO GLUCONATO S.A.L.F.

This medicine will be prepared by a doctor, pharmacist, or nurse and will not be mixed or administered simultaneously with injections containing ceftriaxone or other incompatible medicines.
This medicine must be administered directly into a vein (intravenous infusion) by specialized medical personnel. It must not be injected via other routes of administration (intramuscular, subcutaneous, or into perivascular tissues). The medicine must be administered only when kidney function is normal 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.
After receiving the medicine, remain lying down for a short period of time.
The dose will be adjusted according to age, body weight, and your health condition.
The recommended dose in adults is 2 liters per day, administered at an infusion rate of approximately 300 ml per hour.
Infusions that are too rapid may cause local pain; the infusion rate must be adjusted according to your needs.
Administration must be stopped if you experience pain or redness at the injection site, as this could be due to leakage of the medicine from the vein (drug extravasation).
Use in children
In children, the safety and efficacy of this medicine have not been established.
The dosage and rate of glucose administration must be determined based on the patient's age, weight, and health condition. Particular caution is required in newborns and underweight children (see section "Children").
Preparation of the medicine
Use immediately after opening the container. The container is intended for single, uninterrupted administration and any remaining solution must not be used.
Shake well before administration. Do not use the medicine if the solution is not clear and colorless or slightly yellowish, or if it contains particles. Do not mix with incompatible solutions.
Take all usual precautions to maintain sterility before and during intravenous infusion.
If you use more ELETTROLITICA REIDRATANTE CON GLUCOSIO E CALCIO GLUCONATO S.A.L.F. than you should
Since this medicine will be administered by a doctor or specialized personnel, it is unlikely that you will receive an excessive dose. However, if you think you have been given too much ELETTROLITICA REIDRATANTE CON GLUCOSIO E CALCIO GLUCONATO S.A.L.F., inform your doctor or another healthcare professional immediately.
Following administration of an excessive dose of this medicine, the following may occur:
Increased potassium levels in the blood (hyperkalemia), which may lead to death due to heart damage (cardiac depression, arrhythmias, or arrest);
Increased sodium levels (hypernatremia) and increased blood volume (hypervolemia). If sodium levels in the blood rise too much, fluid loss from internal organs (dehydration), particularly from the brain, may occur, along with fluid accumulation affecting the cerebral, pulmonary, and peripheral circulation, leading to fluid buildup around the lung (pulmonary edema) or swelling in the legs and ankles (peripheral edema);
Increased calcium levels in the blood (hypercalcemia), especially in patients with kidney disease, manifesting with symptoms such as thirst, nausea, vomiting, constipation, increased urine production (polyuria), abdominal pain, muscle weakness, mental disturbances, and, in severe cases, cardiac arrhythmias and coma.
Following administration of high doses of magnesium chloride, the following symptoms of intoxication may occur:
flushing, sweating, reduced arterial pressure (hypotension), paralysis of certain muscles such as respiratory muscles (flaccid paralysis), reduced body temperature (hypothermia), circulatory collapse, cardiac and central nervous system depression, which may progress to respiratory paralysis.
Magnesium intoxication manifests with a sudden increase in blood pressure, difficulty breathing (respiratory paralysis), and loss of the leg extension response following a percussion stimulus (patellar reflex).
With prolonged administration of glucose, accumulation of intracellular fluids (hyperhydration) and solute overload may occur.
In case of overdose, stop the infusion immediately and initiate corrective therapy to reduce elevated blood sugar and ion levels, and restore, if necessary, the acid-base balance.
If you have any doubts about the use of this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following side effects may occur:
Not known (frequency cannot be estimated from the available data):
allergic reactions and urticaria;
stomach and intestinal (gastrointestinal) disorders, nausea, vomiting, diarrhoea, abdominal pain, constipation, intestinal disorders (delayed intestinal transit and paralytic ileus);
thirst, reduced salivation, metallic taste, chalky taste;
nervous and muscular (neuromuscular) disorders, muscle stiffness, altered limb sensation (paraesthesiae), paralysis of certain muscles such as respiratory muscles (flaccid paralysis), weakness;
mental confusion, headache, dizziness, restlessness, irritability;
seizures, coma, death;
drowsiness, confusional states, mental disorders, cerebral oedema (hyponatraemic encephalopathy)*;
irregular heartbeat (arrhythmias), increased heart rate (tachycardia), decreased heart rate (bradycardia), cardiac conduction disturbances, disappearance of the P wave, widening of the QRS complex on electrocardiogram, syncope, ventricular fibrillation, cardiac arrest;
decrease or increase in blood pressure (hypotension, hypertension), swelling of the legs and ankles (peripheral oedema), vasodilation, hot flushes, sweating and shock;
increased levels of sodium (hypernatraemia), chloride (hyperchloraemia) and blood volume (hypervolaemia);
decreased sodium levels in the blood (hospital-acquired hyponatraemia)*;
breathing problems (dyspnoea, respiratory arrest);
fluid accumulation in the lungs (pulmonary oedema) and air around the lung (pneumothorax);
reduced tear production;
kidney problems (renal failure) and excessive urine production (polyuria);
increased calcium levels in the blood (hypercalcaemia), Burnett's syndrome (milk-alkali syndrome), decreased calcium levels in the blood (hypocalcaemia);
muscle weakness;
increased metabolic rate, increased blood glucose levels (hyperglycaemia), decreased blood glucose levels (hypoglycaemia), increased insulin levels, increased adrenaline levels;
fever, infection at the infusion site, local pain or reaction, skin redness, skin irritation (rash);
venous irritation, formation of blood clots in the veins (venous thrombosis);
inflammation of the veins (venous phlebitis) extending from the infusion site;
leakage of the injected solution from the vein (extravasation), tissue damage and tissue death (tissue necrosis);
formation of calcium deposits in tissues (cutaneous calcification), inflammation due to pus accumulation (abscesses);
kidney problems caused by calcium-ceftriaxone deposits. Pain during urination may occur, or the amount of urine produced may decrease.
* Hospital-acquired hyponatraemia may cause irreversible brain damage and death due to the development of acute hyponatraemic encephalopathy.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ELETTROLITICA REIDRATANTE CON GLUCOSIO E CALCIO GLUCONATO S.A.L.F.

Keep this medicine out of the sight and reach of children.
Medical personnel know how to store this medicine.
Do not use this medicine after the expiry date stated on the packaging after "EXP.". The expiry date refers to the last day of that month.
Store in the original packaging and in a tightly closed container. Do not refrigerate or freeze.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ELETTROLITICA REIDRATANTE CON GLUCOSIO E CALCIO GLUCONATO S.A.L.F. contains
The active substances are: sodium chloride, potassium acetate, dibasic anhydrous potassium phosphate, calcium gluconate monohydrate, magnesium sulfate heptahydrate, glucose monohydrate.
1000 ml of solution contain 3.38 g of sodium chloride, 1.96 g of potassium acetate, 0.69 g of dibasic anhydrous potassium phosphate, 0.71 g of calcium gluconate monohydrate, 0.98 g of magnesium sulfate heptahydrate, 55 g of glucose monohydrate.
(Each liter of solution contains 58 mEq of sodium, 28 mEq of potassium, 3 mEq of calcium, 8 mEq of magnesium, 58 mEq of chloride, 8 mEq of phosphate, 8 mEq of sulfate, 20 mEq of acetate, 3 mEq of gluconate, and 277 mmol/liter of glucose).
pH: 5.0 – 6.0.
The other components are: water for injections, hydrochloric acid (as pH regulator).

Description of the appearance of ELETTROLITICA REIDRATANTE CON GLUCOSIO E CALCIO GLUCONATO S.A.L.F. and package contents
PVC bag containing 2000 ml of infusion solution.
5 PVC-free bags containing 2000 ml of infusion solution each.

Marketing Authorization Holder and Manufacturer
S.A.L.F. S.p.A. Laboratorio Farmacologico – Via Marconi, 2 – Cenate Sotto (BG) – Italy.

PACKAGE LEAFLET: Information for the physician

ELECTROLYTE REHYDRATING SOLUTION WITH GLUCOSE AND CALCIUM GLUCONATE S.A.L.F. infusion solution

Equivalent medicine
The following information is intended exclusively for physicians or healthcare professionals

Hyponatremia
Electrolyte balance, serum glucose, serum sodium, and other electrolytes should be monitored before and during administration, especially in patients with increased non-osmotic vasopressin release (syndrome of inappropriate antidiuretic hormone secretion, SIADH) and in patients receiving concomitant therapy with vasopressin agonists, due to the risk of hyponatremia. Monitoring of serum sodium is particularly important for physiologically hypotonic solutions.

Depending on the tonicity of the solution, the volume and rate of infusion, the patient's underlying clinical condition, and the ability to metabolize glucose, intravenous administration of glucose may cause electrolyte disturbances, particularly hypo- or hyperosmolar hyponatremia.

Incompatibilities
Due to the presence of glucose, this medicinal product is incompatible with:
cyanocobalamin;
kanamycin sulfate;
sodium novobiocin;
sodium warfarin.

Furthermore, 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 calcium, this medicinal product is incompatible with:
magnesium sulfate: formation of a precipitate;
medicinal products containing phosphate: formation of calcium phosphate precipitate;
medicinal products containing carbonate: formation of calcium carbonate precipitate;
medicinal products containing tartrate: formation of calcium tartrate precipitate.

Incompatibilities of calcium have been reported with:
aminophylline: due to precipitate formation;
amphotericin B: due to cloudiness development;
cefamandole: due to the presence of sodium carbonate in the cefamandole formulation;
cephalothin: due to physical incompatibility;
cefradine: due to the presence of sodium carbonate in the cefradine formulation;
chlorpheniramine: due to physical incompatibility;
dobutamine: due to cloudiness development;
fat emulsion: due to flocculation;
sodium heparin;
indomethacin: due to precipitate formation;
sodium nitrofurantoin;
promethazine: due to precipitate formation;
propofol: due to precipitate formation;
streptomycin: as calcium may inhibit streptomycin activity;
tetracyclines: calcium salts may complex with tetracyclines.

Calcium salts may form complexes with many drugs, potentially leading to precipitate formation.
Physical incompatibility has been reported with ceftriaxone (see sections 4.3, 4.5 and 4.8, SmPC).

Due to the presence of magnesium, this 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 the concentration of reactants and the pH of solutions.

Management of overdose
Immediately discontinue the infusion and initiate corrective therapy for hyperglycemia and to reduce plasma levels of ions in excess; restore acid-base balance if necessary (see section 4.4, SmPC).
The patient should be closely observed for the onset of any signs and symptoms related to the administered drug, providing appropriate symptomatic and supportive measures as needed.

In case of marked 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 mild calcium overdose, treatment includes immediate discontinuation of the infusion and of any other calcium-containing medication. In case of severe overdose (plasma concentrations >2.9 mmol/l), the following measures should be taken:

rehydration with administration of 0.9% sodium chloride solution;
use of non-thiazide diuretics to enhance calcium excretion;
monitoring of plasma potassium and magnesium levels, with immediate correction to normal values;
monitoring of cardiac function, and use of beta-blockers to reduce the risk of cardiac arrhythmias;
hemodialysis if necessary.

In case of magnesium overdose, artificial ventilation may be required. To counteract the effects of hypermagnesemia, calcium should 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.

Shelf life
36 months

For further information, consult the Summary of Product Characteristics.