Infusion solution
Sodium chloride, potassium acetate, anhydrous dibasic potassium phosphate, calcium gluconate, magnesium sulfate,
glucose monohydrate
Equivalent medicine
Please read this leaflet carefully before using this medicine, as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

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

1. What ELETTROLITICA REIDRATANTE CON GLUCOSIO E CALCIO GLUCONATO GALENICA SENESE is and what it is used for

ELETTROLITICA REIDRATANTE CON GLUCOSIO E CALCIO GLUCONATO GALENICA SENESE is an intravenous 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, magnesium sulfate, glucose monohydrate.
This medicinal product is indicated to provide water and electrolytes to the body in conditions where a caloric intake is required, and for the treatment of mild metabolic acidosis, a condition characterized by increased blood acidity.

What you need to know before using ELETTROLITICA REIDRATANTE CON GLUCOSIO E CALCIO GLUCONATO GALENICA SENESE

Do not use ELETTROLITICA REIDRATANTE CON GLUCOSIO E CALCIO GLUCONATO GALENICA SENESE

if you are allergic to the active substances or to any of the other components of this medicinal product (listed in section 6);
if you have high levels of calcium in the blood (hypercalcemia);
if you have high levels of potassium in the blood (hyperkalemia) or reduced ability to excrete 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 problems with urination (oliguric renal failure, anuria);
if you have breathing difficulties (respiratory rate less than 16 breaths per minute);
if you have an increased blood pH (metabolic or respiratory alkalosis);
if you have severe heart problems and are taking, or have taken in excess, heart medications known as cardioactive glycosides (digitalis toxicity);
if the patient is a neonate (under 28 days of age), ELETTROLITICA REIDRATANTE CON GLUCOSIO E CALCIO GLUCONATO GALENICA SENESE (or other calcium-containing solutions) 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 neonate's bloodstream.
if you are pregnant (see section “Fertility, pregnancy and breastfeeding”).

Glucose solutions must not be administered through the same infusion catheter as whole blood due to the potential risk of red blood cell aggregation (pseudoagglutination and coagulation).
Warnings and precautions

Consult your doctor or nurse before using ELETTROLITICA REIDRATANTE CON GLUCOSIO E CALCIO GLUCONATO GALENICA SENESE.
This medicinal product is a hypertonic solution to be administered intravenously with caution and at a controlled infusion rate.
Depending on the tonicity of the solution, the volume and frequency of infusion, the patient's underlying clinical condition, and the ability to metabolize glucose, intravenous administration of glucose may cause electrolyte imbalances, particularly low levels of sodium in the blood (hypoosmolar or hyperosmolar hyponatremia).

Low levels of sodium in the blood (Hyponatremia)
Patients affected by a condition called syndrome of inappropriate antidiuretic hormone secretion (SIADH), characterized by non-osmotic release of vasopressin (e.g. in the acute phase of illness, pain, postoperative stress, infections, burns, and central nervous system diseases), patients with heart (cardiac), liver (hepatic), or kidney (renal) disorders, and patients treated with drugs that enhance the action of vasopressin (vasopressin agonists) (see section 2) are particularly at risk of acute reduction in blood sodium levels (acute hyponatremia) following infusion of hypotonic solutions.
An acute reduction in blood sodium levels (acute hyponatremia) may cause a condition called acute hyponatremic encephalopathy, characterized by increased fluid in the brain (cerebral edema), with symptoms such as headache, nausea, seizures, drowsiness, and vomiting. These patients are particularly at risk of severe, irreversible, and life-threatening brain damage.
Children, women of childbearing age, and patients with impaired brain function (e.g. meningitis, intracranial hemorrhage, cerebral contusion) are particularly at risk of severe and life-threatening cerebral edema caused by low blood sodium levels (acute hyponatremia).

Use with caution if:

you have diabetes mellitus. Blood glucose levels must be monitored during treatment;
you have heart problems (congestive heart failure);
you have kidney problems (renal insufficiency);
you have fluid accumulation (edema with salt retention);
you are taking corticosteroid anti-inflammatory drugs (corticosteroids) or hormonal medications (corticotropins);
you have adrenal gland disease (adrenal insufficiency);
you have heart problems and are taking heart medications (digitalis);
someone in your family suffers from a disorder characterized by sudden attacks of muscle weakness (familial periodic paralysis);
you have a disease characterized by muscle stiffness (congenital myotonia);
you have recently undergone surgery (early postoperative phase);
you are taking medications used to block muscles during surgery (neuromuscular blockers);
you are taking central nervous system depressants.
During treatment with this medicinal product, your doctor should periodically monitor heart function (via serial electrocardiograms) and blood concentrations of electrolytes (plasma osmolarity), glucose (blood glucose), fluids, and blood pH (acid-base balance). It is also advisable to monitor blood pressure and osteotendinous reflexes to detect any potential respiratory muscle paralysis.

Monitoring of electrolyte balance, blood glucose (serum glucose), serum sodium, and other electrolytes may be necessary before and during administration, with particular attention to serum sodium levels in patients with syndrome of inappropriate antidiuretic hormone secretion (SIADH) or those taking medications that enhance the action of vasopressin (vasopressin agonists), due to the risk of decreased blood sodium levels.
This medicinal product must be used immediately after opening the container. The solution should be clear, colorless or slightly straw-colored, and free from visible particles. It is intended for single, uninterrupted administration only. Any unused portion must not be retained.

Children
The safety and efficacy of this medicinal product in children have not been established.
As with other calcium-containing solutions, concomitant treatment with ceftriaxone is contraindicated in neonates (under 28 days of age) due to the risk of fatal precipitation of ceftriaxone-calcium salt in the neonate's bloodstream (see section “Possible side effects”).

Other medicines and ELETTROLITICA REIDRATANTE CON GLUCOSIO E CALCIO GLUCONATO GALENICA SENESE
Inform your doctor if you are currently using, have recently used, or might use any other medicines.
The following medicines may increase the risk of low blood sodium levels (hospital-acquired hyponatremia) following hospitalization after inadequately balanced intravenous fluid therapy:

medicines that stimulate the release of a hormone called vasopressin (chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics);
medicines that potentiate the effect of a hormone called vasopressin (chlorpropamide, NSAIDs, cyclophosphamide);
medicines similar to a hormone called vasopressin (desmopressin, oxytocin, vasopressin, terlipressin).

Other medicines that increase the risk of reduced blood sodium levels (hyponatremia) include diuretics (in general) and antiepileptic drugs such as oxcarbazepine.

Fertility, pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning pregnancy, or breastfeeding, consult your doctor before receiving this medicinal product.
This medicinal product should not be administered during pregnancy or breastfeeding unless absolutely necessary.
Elettrolitica reidratante con glucosio e calcio gluconato Galenica Senese should be administered with particular caution to pregnant women during labor, especially due to the risk of low blood sodium levels (hyponatremia), when administered in association with a hormone called oxytocin (see sections 2 and 4).

3. How to use ELETTROLITICA REIDRATANTE CON GLUCOSIO E CALCIO GLUCONATO GALENICA SENESE

This medicine will be prepared by a doctor, pharmacist, or nurse.
This medicine must be administered directly into a vein (intravenous infusion).
The dose will be adjusted according to age, body weight, and your health condition.
The medicine must be administered 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.

This medicine must be administered directly into a vein (intravenous infusion) by specialized medical personnel.
Use in children
In children, the safety and efficacy of this medicine have not been established.
Preparation of the medicine: Use immediately after opening the container. The container is intended for single and uninterrupted administration; any remaining solution must not be used.
Shake well before administration. Do not use the medicine if the solution is not clear and colourless or slightly yellowish, or if it contains particles. Do not mix with incompatible solutions.
Observe all standard precautions to maintain sterility before and during intravenous infusion.
If you use more ELETTROLITICA REIDRATANTE CON GLUCOSIO E CALCIO GLUCONATO GALENICA SENESE than you should
Since this medicine will be administered by a doctor or trained medical staff, it is unlikely that you will receive an excessive dose.
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 experiences them.
The following side effects may occur:

stomach and intestinal (gastrointestinal) disorders;
nerve and muscle (neuromuscular) disorders;
altered sensation in the limbs (paraesthesias);
irregular heartbeat (arrhythmias);
reduction in blood pressure (hypotension);
cardiac conduction disturbances;
fever;
infection at the infusion site;
formation of blood clots in the veins (venous thrombosis);
inflammation of the veins (venous phlebitis);
reduction in sodium levels in the blood following hospitalization, known as hospital-acquired hyponatremia*;
a brain disorder called acute hyponatremic encephalopathy*.
Rarely, serious (and in some cases fatal) adverse reactions may occur in neonates under 28 days of age (both preterm and full-term) treated with ceftriaxone and calcium administered intravenously. See section “Children”.

*Reduction in sodium levels in the blood following hospitalization (hospital-acquired hyponatremia) may lead to irreversible brain damage and death due to the development of acute hyponatremic encephalopathy, frequency not known (see sections 2 and 3).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store ELETTROLITICA REIDRATANTE CON GLUCOSIO E CALCIO GLUCONATO GALENICA SENENSE

Keep this medicine out of the sight and reach of children.
Medical personnel know how to store this medicine properly.
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, at a temperature not exceeding 30°C. 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 GALENICA SENESE contains

The active substances are: sodium chloride, potassium acetate, anhydrous dipotassium phosphate, magnesium sulfate, calcium gluconate, glucose monohydrate. 1000 ml of solution contain 3.38 g of sodium chloride, 1.96 g of potassium acetate, 0.69 g of anhydrous dipotassium phosphate, 0.98 g of magnesium sulfate, 0.71 g of calcium gluconate, 55 g of glucose monohydrate. (Each litre of solution contains 58 mEq of sodium, 28 mEq of potassium, 3.2 mEq of calcium, 8 mEq of magnesium, 58 mEq of chloride, 8 mEq of phosphate, 8 mEq of sulfate, 20 mEq of acetate, 3.2 mEq of gluconate and 277.5 mmol/litre of glucose). pH: 5.0 - 6.0.
The other component is: water for injections.

Description of the appearance of ELETTROLITICA REIDRATANTE CON GLUCOSIO E CALCIO GLUCONATO GALENICA SENESE and contents of the pack
Packs containing 1 bag of 1 litre or 2 litres of infusion solution.

Marketing Authorisation Holder and Manufacturer
Industria Farmaceutica Galenica Senese S.r.l. – Via Cassia Nord, 351 - Monteroni d’Arbia (SI) – Italy.