Patient Information Leaflet: Information for the User

ELETTROLITICA EQUILIBRATA GASTRICA MONICO

Infusion Solution
Sodium chloride, potassium chloride, ammonium chloride
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, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What ELETTROLITICA EQUILIBRATA GASTRICA MONICO is and what it is used for
What you need to know before using ELETTROLITICA EQUILIBRATA GASTRICA MONICO
How to use ELETTROLITICA EQUILIBRATA GASTRICA MONICO
Possible side effects
How to store ELETTROLITICA EQUILIBRATA GASTRICA MONICO
Contents of the pack and other information
What ELETTROLITICA EQUILIBRATA GASTRICA MONICO is and what it is used for

ELETTROLITICA EQUILIBRATA GASTRICA MONICO is an infusion solution intended for direct intravenous injection, containing a combination of active substances: sodium chloride, potassium chloride, and ammonium chloride.
This medicine is indicated for body hydration, i.e. providing water and essential electrolytes to the body, and for lowering blood pH (in cases of metabolic alkalosis), following significant losses due to severe vomiting.

2. What you need to know before using ELETTROLITICA EQUILIBRATA GASTRICA

MONICO
Do not use ELETTROLITICA EQUILIBRATA GASTRICA MONICO

if you are allergic to sodium chloride, potassium chloride, ammonium chloride, or any of the other ingredients of this medicine (listed in section 6);
if you have high levels of potassium in the blood (hyperkalemia) or reduced ability to excrete potassium (potassium retention);
if you suffer from adrenal gland disease and are not receiving treatment for it (Addison's disease);
if you experience painful, short-lived muscle cramps (heat cramps);
if you have severe liver problems (hepatic insufficiency);
if you have severe kidney problems (renal insufficiency).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using ELETTROLITICA
EQUILIBRATA GASTRICA MONICO infusion solution.
This medicine must be administered via a very slow infusion, as rapid administration may cause potassium intoxication, which could lead to cardiac dysfunction (cardiac depression), disturbances in heart rhythm (arrhythmias), and potentially fatal cardiac arrest (see section How to use ELETTROLITICA
EQUILIBRATA GASTRICA MONICO).
Due to the presence of sodium, this medicine must be administered with caution in the
following cases:

if you have heart problems (congestive heart failure, cardiac insufficiency) or kidney problems (severe renal insufficiency);
if you have fluid accumulation (edema with salt retention), either in the lungs (pulmonary edema) or associated with swelling of the ankles and legs (peripheral edema);
if you are taking heart medications (cardiotropic agents) or anti-inflammatory drugs (corticosteroids or corticotropins);
if you have high blood pressure (hypertension);
if you suffer from a condition called pre-eclampsia, characterized by high blood pressure, swelling due to fluid retention, and presence of protein in the urine, or other conditions caused by sodium accumulation.

Due to the presence of potassium, this medicine must be administered with caution in the
following cases:

if you have severe kidney problems (renal insufficiency), as this may reduce your body’s ability to eliminate potassium (potassium retention);
if you have heart problems (cardiac insufficiency), especially if you are taking other heart medications (digitalis drugs);
if you have an adrenal gland disorder (adrenal insufficiency);
if you have severe liver problems (hepatic insufficiency);
if you have high levels of acid in the blood (metabolic acidosis);
if any member of your family suffers from a disorder characterized by sudden episodes of muscle weakness (familial periodic paralysis);
if you suffer from a condition causing muscle stiffness (congenital myotonia);
if you have recently undergone surgery (early post-operative phase).

Due to the presence of ammonium, this medicine must be administered under close medical supervision to prevent symptoms of toxicity (ammoniemic toxicity), including elevated ammonium levels in the blood (hyperammonemia), and if you have high levels of acid (respiratory acidosis) and carbon dioxide (hypercapnia) in the blood.
During treatment with this medicine, your doctor must periodically monitor heart function through electrocardiograms, and check blood levels of electrolytes, fluids, osmolarity, and pH.
This medicine must be used immediately after opening the container. The solution must be clear, colorless, and free from visible particles, and is intended for single, uninterrupted administration only. Any unused portion must not be reused.
Children
There are insufficient data to establish the safety and efficacy of this medicine in children.
Other medicines and ELETTROLITICA EQUILIBRATA GASTRICA MONICO
Inform your doctor if you are currently using, have recently used, or might use any other medicines.
This medicine must be administered with caution if you are taking:

antihypertensive drugs such as potassium-sparing diuretics, especially in patients with kidney problems, ACE inhibitors, or other drugs that reduce aldosterone levels, as they may increase potassium levels in the blood (hyperkalemia); in such cases, potassium levels must be closely monitored;
anti-inflammatory steroid drugs (corticosteroids), which may cause sodium and water retention, leading to fluid accumulation (edema) and increased blood pressure (hypertension).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before using this medicine.
This medicine must not be used during pregnancy or breastfeeding, unless strictly necessary and only after careful assessment of the risk/benefit ratio.
Driving and using machines
This medicine does not impair the ability to drive or operate machinery.

3. How to use ELETTROLITICA EQUILIBRATA GASTRICA MONICO

This medicinal product must be administered directly into a vein (intravenous infusion), at a controlled rate, and only by trained healthcare personnel. If you have any doubts, consult your doctor, pharmacist, or nurse.
This medicinal product must only be administered if kidney function is adequate.
The doctor will adjust the dosage and infusion rate according to age, body weight, clinical condition, and the amount of gastric fluid lost (gastric liquid).
The recommended dose in adults is approximately 2.5 litres per day, administered at an infusion rate of about 500 ml per hour and at a potassium infusion rate not exceeding 10 mEq/hour.

Preparation of the medicinal product: Use the solution immediately after opening the container. The solution must be clear, colourless, and free from visible particles, and is intended for single, uninterrupted administration; any remaining residue must not be used.
Shake well before administration. Do not use the medicinal product if the solution is not clear and colourless or if it contains particles.
Ensure all necessary precautions are taken to maintain sterility before and during intravenous infusion.

If you use more ELETTROLITICA EQUILIBRATA GASTRICA MONICO than you should
Since this medicinal product will be administered by a doctor or trained healthcare professional, it is unlikely that you will receive an excessive dose. However, if you think that you have been given an excessive dose of ELETTROLITICA EQUILIBRATA GASTRICA MONICO infusion solution, inform your doctor or another healthcare professional immediately.

Following administration of an excessive dose of this medicinal product, the following may occur:

increased potassium levels in the blood (hyperkalaemia), which may lead to death due to loss of heart function (cardiac depression) and irregular heartbeat (arrhythmias), up to cardiac arrest;
increased sodium levels (hypernatraemia) and increased blood volume (hypervolaemia). If sodium levels in the blood rise too much and renal sodium excretion is impaired, dehydration of internal organs, especially the brain, may occur, along with fluid accumulation affecting the cerebral, pulmonary, and peripheral circulation, leading to fluid buildup around the lung (pulmonary oedema) or swelling in the legs and ankles (peripheral oedema);
increased blood ammonia levels (hyperammonaemia), which may cause symptoms such as pallor, sweating, irregular breathing, reduced heart rate (bradycardia), seizures, and even coma.

In case of administration of an excessive dose of this medicinal product, immediately discontinue the infusion and initiate corrective therapy to reduce ion levels and restore blood acid-base balance.

If you have any doubts about the use of ELETTROLITICA EQUILIBRATA GASTRICA MONICO infusion solution, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:
Not known (frequency cannot be estimated from the available data):

stomach and intestinal (gastrointestinal) disorders, thirst, reduced salivation, nausea, vomiting, diarrhoea, abdominal pain;
nerve and muscle (neuromuscular) disorders, muscle rigidity, altered sensation in the limbs (paraesthesiae), loss of muscle tone (flaccid paralysis), weakness;
confusion, headache, dizziness, restlessness, fever, irritability;
persistent tonic seizures, coma, death;
drowsiness, confusional states;
changes in heart rate (arrhythmias, tachycardia, bradycardia, conduction disorders, disappearance of the P wave, widening of the QRS complex on the electrocardiogram);
severe heart problems (cardiac arrest);
breathing difficulties (dyspnoea, respiratory arrest);
fluid accumulation in the lungs (pulmonary oedema);
reduced tearing;
kidney problems (renal failure);
decreased or increased blood pressure (hypotension, hypertension);
swelling of the legs and ankles (peripheral oedema), pallor, sweating;
increased levels of sodium (hypernatraemia), potassium (hyperkalaemia), ammonia (hyperammonaemia), circulating blood volume (hypervolaemia), and decreased osmolarity (hypo-osmolarity);
fever, infection at the infusion site, pain or local reaction, redness, rash, venous irritation, formation of blood clots in the veins (thrombosis), or inflammation of the veins (venous phlebitis) extending from the infusion site, leakage of medicine from the vein (extravasation) leading to tissue damage and tissue death (tissue necrosis).

Reporting of side effects
If you experience any side effect, 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
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ELETTROLITICA EQUILIBRATA GASTRICA MONICO

infusion solution
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is 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. Pack contents and other information

What ELETTROLITICA EQUILIBRATA GASTRICA MONICO infusion solution contains

The active substances are: sodium chloride, potassium chloride and ammonium chloride. 1000 ml of solution contain 3.7 g of sodium chloride, 1.3 g of potassium chloride, and 3.7 g of ammonium chloride. Each litre of solution contains 63 mEq of sodium, 17 mEq of potassium, 149 mEq of chloride and 69 mEq of ammonium. pH: 5.0 - 7.0.
The other component is water for injections.

Description of the appearance of ELETTROLITICA EQUILIBRATA GASTRICA MONICO and contents of the pack
Glass flacons of 50, 100, 250, 500 or 1000 ml of infusion solution.
Plastic bags of 50, 100, 250, 500 or 1000 ml of infusion solution.

Marketing Authorisation Holder and Manufacturer
Monico spa
Via Ponte di Pietra 7, 30173 Venezia Mestre - Italy

The following information is intended for healthcare professionals only

Warnings and precautions
Due to the risk of hospital-acquired hyponatremia, monitoring of fluid and electrolyte balance, serum electrolytes, and acid-base status—particularly serum sodium—is recommended before and during administration in patients with non-osmotic vasopressin release (syndrome of inappropriate antidiuretic hormone secretion, SIADH) and in patients receiving concomitant therapy with vasopressin agonists.
Monitoring of serum sodium is particularly important when hypotonic solutions are used. The infusion rate and volume depend on the patient's age, weight, and clinical condition (e.g., burns, surgical procedures, head injuries, infections). Concomitant therapy must be determined by a physician experienced in pediatric intravenous fluid therapy.
Infusion of large volumes should be administered under close monitoring in patients with cardiac or pulmonary insufficiency and in patients with non-osmotic vasopressin release (including SIADH), due to the risk of hospital-acquired hyponatremia.
Patients with non-osmotic vasopressin release (e.g., during the acute phase of illness, pain, postoperative stress, infections, burns, and central nervous system disorders), patients with cardiac, hepatic, or renal disease, and patients treated with vasopressin agonists are particularly at risk of acute hyponatremia following infusion of hypotonic solutions. Acute hyponatremia may lead to acute hyponatremic encephalopathy (cerebral edema), characterized by headache, nausea, seizures, lethargy, and vomiting. Patients with cerebral edema are at particular risk of severe, irreversible, and life-threatening brain damage.
Children, women of childbearing age, and patients with reduced cerebral compliance (e.g., meningitis, intracranial hemorrhage, contusion, and cerebral edema) are particularly at risk of severe, life-threatening cerebral edema caused by acute hyponatremia.

Interactions
Medicinal products that may reduce renal free water excretion and increase the risk of hospital-acquired hyponatremia during inadequately balanced intravenous fluid therapy include:

Medications stimulating vasopressin release, e.g.: chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine (MDMA), ifosfamide, antipsychotics, narcotics;
Medications potentiating the action of vasopressin, e.g.: chlorpropamide, NSAIDs, cyclophosphamide;
Vasopressin analogs, e.g.: desmopressin, oxytocin, vasopressin, terlipressin. Other medications increasing the risk of hyponatremia also include diuretics in general and antiepileptic drugs such as oxcarbazepine.

Pregnancy
ELETTROLITICA EQUILIBRATA GASTRICA MONICO should be administered with particular caution during labor in pregnant women, especially regarding serum sodium levels, when administered concomitantly with oxytocin.