Electrolyte solution for maintenance with glucose Galenica Senese

Package leaflet: information for the patient

ELETTROLITICA DI MANTENIMENTO CON GLUCOSIO ELETTROLITICA DI

MAINTENANCE WITH GLUCOSE GALENICA SENESE
infusion solution
sodium chloride, potassium chloride, potassium phosphate dibasic, sodium acetate trihydrate, 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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What ELETTROLITICA DI MANTENIMENTO CON GLUCOSIO GALENICA SENESE is and what it is used for
2. What you need to know before using it
3. How to use ELETTROLITICA DI MANTENIMENTO CON GLUCOSIO GALENICA SENESE
4. Possible side effects
5. How to store ELETTROLITICA DI MANTENIMENTO CON GLUCOSIO GALENICA SENESE
6. Contents of the pack and other information

1. What ELETTROLITICA DI MANTENIMENTO CON GLUCOSIO GALENICA SENESE is and what it is used for

What it is used for
ELETTROLITICA DI MANTENIMENTO CON GLUCOSIO GALENICA SENESE is an intravenous infusion solution intended for direct intravenous administration (intravenous infusion) containing a combination of active substances: sodium chloride, potassium chloride, dipotassium phosphate, sodium acetate trihydrate, monohydrate glucose.
This medicinal product is indicated to provide water and electrolytes to the body in situations where caloric intake must be ensured, and for the treatment of mild to moderate metabolic acidosis, a condition characterized by increased blood acidity.

2. What you should know before using ELETTROLITICA DI MANTENIMENTO CON GLUCOSIO

GALENICA SENESE
Do not use ELETTROLITICA DI MANTENIMENTO CON GLUCOSIO GALENICA SENESE

• 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 potassium in the blood (hyperkalaemia) or reduced ability to excrete potassium (potassium retention);
• if you have severe liver problems (severe hepatic insufficiency) leading to inability to metabolise the acetate ion;
• if you have severe kidney problems (severe renal insufficiency);
• if you have difficulty urinating (oliguric renal insufficiency, anuria);
• if you have serious heart problems (severe myocardial disease);
• if you have an increased blood pH (metabolic and respiratory alkalosis);
• if you have breathing difficulties (respiratory rate less than 16 breaths per minute);
• if you have circulatory problems due to increased tendency of the blood to clot (hypercoagulability);
• if you have low levels of calcium in the blood (hypocalcaemia);
• if you are taking cardiac glycosides, medicines used to treat heart problems;
• if you have bleeding into the spinal cord or brain tissue (spinal or intracranial haemorrhage);
• if you suffer from mental disorders characterised by hallucinations, tremors, sweating (delirium tremens), especially if you are dehydrated;
• if you have low fluid levels in the body (dehydration);
• if the patient is in a coma;
• if you have a disease of the adrenal glands (Addison's disease) and are not receiving treatment for it;
• if you experience painful, short-duration muscle cramps (heat cramps).

If you have recently received blood transfusions, this medicine must not be administered
through the same infusion catheter as whole blood due to the possible risk of red blood cell aggregation (pseudoagglutination).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before being administered ELETTROLITICA DI
MANTENIMENTO CON GLUCOSIO GALENICA SENESE
This medicine must be administered by very slow intravenous infusion
(intravenous infusion), as potassium intoxication may occur, which could lead to death due to loss of heart function (cardiac depression), irregular heartbeat (arrhythmias), up to cardiac arrest (see section “How to use ELETTROLITICA DI MANTENIMENTO CON GLUCOSIO GALENICA SENESE”).
Intravenous glucose infusions are generally isotonic solutions. However, in the body, glucose-containing solutions may become extremely hypotonic physiologically due to the rapid metabolism of glucose (see below).
Depending on the tonicity of the solution, volume and frequency of infusion, the patient's underlying clinical condition, and the ability to metabolise glucose, intravenous administration of glucose may cause electrolyte disturbances and particularly low levels of sodium in the blood (hypo- or hyperosmotic).
Special attention must be paid in:

• Patients suffering from a condition called syndrome of inappropriate antidiuretic hormone secretion, SIADH (e.g. in the acute phase of illness, pain, postoperative stress, infections, burns, and diseases of the central nervous system);
• patients with heart (cardiac), liver (hepatic), or kidney (renal) diseases and patients treated with medicines that increase the activity of a hormone called vasopressin (vasopressin agonists) (see section 2);

These patients are particularly at risk of low sodium levels in the blood (acute hyponatraemia) following infusion of hypotonic solutions.
An acute reduction in sodium levels in the blood (acute hyponatraemia) may cause a condition called acute hyponatraemic encephalopathy, which involves an increase in fluid in the brain (cerebral oedema) and is characterised by 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 reduced brain function (e.g. meningitis, bleeding (haemorrhage) within the skull, cerebral contusion (trauma)) are particularly at risk of severe and life-threatening cerebral fluid accumulation (cerebral oedema) caused by low sodium levels in the blood (acute hyponatraemia).
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, reduced renal function);
• if you have fluid accumulation (oedema with salt retention), either in the lungs (pulmonary oedema) or associated with swelling of the legs and ankles (peripheral oedema);
• if you are taking heart medications (cardiotonic inotropic drugs) or anti-inflammatory corticosteroid or corticotropin medications;
• if you have high blood pressure (hypertension);
• if you suffer from a condition called pre-eclampsia, characterised by high blood pressure, swelling due to fluid accumulation, and presence of proteins 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 kidney problems (renal insufficiency), as this may worsen potassium retention;
• if you have heart problems (cardiac insufficiency) and/or 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 characterised by sudden attacks of muscle weakness (familial periodic paralysis);
• if you suffer from a condition characterised by muscle stiffness (congenital myotonia);
• if you have recently undergone surgery (early postoperative phase).

Due to the presence of phosphates, the infusion of this medicine may cause a reduction in calcium levels in the blood (hypocalcaemia).
Due to the presence of acetate, the medicine must be used with caution in individuals with increased pH (metabolic and respiratory alkalosis) or elevated acetate levels in the blood, such as in individuals with liver problems (mild or moderate hepatic insufficiency).
Due to the presence of glucose, the medicine must be administered with caution in individuals suffering from diabetes mellitus or glucose intolerance and in individuals taking corticosteroid anti-inflammatory medicines (corticosteroids or corticotropin).
During treatment, glucose levels in blood and urine must be monitored, and, if required, insulin should be administered to minimise the risk of increased glucose levels in the blood (hyperglycaemia) and in the urine (glucosuria). During prolonged use of glucose solutions, fluid accumulation (fluid overload, congestive state) and deficiency of electrolytes in the blood may occur.
During treatment with this medicine, your doctor should periodically monitor heart function by serial electrocardiograms and blood electrolyte concentrations (plasma osmolarity), glucose (glycaemia), fluids, and blood pH (acid-base balance). In addition, it is good practice to monitor blood pressure and osteotendinous reflexes to detect any possible respiratory muscle paralysis.
It may be necessary to monitor electrolyte balance (electrolytes), blood glucose (serum glucose), blood sodium (serum sodium), and other electrolytes before and during administration, with particular attention to serum sodium levels in patients suffering from syndrome of inappropriate antidiuretic hormone secretion (SIADH) and in patients taking medicines that increase the action of a hormone called vasopressin (vasopressin agonists), due to the risk of low sodium levels in the blood.
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 and uninterrupted administration and any residual solution must not be used.
Children and adolescents
This medicine must be administered with caution in children, particularly in newborns and children with low body weight, as blood glucose levels may increase (hyperglycaemia). Furthermore, in children with low body weight, rapid or excessive intravenous infusion may cause an increase in serum electrolyte concentration (serum osmolarity) and cerebral haemorrhage due to rupture of blood vessels (intracerebral haemorrhage).
Children are particularly at risk of severe and life-threatening cerebral fluid accumulation (cerebral oedema) caused by low sodium levels in the blood (acute hyponatraemia).
Other medicines and ELETTROLITICA DI MANTENIMENTO CON GLUCOSIO GALENICA SENESE
Inform your doctor or nurse if you are using, have recently used, or might use any other medicine.
This medicine, which contains sodium salts, must be administered with caution if you are taking:

• medicines used to lower blood pressure such as potassium-sparing diuretics, ACE inhibitors, or other medicines that cause a decrease in aldosterone hormone levels, as they may lead to increased potassium levels in the blood (hyperkalaemia) and reduced ability to excrete potassium (potassium retention), especially in individuals with kidney problems (renal dysfunction); in such cases, potassium levels in the blood must be closely monitored;
• steroid anti-inflammatory medicines (corticosteroids) which may cause sodium and water retention, leading to fluid accumulation (oedema) and increased blood pressure (hypertension). Corticosteroids and corticotropin are associated with reduced sugar tolerance, potentially unmasking latent diabetes mellitus; careful monitoring is required if glucose is administered concomitantly.

The following medicines may increase the risk of low sodium levels in the blood following hospitalisation (hospital-acquired hyponatraemia) after inadequately balanced intravenous solution treatment:

• 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 enhance 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 sodium levels in the blood (hyponatraemia) include medicines that increase urine production (diuretics in general) and antiepileptic medicines such as oxcarbazepine.
Fertility, 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 to you.
This medicine must not be used during pregnancy and breastfeeding unless absolutely necessary.
Elettrolitica di mantenimento con glucosio Galenica Senese must be administered with particular caution in pregnant women during labour, particularly regarding blood sodium levels (serum sodium), if administered in association with a hormone called oxytocin (see sections 2 and 4).
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.
ELETTROLITICA DI MANTENIMENTO CON GLUCOSIO GALENICA SENESE contains sodium metabisulphite.
This medicine contains sodium metabisulphite which, rarely, may cause severe hypersensitivity reactions and bronchospasm, particularly in sensitive individuals and/or those suffering from asthma.

3. How to use ELETTROLITICA DI MANTENIMENTO CON GLUCOSIO GALENICA SENESE

This medicine will be prepared by a doctor, pharmacist, or nurse and must not be mixed or administered simultaneously with 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 dose will be adjusted according to age, body weight, blood electrolyte levels, and your health condition (e.g., burns, surgical procedures, head injuries, infections).
Generally, the dose is 4 litres/day, and the infusion rate is approximately 250 ml of solution per hour. The medicine must be administered only if kidney function is normal and at a rate not exceeding 10 mEq of potassium per hour; 0.4–0.8 g of glucose per kilogram of body weight per hour should be administered.
After receiving the medicine, remain lying down for a short period of time.
Infusions that are too rapid may cause local pain, and 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 may 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 dose, frequency, volume, and infusion rate of glucose must be determined based on the child's age, weight, and health status (e.g., burns, surgical procedures, head injuries, infections). Particular caution is required in neonates and underweight children (see section "Children").

Preparation of the medicine: use the solution immediately after opening the container. It 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, colourless, or slightly yellowish, or if it contains particles.
Observe all standard precautions to maintain sterility before and during intravenous infusion.

If you use more ELETTROLITICA DI MANTENIMENTO CON GLUCOSIO GALENICA SENESE than you should
Since this medicine will be administered by a doctor or trained healthcare professional, it is unlikely that you will receive an excessive dose. However, if you think you have been given too much ELETTROLITICA DI MANTENIMENTO CON GLUCOSIO GALENICA SENESE, 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 (hyperkalaemia), which may lead to death due to heart damage (cardiac depression, arrhythmias, or cardiac arrest);
• Increased sodium levels (hypernatraemia) and increased blood volume (hypervolaemia). 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 lungs (pulmonary oedema) or swelling in the legs and ankles (peripheral oedema).

With prolonged administration of glucose, accumulation of intracellular fluids (hyperhydration) and overload of solutes may occur.
In case of overdose, immediately discontinue administration of the medicine and initiate corrective therapy to reduce blood glucose and excess electrolyte levels, and restore acid-base balance if necessary.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist, 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:
Not known (frequency cannot be estimated from the available data):

• allergic reactions and urticaria;
• stomach and intestinal (gastrointestinal) disorders, nausea, vomiting, diarrhoea, abdominal pain;
• thirst, reduced salivation;
• nerve and muscle disorders (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;
• bleeding in the brain (cerebral haemorrhage);
• brain damage caused by poor blood circulation to brain tissues (cerebral ischaemia);
• drowsiness, confusional states, psychiatric disorders;
• irregular heartbeat (arrhythmias), increased heart rate (tachycardia), decreased heart rate (bradycardia), conduction disorders, disappearance of the P wave, widening of the QRS complex on electrocardiogram, syncope, ventricular fibrillation, cardiac arrest;
• reduction or increase in blood pressure (hypotension, hypertension), swelling of the legs and ankles (peripheral oedema), vasodilation, flushing, sweating, and shock;
• increased levels of sodium (hypernatraemia), potassium (hyperkalaemia), and chloride (hyperchloraemia) in the blood;
• increased blood volume (hypervolaemia) and blood osmolarity (hyperosmolarity);
• reduced levels of calcium in the blood (hypocalcaemia);
• increased blood pH (alkalosis);
• breathing difficulties (dyspnoea, respiratory arrest);
• fluid accumulation in the lungs (pulmonary oedema) and air around the membrane surrounding the lung (pneumothorax);
• reduced tear production;
• kidney problems (renal failure) and excessive urine production (polyuria);
• muscle weakness;
• increased metabolic rate, increased blood glucose levels (hyperglycaemia), reduced blood glucose levels (hypoglycaemia), increased insulin levels, increased adrenaline levels;
• fever, infection at the infusion site, pain or local reaction, redness, skin irritation (rash), venous irritation, formation of blood clots in veins (venous thrombosis);
• inflammation of veins (venous phlebitis) extending from the infusion site;
• leakage of the injected solution from the vein (extravasation);
• tissue damage and death (tissue necrosis);
• inflammation due to pus accumulation (abscesses);
• reduced sodium levels in the blood following hospitalisation as hospital-acquired hyponatraemia*;
• a brain disorder called acute hyponatraemic encephalopathy*.

*Reduction in blood sodium levels following hospitalisation (hospital-acquired hyponatraemia) may cause irreversible brain damage and death due to the development of acute hyponatraemic encephalopathy, with frequency not known (see sections 3 and 2).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ELETTROLITICA DI MANTENIMENTO CON GLUCOSIO GALENICA

SENESE
Keep this medicine out of the reach and sight of children.
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 below 30°C.
Keep in the original packaging and in a tightly closed container. Do not refrigerate or freeze.
Do not dispose of medicines 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 DI MANTENIMENTO CON GLUCOSIO GALENICA SENESE contains

• The active substances are: sodium chloride, potassium chloride, dibasic potassium phosphate, sodium acetate trihydrate, glucose monohydrate. 1000 ml of solution contain 0.91 g of sodium chloride, 1.50 g of potassium chloride, 1.30 g of dibasic potassium phosphate, 2.79 g of sodium acetate trihydrate, 55 g of glucose monohydrate (equivalent to 50 mg of glucose). Each litre of solution contains 36 mEq of sodium, 35 mEq of potassium, 36 mEq of chloride, 20 mEq of acetate, 15 mEq of phosphate and 278 mmol of glucose. pH: 5.0 - 6.0.
• The other components are: sodium metabisulfite, hydrochloric acid, water for injections.

Description of the appearance of ELETTROLITICA DI MANTENIMENTO CON GLUCOSIO GALENICA SENESE and contents of the package
ELETTROLITICA DI MANTENIMENTO CON GLUCOSIO GALENICA SENESE solution for infusion.
Glass vial of 100 ml, 250 ml, 500 ml and 1000 ml of solution for infusion.
Plastic bag of 100 ml, 250 ml, 500 ml and 1000 ml of solution for infusion.

Marketing Authorisation Holder and Manufacturer
Industria Farmaceutica Galenica Senese S.r.l.
Via Cassia Nord, 351
53014 Monteroni D’Arbia (SI)
Italy

The following information is intended exclusively for physicians or healthcare professionals

Incompatibilities
If used to dilute medicinal products, consult the pharmacist, if available, before adding any drugs;
nonetheless, consider the characteristics of the products to be added; use aseptic techniques.
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.

Management of overdose
Immediately discontinue the infusion and initiate corrective therapy for hyperglycemia, reduce plasma levels of excess ions, and restore acid-base balance if necessary (see section 4.4).
The patient should be closely monitored for the appearance of any signs and symptoms related to the administered medicinal product, ensuring appropriate symptomatic and supportive measures as required.
In case of marked hypernatremia, loop diuretics may be used.
In case of hyperkalemia, glucose (with or without insulin) or sodium bicarbonate may be administered by intravenous infusion.
Elevated plasma levels of electrolytes may require dialysis.
In the event of excessive glucose administration, reassess the patient's clinical condition and institute appropriate corrective measures.
For further information, refer to the Summary of Product Characteristics.