Glucose with sodium chloride Monico

Italy
Brand name Glucose with sodium chloride Monico
Form solution for injection
Active substance / Dosage
ANHYDROUS GLUCOSE (DEXTROSE)
SODIUM CHLORIDE
Prescription type Prescription only
ATC code
B05BB02
Registration number 030867
Manufacturer MONICO S.P.A.

Table of Contents

PACKAGE LEAFLET: INFORMATION FOR THE USER

GLUCOSE WITH SODIUM CHLORIDE MONICO

4.27% / 0.18% - Infusion solution I
5% / 0.9% - Infusion solution II
2.5% / 0.45% - Infusion solution III
Glucose monohydrate and sodium chloride
Equivalent medicine
Please read all of this leaflet carefully before you start 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 may be harmful.
  • If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or nurse. See section 4.

Contents of this leaflet:

  1. What GLUCOSE WITH SODIUM CHLORIDE MONICO is and what it is used for
  2. What you need to know before using GLUCOSE WITH SODIUM CHLORIDE MONICO
  3. How to use GLUCOSE WITH SODIUM CHLORIDE MONICO
  4. Possible side effects
  5. How to store GLUCOSE WITH SODIUM CHLORIDE MONICO
  6. Package contents and other information

1. What GLUCOSIO CON SODIO CLORURO MONICO is and what it is used for

GLUCOSIO CON SODIO CLORURO MONICO contains the active substances glucose monohydrate and sodium chloride. Administration of glucose increases blood sugar levels (glycaemia), provides calories and water to the body.
Sodium is important for maintaining acid-base balance and proper fluid balance (fluid osmolarity), for cell function (transmembrane potential), and for the proper functioning of the heart, brain, and kidneys. Chloride is mainly present in red blood cells and in the tissue lining the stomach (gastric mucosa) and is absorbed together with sodium.
This medicinal product is indicated to correct hydration of your body and to support an adequate supply of mineral salts (through sodium chloride) and calories (through glucose monohydrate).
Moreover:

  • solutions I and II are also indicated to correct blood sugar levels when they are low (hypoglycaemia);
  • solution III is also indicated to correct blood sodium levels (natriaemia), in association with a minimal caloric intake.

2. What you need to know before using GLUCOSE WITH SODIUM CHLORIDE MONICO

Do not use GLUCOSE WITH SODIUM CHLORIDE MONICO

  • if you are allergic to glucose or sodium chloride or to any of the other ingredients of this medicine (listed in section 6);
  • if you have problems with urination (anuria);
  • if you have bleeding into the tissues of the brain or spinal cord (intracranial or spinal hemorrhage);
  • if you suffer from hallucinations, tremors, and sweating (delirium tremens) caused by excessive loss of body water (dehydration);
  • if you have low levels of fluids in your body (dehydration);
  • if you suffer from liver problems leading to loss of consciousness (hepatic coma);
  • if you have high levels of sodium in your blood (hypernatremia, only for solution II);
  • if you have excessive amounts of salts and fluids in your blood (hypervolemia, only for solutions II and III).

Glucose solutions must not be administered simultaneously with blood transfusions through the same infusion catheter as whole blood, due to the possible risk of red blood cell clumping (pseudoagglutination) or red blood cell breakdown (hemolysis).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using GLUCOSE WITH SODIUM CHLORIDE MONICO.
Use this medicine with caution and inform your doctor in the following cases:

  • if you have diabetes mellitus or are glucose intolerant; during infusion, blood sugar levels (glycemia) and sugar in urine (glycosuria) must be closely monitored to minimize the risk of elevated levels; insulin may be administered if necessary;
  • if you have high blood pressure (hypertension);
  • if you suffer from heart problems (heart failure, congestive cardiac failure) or kidney problems (reduced renal function, severe renal failure);
  • if you are pregnant and suffer from a condition characterized by high blood pressure, swelling due to fluid accumulation, and presence of protein in the urine (pre-eclampsia);
  • if you have fluid accumulation (edema with salt retention), either in the lungs (pulmonary edema) or associated with swelling of the legs and ankles (peripheral edema);
  • if you are taking heart medications (cardiotonic inotropic drugs), corticosteroid anti-inflammatory drugs, or corticotropin hormonal drugs;
  • if you suffer from other disorders associated with high sodium levels (sodium retention).

This medicine should be administered with caution and under specific monitoring due to the risk of reduced sodium concentration in plasma (acute hyponatremia) if:

  • you have heart problems (cardiac diseases);
  • you have liver and/or kidney disease (hepatopathies and/or nephropathies);
  • you are undergoing treatment with vasopressin agonists;
  • you suffer from diseases of the central nervous system, or have recently undergone surgery, have ongoing infections, burns, or pain.

Children, women of childbearing age, and patients with certain brain disorders are more susceptible to reduced plasma sodium levels.
During prolonged treatment with this medicine, excessive accumulation of water in the body (fluid overload and congestive state) and excessive loss of electrolytes (electrolyte deficit) may occur; your doctor should periodically monitor electrolyte concentrations (electrolytes and plasma osmolarity), acid-base balance, and body fluid volume, correcting any excessive losses as needed with electrolyte and vitamin supplementation.
Continuous administration without potassium supplementation may lead to reduced potassium levels in the blood (hypokalemia).
Use the medicine immediately after opening the container. The solution must be clear, colorless, and free from visible particles. The container is intended for single, uninterrupted administration, and any remaining medicine must not be used.
Children
In children, especially newborns and those with low body weight, glucose administration may increase the risk of elevated blood sugar levels (hyperglycemia). Furthermore, in children with low body weight, rapid or excessive infusion may increase blood osmolarity and cause bleeding into brain tissue due to rupture of blood vessels (intracerebral hemorrhage).
Other medicines and GLUCOSE WITH SODIUM CHLORIDE MONICO
Inform your doctor if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
Pay particular attention and consult your doctor if you are taking:

  • corticosteroid anti-inflammatory drugs (corticosteroids) or a hormonal medicine (corticotropin), as they may increase your blood sugar levels, potentially leading to latent diabetes mellitus; if glucose is administered concomitantly, your doctor must monitor you closely;
  • corticosteroid anti-inflammatory drugs (corticosteroids), as their concomitant use with sodium salts may cause water and sodium retention, resulting in swelling (edema) and increased blood pressure (hypertension);
  • medicines that stimulate vasopressin release, for example: chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics;
  • medicines that enhance the action of vasopressin (e.g., chlorpropamide, NSAIDs, cyclophosphamide);

vasopressin analogs (desmopressin, oxytocin, vasopressin, terlipressin) and other medicines such as diuretics and antiepileptics (e.g., oxcarbazepine), as they may increase the risk of decreased plasma sodium concentration (hyponatremia).
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, ask your doctor for advice before using this medicine.
If you are pregnant, this medicine should be administered with particular caution during labor, especially regarding serum sodium levels, particularly if administered together with a drug inducing labor (oxytocin).
There are no data available on possible adverse effects of this medicine when administered during pregnancy or breastfeeding, or on fertility.
Do not use this medicine during pregnancy or breastfeeding unless absolutely necessary and only after careful assessment of the risks and benefits of treatment.
Driving and operating machinery
This medicine does not affect the ability to drive or operate machinery.

3. How to use GLUCOSE WITH SODIUM CHLORIDE MONICO

This medicinal product will be administered to you by a doctor or other specialized medical personnel. If you have any doubts, please consult your doctor, pharmacist, or nurse.
It may be necessary to monitor the patient's electrolyte balance, blood glucose and electrolyte levels, and acid-base balance before and during administration, with particular attention to serum sodium if you suffer from the syndrome of inappropriate antidiuretic hormone secretion (vasopressin), SIADH, or if you are receiving concomitant therapy with vasopressin agonists, due to the risk of reduced plasma sodium concentration (hyponatremia).
Monitoring of serum sodium is particularly important for hypotonic solutions.
This medicine will be administered to you cautiously by direct intravenous infusion (intravenous infusion) and at a controlled infusion rate.
The doctor will determine the appropriate dose based on your age, body weight, health condition, and blood electrolyte levels, particularly sodium levels (electrolyte profile, osmolarity, and sodium deficit).
The medicine must be administered at a rate not exceeding 0.4–0.8 g of glucose per kilogram of body weight per hour.

Use in the elderly
If you are elderly, your doctor will monitor you closely during treatment with this medicine.

Children
The safety and efficacy of this medicine in children have not been established.
Glucose dosage and administration rate must be adjusted according to the child’s age, weight, and health status. Particular caution is required, especially in neonates or children with low body weight, as elevated blood glucose levels (hyperglycemia) may occur.

If you use more GLUCOSE WITH SODIUM CHLORIDE MONICO 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 that an excessive dose of GLUCOSE WITH SODIUM CHLORIDE MONICO has been administered, inform your doctor or another healthcare provider immediately.
In case of accidental administration of excessive doses of GLUCOSE WITH SODIUM CHLORIDE MONICO, an increase in water and solute concentration in the body (hyperhydration and solute overload) may occur. In such cases, the doctor or nurse must immediately discontinue administration of the medicine and initiate corrective therapy to normalize mineral and glucose blood levels (restore acid-base balance and reduce plasma glucose levels).
Administration of large volumes of solution may alter blood electrolyte levels (plasma hypoosmolarity).
Excessive administration of sodium chloride may lead to increased sodium levels in the blood (hypernatremia) and/or increased blood volume (hypervolemia).
Accumulation of chloride ions causes increased blood acidity (acidosis) due to decreased bicarbonate ion concentration.

If you forget to use GLUCOSE WITH SODIUM CHLORIDE MONICO
Since this medicine will be administered under strict medical supervision, it is unlikely that a dose will be missed. However, inform your doctor if you think a dose has been missed.

If you have any questions about the use of this medicine, please contact your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If GLUCOSE WITH MONOSODIUM CHLORIDE is administered improperly or too rapidly, the following side effects may occur (see section “Warnings and precautions”).
Frequency not known (frequency cannot be estimated from the available data):

  • allergic-type reactions (hypersensitivity), skin irritation (urticaria);
  • decreased levels of potassium (hypokalaemia), magnesium (hypomagnesaemia), and phosphate (hypophosphataemia) in the blood;
  • excessive water accumulation in the body (hyperhydration);
  • increased levels of sodium (hypernatraemia) and chloride (hyperchloraemia) following administration of Solution II, leading to increased blood acidity (acidosis);
  • decreased levels of chloride (hypochloraemia) and sodium (hyponatraemia) in the blood following administration of Solution I;
  • increased or decreased blood osmotic pressure (hyperosmolarity or hypoosmolarity);
  • increased blood volume in circulation (hypervolaemia);
  • reduced sodium concentration in plasma (hospital-acquired hyponatraemia) which may cause irreversible brain damage and death due to development of acute hyponatraemic encephalopathy;
  • increased metabolic rate;
  • increased or decreased blood glucose levels (hyperglycaemia or hypoglycaemia);
  • increased insulin levels;
  • increased adrenaline levels;
  • increased heart rate (tachycardia);
  • decreased or increased blood pressure (hypotension or hypertension);
  • fluid accumulation causing swelling in the legs and ankles (peripheral oedema);
  • fluid accumulation in the lungs (pulmonary oedema);
  • breathing difficulties (dyspnoea, respiratory arrest);
  • bleeding into the brain due to rupture of blood vessels (cerebral haemorrhage);
  • brain damage caused by poor cerebral blood circulation (cerebral ischaemia);
  • headache (cephalalgia), dizziness, restlessness, irritability, muscle rigidity, weakness, seizures;
  • coma, death;
  • drowsiness and confusion;
  • thirst, reduced salivation;
  • nausea, vomiting, diarrhoea, abdominal pain;
  • reduced tear production;
  • kidney disorders (renal failure);
  • increased body temperature (fever);
  • leakage of medicine into surrounding tissues at the injection site (extravasation);
  • infection at the infusion site and local pain;
  • circulatory problems due to blood clot formation and inflammation of veins at the infusion site (thrombosis and thrombophlebitis).

Following the instructions provided in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly via the national reporting system at 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 GLUCOSIO CON SODIO CLORURO MONICO

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 product in its original, undamaged packaging, correctly stored.
Store in the original packaging and in a tightly closed container. Do not refrigerate or freeze.
Do not use the medicine if the solution is not clear and colourless or if it contains particles. Use
immediately after opening the container. Intended for single and uninterrupted administration; any
remaining residue must not be used.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What GLUCOSIO CON SODIO CLORURO MONICO contains
GLUCOSIO CON SODIO CLORURO MONICO 4.27% / 0.18% - Infusion solution I

  • The active substances are glucose monohydrate and sodium chloride. 1000 ml of solution contain 47 g of glucose monohydrate (equivalent to 42.7 g of anhydrous glucose) and 1.8 g of sodium chloride. One litre of solution contains: 31 mEq of sodium, 31 mEq of chloride, and 237 mmol of glucose monohydrate. pH: 3.5 - 6.5.
  • The other component is water for injections.

GLUCOSIO CON SODIO CLORURO MONICO 5% / 0.9% - Infusion solution II

  • The active substances are glucose monohydrate and sodium chloride. 1000 ml of solution contain 55 g of glucose monohydrate (equivalent to 50 g of anhydrous glucose) and 9.0 g of sodium chloride. One litre of solution contains: 154 mEq of sodium, 154 mEq of chloride, and 277 mmol of glucose monohydrate. pH: 3.5 - 6.5.
  • The other component is water for injections.

GLUCOSIO CON SODIO CLORURO MONICO 2.5% / 0.45% - Infusion solution III

  • The active substances are glucose monohydrate and sodium chloride. 1000 ml of solution contain 27.5 g of glucose monohydrate (equivalent to 25 g of anhydrous glucose) and 4.5 g of sodium chloride. One litre of solution contains: 77 mEq of sodium, 77 mEq of chloride, and 139 mmol of glucose monohydrate. pH: 3.5 - 6.5.
  • The other component is water for injections.

Description of the appearance of GLUCOSIO CON SODIO CLORURO MONICO and contents of the pack
Sterile, pyrogen-free infusion solution.
GLUCOSIO CON SODIO CLORURO MONICO 4.27% / 0.18% - Infusion solution I
Glass vials of 50, 100, 250, 500, 1000 ml of infusion solution.
Plastic bags of 50, 100, 250, 500, 1000 ml of infusion solution.
GLUCOSIO CON SODIO CLORURO MONICO 5% / 0.9% - Infusion solution II
Glass vials of 50, 100, 250, 500, 1000 ml of infusion solution.
Plastic bags of 50, 100, 250, 500, 1000 ml of infusion solution.
GLUCOSIO CON SODIO CLORURO MONICO 2.5% / 0.45% - Infusion solution III
Glass vials of 50, 100, 250, 500, 1000 ml of infusion solution.
Plastic bags of 50, 100, 250, 500, 1000 ml of infusion solution.
Marketing Authorization 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
Monitoring of serum sodium is particularly important when administering physiologically hypotonic solutions.
GLUCOSE WITH MONOHYDRIC SODIUM CHLORIDE 4.27%/0.18% (infusion solution I) and GLUCOSE
WITH MONOHYDRIC SODIUM CHLORIDE 2.5%/0.45% (infusion solution III) may become
markedly hypotonic after administration due to the metabolism of glucose in the body.
Patients with non-osmotic vasopressin release (e.g., during acute illness, pain, post-operative stress, infections, burns, and central nervous system disorders), patients with cardiac, hepatic or renal diseases, and patients receiving vasopressin agonists are particularly at risk of developing acute hyponatremia following infusion of hypotonic solutions. Acute hyponatremia may cause 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 injury. Children, women of reproductive age, and patients with reduced cerebral compliance (e.g., meningitis, intracranial hemorrhage, and cerebral contusion) are particularly at risk of life-threatening severe cerebral edema due to acute hyponatremia.

Overdose
Treatment
Immediately discontinue the infusion and initiate corrective therapy to reduce plasma levels of glucose and excess ions, and restore acid-base balance if necessary.
The patient should be closely monitored for the onset of any signs and symptoms related to the administered medicinal product, with appropriate symptomatic and supportive measures provided as needed.
In cases of marked hypernatremia, loop diuretics may be used.
Serum sodium levels exceeding 200 mmol/L may require dialysis.

Incompatibilities
Due to the presence of glucose, the medicinal product is incompatible with:

  • cyanocobalamin;
  • kanamycin sulfate;
  • sodium novobiocinate;
  • sodium warfarin.

Furthermore, there are conflicting opinions regarding the compatibility of glucose with hydroxyethyl starch (hetastarch). Glucose solutions without added electrolytes should not be administered through the same infusion catheter as whole blood due to the possible formation of aggregates and the risk of hemolysis. Ampicillin and amoxicillin remain stable in glucose solutions only for a short period. Unless otherwise indicated, mixing this medicinal product with other medicinal products is not recommended. For further information, refer to the Summary of Product Characteristics.