Glucose and potassium chloride Monico

Italy
Brand name Glucose and potassium chloride Monico
Form solution for infusion
Active substance / Dosage
POTASSIUM CHLORIDE
ANHYDROUS GLUCOSE (DEXTROSE)
Prescription type Prescription only
ATC code
B05BB02
Registration number 030866
Manufacturer MONICO S.P.A.

Table of Contents

Package leaflet: Information for the user

GLUCOSE WITH MONOAMMONIUM POTASSIUM CHLORIDE

5%/0.2% Infusion solution I
10%/0.3% Infusion solution II
Glucose monohydrate and potassium chloride
Equivalent medicine
Please read carefully all of this leaflet 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 their symptoms are the same as yours, as it may 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 GLUCOSE WITH MONOAMMONIUM POTASSIUM CHLORIDE is and what it is used for
  2. What you need to know before using GLUCOSE WITH MONOAMMONIUM POTASSIUM CHLORIDE
  3. How to use GLUCOSE WITH MONOAMMONIUM POTASSIUM CHLORIDE
  4. Possible side effects
  5. How to store GLUCOSE WITH MONOAMMONIUM POTASSIUM CHLORIDE
  6. Contents of the pack and other information

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

GLUCOSIO CON POTASSIO CLORURO MONICO is a solution for direct intravenous administration (intravenous infusion) containing the active substances potassium chloride and glucose monohydrate, and belongs to the class of electrolyte solutions combined with carbohydrates.
This medicinal product is indicated to provide water, sugars, and potassium to the body in emergency situations and for the treatment of low blood sugar levels (hypoglycemia).

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

Do not use GLUCOSE WITH MONOPOTASSIUM CHLORIDE

  • if you are allergic to glucose monohydrate, potassium chloride, or any of the other ingredients of this medicine (listed in section 6);
  • if you have problems urinating (anuria);
  • if you have bleeding occurring at the spinal level (spinal hemorrhage) or inside the skull (intracranial hemorrhage);
  • if you experience hallucinations, tremors, and sweating (delirium tremens) in the presence of dehydration;
  • if you have severely low fluid levels in the body (severe dehydration);
  • if you suffer from liver problems leading to loss of consciousness (hepatic coma);
  • if you have severe kidney problems (severe renal failure);
  • if you have high levels of potassium in the blood (hyperkalemia) or if your body has difficulty eliminating potassium (conditions of potassium retention);
  • if you have untreated adrenal gland disorder (Addison's disease);
  • if you experience painful, brief muscle cramps (heat cramps). Glucose solutions must not be administered 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 MONOPOTASSIUM CHLORIDE.
Use this medicine with caution and inform your doctor in the following cases:

  • if you have diabetes mellitus or glucose intolerance; to minimize the risk of high blood sugar levels (hyperglycemia) and sugar in the urine (glycosuria), blood and urine glucose levels must be monitored during administration, and insulin should be administered if necessary;
  • if you have severe kidney problems (severe renal failure), as this may reduce the amount of potassium eliminated by the body (potassium retention);
  • if you are taking steroid anti-inflammatory medicines (corticosteroids);
  • if you are taking the hormone corticotropin;
  • if you have heart problems (heart failure), especially if you are taking digitalis drugs for the treatment of certain heart conditions;
  • if you have adrenal gland problems (adrenal insufficiency);
  • if you have liver problems (hepatic insufficiency);
  • if you have familial periodic paralysis (a disorder characterized by sudden attacks of muscle weakness);
  • if you have congenital myotonia, a disease characterized by prolonged muscle contraction;
  • if you have recently undergone surgery (early post-operative phase);
  • if you have swelling due to fluid accumulation (edema);
  • if you have reduced elimination of fluids and minerals (water and electrolyte retention).
  • if you are in any of the following conditions:
  • acute illness
  • pain
  • recent surgery
  • infections, burns
  • brain diseases
  • liver, heart, and kidney diseases
  • treatment with vasopressin agonists. This may increase the risk of low sodium levels in the blood (hyponatremia), which can cause cerebral edema characterized by headache, nausea, seizures, drowsiness, vomiting, and potentially life-threatening complications. Cerebral edema is more likely to occur in:
  • children
  • women of childbearing age
  • cases of meningitis, intracranial bleeding, or cerebral contusion.

During prolonged treatment with this medicine, excess fluid in the body (fluid overload), congestion, and excessive loss of minerals (electrolyte deficiency) may occur. Your doctor should periodically check the concentration of minerals in the blood (electrolytes, plasma osmolarity) and correct any excessive losses, if necessary, by administering minerals and vitamins.
High levels of potassium in the blood may cause death due to heart function suppression (cardiac depression, cardiac arrest) or severe disturbances in heart rhythm (arrhythmias). To avoid potassium-related toxic effects, intravenous infusion must be slow. During administration of this medicine, heart function (serial electrocardiograms) and levels of fluids and minerals (electrolyte balance and acid-base equilibrium) must be monitored.
The solution must be used immediately after opening the container. The solution must be clear, colorless or slightly yellowish, and free from visible particles. It should be used for a single, uninterrupted administration only. Any remaining solution must not be reused.

Children
In children, particularly in newborns and those with low body weight, glucose administration may increase the risk of elevated blood glucose levels (hyperglycemia). Additionally, in children with low body weight, rapid or excessive infusion may increase blood osmolarity and lead to intracerebral hemorrhage.

Other medicines and GLUCOSE WITH MONOPOTASSIUM CHLORIDE
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
GLUCOSE WITH MONOPOTASSIUM CHLORIDE should be administered with caution if you are taking:

  • anti-inflammatory steroid medicines (corticosteroids) or corticotropin, as they may reduce your tolerance to sugars and may trigger latent diabetes mellitus;
  • medicines that promote urine elimination while reducing potassium loss (potassium-sparing diuretics); these medicines, when taken together with GLUCOSE WITH MONOPOTASSIUM CHLORIDE, especially if you have kidney problems (renal dysfunction), may cause increased potassium levels in the blood (hyperkalemia);
  • medicines used to lower blood pressure (ACE inhibitors), as they may reduce potassium excretion. In such cases, potassium levels in the blood must be closely monitored.
  • medicines that enhance the effect of vasopressin hormone, e.g., chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics, NSAIDs, cyclophosphamide, desmopressin, oxytocin, vasopressin, terlipressin, diuretics in general, and oxcarbazepine.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Do not use this medicine during pregnancy and breastfeeding unless absolutely necessary and always under strict medical supervision.

Driving and using machines
GLUCOSE WITH MONOPOTASSIUM CHLORIDE does not affect the ability to drive vehicles or operate machinery.

3. How to use GLUCOSE WITH MONO-POTASSIUM CHLORIDE

This medicine will be administered to you by a doctor or other qualified medical personnel. If you have
any doubts, consult your doctor, pharmacist, or nurse.
This medicine will be administered cautiously as a direct intravenous infusion (intravenous infusion) at a
controlled infusion rate.
Your doctor will select the appropriate glucose solution concentration based on your age, weight, your
health status, and blood levels of electrolytes and pH.
Before and during administration, your doctor will monitor your fluid, glucose, sodium, and other
electrolyte levels in the blood.
Shake well before administration.
GLUCOSE WITH MONO-POTASSIUM CHLORIDE should only be administered if you do not have kidney
problems and only through a slow intravenous injection (rate not exceeding 10 mEq of potassium per hour).
Use in children and adolescents
Dosage and infusion rate must be determined according to the patient's age, weight, and clinical condition. In children, especially newborns and children with low body weight, this medicine must be administered cautiously and at a controlled rate (See section “Children”).
Use in the elderly
If you are elderly, your doctor will closely monitor you during treatment with this medicine.
If you use more GLUCOSE WITH MONO-POTASSIUM CHLORIDE than you should
Since this medicine is administered by a doctor or qualified medical personnel, it is unlikely that you will receive an excessive dose. However, if you think that you have been given an excessive dose of GLUCOSE WITH MONO-POTASSIUM CHLORIDE, inform your doctor immediately or go to the nearest hospital.
In case of accidental administration of excessive doses of GLUCOSE WITH MONO-POTASSIUM CHLORIDE, an increase in body water and solute concentration may occur (overhydration and solute overload). In such cases, the doctor or nurse must immediately stop administration of the medicine and initiate corrective therapy to reduce elevated blood potassium levels and correct acid-base balance.
If you forget to use GLUCOSE WITH MONO-POTASSIUM CHLORIDE
Since this medicine is administered by a doctor or qualified medical personnel, it is unlikely that a dose will be missed. However, if you think a dose may have been missed, contact your doctor or nurse.
If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, GLUCOSIO CON POTASSIO CLORURO MONICO may 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 (hypersensitivity), skin irritation (urticaria);
  • increased internal blood pressure due to dissolved substances (hyperosmolarity);
  • increase in circulating blood volume (hypervolemia);
  • increased metabolic rate (rate at which substances are burned in the body);
  • increased blood sugar (hyperglycemia);
  • decreased blood sugar (hypoglycemia);
  • increased insulin levels;
  • increased adrenaline levels;
  • low sodium levels in the blood (hyponatremia, which may be hospital-acquired);
  • cerebral edema that may cause brain damage (hyponatremic encephalopathy);
  • decreased blood pressure (hypotension);
  • changes in heart rhythm (arrhythmias, conduction disorders, disappearance of the P wave, widening of the QRS complex on the electrocardiogram);
  • cardiac arrest (heart function blockage);
  • fluid accumulation causing swelling in the legs and ankles (peripheral edema);
  • fluid accumulation in the lungs (pulmonary edema);
  • cerebral hemorrhage;
  • cerebral ischemia (damage to brain tissue);
  • muscle and nerve disorders (neuromuscular disorders);
  • altered sensation in arms and legs (paresthesias), loss of muscle tone (flaccid paralysis), weakness, mental confusion;
  • stomach and intestinal disorders (gastrointestinal disturbances);
  • increased body temperature (fever);
  • leakage of the medicine into surrounding tissues at the injection site (extravasation);
  • infection at the infusion site and local pain;
  • blood clot formation and vein inflammation at the infusion site (thrombosis and thrombophlebitis).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You may 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 GLUCOSIO CON POTASSIO CLORURO MONICO

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container after "EXP.".
The expiry date refers to the last day of that month.
Keep the container tightly closed. 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 GLUCOSIO CON POTASSIO CLORURO MONICO 5%/0,2% Solution for infusion I contains

  • The active substances are monohydrate glucose and potassium chloride. 1000 ml of solution contain: 55 g of monohydrate glucose (equivalent to 50 g of anhydrous glucose) and 2.0 g of potassium chloride. One litre of solution contains: 27 mEq of potassium, 27 mEq of chloride and 555 mmol of monohydrate glucose. pH 3.5 - 6.5.
  • The other component is water for injections.

What GLUCOSIO CON POTASSIO CLORURO MONICO 10%/0,3% Solution for infusion II contains

  • The active substances are monohydrate glucose and potassium chloride. 1000 ml of solution contain: 110 g of monohydrate glucose (equivalent to 100 g of anhydrous glucose) and 3.0 g of potassium chloride. One litre of solution contains: 40 mEq of potassium, 40 mEq of chloride and 555 mmol of monohydrate glucose. pH 3.5 - 6.5.
  • The other component is water for injections.

Description of the appearance of GLUCOSIO CON POTASSIO CLORURO MONICO and contents of the
package
GLUCOSIO CON POTASSIO CLORURO MONICO 5%/0,2% Solution for Infusion I, sterile and pyrogen-free
Glass vials of 50 ml, 100 ml, 250 ml, 500 ml, 1000 ml.
Plastic bags of 50 ml, 100 ml, 250 ml, 500 ml, 1000 ml.
GLUCOSIO CON POTASSIO CLORURO MONICO 10%/0,3% Solution for infusion II, sterile and
pyrogen-free
Glass vials of 50 ml, 100 ml, 250 ml, 500 ml, 1000 ml.
Plastic bags of 50 ml, 100 ml, 250 ml, 500 ml, 1000 ml.

Marketing Authorisation Holder and Manufacturer
MONICO SPA – Via Ponte di Pietra 7, 30173 – VENEZIA/MESTRE – Italy

The following information is intended exclusively for healthcare professionals

Dosage and administration
One gram of glucose provides a caloric contribution of 3.74 kcal (approximately 15.6 kJoules).
The 5% glucose solution (solution I) is slightly hypertonic to blood. The 10% glucose solution (solution II) is hypertonic to blood and must be infused with caution and at a controlled infusion rate; this solution should not be used unless specifically prescribed.
Monitoring of electrolyte balance, serum glucose, serum sodium, and other electrolytes may be necessary before and during administration, particularly in patients with non-osmotic release of vasopressin (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.
Glucose with Potassium Chloride MONICO may become extremely hypotonic after administration due to the metabolism of glucose in the body.

Warnings and precautions
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.
Depending on the tonicity of the solution, volume and frequency of infusion, underlying clinical conditions of the patient, and the capacity for glucose metabolism, intravenous administration of glucose may cause electrolyte disturbances, particularly hypo- or hyperosmolar hyponatremia.

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 diseases, 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 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 severe, life-threatening cerebral edema caused by acute hyponatremia.
Children, women of reproductive age, and patients with reduced cerebral compliance (e.g., meningitis, intracranial hemorrhage, and cerebral contusion) are particularly at risk of severe, life-threatening cerebral edema caused by acute hyponatremia.

Interactions
Medicinal products that increase the effect of vasopressin, causing reduced renal excretion of free water and electrolytes and increasing the risk of hospital-acquired hyponatremia following inadequately balanced intravenous therapy include:

  • Medicinal products stimulating vasopressin release, e.g.: chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics
  • Medicinal products enhancing the action of vasopressin, e.g.: chlorpropamide, NSAIDs, cyclophosphamide
  • Vasopressin analogues: desmopressin, oxytocin, vasopressin, terlipressin

Other medicinal products that increase the risk of hyponatremia include diuretics in general and antiepileptic agents such as oxcarbazepine.

Pregnancy
Glucose with Potassium Chloride MONICO should be administered with particular caution to pregnant women during labor, especially if administered concomitantly with oxytocin, due to the risk of hyponatremia.

Incompatibilities
When used to dilute medicinal products, consult the pharmacist, if available, before adding any medicinal additives; always consider the characteristics of the products to be added; use aseptic techniques.
Due to the presence of glucose, the 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 are stable in glucose solutions only for a short period.
Unless otherwise indicated, co-administration of this medicinal product with other medicinal products is not recommended.

Special precautions for disposal and handling
Adopt all usual precautions to maintain sterility before and during intravenous infusion.
Unused medicinal product and waste materials derived from this medicinal product must be disposed of in accordance with local regulations.

For further information, refer to the Summary of Product Characteristics.