GLUCOSIO 5% + 0.2% Infusion solution

Зміст інструкції

1. GLUCOSIO CON POTASSIO CLORURO MONICO
2. Glucose monohydrate and potassium chloride
   1. What is GLUCOSIO CON POTASSIO CLORURO MONICO and what is it used for
   2. What you need to know before using GLUCOSIO CON POTASSIO CLORURO MONICO
   3. How to use GLUCOSIO CON POTASSIO CLORURO MONICO
3. GLUCOSIO CON POTASSIO CLORURO MONICO, immediately inform the doctor or go to the nearest
   1. Possible side effects
   2. How to store GLUCOSIO CON POTASSIO CLORURO MONICO
   3. Contents of the pack and other information

GLUCOSIO CON POTASSIO CLORURO MONICO

5%/0.2% Infusion Solution I
10%/0.3% Infusion Solution II

Glucose monohydrate and potassium chloride

Equivalent medicinal product

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 pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What is GLUCOSIO CON POTASSIO CLORURO MONICO and what it is used for
• 2. What you need to know before you use GLUCOSIO CON POTASSIO CLORURO MONICO
• 3. How to use GLUCOSIO CON POTASSIO CLORURO MONICO
• 4. Possible side effects
• 5. How to store GLUCOSIO CON POTASSIO CLORURO MONICO
• 6. Contents of the pack and other information

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

GLUCOSIO CON POTASSIO CLORURO MONICO is a solution to be administered directly into
the vein (intravenous infusion), containing the active ingredients potassium chloride and glucose monohydrate and
belonging to the class of electrolytic solutions associated with carbohydrates.
This medicine is indicated to provide the body with water, sugars and potassium in emergency situations and for
the treatment of low blood sugar levels (hypoglycemia).

2. What you need to know before using GLUCOSIO CON POTASSIO CLORURO MONICO

Do not use GLUCOSIO CON POTASSIO CLORURO MONICO

• 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 with urination (anuria);
• if you have bleeding occurring at the spinal level (spinal hemorrhage) or inside the skull (intracranial hemorrhage);
• if you suffer from hallucinations, tremors and sweating (delirium tremens) in the presence of a state of dehydration;
• if you have low levels of fluids in the body (severe dehydration);
• if you suffer from liver problems leading to loss of consciousness (hepatic coma);
• if you suffer from severe kidney problems (severe renal failure);
• if you have high levels of potassium in the blood (hyperkalemia) or if your body has difficulty eliminating it (states of potassium retention);
• if you suffer from a disorder of the adrenal glands (Addison's disease) that is not treated;
• if you experience muscle cramps, painful and short-lived (heat cramps). Glucose solutions should not be administered through the same infusion catheter with whole blood due to the possible risk of red blood cell aggregation (pseudoagglutination) or red blood cell rupture (hemolysis).

Warnings and precautions
Consult your doctor, pharmacist or nurse before using GLUCOSIO CON POTASSIO
CLORURO MONICO.
Use this medicine with cautionand inform your doctor in the following cases:

• if you suffer from diabetes mellitus or are intolerant to glucose; to minimize the risk of hyperglycemia (high blood sugar levels) and glycosuria (presence of sugar in the urine), it is necessary to monitor blood and urine glucose during administration and, if necessary, administer insulin;
• if you suffer from severe kidney problems (severe renal insufficiency), as this may decrease the amount of potassium eliminated from the body (potassium retention);
• if you are taking anti-inflammatory steroid medications (corticosteroids);
• if you are taking corticotropin hormone;
• if you suffer from heart problems (heart failure), especially if you are taking digitalis drugs to treat certain heart disorders;
• if you suffer from problems with the adrenal glands (adrenal insufficiency);
• if you suffer from liver problems (hepatic insufficiency);
• if you have periodic paralysis (a disorder characterized by sudden attacks of muscle weakness);
• if you suffer from congenital myotonia, a disease characterized by prolonged muscle contraction;
• if you have recently undergone surgery (early postoperative period);
• if you have swelling due to fluid accumulation (edema);
• if you have reduced elimination of fluids and minerals (hydrosaline retention).
• if you are in one of the following conditions:
• you have an acute illness
• you have pain
• you have undergone surgery
• you have infections, burns
• you have brain diseases
• diseases of the liver, heart and kidneys
• you are being treated 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 with possible risk of death. Cerebral edema can occur with greater risk:
• in children
• in women of childbearing potential
• in case of meningitis, bleeding in the skull or brain contusion.

During prolonged treatment with this medicine, an excess of water in the body may occur
(fluid overload), congestion and excessive loss of minerals (electrolyte deficiency); the doctor
will need to periodically check the concentration of minerals (electrolytes, plasma osmolarity) and
correct, if necessary, any excessive losses with the administration of minerals and vitamins.
High concentrations of potassium in the blood can cause death due to blockage of heart activity
(cardiac depression, cardiac arrest) or severe disturbances of the heartbeat (arrhythmias). To avoid
the toxic effects of potassium, intravenous infusion must be slow. During the administration of this
medicine, it is necessary to monitor heart function (serial electrocardiograms) and levels of salts
and fluids (electrolyte balance and acid-base balance).

The solution must be used immediately after opening the container. The solution must be clear,
colorless or slightly straw-yellow and free of visible particles and must be used for a
single and uninterrupted administration. Any remaining solution cannot be used.

Children
In children, especially in newborns and children with low body weight, the administration of
glucose may increase the risk of a rise in blood glucose levels (hyperglycemia). In addition, in
children with low body weight, a rapid or excessive infusion may cause an increase in blood osmolarity
and intracranial hemorrhage.

Other medicines and GLUCOSIO CON POTASSIO CLORURO MONICO
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
GLUCOSIO CON POTASSIO CLORURO MONICO must be administered with cautionif you are
taking:

• anti-inflammatory steroid medications (corticosteroids) or corticotropin, as they may cause you to decrease glucose tolerance and possible manifestation of latent diabetes mellitus;
• medicines that facilitate urine elimination and reduce potassium loss (potassium-sparing diuretics); these medicines, when taken together with GLUCOSIO CON POTASSIO CLORURO MONICO, especially if you have kidney problems (renal dysfunction), can cause an increase in potassium levels in the blood (hyperkalemia);
• medicines used to lower blood pressure (ACE inhibitors), as they may reduce the elimination of potassium. In these cases, it is necessary to carefully monitor potassium levels in the blood.
• medicines that increase the effect of the 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, suspect you are pregnant, are planning to become pregnant or are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before using this medicine.
Do not use this medicine during pregnancy and breastfeeding unless absolutely necessary and
always under strict medical supervision.

Driving and operating machinery
GLUCOSIO CON POTASSIO CLORURO MONICO does not impair the ability to drive vehicles and operate
machinery.

3. How to use GLUCOSIO CON POTASSIO CLORURO MONICO

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 to you with caution directly into a vein (intravenous infusion) and at a
controlled infusion rate.
The doctor will choose the concentration of glucose solution to be used based on age, weight, your
health conditions and the levels of minerals and blood pH.
Before and during administration, the doctor will monitor your fluid levels, glucose, sodium and
other mineral salts (electrolytes) in the blood.

Shake well before administration.
GLUCOSIO CON POTASSIO CLORURO MONICO must only be administered to you if you do not suffer from
kidney problems and through a slow injection into a vein (rate not exceeding 10 mEq of potassium per hour).

Use in children and adolescents
The dosage and administration rate must be chosen based on age, weight and
the patient's clinical condition. In children, especially in newborns and children with low
body weight, this medicine should be administered with caution and at a controlled rate (See the
section “Children”).

Use in the elderly
If you are an elderly person, your doctor will keep you under close supervision during treatment with this
medicine.

If you use more GLUCOSIO CON POTASSIO CLORURO MONICO than you should
Since this medicine will be administered to you by a doctor or specialized personnel, it is unlikely that
you will be injected with an excessive dose. However, if you think that you have been given an excessive dose of

GLUCOSIO CON POTASSIO CLORURO MONICO, immediately inform the doctor or go to the nearest

hospital.
In case of accidental intake of excessive doses of GLUCOSIO CON POTASSIO CLORURO MONICO
an increase in the amount of water and solute concentration in the body may occur
(overhydration and solute overload). In this case, the doctor or nurse must immediately stop
administration of the medicine and begin corrective therapy to reduce levels
high potassium in the blood and correct the acid-base balance.

If you forget to useGLUCOSIO CON POTASSIO CLORURO MONICO
Since this medicine will be administered by a doctor or specialized personnel, it is unlikely that
a dose will be forgotten. However, if you think a dose may have been forgotten, contact
the doctor or nurse.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, GLUCOSIO CON POTASSIO CLORURO MONICO can cause side effects,
although not everybody gets them.
The following side effects may occur.

Not known(the frequency cannot be estimated from the available data):

• allergic-type reactions (hypersensitivity), skin irritation (urticaria);
• increased internal blood pressure due to dissolved substances (hyperosmolarity);
• increased blood volume (hypervolemia);
• increased metabolic rate (speed 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 can be acquired in hospital)
• cerebral edema which can cause brain damage (hypotonic encephalopathy)
• decreased blood pressure (hypotension);
• heartbeat alterations (arrhythmias, conduction disturbances, disappearance of the P wave, widening of the QRS complex on the electrocardiogram);
• blockage of heart function (cardiac arrest);
• fluid accumulation with 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 sensitivity of the arms and legs (paresthesia), loss of muscle tone (flaccid paralysis), weakness, mental confusion;
• stomach and intestinal disorders (gastrointestinal disorders);
• increased body temperature (fever);
• leakage of the medicine into the tissues around the injection site (extravasation);
• infection at the infusion site and local pain;
• formation of blood clots and inflammation of the veins in the infusion area (thrombosis and thrombophlebitis).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through 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 which is stated on the packaging 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 in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What GLUCOSIO CON POTASSIO CLORURO MONICO 5%/0.2% Solution for infusion contains
I

• The active ingredients are glucose monohydrate and potassium chloride. 1000 ml of solution contains: 55 g of glucose monohydrate (corresponding 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 277 mmol of glucose monohydrate. 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 ingredients are glucose monohydrate and potassium chloride. 1000 ml of solution contains: 110 g of glucose monohydrate (corresponding 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 glucose monohydrate. 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
pack
GLUCOSIO CON POTASSIO CLORURO MONICO 5%/0.2% Solution for Infusion I sterile and apyrogenic
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
apyrogenic
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
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The following information is intended exclusively for healthcare professionals
Dosage and administration
One gram of glucose provides a caloric contribution equal to 3.74 Kcal (approximately 15.6 Kjoules).
The 5% glucose solution (solution I) is slightly hypertonic with blood. The 10% glucose solution (solution II) is hypertonic with blood and must be infused with caution and at a controlled infusion rate; this solution should not be used unless specifically prescribed.
It may be necessary to monitor electrolyte balance, serum glucose, serum sodium and other electrolytes before and during administration, particularly in patients with increased non-osmotic vasopressin release (syndrome of inappropriate antidiuretic hormone secretion, SIADH) and in patients undergoing 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 can 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 can become extremely hypotonic at the physiological level due to the rapid metabolism of glucose.
Depending on the tonicity of the solution, the volume and frequency of infusion and the underlying clinical conditions of the patient, as well as the ability to metabolize glucose, intravenous administration of glucose can cause electrolyte disturbances and especially hypo- or hyperosmotic hyponatremia. Hyponatremia:
Patients with non-osmotic vasopressin release (e.g. in the acute phase of the disease, pain, post-operative stress, infections, burns and diseases of the central nervous system), patients with heart disease, liver disease and kidney disease and patients treated with vasopressin agonists are particularly at risk of acute hyponatremia following infusion of hypotonic solutions. Acute hyponatremia can cause acute hyponatremic encephalopathy (cerebral edema) characterized by headache, nausea, seizures, lethargy and vomiting. Patients with cerebral edema are particularly at risk of severe, irreversible and life-threatening brain injury. Children, women of childbearing potential and patients with reduced cerebral compliance (e.g. meningitis, intracranial hemorrhage and cerebral contusion) are particularly at risk of severe and life-threatening cerebral edema caused by acute hyponatremia.
Children, women of childbearing potential and patients with reduced cerebral compliance (e.g. meningitis, intracranial hemorrhage and cerebral contusion) are particularly at risk of severe and life-threatening cerebral edema caused by acute hyponatremia.

Interactions
Medicines that increase the effect of vasopressin, causing a reduction in the excretion of free water and electrolytes from the kidneys and an increased risk of hospital-acquired hyponatremia following treatment not adequately balanced with intravenous solutions are

• medicines stimulating vasopressin release, for example: chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics
• medicines that potentiate the action of vasopressin, for example: chlorpropamide, NSAIDs, cyclophosphamide
• vasopressin analogues: desmopressin, oxytocin, vasopressin, terlipressin Other medicines that increase the risk of hyponatremia also include diuretics in general and antiepileptics such as oxcarbazepine.

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

Incompatibilities
If used to dilute medicines, consult the pharmacist, if available, before introducing the additive medicines; however, consider the characteristics of the products to be introduced; use aseptic techniques.
Due to the presence of glucose, the medicine is incompatible with:

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

In addition, 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, it is not recommended to mix the medicine with other medicines.

Special precautions for disposal and handling
Take all usual precautions to maintain sterility before and during intravenous infusion.
Unused medicine and waste derived from such medicine must be disposed of in accordance with local regulations.

For further information consult the Summary of Product Characteristics.