GLUCOSIO 5 % Infusion solution

Зміст інструкції

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

GLUCOSIO MONICO

5%, 10%, 20%, 33%, 50%, 70% - Solution for infusion

Glucosio monoidrato

Equivalent medicine

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 may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is GLUCOSIO MONICO and what is it used for

GLUCOSIO MONICO is a solution to be administered directly into a vein (intravenous
infusion) containing the active substance glucose, belonging to the class of parenteral
nutritional solutions.
This medicine is indicated to provide the body with water and sugars in emergency cases,
especially in patients who do not need salts or in cases where these should be avoided, and for the
treatment of decreased blood sugar (hypoglycemia).

2. What you need to know before using GLUCOSIO MONICO

Do not use GLUCOSIO MONICO

• if you are allergic to glucose or any of the other ingredients of this medicine (listed in section 6);
• if you have problems with urination (anuria);
• if you experience bleeding that occurs at the spinal level (spinal hemorrhage) or inside the skull (intracranial hemorrhage);
• if you suffer from hallucinations, tremors and sweating (delirium tremens) caused by excessive water loss from the body (dehydration);
• if you have low fluid levels in the body (dehydration);
• if you suffer from liver problems leading to loss of consciousness (hepatic coma).

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
Talk to your doctor, pharmacist or nurse before using GLUCOSIO MONICO.
Use this medicine with cautionand inform your doctor in the following cases:

• if you suffer from diabetes or are intolerant to glucose. During the infusion, blood sugar (glycemia) and urine sugar (glycosuria) levels should be carefully monitored to minimize the risk of hyperglycemia and glycosuria; if necessary, insulin should be administered;
• if you suffer from heart problems (heart failure);
• if you suffer from severe kidney problems (severe renal failure);
• if you experience swelling caused by fluid accumulation and retention of mineral salts (edema with hydrosaline retention);
• if you are taking anti-inflammatory corticosteroid medications;
• if you are taking certain hormonal medications (corticotropin).

The 5% solution is isotonic with blood.
The 10%, 20%, 33%, 50% and 70% solutions are hypertonic with blood and must be infused
with caution and at a controlled infusion rate.
One gram of glucose provides a caloric contribution equal to approximately 3.74 Kcal (approximately 15.6 KJoule).
During prolonged treatment with this medicine, an accumulation of water may occur
in the body (fluid overload and congestive state) and an excessive loss of mineral salts
such as potassium and phosphate (electrolyte deficiency); the doctor should periodically check the
concentration of mineral salts (electrolytes), correcting, if necessary, the imbalance
of water and electrolyte balance.
If necessary, vitamins and mineral salts can be administered.
Concentrated glucose solutions should not be administered by subcutaneous injection (subcutaneously) or intramuscular injection (intramuscularly).

Children
In children, especially in newborns and children with low body weight, the
administration of glucose may increase the risk of increased 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 bleeding inside the brain tissue
due to rupture of a blood vessel (intracerebral hemorrhage).

Other medicines and GLUCOSIO MONICO
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
GLUCOSIO MONICO should be administered with cautionif you are taking anti-inflammatory steroid medications (corticosteroids) or hormonal medications (corticotropin), because they may
cause you to have increased blood sugar levels that could lead to latent diabetes mellitus.
Glucose solutions may be incompatible with other infusion solutions.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy 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
No data are available regarding the effects of the medicine on driving and operating machinery.

3. How to use GLUCOSIO 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) at a very controlled infusion rate. Concentrated glucose solutions

must not be administeredby injection under the skin (subcutaneously) or into the muscle (intramuscularly), but exclusively intravenously.
If it should be necessary to administer the solutions through the veins of the arms
(peripherally),, for example in the urgent treatment of low blood glucose levels
(hypoglycemic crises), the solutions must be injected very slowly into a large-caliber vein in the arm.
The infusion rate is generally 0.4-0.8 g of glucose per kilogram of body weight
per hour.
The doctor will choose the concentration of the glucose solution to be used based on age, weight
and your health conditions and the levels of mineral salts and blood pH.
Below are general guidelines on choosing different glucose concentrations:

• 5%-10% solutions are used for the replenishment of fluids and calories;
• 20%-33% solutions are used for caloric replenishment and limited fluid replenishment;
• 50%-70% solutions are used for the treatment of low blood glucose levels (hypoglycemia) due to excessive insulin production (hyperinsulinemia) or other causes.

Use in children and adolescents
In children with a low body weight, this medicine must be administered with
caution and at a controlled rate (See section “Children”). The dosage and rate of
administration must be chosen based on the patient's age, weight and clinical condition.
Generally, solutions with a concentration higher than 10% are not used.

Use in the elderly
There do not appear to be any differences in response between elderly and younger patients following
administration of glucose. As a general rule, caution is required when administering
medicines to elderly patients.
It is recommended to take all usual precautions to maintain sterility before and
during intravenous infusion. Do not use if the packaging is damaged. Do not use the
glucose solution if it is not clear, colorless or slightly straw-yellow
or if it contains particles.

If you use more GLUCOSIO 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
administered an excessive dose of GLUCOSIO MONICO, inform your doctor immediately or go to the nearest hospital.
In case of accidental administration of excessive doses of GLUCOSIO MONICO, an
increase in the concentration of water and solutes in the body (hyperhydration and solute overload) may occur. In this case, the doctor or nurse must immediately stop
administration of the medicine and start corrective therapy.

If you stop taking GLUCOSIO MONICO
In case of sudden discontinuation of glucose infusion, it is recommended to gradually reduce the
dose by administering 5% or 10% glucose, in order to avoid a rapid drop in
blood sugar (rebound hypoglycemia).
If you have any questions about the use of this medicine, ask 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:

• leakage of the medicine into the tissues around the injection site (extravasation);
• infection at the infusion site and local pain;
• circulatory problems due to the formation of blood clots and inflammation of the veins in the infusion area (thrombosis and thrombophlebitis);
• increased body temperature (fever);
• increased water in the body (hyperhydration) and decreased potassium (hypokalaemia), magnesium (hypomagnesaemia) and phosphate (hypophosphataemia);
• increased metabolic rate;
• increased blood sugar (hyperglycaemia);
• increased osmotic pressure of the blood (hyperosmolarity);
• increased blood volume circulating in the body (hypervolaemia);
• reduction of glucose levels in the blood (hypoglycaemia);
• increased insulin level;
• increased adrenaline level;
• accumulation of fluids with swelling at the level of the legs and ankles (peripheral oedema);
• accumulation of fluids in the lungs (pulmonary oedema);
• bleeding into the tissues that make up the brain (cerebral haemorrhage);
• brain damage caused by poor blood circulation to the brain (cerebral ischaemia).

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/it/responsabili. By reporting side effects you can help to provide more information on the safety of this medicine.

5. How to store GLUCOSIO MONICO

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.
Keep the container tightly closed. Do not refrigerate or freeze.
After the first opening of the package, the medicine must be used immediately for
a single and uninterrupted administration and any remaining medicine must be discarded.
Do not administer if the solution is not clear, colourless or slightly yellow
straw-coloured, or if it contains particles.
Do not dispose of any medicine in 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 MONICO contains
GLUCOSIO MONICO 5% solution for infusion

• The active ingredient is glucose monohydrate. 1000 ml of solution contain 55 g of glucose monohydrate. Each liter of solution contains 278 mmol of glucose monohydrate. pH: 3.5 - 6.5.
• The other component is water for injections.

GLUCOSIO MONICO 10% solution for infusion

• The active ingredient is glucose monohydrate. 1000 ml of solution contain 110 g of glucose monohydrate. Each liter of solution contains 555 mmol of glucose monohydrate. pH: 3.5 - 6.5.
• The other component is water for injections.

GLUCOSIO MONICO 20% solution for infusion

• The active ingredient is glucose monohydrate. 1000 ml of solution contain 220 g of glucose monohydrate. Each liter of solution contains 1110 mmol of glucose monohydrate. pH: 3.5 - 6.5.
• The other component is water for injections.

GLUCOSIO MONICO 33% solution for infusion

• The active ingredient is glucose monohydrate. 1000 ml of solution contain 363 g of glucose monohydrate. Each liter of solution contains 1832 mmol of glucose monohydrate. pH: 3.5 - 6.5.
• The other component is water for injections.

GLUCOSIO MONICO 50% solution for infusion

• The active ingredient is glucose monohydrate. 1000 ml of solution contain 550 g of glucose monohydrate. Each liter of solution contains 2775 mmol of glucose monohydrate. pH: 3.5 - 6.5.
• The other component is water for injections.

GLUCOSIO MONICO 70% solution for infusion

• The active ingredient is glucose monohydrate. 1000 ml of solution contain 770 g of glucose monohydrate. Each liter of solution contains 3885 mmol of glucose monohydrate. pH: 3.5 - 6.5.
• The other component is water for injections.

Description of the appearance of GLUCOSIO MONICO and contents of the pack
Solution for infusion.
Glass bottles of ml 50, 100, 250, 500, 1000.
Plastic bags of ml 50, 100, 250, 500, 1000, 2000.

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
Warnings and precautions
Due to the risk of hyponatremia, monitoring of electrolyte balance, serum glucose, serum sodium and other electrolytes before and during administration is necessary, particularly in patients with the syndrome of inappropriate antidiuretic hormone secretion (SIADH) and in patients undergoing concomitant therapy with vasopressin agonists.
Monitoring of serum sodium is particularly important for physiologically hypotonic solutions. GLUCOSIO MONICO may become extremely hypotonic after administration, due to the metabolism of glucose in the body.
Patients with non-osmotic vasopressin release (e.g. in the acute phase of illness, 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.

Interactions
Medicines that can cause a reduction in free water excretion from the kidneys and an increased risk of hospital-acquired hyponatremia following treatment not adequately balanced with intravenous solutions, include:

• medicines stimulating 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; 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
GLUCOSIO 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.