GLUCOSIO 5% Инфузионный раствор

Содержание инструкции

1. GLUCOSIO Bioindustria L.I.M.5% solution for infusion, L.I.M. 10% solution for infusion, L.I.M. 20% solution for infusion, L.I.M. 33% solution for infusion, L.I.M. 50% solution for infusion
   1. What is GLUCOSIO Bioindustria L.I.M. and what is it for
   2. What you need to know before using GLUCOSIO Bioindustria L.I.M.
   3. How to use GLUCOSIO Bioindustria L.I.M.
   4. Possible side effects
   5. How to store GLUCOSIO Bioindustria L.I.M.
   6. Package contents and other information

GLUCOSIO Bioindustria L.I.M.5% solution for infusion, L.I.M. 10% solution for infusion, L.I.M. 20% solution for infusion, L.I.M. 33% solution for infusion, L.I.M. 50% solution for infusion

Glucose monohydrate
Equivalent medicinal product

Read this leaflet carefully before you use this medicine because 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 their symptoms are the same as yours, as it could 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 Bioindustria L.I.M. is and what it is used for
• 2. What you need to know before you use GLUCOSIO Bioindustria L.I.M.
• 3. How to use GLUCOSIO Bioindustria L.I.M.
• 4. Possible side effects
• 5. How to store GLUCOSIO Bioindustria L.I.M.
• 6. Contents of the pack and other information

1. What is GLUCOSIO Bioindustria L.I.M. and what is it for

GLUCOSIO Bioindustria L.I.M. is a solution to be administered directly into a vein (intravenous
infusion) that contains the active ingredient 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 low blood sugar (hypoglycemia).

2. What you need to know before using GLUCOSIO Bioindustria L.I.M.

Do not use GLUCOSIO Bioindustria L.I.M.

• if you are allergic to glucose or to any of the other ingredients of this medicine (listed in section 6);
• if you have problems with urination (anuria);
• if you experience bleeding (haemorrhage) occurring at the spinal level or inside the skull (intracranial);
• if you suffer from hallucinations, tremors and sweating (delirium tremens) associated with excessive fluid 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 breakage (haemolysis).

Warnings and precautions
Consult your doctor, pharmacist or nurse before using GLUCOSIO Bioindustria L.I.M.
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 levels (glycaemia) and urine sugar levels (glycosuria) should be carefully monitored to minimise the risk of hyperglycaemia and glycosuria; if necessary, insulin should be administered;
• if you suffer from severe heart problems (heart failure);
• if you suffer from severe kidney problems (severe renal failure);
• if you have swelling caused by fluid accumulation and retention of mineral salts (oedema with hydrosaline retention);
• if you are taking anti-inflammatory corticosteroid medicines;
• if you are taking certain hormonal medicines (corticotropin).
• if you are in one of the following conditions that can cause high levels of the vasopressin hormone:
• you have an acute illness
• you are in pain
• you have undergone surgery
• you have infections, burns
• you have brain diseases
• you have liver, heart and kidney diseases. This can increase the risk of low sodium levels in the blood (hyponatraemia) with headache, nausea, seizures, drowsiness, vomiting, cerebral oedema which can lead to death. People with a higher risk of cerebral oedema are:
• children
• women (especially of childbearing potential)
• people with altered fluid levels in the brain (e.g. due to meningitis, bleeding in the skull or brain contusion).

During prolonged treatment with this medicine, an excess of water may occur in the body (fluid overload and congestion) 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 any excessive losses if necessary with the administration of mineral salts and vitamins. Concentrated glucose solutions must not be administeredby subcutaneous injection (subcutaneous route) or by intramuscular injection (intramuscular route).

Children
In children, particularly in newborns and children with low body weight, the administration of glucose may increase the risk of a rise in blood glucose levels (hyperglycaemia). In addition, in children with low body weight, a rapid or excessive infusion may cause an increase in the concentration of substances in the blood (osmolarity) and bleeding inside the brain tissue due to rupture of a blood vessel (intracerebral haemorrhage).

Other medicines and GLUCOSIO Bioindustria L.I.M.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
GLUCOSIO Bioindustria L.I.M. must be administered with cautionif you are taking:

• anti-inflammatory steroid medicines (corticosteroids) or hormonal medicines (corticotropin), as they may cause an increase in blood sugar levels which could lead to latent diabetes mellitus;
• medicines that act on the vasopressin hormone e.g.: chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxymethamphetamine, ifosfamide, antipsychotics, narcotics, NSAIDs, cyclophosphamide, desmopressin, oxytocin, vasopressin, terlipressin, diuretics in general and oxcarbazepine as they may increase the risk of hyponatraemia.

Glucose solutions may be incompatible with other infusion solutions.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before this medicine is administered to you.
Do not use this medicine during pregnancy unless in cases of absolute necessity and always under strict medical supervision.
If you are pregnant, this medicine must be administered with particular caution during labour due to the risk of hyponatraemia, especially if administered in association with a medicine that induces labour (oxytocin).
No data are available to establish the effect of this medicine during breastfeeding, therefore take particular care if you are breastfeeding.

Driving and using machines
No data are available regarding the effects of the medicine on driving and operating machinery.

3. How to use GLUCOSIO Bioindustria L.I.M.

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.
Before and during administration, the doctor will monitor your fluid levels in the body, glucose and salts, particularly sodium in the blood.
This medicine will be administered 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.
The infusion rate is generally 0.4 - 0.8 g/hour per kg of body weight.
The doctor will choose the concentration of the glucose solution to be used based on age, weight and your health condition and the levels of minerals and pH in the blood.
Below are general guidelines on choosing different glucose concentrations:

• 5%-10% solutions are used for replenishing fluids and calories;
• 20%-33% solutions are used for caloric replenishment and limited fluid replenishment;
• 50% 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 administration rate must be chosen based on the age, weight and clinical condition of the patient. Generally, solutions with a concentration higher than 10% are not used.
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.

Use in the elderly
There do not appear to be any differences in response between elderly and younger patients following glucose administration. As a general rule, caution is required when administering drugs to elderly patients.

If you use more GLUCOSIO Bioindustria L.I.M. than you should
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 Bioindustria L.I.M., inform your doctor immediately or go to the nearest hospital.
In case of accidental administration of excessive doses of GLUCOSIO Bioindustria L.I.M., 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 administering the medicine and start corrective therapy.

If you stop taking GLUCOSIO Bioindustria L.I.M.
If the concentrated glucose infusion needs to be stopped suddenly, it is recommended to gradually reduce the dose with the administration of 5% or 10% glucose, in order to avoid a rapid drop in blood sugar (rebound hypoglycemia).
If you have any doubts 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;
• circulation 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 amount of blood circulating in the body (hypervolaemia);
• decreased blood sugar (hypoglycaemia);
• increased insulin level;
• increased adrenaline level;
• low levels of sodium in the blood (hospital-acquired hyponatraemia**);
• brain edema (hyponatremic encephalopathy**);
• fluid accumulation with swelling in the legs and ankles (peripheral edema);
• fluid accumulation in the lungs (pulmonary edema);
• bleeding in the head (cerebral haemorrhage);
• damage to the head caused by poor blood circulation to the brain (cerebral ischaemia).

** Hospital-acquired hyponatraemia can cause irreversible brain damage and death, due to
the development of acute hyponatremic encephalopathy.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, 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-reazione-avversa. By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store GLUCOSIO Bioindustria L.I.M.

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 freeze. Do not refrigerate.
After the first opening of the package, the medicine must be used immediately for
a single and uninterrupted administration, any remaining product must be discarded.
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 Bioindustria L.I.M. contains
GLUCOSIO Bioindustria L.I.M. 5% solution for infusion

• The active ingredient is glucose. Each litre of solution contains 55 g of glucose monohydrate (50 g of anhydrous glucose) (278 mOsmol/L, pH 3.5 - 6.5).
• The other component is water for injections.

GLUCOSIO Bioindustria L.I.M. 10% solution for infusion

• The active ingredient is glucose. Each litre of solution contains 110 g of glucose monohydrate (100 g anhydrous glucose) (555 mOsmol/L, pH 3.5 - 6.5).
• The other component is water for injections.

GLUCOSIO Bioindustria L.I.M. 20% solution for infusion

• The active ingredient is glucose. Each litre of solution contains 220 g of glucose monohydrate (200 g anhydrous glucose) (1110 mOsmol/L, pH 3.5 - 6.5).
• The other component is water for injections.

GLUCOSIO Bioindustria L.I.M. 33% solution for infusion

• The active ingredient is glucose. Each litre of solution contains 363 g of glucose monohydrate (330 g anhydrous glucose) (1832 mOsmol/L, pH 3.5 - 6.5).
• The other component is water for injections.

GLUCOSIO Bioindustria L.I.M. 50% solution for infusion

• The active ingredient is glucose. Each litre of solution contains 550 g of glucose monohydrate (500 g anhydrous glucose) (2775 mOsmol/L, pH 3.5 - 6.5).
• The other component is water for injections.

Description of the appearance of GLUCOSIO Bioindustria L.I.M. and contents of the pack
Solution for infusion
1 vial of 50 ml;
1 vial of 100 ml;
1 vial of 250 ml;
1 vial of 500 ml;
50 ml in a 100 ml vial;
100 ml in a 250 ml vial;
250 ml in a 500 ml vial.

Marketing Authorisation Holder and manufacturer
BIOINDUSTRIA Laboratorio Italiano Medicinali S.p.A.
Via De Ambrosiis, 2
15067 Novi Ligure (AL)
Italy

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The following information is intended exclusively for doctors or healthcare professionals
GLUCOSIOBioindustria L.I.M. 5%, 10%, 20%, 33%, 50% solution for infusion
CLINICAL INFORMATION
Glucose solutions are administered intravenously.
The 5% solution is isotonic with blood.
The 10%, 20%, 30%, 33%, 50% solutions are hypertonic with blood and must be infused
with caution and at a controlled infusion rate.
The 20%, 30%, 33%, 50% solutions must be administered exclusively through a central
venous catheter.
If it should be necessary to administer the solutions peripherally, for example in the
emergency treatment of hypoglycemic crises, the solutions must be injected very
slowly into a large-caliber vein in the arm.
One gram of glucose provides a caloric contribution equal to 3.74 Kcal (approximately 15.6 Kjoules).
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. Glucosio Bioindustria L.I.M. solution for infusion can become extremely
hypotonic after administration, due to the metabolism of glucose in the body
Intravenous infusions of glucose are typically isotonic solutions. However, in the body, the
solutions containing glucose can become extremely hypotonic physiologically 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 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 age 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.

Incompatibilities
Glucose solutions for intravenous use are incompatible with:

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

In addition, there are conflicting opinions regarding the compatibility of glucose with the following
solutions:

• calcium chloride;
• magnesium chloride;
• potassium chloride;
• sodium chloride;
• sodium lactate;
• hetastarch

Glucose solutions that do not contain electrolytes should not be administered through
the same infusion catheter with whole blood due to the possible formation of aggregates and for the
risk of hemolysis.
Ampicillin and amoxicillin are stable in glucose solutions only for a short period.

For further information, see the Summary of Product Characteristics.