Glucose Bioindustria L.I.M.

Package leaflet: Information for the user

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

Glucose monohydrate
Equivalent medicine
Read this entire 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including 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 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. Contents of the pack and other information

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

GLUCOSIO Bioindustria L.I.M. is a solution for direct intravenous administration (intravenous infusion) containing the active substance glucose monohydrate, belonging to the class of parenteral nutritional solutions.
This medicinal product is indicated to provide the body with water and sugars capable of supplying caloric intake in emergency situations, especially in patients who do not require salts or when salts should be avoided, and for the treatment of low blood sugar levels (hypoglycaemia).
Concentrated glucose solutions may be mixed with other medicinal products for the preparation of solutions used for direct intravenous nutrition (Total Parenteral Nutrition).
Low-concentration glucose solutions may also be used to dilute other medicinal products intended for direct intravenous injection.

2. What you should 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 urinating (anuria);
• if you have bleeding occurring at the spinal level (spinal haemorrhage) or within the skull with bleeding into brain tissue (intracranial haemorrhage);
• if you suffer from hallucinations, tremors, and sweating (delirium tremens) associated with excessive loss of water from the body (dehydration);
• if you have low levels of fluids in the body (dehydration);
• if you suffer from liver problems leading to loss of consciousness (hepatic coma).

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 (haemolysis).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using GLUCOSIO Bioindustria L.I.M.

Use this medicine with caution and inform your doctor in the following cases:

• if you have diabetes or are glucose intolerant. During infusion, blood sugar levels (glycaemia) and sugar in the urine (glycosuria) must be closely monitored to minimize the risk of elevated levels; insulin should be administered if necessary;
• 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 salt retention (oedema with hydro-saline retention);
• if you are taking corticosteroid anti-inflammatory medicines;
• if you are taking certain hormonal medicines (corticotrophin).

Children
In children, particularly in newborns and low-body-weight infants, administration of glucose may increase the risk of elevated blood glucose levels (hyperglycaemia). Moreover, in low-body-weight children, rapid or excessive infusion may cause an increase in blood osmolarity and bleeding within 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 caution if you are taking steroid anti-inflammatory medicines (corticosteroids) or hormonal medicines (corticotrophin), as they may cause an increase in blood sugar levels which could lead to latent diabetes mellitus. Medical monitoring is required during treatment if you need to take these medicines.

Glucose solutions may be incompatible with other infusion solutions.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

Do not use this medicine during pregnancy unless absolutely necessary and always under strict medical supervision.

There are no available data to establish the effect of this medicine during breastfeeding; therefore, exercise particular caution if you are breastfeeding.

Driving and using machines
There are no available data regarding the effects of this medicine on driving or operating machinery.

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

This medicine will be administered to you by a doctor or specialized healthcare professional. If you have any doubts, consult your doctor, pharmacist, or nurse.
GLUCOSIO Bioindustria L.I.M. 5% and 10% will be administered cautiously directly into a vein (intravenous infusion) or into a muscle (intramuscular route) at a controlled infusion rate, and not by subcutaneous route, as it may cause irritation.
GLUCOSIO Bioindustria L.I.M. 20% and 33% MUST NOT be administered by subcutaneous or intramuscular injection, but exclusively by direct intravenous injection (via central venous catheter).

Use in adults
The doctor will select the appropriate glucose solution concentration based on your age, body weight, health status, and blood electrolyte levels and pH.

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

Use in children and adolescents
In children with low body weight, this medicine must be administered cautiously and at a controlled rate (see section "Children"). Dosage and administration rate must be adjusted according to the patient's age, weight, and clinical condition. Generally, solutions with a concentration higher than 10% are not used.

If you use more GLUCOSIO Bioindustria L.I.M. than you should
Since this medicine is administered by a doctor or trained healthcare professional, it is unlikely that you will receive an excessive dose. However, if you think you have been given too much GLUCOSIO Bioindustria L.I.M., inform your doctor immediately or go to the nearest hospital.
In case of accidental administration of an excessive dose of GLUCOSIO Bioindustria L.I.M., an increase in body water and an increase in solutes in the body (hyperhydration and solute overload) may occur. In such cases, the doctor or nurse must immediately stop administration of the medicine and initiate corrective therapy.

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

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everybody gets them.
The following side effects may occur:

• leakage of the medicine into the surrounding tissues at the injection site (extravasation);
• infection at the infusion site and local pain;
• circulation problems due to blood clot formation and inflammation of the veins at the infusion site (thrombosis and thrombophlebitis);
• increased body temperature (fever);
• increased metabolic rate;
• increased blood sugar (hyperglycemia);
• increased insulin levels;
• increased adrenaline levels;
• fluid retention causing swelling in the legs and ankles (peripheral edema);
• bleeding in the brain (cerebral hemorrhage);
• brain damage caused by poor blood circulation to the brain (cerebral ischemia).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
http://www.agenziafarmaco.gov.it/it/responsabili. 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 stated on the packaging after "EXP.".
The expiry date refers to the last day of that month.
Do not use the glucose solution if it is not clear and colourless or slightly yellowish, or if it contains particles.
Keep the container tightly closed. Do not refrigerate.
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 Bioindustria L.I.M. contains
GLUCOSIO BIOINDUSTRIA L.I.M. 5% injectable solution

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

GLUCOSIO BIOINDUSTRIA L.I.M. 10% injectable solution

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

GLUCOSIO BIOINDUSTRIA L.I.M. 20% injectable solution

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

GLUCOSIO BIOINDUSTRIA L.I.M. 33% injectable solution

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

Description of the appearance of GLUCOSIO Bioindustria L.I.M. and package contents
Injectable solution.
Packaging: 10 vials of 5 ml;
Packaging: 10 vials of 10 ml;
Packaging: 5 vials of 20 ml.

Marketing Authorization Holder and Manufacturer
BIOINDUSTRIA Laboratorio Italiano Medicinali S.p.A. - Via De Ambrosiis, 2 - 15067 Novi Ligure (AL)

Package leaflet: information for the physician
The following information is intended exclusively for physicians or healthcare professionals

Special warnings and precautions for use
The 5% solution is isotonic with blood.
The 10%, 20%, and 33% solutions are hypertonic with respect to blood and must be administered with caution and at a controlled infusion rate.

Dosage and method of administration
If peripheral administration is required, for example in emergency treatment of hypoglycemic crises, the solutions must be injected very slowly into a large-bore vein of the arm.
All standard precautions to maintain sterility before and during intravenous infusion should be observed. Do not use if the packaging is damaged. Do not use the glucose solution if it is not clear and colorless or slightly yellowish, or if it contains particles.

Incompatibilities
Glucose solutions for intravenous use are incompatible with:

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

Additionally, 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 without added electrolytes should not be administered through the same infusion catheter as whole blood, due to the possible formation of clumps and the risk of hemolysis. Ampicillin and amoxicillin remain stable in glucose solutions only for a short period.

For further information, consult the Summary of Product Characteristics.