GLUCOCEMIN 50% CONCENTRATE FOR PERFUSION SOLUTION

Introduction

Package Leaflet: Information for the User

Glucocemin 50%

Concentrate for Solution for Infusion

Anhydrous glucose, 500 mg/ml

Read all of this leaflet carefully before you start using this medicine

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet:

1. What is GLUCOCEMIN 50% and what is it used for
2. What you need to know before you use GLUCOCEMIN 50%
3. How to use GLUCOCEMIN 50%
4. Possible side effects
5. Storage of GLUCOCEMIN 50%

1. Contents of the pack and further information

1. What is Glucocemin 50% and what is it used for

Glucocemin belongs to the group of solutions for parenteral nutrition (directly into a vein) intended for the supply of sugar as energy.

Glucocemin is a concentrate for solution for infusion (which is administered diluted through a drip) that is used:

• as an energy supplement in parenteral nutrition (feeding directly into a vein) when oral food intake is limited,

• in glucose deficit of any cause.

2. What you need to know before you use Glucocemin 50%

Do not useGLUCOCEMIN 50%

• if you are allergic (hypersensitive) to glucose or any of the other components of Glucocemin 50%,
• in states of excess glucose in the blood (hyperglycemia),
• if you have excess acid in the body (acidosis),
• if you have a potassium deficit in the blood (hypokalemia).

Be careful with GLUCOCEMIN 50%

Tell your doctor if:

• you have diabetes. It can be used if adequate insulin treatment is initiated beforehand,
• you suffer from kidney or liver failure.

GLUCOCEMIN should not be administered with the same infusion equipment (equipment used to administer medications directly into the blood), either at the same time, before, or after a blood transfusion, as incompatibilities may occur.

Regular monitoring of blood sugar levels, electrolyte levels (especially sodium), and water balance is required.

Adequate vitamin intake (especially vitamin B1) must be ensured.

Along with glucose solution, potassium may be administered to prevent hypokalemia (low potassium levels in the blood) that may occur during parenteral nutrition.

Patients with critical conditions, pain, postoperative stress, infections, burns, neurological, cardiac, hepatic, and renal diseases, and patients taking medications that increase the effect of vasopressin (a hormone that regulates body fluids), when administered Glucocemin 50%, have a certain risk of developing abnormally low sodium levels in the blood (acute hyponatremia) that can lead to brain inflammation (encephalopathy).

Acute hyponatremia can cause acute hyponatremic encephalopathy (brain edema) characterized by headache, nausea, seizures, lethargy, and vomiting. Patients with brain edema are at special risk of suffering severe, irreversible, and potentially fatal brain damage.

Children, women of childbearing age, and patients with severe brain diseases such as meningitis (infection in the membranes surrounding the brain) or brain damage are at risk of severe and potentially fatal brain inflammation caused by a sudden decrease in sodium levels in the blood.

Use in elderly patients

It should be administered with caution in elderly patients, as they may have impaired liver and/or kidney function.

Use of other medications

Tell your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Taking some medications at the same time can be hazardous. The use of Glucocemin with other medications can alter the effectiveness of both treatments.

In particular, it is essential to inform your doctor if you are taking any of the following medications:

• Insulin or oral antidiabetics (biguanides, sulfonylureas): these medications decrease the effect of glucose.
• Corticosteroids (cortisol): due to the risk of increased glucose in the blood or the ability of these medications to retain sodium and water.
• Digitalis glycosides (digoxin): because there is a risk of developing an overdose of these medications.
• Medications that increase the effect of vasopressin and the risk of low sodium levels (hyponatremia):

• Carbamazepine and oxcarbazepine used to treat epilepsy.
• Vincristine and Ifosfamide used to treat cancer.
• Cyclophosphamide to treat cancer and autoimmune diseases.
• Selective serotonin reuptake inhibitors (SSRIs) to treat depression.
• Antipsychotics for mental disorders.
• Opioid analgesics to relieve severe pain.
• Non-steroidal anti-inflammatory medications to relieve mild to moderate pain and to treat body inflammation.
• Desmopressin to treat diabetes insipidus (extreme thirst and continuous production of large volumes of diluted urine).
• Oxytocin used during childbirth.
• Vasopressin and terlipressin used to treat "bleeding esophageal varices" (dilated veins in the esophagus caused by liver problems).
• Diuretics (medications that increase the amount of urine excreted).

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Glucose solutions should be administered with caution in pregnant women, as they cross the placenta. In case of pregnancy, your doctor will decide on the convenience of its use.

The administration of glucose by vein during pregnancy may increase glucose and insulin levels as well as acidic components in the fetus's blood.

Glucose solutions should be administered with special caution in pregnant women during childbirth, especially if administered in combination with oxytocin, due to the risk of hyponatremia.

There is no evidence to suggest that glucose solutions can cause adverse effects in the newborn during breastfeeding. However, it is recommended to use them with caution during this period.

3. How to use Glucocemin 50%

This medication will always be administered by healthcare personnel.

Your doctor will decide on the most suitable dose in each case, and this will depend on the patient's condition (age, weight, clinical situation, and metabolic state).

Your doctor will monitor the water balance, glucose levels, and electrolyte levels (mainly sodium) in the blood before and during treatment, especially in patients with alterations in vasopressin release (a hormone that regulates body fluids) and in patients taking medications that increase the action of vasopressin due to the risk of abnormally low sodium levels in the blood (hyponatremia).

Glucocemin 50% can become extremely hypotonic after administration due to glucose metabolism in the body.

If you use more GLUCOCEMIN 50% than you should

This is unlikely to happen, as your doctor will determine your daily doses. However, if you receive a larger amount of medication than you should, you may experience water excess (hyperhydration), excess glucose in the blood (hyperglycemia), and alterations in the balance of salts in the blood (hyperosmolarity), which are accompanied by disturbances of consciousness, seizures, and coma.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

In case of overdose or accidental ingestion, consult the Toxicology Information Service (telephone: 91.562 04 20) or consult your doctor or pharmacist. Bring this leaflet with you.

4. Possible side effects

Like all medications, GLUCOCEMIN 50% can cause side effects, although not everyone gets them.

Side effects can occur if the solution is administered too quickly or if the amount administered is excessive. In this case, the following may appear:

Excess glucose in the blood (hyperglycemia), glucose elimination in the urine (glucosuria), or alterations in fluid and salt levels.

The resulting hyperglycemia from rapid or excessive administration should be carefully monitored in severe cases of diabetes mellitus.

You may develop an imbalance in fluid and mineral levels in your body. You may develop low sodium (hyponatremia), potassium, phosphate, and magnesium levels in the blood, hospital hyponatremia, and hyponatremic encephalopathy.

General disorders and administration site reactions:

Itching, pain, infection, inflammation of the vein wall (phlebitis).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Glucocemin 50%

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

Do not use GLUCOCEMIN after the expiry date stated on the packaging (after EXP:). The expiry date is the last day of the month indicated.

Do not use GLUCOCEMIN if you notice that the solution is not clear, has particles at the bottom (sedimentation), or if the packaging shows visible signs of deterioration.

Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the pack and further information

Composition of Glucocemin 50%:

The other ingredients are: water for injectable preparations.

Appearance of the product and packaging contents

GLUCOCEMIN 50% is a concentrate for solution for infusion presented in 20 ampoules of 20 ml of Miniplasco Classic or Miniplasco Connect.

Not all pack sizes may be marketed.

Marketing authorization holder

B|BRAUN

• Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

Manufacturer

• Braun Melsungen AG

Carl-Braun-Straße 1

34212 Melsungen

Mailing address:

34209 Melsungen

This leaflet was approved in December 2024

Detailed information on this medication is available on the website of the Spanish Agency for Medicines and Health Products.

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This information is intended only for healthcare professionals:

The contents of each pack are for single use. The unused fraction must be discarded.

The solution should be visually inspected before use. The solution must be transparent, not contain precipitates, and the packaging must be intact. Do not administer otherwise.

Do not administer intramuscularly.

GLUCOCEMIN 50% should always be administered diluted, as an additive to infusion solution, to avoid vein irritation.

These solutions should not be administered through the same infusion equipment used, being used, or to be used for blood administration, as there is a possibility of pseudoagglutination.

In critically ill patients, the administration rate should not exceed 6 mg of glucose per kilogram of body weight per minute. Only exceptionally, the administration rate could reach 9 mg of glucose per kilogram of body weight per minute.

Duration of use

The duration of administration can be as long as necessary.

Disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.