Label: information for the user

Glucocemin 50%

Concentrate for perfusion solution

Dehydrated glucose, 500 mg/ml

Read the entire label carefully before starting to use the medication

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

6. Contents of the container and additional information

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

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

• as a source of energy in parenteral nutrition (feeding directly through the vein) when oral food intake is limited,

• in glucose deficiency of any cause.

No 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 acids in the body (acidosis),
• If you have a potassium deficiency in the blood (hypokalemia).

Be especially careful with GLUCOCEMIN 50%

Inform your doctor if:

• You have diabetes. It can be used if the appropriate treatment with insulin is initiated first,
• You suffer from kidney or liver insufficiency.

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

Regularly monitor your blood sugar levels, electrolyte levels, and fluid balance..

Adequate vitamin intake (particularly vitamin B1) should be ensured.

In addition to 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 (hormone that regulates fluid levels in the body) have a certain risk of developing abnormally low sodium levels in the blood (acute hyponatremia) when administered with Glucocemin 50%, which may lead to cerebral inflammation (encephalopathy).

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

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

Use in elderly patients

Administer with caution in elderly patients, as they may have impaired liver and/or kidney function.

Use of other medications

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

Taking some medications at the same time can be hazardous. The use of Glucocemin with other medications may 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 antidiabetic medications (biguanides, sulfonylureas): these medications decrease the effect of glucose.
• Corticosteroids (cortisol): due to the risk of increased blood glucose or the ability of these medications to retain sodium and water.
• Digitalis glycosides (digoxin): because there is a risk of developing digitalis toxicity.
• 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 receptor inhibitors (SSRIs) to treat depression.
• Antipsychotics to treat mental disorders.
• Opioid analgesics to relieve severe pain.
• Nonsteroidal anti-inflammatory drugs (NSAIDs) to relieve mild to moderate pain and treat bodily 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 esophageal varices (dilated veins in the esophagus caused by liver problems).
• Diuretics (medications that increase urine production).

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication.

Glucose solutions should be administered with caution in pregnant women, as it crosses the placenta. If pregnant, your doctor will decide on the convenience of its use.

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

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 neonate during lactation. However, it is recommended to use them with caution during this period.

This medication will always be administered by healthcare personnel.

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

Your doctor will monitor the patient's fluid balance, blood glucose levels, and electrolyte levels (mainly sodium) before and during treatment, especially in patients with alterations in vasopressin release (the hormone that regulates fluid balance) and in patients taking medications that increase vasopressin action due to a 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 received an amount of medication greater than what you should have, you could experience excessive water (hyperhydration), excessive glucose in the blood (hyperglycemia), and alterations in the balance of salts in the blood (hyperosmolarity), which are accompanied by disturbances in consciousness, seizures, and coma.

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

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

Like all medications, GLUCOCEMIN 50% may produce adverse effects, although not everyone will experience them.

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

Excessive glucose in the blood (hyperglycemia), glucose elimination through urine (glucosuria), or alterations in fluid and electrolyte levels.

Excessive glucose in the blood (hyperglycemia) resulting from too rapid or excessive administration, must be closely monitored in severe cases of diabetes mellitus.

You may develop a fluid and electrolyte imbalance in your body. You may develop low levels of sodium (hyponatremia), potassium, phosphate, and magnesium in the blood, hospital-acquired hyponatremia, and hyponatremic encephalopathy.

General disorders and changes at the administration site:

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

No special storage conditions are required.

Do not use GLUCOCEMIN after the expiration date shown on the packaging (after CAD:). The expiration date is the last day of the month indicated.

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

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

Glucocemin 50% Composition:

The other components are: water for injection preparations.

Appearance of the product and contents of the package

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

Only some sizes of containers may be commercially available.

Holder of the marketing authorization

B|BRAUN

B. Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

Responsible for manufacturing

B. Braun Melsungen AG

Carl-Braun-Straße 1

34212 Melsungen

Postal address:

34209 Melsungen

This leaflet was approved in December 2024

The detailed information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices.

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This information is intended solely for doctors or healthcare professionals:

The contents of each container are for single use. Dispose of the unused portion.

Visually inspect the solution before use. The solution must be transparent, not contain precipitates, and the container must be intact. Do not administer otherwise.

Do not administer intramuscularly.

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

These solutions must not be administered through the same infusion equipment that is being used, has been used, or will be used for the administration of blood, as there is a possibility of pseudoagglutination.

In critically ill patients, the administration rate must 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 may be as long as necessary.

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