Label: information for the user

Glucocemin 33%

Injectable solution

Dehydrated glucose, 330 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 33% belongs to the group of parenteral nutrition solutions (directly into a vein) intended for the provision of sugar as energy.

GLUCOCEMIN 33% is an injectable solution that is used:

- in glucose deficiency of any cause.

• as an additive for energy supply in parenteral nutrition (feeding directly through a vein) when oral food intake is limited.

No useGLUCOCEMIN 33%

• If you are allergic (hypersensitive) to glucose or any of the other components of GLUCOCEMIN 33%.
• In states of excess glucose in the blood (hyperglycemia).
• If you have excess acids in the body (acidosis).

Be especially careful with GLUCOCEMIN 33%

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 33%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 there may be incompatibilities.

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

Ensure an adequate intake of vitamins (particularly vitamin B1).

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

Patients with critical states, 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 33%, which can lead to cerebral inflammation (encephalopathy).

Acutely low sodium levels can cause a condition known as 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 blood sodium levels.

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 33%with other medications may alter the effectiveness of both treatments.

Particularly, 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).

Use in children

For children over 2 years:

The dose is the same as recommended for adults.

Newborns and children under 2 years:

For the treatment of hypoglycemia (decreased glucose concentration in the blood) in this type of patient, it is preferable to use a less concentrated glucose solution than GLUCOCEMIN 33%.

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication.

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

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 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 and this 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 (hormone that regulates body fluids) and in patients taking medications that increase vasopressin action due to a risk of abnormally low sodium levels in the blood (hyponatremia).

Glucocemin 33% may become extremely hypotonic after administration due to glucose metabolism in the body.

If you use more GLUCOCEMIN 33% 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 33% may produce adverse effects, although not everyone will experience them.

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

Excessive glucose in the blood (hyperglycemia), elimination of glucose through urine (glucosuria).

The resulting excessive glucose in the blood (hyperglycemia) 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, hyponatremic hospitalization, and hypnatremic 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 that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines 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 33% 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 33% if you observe that the solution is not clear, presents particles at the bottom (sedimentation), or if the packaging shows visible signs of deterioration.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of GLUCOCEMIN 33%:

The other components are: water for injectable preparations.

Appearance of the product and contents of the packaging

GLUCOCEMIN 33% is an injectable solution that is presented in packaging of 20 ampoules of 10 ml of Miniplasco Classic or of Miniplasco Connect.

It may only be commercially available in some sizes of packaging.

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 has been approved in December 2024

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

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This information is intended solely for doctors or healthcare professionals:

The contents of each package 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 packaging must be intact. Do not administer otherwise.

Do not administer intramuscularly.

GLUCOCEMIN 33% must be administered by slow intravenous injection or as an additive to another perfusion solution.

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.