Glucocemin 33% solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Glucocemin 33%

Injectable solution

Anhydrous glucose, 330 mg/ml

Read the entire leaflet carefully before you start using the medicine

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you and must not be given to other people, 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 effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What GLUCOCEMIN 33% is and what it is used for

2. What you need to know before using GLUCOCEMIN 33%

3. How to use GLUCOCEMIN 33%

4. Possible adverse effects

5. Storage of GLUCOCEMIN 33%

6. Contents of the container and additional information

1. What Glucocemin 33% is and what it is used for

GLUCOCEMIN 33% belongs to the group of solutions for parenteral nutrition (administered directly into the vein) intended to provide sugar as an energy source.

GLUCOCEMIN 33% is an injectable solution used:

• in glucose deficiency of any cause.
  • as an additive to provide energy in parenteral nutrition (feeding directly into the vein) when oral intake of food is limited.

2. What you need to know before starting to use Glucocemin 33%

Do not use GLUCOCEMIN 33%

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

Take special care with GLUCOCEMIN 33%

Inform your doctor if:

• you have diabetes. It may be used only if appropriate insulin treatment is initiated beforehand.
• you suffer from kidney or liver insufficiency.

GLUCOCEMIN 33% must not be administered using the same infusion set (equipment used to deliver medications directly into the bloodstream), nor simultaneously, before, or after a blood transfusion, due to possible incompatibilities.

Your blood glucose levels, electrolyte levels, and fluid balance should be monitored regularly.

An adequate supply of vitamins (particularly vitamin B1) must be ensured.

Potassium may be administered together with the glucose solution to prevent hypokalemia (low potassium levels in blood), which may occur during parenteral (intravenous) nutrition.

Patients in critical conditions, experiencing pain, postoperative stress, infections, burns, nervous system, cardiac, hepatic or renal diseases, and patients taking medications that enhance the effect of vasopressin (a hormone that regulates body fluid levels), are at a certain risk of developing abnormally low sodium levels in blood (acute hyponatremia) when receiving Glucocemin 33%, which may lead to cerebral edema (encephalopathy).

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

Children, women of childbearing age, and patients with severe brain disorders such as meningitis (infection of the membranes surrounding the brain) or brain injury are at a certain risk of developing severe and potentially fatal cerebral edema caused by an acute decrease in blood sodium levels.

Use in elderly patients

Administration should be cautious in elderly patients, as they may have impaired liver and/or kidney function.

Use of other medicines

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

Taking certain medicines at the same time may be dangerous. The use of GLUCOCEMIN 33% together with other medicines may alter the effectiveness of both treatments.

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

• Insulin or oral antidiabetics (biguanides, sulfonylureas): these medicines reduce the effect of glucose.

• Corticosteroids (cortisol): due to the risk of increased blood glucose or the sodium- and water-retaining effects of these medicines.

• Digitalis glycosides (digoxin): because of the risk of developing toxicity from these medicines.

• Medicines 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, used to treat cancer and autoimmune diseases.
  • Selective serotonin reuptake inhibitors (SSRIs), used to treat depression.
  • Antipsychotics, for mental disorders.
  • Opioid analgesics, to relieve severe pain.
  • Non-steroidal anti-inflammatory drugs (NSAIDs), to relieve mild to moderate pain and treat body inflammation.
  • Desmopressin, used to treat diabetes insipidus (excessive thirst and continuous production of large volumes of dilute urine).
  • Oxytocin, used during childbirth.
  • Vasopressin and terlipressin, used to treat bleeding esophageal varices (dilated veins in the esophagus caused by liver disease).
  • Diuretics (medicines that increase urine output).

Use in children

For children over 2 years of age:

The dosage is the same as that recommended for adults.

Newborns and children under 2 years of age:

For the treatment of hypoglycemia (low blood glucose concentration) in these patients, a less concentrated glucose solution than GLUCOCEMIN 33% is preferred.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Glucose solutions should be administered with caution in pregnant women. During pregnancy, your doctor will decide whether their use is appropriate.

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

There is no evidence suggesting that glucose solutions may cause adverse effects in the newborn during breastfeeding. Nevertheless, they are recommended to be used with caution during this period.

3. How to use Glucocemin 33%

This medicine will always be administered by healthcare professionals.

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

Your doctor will monitor fluid balance, blood glucose levels, and electrolyte levels (mainly sodium) in the blood before and during treatment, especially in patients with impaired vasopressin release (a hormone that regulates body fluids) and in patients taking medicines that enhance the action of vasopressin, due to the risk of abnormally low blood sodium levels (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

It is unlikely that this will occur, as your doctor will determine your daily doses. However, if you were to receive a higher amount of medicine than required, it could lead to excess body water (hyperhydration), high blood glucose levels (hyperglycemia), and disturbances in blood salt balance (hyperosmolality), accompanied by altered consciousness, seizures, and coma.

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

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

4. Possible adverse effects

Like all medicines, GLUCOCEMIN 33% may produce adverse effects, although not everyone will experience them.

Adverse effects may occur if the solution is administered too rapidly or if the amount administered is excessive. In such cases, the following may appear:

Excess glucose in the blood (hyperglycemia), glucose elimination in urine (glucosuria).

Excess glucose in the blood (hyperglycemia) resulting from administration that is too rapid or in higher amounts than necessary must be carefully monitored in severe cases of diabetes mellitus.

You may develop an imbalance in fluid levels and certain minerals 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 administration site reactions:

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

Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Glucocemin 33%

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

No special storage conditions are required.

Do not use GLUCOCEMIN 33% after the expiry date stated on the container (after EXP:). The expiry date refers to the last day of the month indicated.

Do not use GLUCOCEMIN 33% if you notice that the solution is not clear, contains particles at the bottom (sedimentation), or if the container shows any visible signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the package and additional information

Composition of GLUCOCEMIN 33%:

The other components are: water for injections.

Appearance of the medicinal product and contents of the container

GLUCOCEMIN 33% is an injectable solution supplied in packs of 20 vials of 10 ml made of Miniplasco Classic or Miniplasco Connect.

Only certain 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

Postal address:

34209 Melsungen

This summary of product characteristics was approved in December 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS).

This information is intended exclusively for physicians or healthcare professionals:

The contents of each container are for single use only. Any unused portion must be discarded.

The solution should be inspected visually before use. The solution must be clear and free from precipitates, and the container must be intact. Do not administer if these conditions are not met.

Do not administer by intramuscular route.

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

These solutions must not be administered using the same infusion sets currently in use, previously used, or intended to be used for blood administration, due to the risk of pseudoagglutination.

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

Duration of use

The duration of administration may be as long as clinically necessary.

Disposal of unused medicinal product and of all materials that have been in contact with it must be carried out in accordance with local regulations.