Glucose B. Braun 70% solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Glucose B.Braun 70% solution for infusion

Package leaflet contents:

1. What Glucosa B.Braun 70% is and what it is used for
2. What you need to know before using Glucosa B.Braun 70%
3. How to use Glucosa B.Braun 70%
4. Possible side effects
5. Storage of Glucosa B.Braun 70%
6. Contents of the pack and other information

1. What Glucosa B. Braun 70% is and what it is used for

Glucosa B. Braun 70% is a solution for infusion used for:

• providing a source of carbohydrates (sugar) for parenteral nutrition. Parenteral nutrition is used to feed patients who cannot eat. It is administered by infusion (slow injection) through a vein.
• preventing or treating low blood sugar levels (hypoglycaemia).
• providing additional fluid to the patient when the body does not have enough water (dehydration).

2. What you need to know before using Glucosa B. Braun 70%

Do not use Glucosa B. Braun 70%:

If you are allergic to Glucose or to any of the other components of this medicine (listed in section 6).

If you have:

• high blood glucose levels (hyperglycemia) or abnormally high blood lactate concentration (hyperlactatemia), diabetes mellitus, glucose intolerance, or diabetic coma.
• low blood sodium or potassium levels (hyponatremia or hypokalemia).
• blood dilution due to excessive fluid administration (hemodilution) and excess fluid in the body's extracellular spaces (extracellular hyperhydration).
• severe renal failure (when kidneys do not function properly and dialysis is required) with anuria (suppressed urine production).
• after a cerebrovascular accident (hemorrhage).
• low blood volume with hypoxia (oxygen deficiency in the body).
• during the first 24 hours after head trauma.

Additional contraindications may arise if large amounts of the solution are administered, due to the infusion of high amounts of glucose and fluids.

Warnings and precautions

Patients must be evaluated with consideration of water, ion, and blood glucose balance. Changes in these parameters may require appropriate treatment.

Prolonged administration of glucose may cause potassium, phosphate, or magnesium deficiency and may increase extracellular fluid volume, leading to water intoxication.

Rapid administration of concentrated glucose solutions may cause elevated blood glucose levels and hyperosmolar syndrome. The risk of cardiovascular system overload (heart and blood circulation), with fluid accumulation in the lungs (edema), should be considered—especially in sensitive patients or when high volumes of fluid are administered.

Frequent monitoring of blood glucose levels is required, and insulin may be administered if necessary: one unit for every 10 g of glucose.

For the treatment of hypoglycemic states in neonates or young children, less concentrated glucose solutions (10–25%) are recommended.

Critically ill patients, those 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 regulating body fluid balance) are at specific risk of developing abnormally low blood sodium levels (acute hyponatremia) when this solution is administered. This 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 particular risk of severe and potentially fatal cerebral edema caused by acute reduction in blood sodium levels.

Use with caution in elderly patients or those with liver impairment.

Use of Glucosa B. Braun 70% with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines, especially the following medicines that increase the effect of vasopressin and the risk of low sodium levels (hyponatremia):

• Carbamazepine and oxcarbazepine used for the treatment of epilepsy.
• Vincristine and ifosfamide used for cancer treatment.
• Cyclophosphamide for treating cancer and autoimmune diseases.
• Selective serotonin reuptake inhibitors (SSRIs) for treating depression.
• Antipsychotics for mental disorders.
• Opioid analgesics for relief of severe pain.
• Non-steroidal anti-inflammatory drugs (NSAIDs) for relief of mild to moderate pain and treatment of bodily inflammation.
• Desmopressin for treating diabetes insipidus (extreme 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 problems).
• Diuretics (medications that increase urine excretion).

The use of Glucosa B. Braun 70% with other medicines may alter the effectiveness of both treatments.

Administration of glucocorticoids, diuretics, phenytoin, and chlorpropamide increases blood glucose levels.

Intravenous glucose administration in patients treated with insulin or oral antidiabetics (biguanides, sulfonylureas) may reduce the therapeutic efficacy of these agents.

If glucose is administered together with digitalis glycosides (digoxin), increased digitalis activity may occur, increasing the risk of toxicity from these medications.

Your doctor will check the compatibility of this solution with any additives before use. These solutions must not be administered using the same infusion equipment used or intended for blood transfusion, due to the risk of agglutination.

Pregnancy and breastfeeding

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

Glucose crosses the placenta, whereas insulin does not; therefore, the fetus itself is responsible for insulin synthesis in response to glucose administration. Infusions exceeding 10 g/hour cause increases in fetal insulin. Therefore, use with caution during pregnancy.

The use of large amounts of glucose solution during childbirth, especially in complicated deliveries, may lead to hyperglycemia (high blood glucose), hyperinsulinemia (high insulin levels), hyponatremia, and fetal acidosis, and may therefore be harmful to the newborn. Hence, use with caution during pregnancy.

On the other hand, there is no evidence suggesting adverse effects during breastfeeding in the neonate. Nevertheless, caution is also recommended during this period.

3. How to use Glucosa B. Braun 70%

Follow exactly the instructions for administration of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

This medicine will be administered only by healthcare professionals, and the dosage depends on the requirements imposed by the patient's condition, body weight, clinical status, and metabolic state. According to individual needs, administer between 0.7 and 4 g of glucose per kg of body weight per day; or up to 0.5 g of glucose per kg of body weight per hour.

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

Glucosa B. Braun 70% may become extremely hypotonic after administration due to the metabolism of glucose in the body.

If you use more Glucosa B. Braun 70% than you should

This is unlikely to occur, as your doctor will determine your daily doses. However, if you were to receive an overdose of this medicine, it could lead to excess body water (hyperhydration), high blood glucose levels (hyperglycemia), and disturbances in the balance of salts in the blood (hyperosmolality), which may result in 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. Take this leaflet with you.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist. They may be signs of a very serious or even life-threatening allergic reaction (hypersensitivity):

• swelling of the skin of the face and lips or swelling of the throat.
• difficulty breathing.
• skin rash.
• redness of the skin (cutaneous erythema).
• hives (urticaria).

You will be prescribed treatment according to the symptoms.

Other adverse effects are:

• changes in blood chemical levels (electrolyte disturbances), including:
  • low blood potassium levels (hypokalemia).
  • low blood magnesium levels (hypomagnesemia).
  • low blood phosphate levels (hypophosphatemia).
  • high blood sugar levels (hyperglycemia).
• excess fluid in the blood vessels (hemodilution and hypervolemia).
• sugar in the urine (glucosuria).
• chills.
• sweating.
• fever (febrile reaction).
• infection at the injection site.
• reactions related to the route of administration:
  • local reaction or pain (redness or swelling at the infusion site).
  • irritation and inflammation of the vein used for infusion (phlebitis). This may cause redness, pain, burning, or swelling in the vein used for infusion.
  • formation of a blood clot (venous thrombosis) at the infusion site, causing pain, swelling, or redness in the area of the clot.
  • leakage of the infusion solution into the surrounding tissues (extravasation). This may damage tissues and lead to scarring.
• Hospital-acquired hyponatremia.
• Hyponatremic encephalopathy.

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 Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Glucose B. Braun 70%

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging (after EXP). The expiry date refers to the last day of the month indicated.

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

6. Contents of the container and additional information

Composition of Glucosa B. Braun 70%:

• The active substance is Glucose. Each 100 ml container contains 70 g of Glucose (as glucose monohydrate, 770 mg/ml).
• The other components (excipients) are hydrochloric acid (for pH adjustment) and water for injections.

Appearance of the product and contents of the container

Glucosa B.Braun 70% is an infusion solution presented in glass bottles of 250 and 500 ml (not all sizes may be marketed).

Marketing Authorization Holder and Manufacturing Responsible Party

B|BRAUN

• Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

Date of the most recent review of this package leaflet: October 2019.

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)

This information is intended for healthcare professionals only:

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

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

An aseptic technique must be used when administering the solution and when adding medications, if necessary.

Before adding medications to the solution or administering concomitantly with other drugs, compatibility must be verified to ensure no incompatibilities exist.

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.

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