Glucose Grifols 5% solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Glucosada Grifols 5% Solution for infusion

Glucose

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, ask your doctor or nurse.

• If you experience any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Glucosada Grifols 5% is and what it is used for

2. What you need to know before using Glucosada Grifols 5%

3. How to use Glucosada Grifols 5%

4. Possible side effects

5. How to store Glucosada Grifols 5%

6. Contents of the pack and other information

1. What Glucosada Grifols 5% is and what it is used for

Glucosada Grifols 5% is an intravenous glucose solution used to provide calories and water.

Glucosada Grifols 5% is indicated for:

• Hypertonic dehydration states (without significant electrolyte loss)

• Disorders of carbohydrate metabolism

• Parenteral nutrition (as an energy source), when oral intake of food is limited

• As a vehicle for the administration of medications and electrolytes.

2. What you need to know before using Glucosada Grifols 5%

Do not use Glucosada Grifols 5%

• if you are allergic (hypersensitive) to glucose or to any of the other components of this medicine (listed in section 6)

  • if you suffer from significant disturbances in glucose tolerance, including hyperosmolar coma
  • in cases of hyperhydration (excess water in the body)
  • in cases of hypotonic dehydration (with loss of salts), unless the lost electrolytes are simultaneously replaced
  • in conditions involving edema due to fluid accumulation in tissues
  • if you have hyperglycemia (high blood glucose levels)

• if you have hypokalemia (low potassium levels in blood)

• if you have hyperlactacidemia (accumulation of lactic acid in blood)

• within the first 24 hours after head trauma.

Warnings and precautions

Talk to your doctor or nurse before starting treatment with Glucosada Grifols 5%.

• Blood glucose concentration should be carefully monitored during episodes of intracranial hypertension.

• Special caution is required if you have suffered acute ischemic events (reduced or absent blood flow in arteries), as hyperglycemia has been associated with increased cerebral ischemic damage and impaired recovery.

• In cases of shock or disturbances in acid-base balance, electrolytes should be administered according to your individual needs before initiating glucose solution therapy. In case of sodium deficit, administration of sodium-free solutions could lead to peripheral circulatory collapse and oliguria.

• Regular monitoring of blood glucose levels is recommended, especially if you are diabetic. In such cases, your insulin requirements may need to be adjusted.

• Regular monitoring of serum electrolytes and fluid balance is also recommended, as frequent and massive administration of parenteral solutions may lead to significant ionic depletions.

• The risk of hyperhydration can be avoided by maintaining a complete balance between fluid intake and loss.

• Isotonic glucose solutions may become extremely hypotonic in the body due to the rapid metabolism of glucose (see section 3).

• Depending on the tonicity of the solution, the volume and rate of infusion, your initial clinical condition, and your ability to metabolize glucose, intravenous glucose administration may cause electrolyte disturbances, the most important being hypoosmotic or hyperosmotic hyponatremia (low sodium levels in blood).

Hyponatremia:

If you are a patient with non-osmotic release of vasopressin (antidiuretic hormone) (e.g., in critical conditions, pain, postoperative stress, infections, burns, and central nervous system diseases), if you have heart, liver, or kidney disease, or if you are exposed to vasopressin agonists (see next subsection), you are at special risk of developing acute hyponatremia following administration of hypotonic solutions.

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 reduced cerebral compliance (e.g., in cases of meningitis, intracranial hemorrhage, and cerebral contusion) are at special risk of developing severe and potentially fatal cerebral edema caused by acute hyponatremia.

• To prevent hypokalemia occurring during prolonged parenteral feeding with glucose, potassium may be added to the glucose solution as a safety measure.

• If you are malnourished, you may have a deficiency in vitamin B1. This vitamin is essential for glucose metabolism; therefore, this deficiency should be corrected first if necessary.

• Continuous infusion at the same site may lead to thrombophlebitis (vein inflammation associated with clot formation).

• Special attention should be paid when using this solution in elderly patients, as they may have impaired liver and/or kidney function.

• Do not administer by intramuscular route.

Other medicines and Glucosada Grifols 5%

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines.

Certain medicines may interact with Glucosada Grifols 5%. In such cases, it may be necessary to adjust the dose or discontinue treatment with one of the medicines.

It is important that you inform your doctor if you are taking any of the following medicines:

• Insulin or oral antidiabetics (biguanides, sulfonylureas), as intravenous glucose administration in patients treated with these medicines may reduce their therapeutic efficacy (antagonistic action).

• Corticosteroids: Intravenous glucose administration in patients treated with systemic corticosteroids having glucocorticoid activity (cortisol) may lead to a significant increase in plasma glucose levels due to the hyperglycemic effect of these agents. As for corticosteroids with mineralocorticoid activity, they should be used with caution due to their capacity to retain water and sodium.

• Digitalis glycosides (digoxin), as intravenous glucose administration together with these medicines may increase digitalis activity, increasing the risk of toxicity. This is due to hypokalemia that may result from glucose administration if potassium is not added to the solution.

• Medicines that enhance the effect of antidiuretic hormone (such as chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics, NSAIDs (non-steroidal anti-inflammatory drugs), cyclophosphamide, desmopressin, oxytocin, vasopressin, terlipressin): Intravenous administration of glucose solutions together with these medicines, which reduce water excretion in urine, increases the risk of hospital-acquired hyponatremia (see previous subsection and sections 3 and 4).

• Diuretics in general and antiepileptic drugs such as oxcarbazepine, which increase the risk of hyponatremia.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

During pregnancy, your doctor will decide whether 5% glucose solution should be used, as it must be used with caution in this situation.

Excessive administration of glucose during pregnancy may cause fetal hyperglycemia, hyperinsulinemia, and acidosis, and thus may be harmful to the newborn.

This medicine should be administered with special caution in pregnant women during labor, especially if administered in combination with oxytocin, due to the risk of hyponatremia (see previous subsections and section 4).

There is no evidence suggesting that 5% glucose solution may cause adverse effects in the neonate during breastfeeding. Nevertheless, caution is recommended during lactation.

Driving and using machines

There is no indication that this medicine may affect the ability to drive or operate machinery.

3. How to use Glucosada Grifols 5%

It is provided as a solution and will be administered in a hospital setting by qualified healthcare personnel.

Glucosada Grifols 5% is administered intravenously by infusion.

Your doctor will determine the duration of your treatment with Glucosada Grifols 5%.

Dosages may be adjusted at the physician's discretion, depending on age, body weight, clinical condition, fluid balance, electrolyte levels, and acid-base balance of the patient.

The maximum daily dose is 40 ml/kg body weight/day (2 g of glucose/kg body weight/day), and the maximum infusion rate is 5 ml/kg body weight/hour (0.25 g of glucose/kg body weight/hour).

For continuous infusion, it is recommended to administer the solution at an average rate of 40 to 60 drops per minute (120–180 ml/h).

You may need to be monitored for fluid balance, serum glucose, serum sodium, and other electrolytes before and during administration, especially if you have non-osmotic release of vasopressin (syndrome of inappropriate antidiuretic hormone secretion, SIADH) or are receiving concomitant treatment with vasopressin agonists, due to the risk of hyponatremia. Monitoring of serum sodium is particularly important when physiologically hypotonic solutions are administered. This medicine may become extremely hypotonic after administration due to the rapid metabolism of glucose in the body (see sections 2 and 4).

If you receive more Glucosada Grifols 5% than you should

Given the nature of the product, if its indication and administration are correct and properly controlled, there is no risk of intoxication.

In case of overdose, the following symptoms may occur: hyperglycemia, glucosuria (glucose in urine), hyperhydration, or electrolyte disturbances. In such cases, administration should be discontinued and symptomatic treatment initiated. In the event of elevated blood glucose, insulin should be administered.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everybody will experience them.

Hyperglycemia, glucosuria, or disturbances in fluid or electrolyte balance may occur if the solution is administered too rapidly, if the fluid volume is excessive, or in cases of metabolic insufficiency.

Hyperglycemia resulting from rapid infusion or excessive volume should be closely monitored, especially in severe cases of diabetes mellitus. This can be avoided by reducing the dose and infusion rate, or by administering insulin.

In patients with non-osmotic vasopressin release, in patients with heart, liver, or kidney disease, and in patients treated with vasopressin agonists, the risk of developing acute hyponatremia after administration of hypotonic solutions is increased. Hospital-acquired hyponatremia may cause irreversible brain damage and death due to cerebral edema (see sections 2 and 3).

If used as a vehicle for the administration of other medicines, the nature of the added medicines will determine the likelihood of other adverse reactions.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through 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 Glucosada Grifols 5%

Store below 25°C for the 50/100 ml and 100/250 ml presentations in the Fleboflex Luer container.

Other presentations do not require special storage conditions.

Once the container has been opened, the solution must be used immediately.

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

Do not use this medicine after the expiry date stated on the container. The expiry date is the last day of the month indicated.

Do not use this medicine if you notice that the solution is not clear or contains particles.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point (SIGRE symbol) at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Glucosada Grifols 5%

The active substance is glucose. Each 100 ml of solution contains 5 g of glucose (as monohydrate).

The other components (excipients) are: hydrochloric acid (for pH adjustment) and water for injections.

Appearance of the product and contents of the pack

Glucosada Grifols 5% is a clear, colourless infusion solution, supplied in glass bottles containing 50, 100, 250, 500 and 1000 ml; in flexible polypropylene bags (Fleboflex) containing 50, 100, 250, 500 and 1000 ml; and in flexible polypropylene bags (Fleboflex Luer) containing 50, 100, 250 and 500 ml.

Marketing Authorisation Holder

LABORATORIOS GRIFOLS, S.A.
Can Guasch, 2
08150 Parets del Vallès, Barcelona (SPAIN)

Manufacturer

LABORATORIOS GRIFOLS, S.A.
Polígono Industrial Los Llanos. C/ Marte, 4
30565 Las Torres de Cotillas, Murcia (SPAIN)

LABORATORIOS GRIFOLS, S.A.
Polígono Industrial Autopista. Passeig Fluvial, 24
08150 Parets del Vallès, Barcelona (SPAIN)

Date of the most recent review of this summary: June 2018

Other sources of information

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:

Glucosada Grifols 5% is an infusion solution.

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

The solution should be clear and free from precipitates. Do not administer if otherwise.

Fleboflex and Fleboflex Luer bags:

• Check for the absence of small leaks by firmly pressing the bag. If leaks are detected, discard the product.
• To connect the infusion set, remove the protective tab from the infusion port (for Fleboflex bags) or break the valve by twisting (for Fleboflex Luer bags), exposing the access membrane to the bag.

When administering the solution or preparing mixtures, maximum aseptic conditions must be maintained.

For the purpose of adding medications to the solution when necessary, containers with capacities of 100 ml, 250 ml, 500 ml and 1000 ml are available, containing 50 ml, 100 ml, 250 ml and 500 ml of solution, respectively.

Before adding medications to the solution or administering concomitantly with other medicinal products, compatibility must be verified.

Various studies have reported incompatibility signs between 5% glucose solutions and amoxicillin sodium/clavulanic acid, sodium ampicillin, bleomycin sulfate, cisplatin, cladribine, hydralazine hydrochloride, melphalan hydrochloride, sodium phenytoin, interferon alfa-2b, mechlorethamine hydrochloride, and mitomycin.

In addition, incompatibility has been observed with erythromycin lactobionate and procainamide hydrochloride due to pH-related issues, unless the solution is neutralized.

Furthermore, mixing 5% glucose solution with sodium amoxicillin, sodium imipenem-cilastatin, meropenem, rifampicin, and trimethoprim-sulfamethoxazole is only recommended if the time between dissolution and administration is short.

Likewise, amrinone lactate cannot be diluted in 5% glucose solution, but may be injected directly into the injection site while this solution is being administered.

Electrolyte-free glucose solutions must not be administered through the same infusion set, simultaneously, before, or after blood transfusion, due to the risk of pseudoagglutination.