GLUCOSADA GRIFOLS 5% SOLUTION FOR INFUSION

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, you may need to read it again.
• If you have any further questions, ask your doctor or nurse.

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

Contents of thepackage leaflet

1. What is Glucosada Grifols 5% and what is it used for
2. What you need to know before you start using Glucosada Grifols 5%
3. How to use Glucosada Grifols 5%
4. Possible side effects
5. Storage of Glucosada Grifols 5%

1. Contents of the pack and further information

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

Glucosada Grifols 5% is an intravenous glucose solution used as a source of calories and water.

Glucosada Grifols 5% is indicated in:

• Hypertonic dehydration states (without significant loss of salts)
• Alterations of carbohydrate metabolism
• Parenteral nutrition (as an energy source), when oral food intake is limited

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

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

Do not use Glucosada Grifols5%

• if you are allergic (hypersensitive) to glucose or any of the other components of this medicine (listed in section 6)
  • if you suffer from significant alterations of glucose tolerance, including hyperosmolar coma
  • in states of hyperhydration (excess water in the body)
  • in case of hypotonic dehydration (with loss of salts), if the lost electrolytes are not administered simultaneously
  • in situations of edema due to fluid accumulation in tissues
  • if you have hyperglycemia (high blood glucose levels)

• if you have hypokalemia (low potassium levels in the blood)
• if you have hyperlactatemia (lactic acid accumulation in the blood)
• in the first 24 hours after a head injury.

Warnings and precautions

Consult your doctor or nurse before starting to use Glucosada Grifols 5%.

• The concentration of glucose in the blood must be carefully monitored during episodes of intracranial hypertension.

• Special caution should be exercised in case of having suffered acute ischemic attacks (decreased or absent circulation in arteries), since hyperglycemia has been related to an increase in ischemic brain damage and difficulty in recovery.

• In case of shock and acid-base balance disorders, electrolytes should be administered according to individual requirements before starting the administration of glucose solutions. In case of sodium deficiency, the administration of sodium-free solutions could produce peripheral circulatory collapse and oliguria.

• It is recommended that regular controls of blood glucose levels be performed, especially if you are diabetic. In this case, it may be necessary to modify insulin requirements.

• It is also recommended that regular controls of serum electrolytes and water balance be performed, as frequent and massive administration of parenteral solutions can cause significant ionic depletions.

• The possibility of hyperhydration can be avoided by means of a total balance of the incorporated and lost fluid.

• Isotonic glucose solutions can 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, the initial clinical condition, and the ability to metabolize glucose, intravenous administration of glucose can cause electrolyte disturbances, the most important being hyponatremia (low sodium levels in the blood) hypotonic or hypertonic.

Hyponatremia:

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

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, women of childbearing age, and patients with reduced cerebral distensibility (e.g., in cases of meningitis, intracranial hemorrhage, and cerebral contusion) have a special risk of suffering from severe and potentially fatal cerebral edema caused by acute hyponatremia.

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

• If you have malnutrition, you may have a vitamin B1 deficiency. This vitamin is essential for glucose metabolism, so if necessary, this deficiency should be corrected first.

• If you are administered continuously in the same infusion site, thrombophlebitis (inflammation of a vein associated with the formation of a clot) may occur.

• Special attention should be paid if used in elderly patients, as they may have affected liver and/or kidney function.

• Do not administer intramuscularly.

Other medicines and Glucosada Grifols 5%

Tell your doctor if you are using, have recently used, or may need to use any other medicine.

Certain medicines may interact with Glucosada Grifols 5%. In this case, it may be necessary to change the dose or interrupt treatment with one of the medicines.

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

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

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

• Digitalis glycosides (digoxin), as when intravenous administration of glucose coincides with therapy with these medicines, an increase in digitalis activity may occur, with the risk of developing intoxication with these medicines. This is due to the hypokalemia that can be caused by glucose administration if potassium is not added to the solution.

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

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

Pregnancy and lactation

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

In case of pregnancy, your doctor will decide whether to use a 5% glucose solution, as it should be used with caution in this case.

Excessive glucose administration during pregnancy may cause hyperglycemia, hyperinsulinemia, and fetal acidosis, and may therefore 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 to suggest that the 5% glucose solution may cause adverse effects during the lactation period in the neonate. However, it is recommended to use with caution during lactation.

Driving and using machines

There is no indication that this medicine may affect the ability to drive or use machines.

3. How to use Glucosada Grifols 5%

It is presented in the form of a solution and will be used in a hospital by the corresponding healthcare personnel.

Glucosada Grifols 5% is administered intravenously by infusion.

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

Doses may vary according to medical criteria, depending on age, weight, clinical condition, fluid balance, electrolytes, and acid-base balance of the patient.

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

In continuous infusion, it is recommended to administer the solution at a medium rate of 40 to 60 drops per minute (120-180 ml/h).

You may need to monitor your fluid balance, blood glucose, serum sodium, and other electrolytes before and during administration, especially if you have an increased release of non-osmotic vasopressin (syndrome of inappropriate secretion of antidiuretic hormone, SIADH) and if you receive vasopressin agonists simultaneously, due to the risk of hyponatremia. Monitoring of serum sodium is especially important when administering physiologically hypotonic solutions. This medicine can 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 Grifols5% than you should

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

In case of overdose, the following symptoms may appear: hyperglycemia, glucosuria (glucose in urine), hyperhydration, or electrolyte disorders. In these cases, administration will be suspended and symptomatic treatment will be resorted to. In case of increased glucose levels, insulin will be administered.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

The resulting hyperglycemia from rapid or excessive infusion should be monitored especially in severe cases of diabetes mellitus, and can be avoided by decreasing the dose and infusion rate or by administering insulin.

In patients with non-osmotic release of vasopressin, in patients with heart, liver, and kidney diseases, and in patients treated with vasopressin agonists, the risk of acute hyponatremia after administration of hypotonic solutions is increased. Hospital hyponatremia can cause irreversible and potentially fatal brain damage due to the occurrence of 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 side effects

If you experience any side effects, consult your doctor or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Glucosada Grifols 5%

Store below 25°C for 50/100 ml and 100/250 ml formats of the Fleboflex Luer pack.

The rest of the formats do not require special storage conditions.

Once the pack is opened, the solution should be used immediately.

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

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

Do not use this medicine if you observe that the solution is not transparent or contains particles.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packs and medicines you no longer need in the SIGRE collection point (SIGRE symbol) at the pharmacy. If in doubt, ask your pharmacist how to dispose of packs and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Glucosada Grifols 5%

The active ingredient 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 injectable preparations.

Appearance of the product and contents of the pack

Glucosada Grifols 5% is a clear and colorless solution for infusion, presented in glass vials 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 authorization 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 last revision of this leaflet:June 2018

Other sources of information

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

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This information is intended only for healthcare professionals:

Glucosada Grifols 5% is a solution for infusion.

The content of each pack of this medicine is for single infusion. The unused fraction should be discarded.

The solution should be transparent and not contain precipitates. Do not administer otherwise.

Fleboflex and Fleboflex Luer bags:

• Check for the absence of small leaks by pressing the bag firmly. If leaks are detected, discard the product.
• To connect the infusion equipment, separate 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.

To administer the solution and in case of preparation of mixtures, maximum asepsis should be maintained.

In order to add medicines to the solution if necessary, packs of 100 ml, 250 ml, 500 ml, and 1000 ml capacity are available, containing 50 ml, 100 ml, 250 ml, and 500 ml of solution, respectively.

Before adding medicines to the solution or administering them simultaneously with other medicines, it should be checked that there are no incompatibilities.

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

Similarly, incompatibility has been observed with erythromycin lactobionate and procainamide hydrochloride due to pH problems, unless the solution is neutralized.

On the other hand, the mixture of 5% glucose solution with amoxicillin sodium, imipenem-cilastatin sodium, meropenem, rifampicin, and trimethoprim-sulfamethoxazole is only recommended if short periods of time elapse between dissolution and administration.

Similarly, amrinone lactate cannot be diluted in the 5% glucose solution, but it can be injected directly into the injection point while this solution is being administered.

Electrolyte-free glucose solutions should not be administered with the same infusion equipment, simultaneously, before, or after the administration of blood, due to the possibility of pseudoagglutination.