Label: information for the user

Glucosada Grifols 5% Infusion Solution

Glucose

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or nurse.

-If you experience any adverse effects, consult your doctor or nurse, even if they are not listed in this label. See section 4.

Contents of thelabel

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

6. Contents of the package and additional information

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

Glucosada Grifols 5% is indicated for:

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

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

No use Glucosada Grifols5%

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

• if you have significant alterations in glucose tolerance, including hyperosmolar coma
• in states of hyperhydration (excess of water in the body)
• in cases of hypotonic dehydration (loss of salts), if electrolytes are not administered simultaneously
• in situations of edema due to accumulation of fluid in tissues
• if you have hyperglycemia (high levels of glucose in blood)

-if you have hypokalemia (low levels of potassium in blood)

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

-in the first 24 hours after a head trauma.

Warnings and precautions

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

• Glucose levels in blood must be closely monitored during episodes of intracranial hypertension.

• You should exercise special cautionin case of having suffered acute ischemic attacks (decrease or absence of circulation in arteries), as hyperglycemia has been related to an increase in ischemic brain damage and difficulty in recovery.

• In cases of shock and alterations of acid-base balance, you should be administered electrolytes according to your individual needs before starting the administration of glucose solutions. In case of sodium deficiency, the administration of solutions without sodium could cause peripheral circulatory collapse and oliguria.

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

• It is also recommended that you undergo regular controls of serum electrolytes and fluid balance, as frequent and massive administration of parenteral solutions can cause important ionic depletions.

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

• Glucose isotonic 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 speed of perfusion, your initial clinical condition, and your ability to metabolize glucose, the intravenous administration of glucose can cause you alterations in electrolytes, the most important being hyponatremia (low levels of sodium in 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, convulsions, lethargy, and vomiting. Patients with cerebral edema have a special risk of suffering from severe and irreversible brain damage, potentially fatal.

Children, fertile women, and patients with reduced cerebral compliance (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 nutrition with glucose, you may be added potassium to the glucose solution, as a safety measure.

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

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

• You should exercise special attention if you use it in elderly patients, as they may have impaired liver and/or kidney function.

• Do not administer by intramuscular route.

Other medications and Glucosada Grifols 5%

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

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

It is essential to inform your doctor if you use any of the following medications:

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

• Corticosteroids: The 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 hypoglycemic action of these medications. In the case of corticosteroids with mineralocorticoid activity, they should be administered with caution due to their ability to retain water and sodium.

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

• Medications that increase the effect of antidiuretic hormone (such as chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methylamphetamine, ifosfamide, antipsychotics, narcotics, NSAIDs, cyclophosphamide, desmopressin, oxytocin, vasopressin, terlipressin): The intravenous administration of glucose solutions together with these medications that reduce water excretion in urine increases the risk of hospital hyponatremia (see previous subsection and sections 3 and 4).

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

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor before using this medication.

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 administration of glucose during pregnancy can cause hyperglycemia, hyperinsulinemiaand fetal acidosis, and may be harmful to the newborn.

This medicationshould be administered with special caution in pregnant women during delivery, especially if it is 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 lactation in the neonate. However,it is recommended to use with caution during lactation.

Driving and operating machinery

There is no indication that this medication may affect your ability to drive or operate machinery.

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

Glucosada Grifols 5% is administered intravenously via infusion.

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

Doses may be varied 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 of body weight/day (2 g of glucose/kg of body weight/day) and the maximum infusion rate is 5 ml/kg of body weight/hour (0.25 g of glucose/kg of body weight/hour).

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

You may need to monitor fluid balance, serum glucose, serum sodium, and other electrolytes before and during administration, especially if you have an increased non-osmotic release of vasopressin (syndrome of inappropriate antidiuretic hormone secretion, SIADH) and if you are receiving simultaneously medication with vasopressin agonists, due to the risk of hyponatremia. Serum sodium monitoring is especially important when administering hypotonic physiological solutions.This medicationcan 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 your indication and administration are correct and controlled, there is no risk of overdose.

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 sought. In the event of increased glucose levels, insulin will be administered.

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

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

Like all medications,this medicationmay cause adverse effects, although not all people will experience them.

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

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

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

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

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

Once the packaging is opened, the solution must be used immediately.

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

Do not use this medication after the expiration date that appears on the packaging.The expiration date is the last day of the month indicated.

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

Medications should not be disposed of through drains or trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point (SIGRE symbol) at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Glucosada Grifols 5% Composition

The active principle 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 package

Glucosada Grifols 5% is a transparent and colorless infusion solution, which is presented 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 Authorization Holder

LABORATORIOS GRIFOLS, S.A.

Can Guasch, 2

08150 Parets del Vallès, Barcelona (SPAIN)

Responsible for manufacturing

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)

Last review date of this leaflet:June 2018

Other sources of information

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)

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This information is intended solely for healthcare professionals:

Glucosada Grifols 5% is an infusion solution.

The contents of each package ofthis medicineare for a single infusion. Dispose of the unused portion.

The solution must be transparent and free of precipitates. Do not administer otherwise.

Fleboflex and Fleboflex Luer bags:

-Check for the absence of small leaks by pressing firmly on the bag. If leaks are detected, discard the product.

-To connect the infusion equipment, separate the protective cap 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 must be maintained.

In order to be able to add medications to the solution if necessary, packages of 100 ml, 250 ml, 500 ml, and 1000 ml capacity are available, which contain 50 ml, 100 ml, 250 ml, and 500 ml of solution, respectively.

Before adding medications to the solution or administering simultaneously with other medications, it must 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, chlorohydralazine hydrochloride, chlorophyllan hydrochloride, phenytoin sodium, interferon alfa-2b, chlorophyllan hydrochloride, and mitomycin.

Similarly, incompatibility has been observed with lactobionate erythromycin and chlorophyllan 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 between dissolution and administration short periods of time elapse.

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

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