Label:information for the user

Glucosalina Grifols Infusion Solution

Glucose, Sodium Chloride

Read this label carefully before starting to use this medication,because 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.

6. Contents of the container andadditional information

Glucosalina Grifols belongs to the group of intravenous solutions that affect the electrolyte balance.

Glucosalina Grifols is indicated for:

• States of dehydration (loss of body water) with moderate losses of electrolytes
• Alterations of the hydrocarbonate metabolism
• Mild states of alkalosis

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

No use Glucosalina Grifols

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

• if you have states of hyperhydration (excess of fluids in the body)
• in situations of generalized edema (accumulation of fluid in the body tissues) or ascitic cirrhosis (chronic progressive liver disease with fluid accumulation)
• if you have hyperglycemia (high blood glucose levels)
• if you have hypernatremia (high blood sodium levels)
• if you have hyperchloremia (high blood chloride levels)

-in states of hyperosmolar coma (loss of consciousness due to an increase in the concentration of solutes in the blood)

• in states of hyperlactacidemia (presence of lactic acid in the blood)
• in severe cases of heart, liver, or kidney failure (failure of the heart, liver, or kidneys respectively)

-in the first 24 hours after a head trauma.

Warnings and precautions

Consult your doctor or nurse before starting to use Glucosalina Grifols.

-The frequent and massive administration of glucose solutions can cause fluid overload (hyperhydration), acid-base balance alterations, and significant electrolyte depletions, including hypomagnesemia (low magnesium levels in the blood), hypokalemia (low potassium levels in the blood), and hypophosphatemia (low phosphate levels in the blood). In these cases, you will need to be administered electrolyte supplements. For this reason, it is recommended that you undergo regular monitoring of your blood glucose levels, serum electrolytes, water balance, and acid-base balance.

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

• Depending on the volume and rate of infusion, your initial clinical condition, and your ability to metabolize glucose, the intravenous administration of glucose can cause electrolyte imbalances such as hyponatremia (low sodium levels in the blood).

Hyponatremia:

If you are a patient with non-osmotic vasopressin release (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 developing 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 developing severe, irreversible, and potentially fatal brain damage.

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 developing severe and potentially fatal cerebral edema caused by acute hyponatremia.

-To avoid hypokalemia produced during prolonged infusions with glucose solutions, it is recommended to add potassium to the solution as a safety measure.

-Blood glucose levels should be closely monitored during episodes of intracranial hypertension.

-You should be especially cautious if you have 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.

-You should be especially careful if you have any of the following diseases: hypertension, heart failure, peripheral or pulmonary edema, renal dysfunction, preeclampsia (symptoms that precede convulsions and blood pressure drop in pregnant women), or other problems associated with sodium retention.

-The administration of solutions containing glucose may cause vitamin B1 deficiency, especially in cases of malnutrition.

-In cases of diabetes mellitus, glucose-containing solutions can be used as long as you receive the initial appropriate treatment (insulin). Additionally, these solutions should be used with caution if you have Addison's disease or carbohydrate intolerance.

-You should be especially cautious if you are administered continuously in the same injection site, due to the risk of developing thrombophlebitis.

-This medication should be used with cautionif the heart, liver, and/or kidneys do not function correctly, especially if you are elderly.

Other medications and Glucosalina Grifols

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

Certain medications may interact with Glucosalina Grifols. In this case, you may need 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-containing solutions 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 solution in patients treated with systemic corticosteroids with glucocorticoid activity (cortisol) may lead to an 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 a glucose-containing solution coincides with a therapy with these medications, there may be an increase in digitalis activity, and there is a risk of developing intoxication with these medications. This is due to the hypokalemia that may be caused by the administration of glucose if potassium is not added to the solution.
• Lithium carbonate, as the administration of sodium chloride accelerates the renal excretion of lithium, leading to a decrease in the therapeutic effect of this medication.
• Medications that increase the effect of antidiuretic hormone (such as chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics, NSAIDs, cyclophosphamide, desmopressin, oxytocin, vasopressin, terlipressin): The intravenous administration of a glucose solution along 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 or plan to become pregnant,consult your doctor before using this medication.

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

The excessive administration of glucose-containing solutions during pregnancy can cause hyperglycemia, hyperinsulinemia(high insulin levels in the blood)and acidosis in the fetus, 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 Glucosalina Grifols may cause adverse effects during lactation in the neonate. However,it is recommended to use with caution during this period.

Driving and operating machinery

There isnoindication thatthis medicationmay affect your ability to drive or operate machinery.

Glucosalina Grifols is presented in the form of a solution for intravenous administration.

This medication will be used in a hospital by the corresponding healthcare staff.

Your doctor will inform you of the duration of your treatment with Glucosalina Grifols.

The dose may be adjusted according to medical criteria, always adjusting the mean infusion rate to the patient's clinical needs based on age, weight, clinical condition, glucose levels, and electrolyte and acid-base balance.Generally, it is recommended to administer the solution at a mean infusion rate of 40 to 80 drops per minute (120-240 ml/h). In adults, the daily dose is usually 40 ml/kg of body weight, with a maximum daily dose of 3000 ml not to be exceeded.

You may need to be monitored for 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 simultaneous medication with vasopressin agonists, due to the risk of hyponatremia. Monitoring of serum sodium is especially important when administering hypotonic solutions.This medicationmay become hypotonic after administration due to the rapid metabolism of glucose in the body (see sections 2 and 4).

If you receive more Glucosalina Grifols than you should

If the administration of the glucosalina solution is not performed correctly and under control, some of the following signs of overdose may appear: overhydration, electrolyte imbalances, and acid-base balance disturbances.

In the event that these requirements are not met and symptoms of intoxication appear, administration will be suspended and symptomatic treatment will be sought.

In the event of an overdose or accidental ingestion, consult the Toxicological Information Service. Phone: 915 620 420.

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

Like all medications,this medicationcan produce adverse effects, although not all people will experience them.

If the administration of the solution is performed correctly and under control, the only possible complications are those derived from the administration technique by intravenous route, whichinclude fever, infection at the injection site, pain, reaction and/or irritation at the injection site, venous thrombosis or phlebitis extending from the injection site and extravasation.

To avoid the risk of suffering from thrombophlebitis (inflammation of a vein by a blood clot), it is recommended to vary the insertion site of the catheter (every 24-48 hours).

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 suffering from acute hyponatremia after administration of hypotonic solutions is increased. Hospital hyponatremia can cause irreversible brain damage and death due to the appearance of cerebral edema (see sections 2 and 3).

The frequencies of the possible adverse effects described are not established, as there are no clinical studies conducted withthis medication.

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

Reporting Adverse Effects

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

No requires special conservation conditions.

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

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

Do not usethis medicationafter the expiration date that appears on the container. The expiration date is the last day of the month indicated.

Do not usethis medicationif you observe that the solution is not transparent or contains precipitates.

Medications should not be thrown down the drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE Point (SIGRE symbol) of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Composition of Glucosalina Grifols

The active principles are glucose and sodium chloride. Each 100 ml of solution contains 3.3 g of glucose (as monohydrate) and 0.3 g of sodium chloride.

The other components (excipients) arehydrochloric acid (for pH adjustment) and water for injectable preparations.

Appearance of the product and contents of the package

Glucosalina Grifols is a transparent and colorless infusion solution, presented in glass bottles of 250 and 500 mland in flexible polypropylene bags (Fleboflex) of 250, 500 and 1000 ml.

Holder of the marketing authorization

LABORATORIOS GRIFOLS, S.A.

Can Guasch, 2

08150ParetsdelVallès, Barcelona (SPAIN)

Responsible for manufacturing

LABORATORIOS GRIFOLS, S.A.

Polígono Industrial Autopista. Passeig Fluvial, 24

08150 Parets del Vallès, Barcelona (SPAIN)

Laboratorios Grifols, S.A.

Polígono Industrial Los Llanos. C/ Marte, 4

30565 Las Torres de Cotillas, Murcia (SPAIN)

Last review date of this leaflet:July 2018

Other sources of information

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

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This information is intended solely for healthcare professionals:

Glucosalina Grifols will be administered by infusion.

The contents of each package of Glucosalina Grifols are for a single infusion.

Once the package is opened, the solution must be administered immediately. Discard the unused portion.

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

Fleboflex 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 tongue from the infusion port, leaving the access membrane to the bag exposed.

To administer the solution and in case of adding medications, maximum asepsis must be maintained.

In order to be able to add medications to the solution or to administer simultaneously with other medications, it must be checked that there are no incompatibilities.

It has been described that the glucose saline solution with a glucose content of 3.3% and sodium chloride of 0.3% is incompatible with mitomycin, due to the low pH of this solution.

Similarly, incompatibility samples have been observed for different isotonic glucose saline solutions with: amoxicillin sodium, heparin sodium, imipenem-cilastatin sodium and meropenem. However, these medications may be compatible with this type of solutions depending on different factors such as the concentration of the medication (heparin sodium) or well, the time that elapses between dissolution and administration (amoxicillin sodium, imipenem-cilastatin sodium and meropenem).

On the other hand, incompatibility samples have been described when some medications are diluted in solutions containing glucose, among them: ampicillin sodium, amrinone lactate, amoxicillin sodium/clavulanic acid, interferon alfa-2b, procainamide hydrochloride. However, amrinone lactate or amoxicillin sodium/clavulanic acid, may be injected directly into the injection site while these infusion solutions are being administered.

Also, incompatibility samples have been described when some medications are diluted in solutions containing chloride. Among them, amsacrine and trimetrexate glucuronate.