GLUCOSALINA MEIN SOLUTION FOR PERFUSION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Glucosalina Mein solution for infusion

Glucose and Sodium Chloride

Contents of the package leaflet:

1. What is Glucosalina Mein and what is it used for
2. Before using Glucosalina Mein
3. How to use Glucosalina Mein
4. Possible side effects
5. Storage of Glucosalina Mein
6. Additional information

1. WHAT IS GLUCOSALINA MEIN AND WHAT IS IT USED FOR

Glucosalina Mein is a solution for intravenous infusion presented in bottles of 250 ml, 500 ml, and 1000 ml.

This medicinal product belongs to the group of intravenous solutions that affect the electrolyte balance with carbohydrates.

Glucosalina Mein is indicated in:

• States of dehydration with moderate electrolyte losses.
• Disorders of carbohydrate metabolism.
• As a vehicle for the administration of medications and electrolytes.

2. BEFORE USING GLUCOSALINA MEIN

Do not use Glucosalina Mein

• If you are allergic (hypersensitive) to the active substance or any of the other components of Glucosalina Mein.
• In states of hyperhydration (fluid overload).
• In situations of generalized edema (fluid accumulation in body tissues) or ascitic cirrhosis (chronic progressive liver disease with fluid accumulation).
• In states of hyperglycemia (increased blood glucose levels).
• In states of hyponatremia (decreased sodium in the blood).
• In states of hypochloremia (decreased chloride in the blood).
• In states of hyperosmolar coma (loss of consciousness due to increased salt concentration in the blood).
• In states of hyperlactatemia (presence of lactic acid in the blood).
• In severe cases of heart, liver, or kidney failure.
• During the first 24 hours after a head injury.

Warnings and precautions

Be particularly careful with Glucosalina Mein

• It is recommended that regular analytical controls be performed on blood glucose, electrolyte, water balance, and acid-base balance, as frequent and massive administration of glucose solutions can cause fluid overload (hyperhydration), acid-base balance disorders, and significant ionic depletions. In these cases, it will be necessary to administer electrolyte supplements.
• This medicine will be administered with caution if you have the following diseases: hypertension, heart failure, peripheral or pulmonary edema, renal dysfunction, pre-eclampsia (symptoms preceding convulsions and drop in blood pressure in pregnant women), cardiac, hepatic, and/or renal disorders, or if you are an elderly patient.
• Glucosalina Mein will be administered with caution to premature and full-term infants.
• Blood glucose levels will be carefully determined in case of intracranial hypertension.
• If you have had an acute ischemic attack (sudden onset of lack of blood flow), this medicine should not be administered.
• If this medicine is administered for a prolonged period, it is recommended to add potassium to the solution as a safety measure.

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

• If you have diabetes mellitus, solutions containing glucose can be used provided that you have initially received appropriate treatment (insulin). Similarly, these solutions should be used with caution if you have Addison's disease or carbohydrate intolerance.

• Continuous administration at the same injection site should be avoided due to the risk of thrombophlebitis.

• If you suffer from critical conditions, pain, postoperative stress, infections, burns, or central nervous system diseases.

• You have any type of heart, liver, or kidney disease and are being treated with a medicine that increases the effect of vasopressin (a hormone that regulates water retention in the body) because it can increase the risk of acquiring low sodium levels in the blood (hyponatremia) in the hospital (see the section "Other medicines and Glucosalina Mein").

All patients must be closely monitored. In cases where normal regulation of blood water content is altered due to increased vasopressin secretion, also known as Antidiuretic Hormone (ADH), perfusion of fluids with low sodium chloride concentration (hypotonic fluids) can result in low sodium levels in the blood (hyponatremia). This can cause headache, nausea, seizures, lethargy, coma, brain inflammation (cerebral edema), and death; therefore, these symptoms (acute symptomatic hyponatremic encephalopathy) are considered a medical emergency (see section 4. Possible side effects).

Children, women of childbearing age, and patients with brain diseases such as meningitis, cerebral hemorrhage, cerebral contusion, and cerebral edema have a special risk of suffering from severe and potentially fatal brain inflammation caused by acute hyponatremia.

Other medicines and Glucosalina Mein

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription, as it may be necessary to interrupt treatment or adjust the dose of one of them.

Certain medicines may interact with Glucosalina Mein. In this case, it may be necessary to change the dose or interrupt treatment of one of the medicines.

It is essential that you inform your doctor if you are using any of the following medicines:

• Insulin or oral antidiabetics (biguanides, sulfonylureas), these medicines decrease the effect of glucose.
• Corticosteroids due to the risk of increased blood glucose levels or due to their ability to retain sodium and water.
• Digitalis glycosides (digoxin), may cause an increase in digitalis activity, with the risk of developing intoxication.
• Lithium carbonate, as the administration of sodium chloride accelerates the renal excretion of lithium, leading to a decrease in the therapeutic effect of the latter.
• Medicines that lead to an increase in the effect of vasopressin (see the section "Warnings and precautions"), for example:
• Medicines that stimulate the release of vasopressin (e.g., antipsychotics, narcotics).
• Medicines that potentiate the action of vasopressin (e.g., non-steroidal anti-inflammatory drugs).
• Medicines that act like vasopressin, called vasopressin analogs.
• Other medicines that increase the risk of hyponatremia, including diuretics in general and antiepileptics such as oxcarbazepine.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

This medicine should be administered with special caution in pregnant women during labor, especially if administered in combination with oxytocin (a hormone that can be administered to induce labor and control bleeding) due to the risk of hyponatremia.

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

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

There is no evidence to suggest that Glucosalina Mein may cause adverse effects during the breastfeeding period in the newborn. However, it is recommended to use with caution during this period.

Driving and using machines

There is no indication that Glucosalina Mein may affect the ability to drive or use machines.

3. HOW TO USE GLUCOSALINA MEIN

Follow exactly the administration instructions of Glucosalina Mein indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

They will monitor your fluid balance and plasma concentrations of glucose and electrolytes (especially sodium) during administration.

Your doctor will decide the dose and frequency at which the solution will be administered, depending on your age, weight, clinical situation (particularly the state of hydration), and the nature of any medication that may have been added to the solution.

The recommended dosage is:

For adults, elderly, and adolescents: 500 ml to 3000 ml every 24 hours.

For infants and children:

• From 0 to 10 kg of body weight: 100 ml/kg/24 h.
• From 10 to 20 kg of body weight: 1000 ml + 50 ml/kg/24 h for weight above 10 kg.
• > 20 kg of body weight: 1500 ml + 20 ml/kg/24 h for weight above 20 kg.

If you use more Glucosalina Mein than you should

If the administration of the glucose solution is not performed correctly and under control, some signs of overdose may appear: hyperhydration, electrolyte disturbances, and acid-base balance disorders.

In case of non-compliance with these requirements and the presence of symptoms of intoxication, administration will be suspended, and symptomatic treatment will be initiated.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Phone: 91 562 04 20.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Glucosalina Mein can cause side effects, although not everybody gets them.

Adverse reactions can be associated with the administration technique, including fever, infection at the injection site, local reaction or pain, venous irritation, venous thrombosis, or phlebitis extending from the injection site, extravasation, and hypervolemia.

Adverse reactions may be associated with the medicines added to the solution; the nature of the added medicines will determine the possibility of any other undesirable effect.

In case of adverse reactions, the infusion should be interrupted.

Headache, nausea, seizures, lethargy. This can be caused by low sodium levels in the blood. When sodium levels in the blood drop significantly, water enters the brain cells, causing them to swell. This results in increased intracranial pressure and causes hyponatremic encephalopathy.

If you consider any of the side effects serious or if you notice any side effect not mentioned in this leaflet, please inform your doctor or pharmacist.

5. STORAGE OF GLUCOSALINA MEIN

No special storage conditions are required.

Keep out of the reach and sight of children.

Do not use Glucosalina Mein after the expiration date stated on the packaging.

Do not use Glucosalina Mein if the solution is not transparent and contains precipitates.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Glucosamine Mein

The active ingredients are glucose and sodium chloride. Each 100 ml of solution contains 3.5 g of glucose (as monohydrate) and 0.35 g of sodium chloride.

The other components are: water for injectables.

Theoretical osmolality: 313 mOsm/l.

pH: 3.2 – 6.5.

Cl- (theoretical): 60 mmol/l.

Na+ (theoretical): 60 mmol/l.

Theoretical calories: 140 kcal/l.

Appearance of the product and packaging contents

Glucosalina Mein is a clear, transparent, and colorless solution. It is presented in bottles of 250 ml, 500 ml, and 1000 ml.

Marketing authorization holder

Fresenius Kabi España S.A.

C/ Marina 16-18.

08005-Barcelona (Spain).

Manufacturer

Fresenius Kabi Italia S.R.L.

Via Camagre, 41/43.

37063 Isola della Scala (VR) (Italy).

This leaflet was last revised in

August 2018.

<>This information is intended only for healthcare professionals:

Glucosalina Mein is presented in the form of a solution for intravenous administration and will be used in a hospital by the corresponding healthcare personnel.

Glucosalina Mein will be administered by perfusion.

The contents of each Glucosalina Mein packaging are for single perfusion.

Once the packaging is opened, the solution must be administered immediately. The unused fraction must be discarded.

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

Administration rate:

The perfusion rate is normally 40 ml/kg/24 h in adults, elderly, and adolescents.

In pediatric patients, the perfusion rate is 5 ml/kg/h on average, but this value varies with age: 6-8 ml/kg/h for children under 12 months, 4-6 ml/kg/h for children from 12 to 23 months, and 2-4 ml/kg/h for school-age children (2-11 years).

The perfusion rate should not exceed the patient's glucose oxidation capacity to avoid hyperglycemia. Therefore, the maximum dose ranges from 5 mg/kg/min for adults to 10-18 mg/kg/min for infants and children, depending on age and total body weight.

To administer the solution and in case of addition of medicines, maximum asepsis must be maintained.

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

It has been described that the glucose solution with a glucose content of 3.5% and sodium chloride of 0.35% is incompatible with mitomycin, due to the low pH of this solution.

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

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

Also, samples of incompatibility have been described when certain medicines are diluted in solutions containing chloride, among them: amsacrine and trimetrexate glucuronate.

General advice

It may be necessary to monitor water balance, serum glucose, serum sodium, and other electrolytes before and during administration, especially in patients with increased non-osmotic release of vasopressin (Syndrome of Inappropriate Antidiuretic Hormone Secretion, SIADH) and in patients receiving concomitant medication with vasopressin agonists due to the risk of hyponatremia.

Monitoring of serum sodium is especially important in products with a lower sodium concentration compared to serum sodium concentration. After perfusion of Glucosalina Mein, rapid and active transport of glucose to the body's cells occurs. This condition promotes an effect that can be considered as a supply of free water and can lead to severe hyponatremia.