GLUCOSALINE MEIN SOLUTION FOR INFUSION

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Glucosalina Mein solution for infusion

Glucose and Sodium chloride

Package leaflet:

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

1. What GLUCOSALINA MEIN is and what it is used for

Glucosalina Mein is an intravenous infusion solution available in 250 ml, 500 ml, and 1000 ml bottles.

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

Glucosalina Mein is indicated for:

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

2. BEFORE USING GLUCOSALINA MEIN

Do not use Glucosalina Mein

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

Warnings and precautions

Take special care with Glucosalina Mein:

• Regular blood tests to monitor glucose, electrolytes, fluid balance, and acid-base balance are recommended, as frequent and massive administration of glucosaline solutions may cause fluid overload (hyperhydration), disturbances in acid-base balance, and significant ionic depletions. In such cases, electrolyte supplementation may be necessary.

• This medicine will be administered with caution if you have any of the following conditions: hypertension, heart failure, peripheral or pulmonary edema, renal dysfunction, preeclampsia (symptoms preceding seizures and drop in blood pressure in pregnant women), or cardiac, hepatic and/or renal disorders, or if you are an elderly patient.

• Glucosalina Mein will be administered with caution in premature infants and full-term neonates.

• Your blood glucose will be carefully monitored if you have intracranial hypertension.

• If you have suffered an acute ischemic stroke (sudden onset of insufficient blood supply), this medicine should not be administered.

• If this medicine is administered for prolonged periods, it is recommended to add potassium to the solution as a safety measure.

• Administration of solutions containing glucose may lead to vitamin B1 deficiency, especially in cases of malnutrition.

• If you have diabetes mellitus, glucose-containing solutions may be used only if appropriate treatment (insulin) has been initiated. These solutions should also be used with caution if you have Addison's disease or carbohydrate intolerance.

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

• If you are experiencing critical conditions, pain, postoperative stress, infections, burns, or diseases of the central nervous system.

• If you have any type of heart, liver, or kidney disease and are being treated with a medicine that enhances the effect of vasopressin (a hormone regulating the body's water retention), because this may increase the risk of developing low blood sodium levels (hyponatremia) in hospital settings. (See section "Other medicines and Glucosalina Mein")

All patients must be closely monitored. In cases where normal regulation of blood water content is disrupted due to increased secretion of vasopressin, also known as Antidiuretic Hormone (ADH), infusion of fluids with low sodium chloride concentration (hypotonic fluids) may result in low blood sodium levels (hyponatremia). This can cause headache, nausea, seizures, lethargy, coma, brain swelling (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 disorders such as meningitis, cerebral hemorrhage, cerebral contusion, and cerebral edema are at special risk of developing severe and potentially fatal brain swelling caused by acute hyponatremia.

Other medicines and Glucosalina Mein

Inform your doctor or pharmacist if you are currently 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 or more of them.

Certain medicines may interact with Glucosalina Mein. In such cases, it may be necessary to change the dose or interrupt treatment with one or more 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 these medicines reduce the effect of glucose.
• Corticosteroids, due to the risk of increased blood glucose or because of these medicines' ability to retain sodium and water.
• Digitalis glycosides (digoxin), as digitalis activity may increase, increasing the risk of toxicity.
• Lithium carbonate, as administration of sodium chloride accelerates renal excretion of lithium, leading to reduced therapeutic effect of lithium.
• Medicines that lead to increased vasopressin effect (see section Warnings and precautions), for example:
  • Medicines that stimulate vasopressin release (e.g., antipsychotics, narcotics)
  • Medicines that potentiate vasopressin action (e.g., non-steroidal anti-inflammatory drugs)
  • Medicines that act like vasopressin, known as vasopressin analogues
  • 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 may be given to induce labor and control bleeding), due to the risk of hyponatremia.

During pregnancy, your doctor will decide whether the use of glucosaline solution is appropriate, as it should be used with caution in such cases.

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 suggesting that Glucosalina Mein may cause adverse effects in the neonate during breastfeeding. Nevertheless, caution is recommended during this period.

Driving and using machines

There is no indication that Glucosalina Mein may affect the ability to drive or operate machinery.

3. HOW TO USE GLUCOSALINA MEIN

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

Your fluid balance and plasma levels of glucose and electrolytes (especially sodium) will be monitored during administration.

Your doctor will determine the dose and frequency at which the solution will be administered, depending on your age, body weight, clinical condition (particularly hydration status), and the nature of any medications that may have been added to the solution.

The recommended dosage is:

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

For infants and children:

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

• 20 kg body weight: 1500 ml + 20 ml/kg/24 h for each kg above 20 kg

If you use more Glucosalina Mein than you should

If the glucosaline solution is not administered correctly and under proper control, one or more of the following signs of overdose may occur: hyperhydration, electrolyte disturbances, and acid-base imbalances.

If these requirements are not met and symptoms of intoxication occur, administration must be discontinued and symptomatic treatment initiated.

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

4. Possible adverse effects

Like all medicines, Glucosalina Mein may produce adverse effects, although not everyone will experience them.

Adverse reactions related to the administration technique may occur, 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 also be associated with medications added to the solution; the nature of the added medications will determine the possibility of any additional undesirable effects.

If adverse reactions occur, the infusion must be discontinued.

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

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, 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 expiry date stated on the packaging.

Do not use Glucosalina Mein if the solution is not clear or contains precipitates.

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

6. ADDITIONAL INFORMATION

Composition of Glucosamina Mein

The active substances 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 injections.

Osmolality (theoretical): 313 mOsm/L

pH: 3.2 – 6.5

Cl⁻ (theoretical): 60 mmol/L

Na⁺ (theoretical): 60 mmol/L

Calories (theoretical): 140 kcal/L

Appearance of the product and contents of the container

Glucosalina Mein is a clear, transparent, and colourless solution. It is available in 250 ml, 500 ml, and 1000 ml bottles.

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 summary of product characteristics was last revised in

August 2018

<>This information is intended only for healthcare professionals:

Glucosalina Mein is presented as a solution for intravenous administration and will be used in a hospital setting by appropriate healthcare personnel.

Glucosalina Mein is administered by infusion.

The contents of each Glucosalina Mein container are intended for single use only.

Once the container has been opened, the solution should be administered immediately. Any unused portion must be discarded.

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

Rate of administration:

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

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

The infusion rate should not exceed the patient's glucose oxidative capacity in order to avoid hyperglycaemia. Therefore, the maximum dose ranges from 5 mg/kg/min in adults to 10–18 mg/kg/min in infants and children, depending on age and total body mass.

To administer the solution, and especially when adding medications, maximum aseptic technique must be maintained.

When adding medications to the solution or administering simultaneously with other drugs, compatibility must be verified.

It has been reported that the glucosaline solution containing 3.5% glucose and 0.35% sodium chloride is incompatible with mitomycin due to the low pH of this solution.

In addition, incompatibilities have been observed with various isotonic glucosaline solutions when mixed with: sodium amoxicillin, sodium heparin, sodium imipenem-cilastatin, and meropenem. However, these medications may be compatible with this type of solution depending on various factors such as drug concentration (sodium heparin) or the time elapsed between reconstitution and administration (sodium amoxicillin, sodium imipenem-cilastatin, and meropenem).

Furthermore, incompatibilities have been reported when certain drugs are diluted in glucose-containing solutions, including: sodium ampicillin, amrinone lactate, sodium amoxicillin/clavulanic acid, interferon alfa-2b, and procainamide hydrochloride. However, amrinone lactate or sodium amoxicillin/clavulanic acid may be directly injected into the infusion site while these perfusion solutions are being administered.

Incompatibilities have also been described when certain drugs are diluted in chloride-containing solutions, including amsacrine and trimetrexate glucuronate.

General advice

Monitoring of fluid balance, serum glucose, serum sodium, and other electrolytes may be required before and during administration, particularly in patients with increased non-osmotic release of vasopressin (syndrome of inappropriate antidiuretic hormone secretion, SIADH) and in patients receiving concomitant treatment with vasopressin agonists, due to the risk of hyponatraemia.

Monitoring of serum sodium is especially important with products having a lower sodium concentration compared to serum sodium levels. Following infusion of Glucosalina Mein, there is rapid and active transport of glucose into body cells. This condition promotes an effect akin to the administration of free water and may lead to severe hyponatraemia.