APIROSERUM GLUCOSALINE 1/5 SOLUTION FOR INFUSION

2. What you need to know before starting to use Apiroserum Glucosalino 1/5

Do not use Apiroserum Glucosalino 1/5

• If you are allergic to the active substances or to any of the other components of this medicine (listed in section 6).
• In situations of hyperhydration (excess fluid in the body).
• In situations of generalized edema (fluid accumulation in body tissues) or ascitic cirrhosis (chronic progressive liver disease with fluid accumulation).
• In states of hyperglycemia (high blood glucose levels).
• In states of hyponatremia (low sodium levels in blood).
• In states of hypochloremia (low chloride levels in blood).
• In states of hypokalemia (low potassium levels in blood).
• In states of hyperosmolar coma (loss of consciousness due to increased salt concentration in blood).
• In states of hyperlactatemia (presence of lactic acid in blood).
• In severe cases of heart, liver, or kidney failure.
• During the first 24 hours after a cranial trauma

Warnings and precautions

Consult your doctor or nurse before starting to use Apiroserum Glucosalino 1/5.

Apiroserum Glucosalino 1/5 should be injected totally or partially once the injector equipment is connected to the vial, to avoid possible contamination.

In case of mixing with other products, maximum asepsis should be maintained during the addition of these medications to the intravenous fluids, and these mixtures should be used within 6 hours of preparation.

• 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 alterations, and significant ionic depletions, including hypomagnesemia (low magnesium levels in blood), hypokalemia (low potassium levels in blood), and hypophosphatemia (low phosphate levels in blood). In these cases, it will be necessary to administer electrolyte supplements. For this reason, it is recommended that regular controls of blood glucose, serum electrolytes, water balance, and acid-base balance be performed. To avoid hypokalemia produced during prolonged perfusions with glucose solutions, it is recommended to add potassium to the solution as a safety measure.

• The blood glucose concentration should be carefully monitored during episodes of intracranial hypertension.

• This medicine should be administered with caution if you have the following diseases: hypertension, heart failure, peripheral or pulmonary edema, renal dysfunction, preeclampsia (symptoms preceding convulsions and blood pressure drop in pregnant women, and if the heart, liver, and/or kidneys are not functioning properly, especially if you are elderly.

• Apiroserum Glucosalino 1/5 will be administered with caution to premature and full-term infants.

• If you have had an acute ischemic attack (decreased or absent blood flow), this medicine should not be administered to you

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

• The administration of glucose-containing solutions like this one can cause vitamin B1 deficiency, especially in cases of malnutrition.

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

• Avoid continuous administration at the same injection site due to the risk of thrombophlebitis.

Interaction of Apiroserum Glucosalino 1/5 with other medicines

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

If Apiroserum Glucosalino 1/5 is mixed with other substances, other incompatibilities may appear.

It is important to 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 or the ability of these medicines to retain sodium and water.
• Digitalis glycosides (digoxin), as increased digitalis activity may occur, 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.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or 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 glucose solution, as it should be used with caution in this case.

Excessive administration of glucose-containing solutions during pregnancy may cause hyperglycemia, hyperinsulinemia (high insulin levels in blood), and acidosis in the fetus, and may be harmful to the newborn.

There is no evidence to suggest that Apiroserum Glucosalino 1/5 may cause adverse effects during breastfeeding in newborns. However, it is recommended to use with caution during this period.

Driving and using machines

There is no indication that this medicine affects the ability to drive and use machines.

3. How to use Apiroserum Glucosalino 1/5

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor again.

Apiroserum Glucosalino 1/5 is presented in the form of a solution that is administered by perfusion (intravenous drip).

Your doctor will monitor 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, always adjusting the average perfusion rate to the patient's clinical need based on age, weight, clinical condition, blood glucose, and hydroelectrolytic and acid-base balance.

In adults, the recommended dose is between 500 ml and 3 liters every 24 hours, and Apiroserum Glucosalino 1/5 will be administered at an approximate rate of 30 to 60 drops per minute (1.5 to 3 ml/min). The maximum perfusion rate is 5 ml/kg body weight/hour = 0.24 g glucose/kg body weight/hour.

Use in 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 weight above 10 kg.

?>20 kg body weight: 1500 ml + 20 ml/kg/24 h for weight above 20 kg

In children, the perfusion rate depends on the age and weight of the child, and generally should not exceed: 10-18 mg glucose (0.2-0.38 ml solution)/kg/min.

If you use more Apiroserum Glucosalino 1/5 than you should

If the administration of the glucose solution is not performed correctly and controlled, some signs of overdose may appear: hyperhydration, electrolyte alterations, and acid-base balance alterations. In these cases, administration will be discontinued and symptomatic treatment will be used.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Phone: 915 620 420.

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

4. Possible side effects

Like all medicines, Apiroserum Glucosalino 1/5 can cause side effects, although not everyone gets them.

If Apiroserum Glucosalino 1/5 is administered too quickly, it can cause dehydration.

If the administration of the solution is performed correctly and controlled, the only possible complications are those derived from the intravenous administration technique, which include fever, infection at the injection site, pain, reaction and/or irritation at the injection site, venous thrombosis or phlebitis that extends from the injection site, extravasation, and hypervolemia.

The frequencies of the possible side effects described are not established, as no clinical studies have been conducted with Apiroserum Glucosalino 1/5.

If used as a vehicle for the administration of other medicines, the nature of the added medicines will determine the likelihood of other side effects.

In case of adverse reactions, perfusion should be discontinued.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is 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 contribute to providing more information on the safety of this medicine.

5. Conservation of Apiroserum Glucosalino 1/5

Keep at a temperature below 25°C.

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

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

Do not use Apiroserum Glucosalino 1/5 if the solution is not transparent and contains precipitates.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and unused medicines in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

6. Contents of the package and additional information

Composition of Apiroserum Glucosalino 1/5

The active ingredients are glucose and sodium chloride. Each ml of solution contains 47 mg of anhydrous glucose (equivalent to 51.7 mg of glucose monohydrate) and 1.8 mg of sodium chloride

The other components (excipients) are: water for injectable preparations, q.s.

Millequivalents/liter:

Chloride ion 30.8 mEq; Sodium ion 30.8 mEq

Calories: 188 kcal/liter

Osmolality: 320 mOsmol/liter

Appearance of the product and contents of the package

Apiroserum Glucosalino 1/5 is a clear, transparent, and colorless solution. It is presented in:

Bottles with 250 and 500 ml.

Clinical package with 12 bottles of 250 and 500 ml.

Marketing authorization holder

Fresenius Kabi España, S.A.U.

Torre Mapfre – Vila Olímpica

C/ Marina 16-18, 08005-Barcelona

Manufacturer

Fresenius Kabi Italia S.r.l.

Via Camagre, 41/43

37063 Isolla della Scala - Verona

Italy

Date of the last revision of this leaflet February 2022

Detailed and updated 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 doctors or healthcare professionals:

Apiroserum Glucosalino 1/5 is presented in the form of a solution for intravenous administration and will be used in a hospital by the corresponding healthcare personnel.

Apiroserum Glucosalino 1/5 will be administered by perfusion.

The contents of each package of Apiroserum Glucosalino 1/5 are for single perfusion.

Once the package is opened, the solution should be administered immediately. The unused fraction should be discarded.

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

Administration rate:

In adults, Apiroserum Glucosalino 1/5 will be administered at an approximate rate of 30 to 60 drops per minute (1.5 to 3 ml/min). The maximum perfusion rate is 5 ml/kg body weight/hour = 0.24 g glucose/kg body weight/hour.

In children, the preferred veins will be epicranial or those on the back of the hand or foot, and the recommended doses are as follows:

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 weight above 10 kg.
• >20 kg body weight: 1500 ml + 20 ml/kg/24 h for weight above 20 kg.

In children, the perfusion rate depends on the age and weight of the child, and generally should not exceed: 10-18 mg glucose (0.2-0.38 ml solution)/kg/min.

The perfusion rate should not exceed the patient's glucose oxidation capacity in order to avoid hyperglycemia.

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

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

Apiroserum Glucosalino 1/5 should not be administered with the same perfusion equipment, nor at the same time, nor before or after a blood transfusion, as incompatibilities may occur.

Similarly, incompatibility samples have been observed for different isotonic glucose solutions with: sodium amoxicillin, sodium heparin, sodium imipenem-cilastatin, 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, sodium imipenem-cilastatin, and meropenem).

On the other hand, incompatibility has been described when some medicines are diluted in solutions containing glucose, including: 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 point while these perfusion solutions are being administered.

Incompatibility has also been described when some medicines are diluted in solutions containing chloride, including: amsacrine and trimetrexate glucuronate