Apiroserum Glucosalino 1/5 solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Apiroserum Glucosalino 1/5 infusion solution

Glucose - Sodium chloride

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms of illness, as it may harm them.
• If you experience any adverse effects, consult your doctor or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Apiroserum Glucosalino 1/5 is and what it is used for
2. What you need to know before using Apiroserum Glucosalino 1/5
3. How to use Apiroserum Glucosalino 1/5
4. Possible side effects
5. How to store Apiroserum Glucosalino 1/5
6. Contents of the pack and other information

1. What Apiroserum Glucosalino 1/5 is and what it is used for

Apiroserum Glucosalino 1/5 is a rehydration solution belonging to the group of intravenous solutions that affect electrolyte balance.

Apiroserum Glucosalino 1/5 is indicated for:

• Hypertonic or isotonic dehydration
• Mild alkalosis
• Vehicle solution for compatible electrolyte concentrates and medications
• Partial coverage of energy requirements

2. What you need to know before starting to use Apiroserum Glucosaline 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 conditions of hyperhydration (excess fluid in the body).
• In cases 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 concentration of solutes in the blood).
• In states of hyperlactacidemia (elevated lactic acid levels in blood).
• In severe cases of cardiac, hepatic, or renal failure (impaired function of the heart, liver, or kidneys, respectively).
• During the first 24 hours following a head injury.

Warnings and precautions

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

Apiroserum Glucosalino 1/5 should be completely or partially administered immediately after connecting the infusion set to the vial, to avoid potential contamination.

If this product is mixed with other medications, maximum aseptic technique must be maintained during the addition of such drugs to intravenous fluids, and these mixtures should be used within 6 hours of preparation.

• Regular blood tests to monitor glucose levels, electrolytes, fluid balance, and acid-base equilibrium are advisable, since frequent and large-volume administration of glucose-saline solutions may lead to fluid overload (hyperhydration), disturbances in acid-base balance, 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 such cases, administration of electrolyte supplements may be necessary. For this reason, regular monitoring of blood glucose, serum electrolytes, fluid balance, and acid-base equilibrium is recommended. To prevent hypokalemia during prolonged infusions with glucose-saline solutions, it is advisable as a safety measure to add potassium to the solution.

• Blood glucose concentration should be carefully monitored during episodes of increased intracranial pressure.

• This medicine should 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 if your heart, liver, and/or kidneys are not functioning properly, especially if you are elderly.

• Apiroserum Glucosalino 1/5 should be administered with caution in premature infants and full-term neonates.

• This medicine must not be administered if you have suffered an acute ischemic stroke (sudden reduction or absence of blood supply to the brain).

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

• Administration of glucose-containing solutions such as this may cause vitamin B1 (thiamine) deficiency, particularly in cases of malnutrition.

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

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

Interaction of Apiroserum Glucosalino 1/5 with other medicines

Inform your doctor if you are taking, have recently taken, or might need to take any other medicine.

If Apiroserum Glucosaline 1/5 is mixed with other substances, additional incompatibilities may occur.

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 glucose levels.
• Corticosteroids, due to the risk of increased blood glucose or the ability of these medicines to retain sodium and water.
• Digitalis glycosides (digoxin), as an increase in digitalis activity may occur, with a risk of developing toxicity.
• Lithium carbonate, since administration of sodium chloride accelerates renal excretion of lithium, leading to a reduction in its therapeutic effect.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

During pregnancy, your doctor will decide whether the use of glucose-saline 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 (high levels of insulin in blood), and acidosis in the fetus, and consequently may be harmful to the newborn.

There is no evidence suggesting that Apiroserum Glucosalino 1/5 may cause adverse effects in the neonate during breastfeeding. Nevertheless, it is recommended to use with caution during this period.

Driving and use of machines

There are no known effects of this medicine on the ability to drive or operate machinery.

3. How to use Apiroserum Glucosalino 1/5

Follow exactly the instructions for administration of this medicine as given by your doctor. If in doubt, consult your doctor again.

Apiroserum Glucosalino 1/5 is supplied as a solution for infusion (intravenous drip injection).

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

Your doctor will decide the dose and frequency at which the solution will be administered, always adjusting the average infusion rate according to the patient's clinical need, depending on age, body weight, clinical condition, blood glucose levels, and water-electrolyte and acid-base balance.

In adults, the recommended dose is between 500 ml and 3 litres every 24 hours, administered at an approximate rate of 30 to 60 drops per minute (1.5 to 3 ml/min). The maximum infusion rate is 5 ml/kg body weight/hour = 0.24 g of 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 infusion rate depends on the child's age and weight, and generally should not exceed: 10–18 mg of glucose (0.2–0.38 ml of solution)/kg/min.

If you use more Apiroserum Glucosaline 1/5 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 imbalances, and acid-base disturbances. In such cases, administration must be discontinued and symptomatic treatment initiated.

If symptoms related to adverse effects arise due to failure to meet these requirements, administration must be stopped and symptomatic treatment initiated.

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

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

4. Possible adverse effects

Like all medicines, Apiroserum Glucosalino 1/5 may cause adverse effects, although not everyone will experience them.

If Apiroserum Glucosalino 1/5 is administered too rapidly, it may cause dehydration.

If the solution is administered correctly and under control, the only possible complications are those related to the intravenous administration technique, including fever, infection at the injection site, pain, reaction and/or irritation at the injection site, venous thrombosis or phlebitis extending from the injection site, extravasation, and hypervolemia.

Frequencies of the possible adverse effects described are not established, due to the lack of clinical studies conducted with Apiroserum Glucosalino 1/5.

When used as a vehicle for the administration of other medicinal products, the nature of the added drugs will determine the likelihood of additional adverse effects.

In the event of adverse reactions, the infusion must be discontinued.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Apiroserum Glucosalino 1/5

Store below 25°C.

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

Do not use this medicine after the expiry date stated on the container after “EXP”. The expiry date refers to the last day of the month indicated.

Do not use Apiroserum Glucosalino 1/5 if the solution is not clear or contains precipitates.

Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be returned to the SIGRE Point at your pharmacy. If you are unsure, please consult your pharmacist on how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Apiroserum Glucosalino 1/5

The active substances 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 injections, q.s.

Milliequivalents/litre:

Chloride ion 30.8 mEq; Sodium ion 30.8 mEq

Calories: 188 kcal/litre

Osmolality: 320 mOsmol/litre

Appearance of the product and contents of the pack

Apiroserum Glucosalino 1/5 is a clear, transparent, colourless solution. It is available in:

Bottles of 250 ml and 500 ml.

Clinical pack containing 12 bottles of 250 ml and 500 ml.

Marketing Authorisation Holder

Fresenius Kabi España, S.A.U.

Torre Mapfre – Vila Olímpica

C/ Marina 16-18, 08005-Barcelona

Spain

Manufacturer

Fresenius Kabi Italia S.r.l.

Via Camagre, 41/43

37063 Isola della Scala - Verona

Italy

Date of latest revision of this leaflet: February 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

This information is intended for healthcare professionals only:

Apiroserum Glucosalino 1/5 is supplied as a solution for intravenous administration and will be used in a hospital setting by qualified healthcare personnel.

Apiroserum Glucosalino 1/5 is administered by infusion.

The contents of each container of Apiroserum Glucosalino 1/5 are intended for single use only.

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

The solution should be clear and free from precipitates. Do not administer if this is not the case.

Rate of administration:

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

In children, epicranial veins or veins on the back of the hand or foot are preferred. The recommended doses are as follows:

Infants and children:

• 0 to 10 kg body weight: 100 ml/kg/24 h
• 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 infusion rate depends on age and body weight, and generally should not exceed: 10–18 mg of glucose (0.2–0.38 ml of solution)/kg/min.

The infusion rate should not exceed the patient's capacity for glucose oxidation in order to avoid hyperglycaemia.

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

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

Apiroserum Glucosalino 1/5 must not be administered using the same infusion set, either simultaneously, before, or after a blood transfusion, due to potential incompatibilities.

In addition, incompatibilities have been reported for various isotonic glucose-saline solutions with: sodium amoxicillin, sodium heparin, sodium imipenem-cilastatin, and meropenem. However, these drugs may be compatible with this type of solution depending on various factors such as drug concentration (sodium heparin) or the time interval between reconstitution and administration (sodium amoxicillin, sodium imipenem-cilastatin, and meropenem).

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

Incompatibilities have also been reported when certain drugs are diluted in chloride-containing solutions. These include amsacrine and trimetrexate glucuronate.