Hospasol 145 mmol/L solution for infusion

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

HOSPASOL® 145 mmol/l Solution for infusion

Sodium bicarbonate

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if it is a side effect not listed in this leaflet. See section 4.

Leaflet contents:

1. What Hospasol 145 mmol/l is and what it is used for
2. What you need to know before using Hospasol 145 mmol/l
3. How to use Hospasol 145 mmol/l
4. Possible side effects
5. How to store Hospasol 145 mmol/l
6. Contents of the pack and other information

1. What Hospasol 145 mmol/l is and what it is used for

Hospasol 145 mmol/l is used in hospitals or specialized centers during dialysis sessions to correct the chemical imbalance in the blood caused by renal failure.

It replenishes the bicarbonate lost by the body during:

• Acetate-Free Biofiltration (AFB) or
• Acetate-Free Continuous Veno-Venous Hemofiltration (AFCVVHF).

It also helps restore the body's bicarbonate levels, which are lost when the kidneys do not function properly (renal failure).

2. What you need to know before starting to use Hospasol 145 mmol/l

Do not use Hospasol 145 mmol/l

If you are undergoing a dialysis method that uses a supplementary buffer.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Hospasol 145 mmol/l. It is important to monitor the concentration of salts (electrolytes) in the blood, as well as the body's acid-base balance. Therefore, blood composition should be checked regularly.

Pay special attention to the following:

• The pH value of the blood. In case of high pH (alkalosis), Hospasol 145 mmol/l must not be used.

• The level of sodium in the blood, especially if you have heart and/or kidney failure. Excess sodium may lead to fluid retention in the body (hypervolemia) and particularly in the lungs (pulmonary edema).

• The blood vessels, since inflammation associated with thrombus formation (thrombophlebitis) may occur if the product is administered into a small peripheral vein.

• The levels of proteins, amino acids, and water-soluble vitamins in the blood, as significant losses may occur during dialysis.

Use of Hospasol 145 mmol/l with other medicines

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

This is important because the blood concentration of some of these medicines may decrease during treatment with Hospasol 145 mmol/l. Your doctor will decide whether any adjustment of your medications is necessary.

Pregnancy, breastfeeding, and fertility

There are no adequate data on the use of Hospasol 145 mmol/l in pregnant or breastfeeding women.

If you are pregnant or breastfeeding, your doctor will decide whether you should undergo treatment with Hospasol 145 mmol/l.

Driving and using machines

Hospasol 145 mmol/l has no influence on the ability to drive or operate machinery.

3. How to use Hospasol 145 mmol/l

Hospasol 145 mmol/l is a product used in hospitals or specialized centers with dialysis equipment. It must only be administered by medical professionals.

The volume of Hospasol 145 mmol/l, and therefore the dose used, will depend on the patient's condition. The physician responsible for the treatment must determine the dose volume.

Do not use Hospasol 145 mmol/l if the solution is cloudy or if the packaging is damaged.

All seals must be intact.

If you use more Hospasol 145 mmol/l than you should

An overdose may lead to abnormally low levels of potassium (hypokalaemia) and/or glucose (hypoglycaemia) in the blood. If an overdose occurs, administration of Hospasol 145 mmol/l must be stopped immediately and dialysis should be performed. Continuous monitoring of blood gases should be carried out.

Your doctor will take the necessary corrective measures and adjust the dose accordingly.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

There are some adverse effects that may be related to the hemodialysis process, for example:

• nausea
• vomiting
• muscle cramps
• high blood pressure (hypertension)
• chills
• fever

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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 Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Hospasol 145 mmol/l

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

Do not store below +4°C.

Do not use Hospasol 145 mmol/l after the expiry date stated on the label and on the container. The expiry date is the last day of the month indicated.

Hospasol 145 mmol/l may be disposed of via wastewater without causing any harm to the environment.

6. Contents of the container and additional information

Composition of Hospasol 145 mmol/l

The active substance is:

1000 ml of solution contains: Sodium bicarbonate 12.18 g

Which corresponds to:

Sodium, Na+ 145 mmol/l (145 mEq/l)

Bicarbonate, HCO3 145 mmol/l (145 mEq/l)

Theoretical osmolarity: 290 mOsm/l

The other components are:

• Carbon dioxide (for pH adjustment)
• Water for injections

Appearance of the product Hospasol 145 mmol/l and contents of the container

Hospasol 145 mmol/l comes in a single-compartment bag. The solution is clear and colourless.

Each bag contains 3000 ml or 5000 ml of infusion solution. The bag is wrapped in transparent film.

Each carton contains three 3000 ml bags or two 5000 ml bags and one package leaflet.

Marketing Authorization Holder

Vantive Belgium SRL

Boulevard d’Angleterre, 2

1420 Braine-l’Alleud

Belgium

Manufacturer

BIEFFE MEDITAL S.P.A.

Via Stelvio 94

23035 Sondalo (SO)

Italy

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Vantive Health, SL

c/ Pouet de Camilo, 2

46394 Ribarroja del Turia

Valencia

Spain

Date of the most recent review of this leaflet:

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.es

_______________________________________________________________________

This information is intended for healthcare professionals only:

Hospasol® 145 mmol/l infusion solution

A buffer-free dialysis solution (free from acetate and bicarbonate) must be used. A dialysis solution with an appropriate composition for Acetate-Free Biofiltration must be selected.

A buffer-free substitution fluid (free from acetate and bicarbonate) must be used. A substitution fluid with an appropriate composition for Acetate-Free Continuous Veno-Venous Hemofiltration must be selected.

Hospasol 145 mmol/l must be administered alone, without adding any other medicinal product, particularly solutions containing calcium or magnesium, as this could cause precipitation of calcium or magnesium carbonate.

Hospasol 145 mmol/l is infused into the venous return line or into the extracorporeal circuit either before (pre-dilution) or after (post-dilution) the hemofilter.

The responsible physician must determine the volume, flow rate, and duration of dialysis.

Typical flow rates used in Acetate-Free Biofiltration are:

• Adults, adolescents, and elderly patients: 2000 to 2500 ml/hour
• Children: 40 to 60 ml/kg/hour

Typical flow rates used in Acetate-Free Continuous Veno-Venous Hemofiltration are:

• Adults, adolescents, and elderly patients: 100 to 600 ml/hour
• Children: 2 to 12 ml/kg/hour

Instructions for Use and Handling

Hospasol 145 mmol/l is indicated for use only with dialysis machines specifically designed for Acetate-Free Biofiltration (a special hemodialysis technique) or for Acetate-Free Continuous Veno-Venous Hemofiltration.

Consult the dialysis machine’s instructions for use before initiating treatment with Hospasol 145 mmol/l.

Do not remove from the packaging until ready for use.

Hospasol 145 mmol/l should only be used if the solution is clear, free from particles, and all seals are intact.

Aseptic techniques must be used throughout the administration process.

Before connecting, and after removing the cap from the bag connector (the safety connector - safelink), disinfectant should be applied to the inside of the connector.

Before disconnecting, it is recommended to disinfect the external surfaces of the line connector and the safety connector (safelink).

The solution is for single use only. Immediately discard any unused portion.

From a microbiological standpoint, once opened, the product should be used immediately. If not used immediately, the user assumes responsibility for the storage time and conditions prior to use.