PATIENT INFORMATION LEAFLET

HOSPASOL®145 mmol/l Infusion Solution

Sodium Bicarbonate

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

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

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

Replenishes the bicarbonate that the body loses during:

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

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

Do not use Hospasol 145 mmol/l

If you are undergoing treatment with 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 essential to monitor the concentration of salts (electrolytes) in the blood, as well as the acid-base balance of the body. Therefore, the blood composition should be checked regularly.

Pay special attention to the following:

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

The level of sodium in the blood, if you have heart and/or kidney failure. A sodium overdose can cause fluid retention within the body (hypervolemia) and particularly in the lungs (pulmonary edema).

The blood vessels, as it may cause inflammation associated with thrombus formation (thrombophlebitis) if the product is administered through a small peripheral vein.

The level 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 medications

Inform your doctor, pharmacist or nurse if you are using, have used recently or may need to use any other medication.

You should do this because the concentration of some of these medications in the blood may decrease during treatment with Hospasol 145 mmol/l. Your doctor will decide if any of the medications need to be changed.

Pregnancy, breastfeeding and fertility

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

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

Driving and operating machines

Hospasol 145 mmol/l has no effect whatsoever on the ability to drive and operate machines.

Hospasol 145 mmol/l is a product used in hospitals or specialized centers with dialysis equipment. It should 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 treating physician should determine the volume of the dose.

Do not useHospasol 145 mmol/l if the solution is cloudy or if the packaging shows any damage.

All seals must be intact.

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

A overdose may lead to a too low concentration of potassium (hypokalemia) and/or glucose (hypoglycemia) in the blood. If an overdose occurs, administration of Hospasol 145 mmol/l should be stopped immediately and dialysis should be performed. Continuous blood gas monitoring should be carried out.

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

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

There are some adverse effects that may be due to thehemodialysis processes, for example:

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not store below + 4°C.

Do not use Hospasol 145 mmol/l after the expiration date that appears on the label and on the packaging. The expiration date is the last day of the month indicated.

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

Composition of Hospasol 145 mmol/l

Theactive principleis:

1000 ml of solution contain: Sodium bicarbonate 12.18 g

Which corresponds to

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

Bicarbonate, HCO3145 mmol/l (145 mEq/l)

Theoretical osmolarity: 290 mOsm/l

Theother componentsare:

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

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

Hospasol 145 mmol/l comes in a single compartment bag. The solution is transparent and colorless.

Each bag contains a 3000 ml or 5000 ml dialysis solution. The bag is wrapped in transparent film.

Each box contains three 3000 ml bags or two 5000 ml bags and a 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

You can request more information about this medication by contacting 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 last review of this leaflet:

The detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es

_______________________________________________________________________

This information is intended solely for healthcare professionals:

Hospasol 145 mmol/l dialysis solution

It is essential to use a bicarbonate-free dialysis solution (that does not contain acetate or bicarbonate). A dialysis solution with an appropriate composition for Free Acetate Biofiltration should be selected.

It is essential to use a bicarbonate-free substitution fluid (that does not contain acetate or bicarbonate). A substitution fluid with an appropriate composition for Continuous Veno-Venous Hemofiltration Free Acetate should be selected.

Hospasol 145 mmol/l should only be administered without adding any other medication, particularly solutions containing calcium or magnesium, as they may cause precipitation of calcium or magnesium carbonate.

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

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

The usual flow rates for Free Acetate Biofiltration are:

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

The usual flow rates for Continuous Veno-Venous Hemofiltration Free Acetate are:

• Adults, adolescents, and elderly: 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 in dialysis machines specifically designed for Free Acetate Biofiltration (special technique of hemodialysis) or for Continuous Veno-Venous Hemofiltration Free Acetate.

Consult the dialysis machine instructions before starting treatment with Hospasol 145 mmol/l.

Do not remove from packaging until ready to use.

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

Asptic techniques should be used throughout the administration process to the patient.

Before connecting and after removing the cap from the bag connector (safety connector), 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.

The solution is for single use only. Dispose of any unused remainder immediately.

From a microbiological point of view, once opened, the product should be used immediately. If not used immediately, the user will be responsible for the time and storage conditions prior to its use.