PATIENT INFORMATION LEAFLET

HOSPASOL®167 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 167 mmol/l is used in hospitals or special centers during dialysis sessions to correct the chemical imbalance in 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 167 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 167 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 167 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 in 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 167 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 167 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 167 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 167 mmol/l.

Driving and operating machines

Hospasol 167 mmol/l has no effect on your ability to drive and operate machines.

Hospasol 167 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 167 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 167 mmol/l if the solution is cloudy or if the packaging shows any damage. All seals must be intact.

If you use more Hospasol 167 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 167 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 about possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines 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 167 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 167 mmol/l may be disposed of with wastewater without causing any harm to the environment.

Composition of HOSPASOL 167 mmol/l

Theactive principleis:

1000 ml of solution contain: Sodium bicarbonate 14.0 g

Which corresponds to

Sodium, Na+167 mmol/l (167 mEq/l)

Bicarbonate, HCO3167 mmol/l (167 mEq/l)

Theoretical osmolality: 334 mOsm/l

Theother componentsare:

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

Appearance of the product Hospasol 167 mmol/l and contents of the package

Hospasol 167 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

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

Last review date of this leaflet:

The detailed and updated information about this medicinal product 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 medical professionals or healthcare professionals:

HOSPASOL®167 mmol/l dialysis solution

It is essential to use a dialysis solution without a buffer (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 substitution fluid without a buffer (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 167 mmol/l should only be administered without adding any other medication, in particular, solutions containing calcium or magnesium, as they may cause precipitation of calcium or magnesium carbonate.

Hospasol 167 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 must determine the volume, flow rate, and duration of dialysis.

The usual flow rates for Free Acetate Biofiltration are:

• Adults, adolescents, and elderly: 1500 to 2000 ml/hour
• Children: 30 to 40 ml/kg/hour

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

• Adults, adolescents, and elderly: 85 to 530 ml/hour
• Children: 1.70 to 10.5 ml/kg/hour

USE AND HANDLING INSTRUCTIONS

Hospasol 167 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 167 mmol/l.

Do not remove from packaging until ready to use.

Hospasol 167 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 it.

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 must be used immediately. If not used immediately, the user will be responsible for the time and storage conditions prior to its use.