Hospasol 167 mmol/L solution for infusion

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

HOSPASOL® 167 mmol/l Solution for infusion

Sodium bicarbonate

Read the entire 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 adverse reactions, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Leaflet contents:

1. What Hospasol 167 mmol/l is and what it is used for
2. What you need to know before using Hospasol 167 mmol/l
3. How to use Hospasol 167 mmol/l
4. Possible adverse effects
5. How to store Hospasol 167 mmol/l
6. Contents of the pack and other information

1. What Hospasol 167 mmol/l is and what it is used for

Hospasol 167 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 167 mmol/l

Do not use Hospasol 167 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 167 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 167 mmol/l must not be used.

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

• The blood vessels, since administration into a small peripheral vein may induce inflammation associated with thrombus formation (thrombophlebitis).

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

Use of Hospasol 167 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 necessary because the blood concentration of some of these medicines may be reduced during treatment with Hospasol 167 mmol/l. Your doctor will decide whether any of your medicines need to be adjusted.

Pregnancy, breastfeeding, and fertility

There are no adequate data on the use of Hospasol 167 mmol/l in pregnant or breastfeeding women.

If you are pregnant or breastfeeding, your doctor will decide whether you should receive treatment with Hospasol 167 mmol/l.

Driving and using machines

Hospasol 167 mmol/l has no influence on the ability to drive or use machines.

3. How to use Hospasol 167 mmol/l

Hospasol 167 mmol/l is a product used in hospitals or specialized centers equipped with dialysis equipment. It must 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 physician in charge of the treatment must determine the dose volume.

Do not use Hospasol 167 mmol/l if the solution is cloudy or if the packaging is damaged. All seals must be intact.

If you use more Hospasol 167 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 167 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 167 mmol/l

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

Do not store below 4°C.

Do not use Hospasol 167 mmol/l after the expiry date stated on the label and packaging. The expiry date refers to the last day of the month indicated.

Hospasol 167 mmol/l may be disposed of via wastewater without causing any harm to the environment.

6. Contents of the pack and other information

Composition of HOSPASOL 167 mmol/l

The active substance is:

1000 ml of solution contains: Sodium bicarbonate 14.0 g

Corresponding to:

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

Bicarbonate, HCO3 167 mmol/l (167 mEq/l)

Theoretical osmolarity: 334 mOsm/l

The other components are:

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

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

Hospasol 167 mmol/l comes in a single-compartment bag. The solution is clear and colourless.

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

Each carton contains three 3000 ml bags or two 5000 ml bags and a 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 revision of this leaflet:

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

This information is intended for healthcare professionals only:

HOSPASOL® 167 mmol/l solution for infusion

A buffer-free dialysis solution (containing neither acetate nor bicarbonate) must be used. A dialysis solution with a composition appropriate for Acetate-Free Biofiltration must be selected.

A buffer-free replacement fluid (containing neither acetate nor bicarbonate) must be used. A replacement fluid with a composition appropriate for Acetate-Free Continuous Veno-Venous Hemofiltration must be selected.

Hospasol 167 mmol/l must be administered alone, without adding any other medicinal product, particularly solutions containing calcium or magnesium, as these could cause precipitation of calcium or magnesium carbonate.

Hospasol 167 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 for Acetate-Free Biofiltration are:

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

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

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

INSTRUCTIONS FOR USE AND HANDLING

Hospasol 167 mmol/l is indicated for use only in dialysis machines specifically designed for Acetate-Free Biofiltration (a special hemodialysis technique) or for Acetate-Free Continuous Veno-Venous Hemofiltration.

Refer to the dialysis machine's instructions for use before starting treatment with Hospasol 167 mmol/l.

Do not remove from the packaging until ready to use.

Hospasol 167 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 safelink 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 safelink connector.

The solution is for single use only. Any unused portion should be discarded immediately.

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