Hemosol B0 solution for hemofiltration and hemodialysis: detailed information

Brand name Hemosol B0 solution for hemofiltration and hemodialysis

Form solution for hemofiltration

Active substance / Dosage

CALCIUM CHLORIDE DIHYDRATE · 5145 mg

MAGNESIUM CHLORIDE HEXAHYDRATE · 2033 mg

SODIUM BICARBONATE · 3090 mg

SODIUM CHLORIDE · 6450 mg

SODIUM LACTATE · 5400 mg

Prescription type Hospital Use Only

ATC code

B05Z B05ZB

Registration number 62900

Manufacturer Vantive Belgium

Hemosol B0 solution for hemofiltration and hemodialysis solution for hemofiltration

Table of Contents

Package leaflet: Information for the user
Introduction
1. What Hemosol B0 is and what it is used for
2. Before using Hemosol B0
3. How to use Hemosol B0
4. Possible adverse effects
5. Storage of Hemosol B0
6. Additional Information

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Hemosol B0 solution for haemodialysis and haemofiltration

Sodium chloride/calcium chloride dihydrate/magnesium chloride hexahydrate/lactic acid/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, ask your doctor, pharmacist or nurse.
If you experience any side effects, talk to your doctor, pharmacist or nurse, even if it is a side effect not listed in this leaflet. See section 4.

In this leaflet:

What Hemosol B0 is and what it is used for
What you need to know before using Hemosol B0
How to use Hemosol B0
Possible side effects
How to store Hemosol B0
Contents of the pack and other information

1. What Hemosol B0 is and what it is used for

Hemosol B0 is used in hospitals during intensive care treatments to correct chemical imbalances in the blood caused by renal failure. The aim of these treatments is to remove waste products from the blood that accumulate when the kidneys do not function properly.

Hemosol B0 is used in the following types of treatment for adults and children of all ages:

hemofiltration,
hemodiafiltration, and
hemodialysis.

2. Before using Hemosol B0

Do not use Hemosol B0:

If you are allergic to one of the active substances or to any of the other components (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Hemosol B0.

Hemosol B0 is a hospital-use product that must only be administered by medical professionals. They will ensure that the medicine is used safely.

Blood status will be checked before and during treatment. For example, acid-base balance and blood electrolyte concentrations will be monitored, including all fluid inputs (intravenous infusion) and outputs (diuresis), even those not directly related to the treatment.

Since Hemosol B0 does not contain potassium, special attention must be paid to blood potassium levels. If levels are low, potassium supplementation may be required.

Children

There are no specific warnings or precautions for children related to the use of this medicine.

Use of Hemosol B0 with other medicines

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

This is necessary because blood concentrations of certain medicines may decrease during treatment with Hemosol B0. Your doctor will decide whether any of your medications need to be adjusted.

Specifically, talk to your doctor if you are taking any of the following medicines:

Digitalis preparations (used to treat certain heart failures), as the risk of cardiac arrhythmias induced by these medicines increases when blood potassium levels are low (hypokalaemia).
Vitamin D and medicines containing calcium, as they may increase the risk of high blood calcium levels (hypercalcaemia).
Any bicarbonate solution supplement (or other buffered source), as this may increase the risk of basic compounds in the blood (metabolic alkalosis).

When citrate is used as an anticoagulant, it may reduce plasma calcium levels.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. No effects on fertility, pregnancy, or newborns/infants are expected. Your doctor will decide whether Hemosol B0 should be administered if you are pregnant or breastfeeding.

Driving and using machines

Hemosol B0 does not affect the ability to drive or operate machinery.

3. How to use Hemosol B0

Hemosol B0 is a product that should only be administered by medical professionals.

The volume of Hemosol B0, and therefore the dose used, will depend on your condition. The dose volume will be determined by the physician in charge of treatment.

Hemosol B0 can be administered directly into the bloodstream (intravenously) or during hemodialysis, a technique in which the solution flows on one side of the dialysis membrane while blood flows on the other.

If you are given more Hemosol B0 than you should

Hemosol B0 is a hospital-use product that should only be administered by medical professionals. In addition, careful monitoring of fluid balance, electrolyte balance, and acid-base balance is carried out.

Therefore, it is unlikely that you will receive more Hemosol B0 than required.

In the unlikely event that an overdose is administered, the physician will take the necessary corrective measures and adjust the dose accordingly.

An overdose may result in:

fluid overload in the blood,
increased blood bicarbonate levels (metabolic alkalosis),
and/or reduced levels of salts in the blood (hypophosphatemia, hypokalemia).

For instructions for use, see section “This information is intended for healthcare professionals only”.

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 can cause adverse effects, although not everyone experiences them.

The following adverse effects have been reported:

Frequency not known (cannot be estimated from available data)

Changes in blood electrolyte levels (electrolyte imbalances, such as, for example, hypophosphatemia, hypokalemia).
Increased concentration of bicarbonate in plasma (metabolic alkalosis) or reduced concentration of bicarbonate in plasma (metabolic acidosis).
Abnormally high or low body water volume (hyper- or hypovolemia).
Nausea.
Vomiting.
Muscle cramps.
Low blood pressure (hypotension).

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: www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Hemosol B0

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

Do not use this medicine after the expiry date stated on the back of the bag and on the label after EXP. The expiry date refers to the last day of the month indicated.

Do not store at temperatures below 4°C.

The physical and chemical stability of the reconstituted solution has been demonstrated for 24 hours when stored at 22°C. From a microbiological standpoint, the reconstituted solution should be used immediately. The use of the solution stored under other conditions and for longer periods is the responsibility of the user and should not exceed 24 hours, including the duration of administration.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Additional Information

HEMOSOL B0 – PVC WITH LUER CONNECTOR AND VALVE

Composition of Hemosol B0

The active substances before and after reconstitution are:

Active substances before reconstitution:

1000 ml of solution in the small compartment (A) contains:

Calcium chloride, 2H2O 5.145 g

Magnesium chloride, 6H2O 2.033 g

Lactic acid 5.4 g

1000 ml of solution in the large compartment (B) contains:

Sodium bicarbonate 3.09 g

Sodium chloride 6.45 g

Active substances after reconstitution:

The solutions from compartments A (250 ml) and B (4750 ml) are mixed to produce a reconstituted solution (5000 ml) with the following composition:

mmol/l

Calcium, Ca2+ 1.75

Magnesium, Mg2+ 0.5

Sodium, Na+ 140

Chloride, Cl- 109.5

Lactate 3

Bicarbonate, HCO3- 32

Theoretical osmolarity: 287 mOsm/l

Other components are: carbon dioxide (E-290) and water for injectable preparations.

Appearance of the product and contents of the pack

Hemosol B0 is supplied in a two-compartment bag. The bag is covered by a transparent overwrap.

The final reconstituted solution is obtained after breaking the breakable rod and mixing both solutions.

The reconstituted solution is clear and colourless. Each bag (A+B) contains 5000 ml of solution for haemofiltration, haemodiafiltration and/or haemodialysis.

Each carton contains two bags and a leaflet.

Marketing Authorisation 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

or

Vantive Manufacturing Limited
Moneen Road,
Castlebar, Co. Mayo F23 XR63
Ireland

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

Vantive Health, S.L.
Polígono industrial sector 14
C/ Pouet de Camilo nº2
46394 Ribarroja del Turia
Valencia
Spain

This medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:

Germany, Austria, Belgium, Bulgaria, Croatia, Cyprus, Denmark, Slovakia, Slovenia, Spain, Estonia, Finland, France, Greece, Iceland, Ireland, Latvia, Lithuania, Luxembourg, Malta, Norway, Netherlands, Poland, Portugal, United Kingdom (Northern Ireland), Czech Republic and Sweden: Hemosol B0.

Date of latest review of this leaflet: 11/2018

__________________________________________________________________________

This information is intended for healthcare professionals only

Hemosol B0 solution for haemodialysis and haemofiltration

Precautions

You must follow exactly the instructions for use and handling of Hemosol B0.

The solutions from the two compartments must be mixed before use. The use of a contaminated haemofiltration solution may cause sepsis, shock and fatal disorders.

To increase patient comfort, Hemosol B0 may be warmed up to 37°C. Pre-warming of the solution should be performed before reconstitution using dry heat only. Solutions must not be warmed in water or in a microwave oven. Before administration, and whenever the solution and container permit, visually inspect the solution for particulate matter and any change in colour. Do not administer the solution unless it is clear and the seal is intact.

The addition of replacement sodium bicarbonate may increase the risk of metabolic alkalosis.

Careful monitoring of electrolyte and acid-base balance is required before and during treatment. Since Hemosol B0 does not contain potassium, serum potassium concentration must be monitored before and after haemofiltration and/or haemodialysis. Potassium supplementation may be necessary.

Up to 1.2 mmol/l of phosphate may be added to the solution. If potassium phosphate is added, the total potassium concentration must not exceed 4 mEq/l (4 mmol/l).

The volume and rate at which Hemosol B0 is used depend on blood electrolyte concentrations, acid-base balance and the patient's overall clinical condition. The administration regimen (dose, infusion rate and cumulative volume) of Hemosol B0 must be determined by a physician. Continuous application of haemofiltration will remove excess fluid and electrolytes.

In cases of fluid imbalance, the clinical status should be closely monitored and fluid balance corrected as necessary.

Overdose will result in fluid overload in patients with renal insufficiency, which could have very serious consequences such as congestive heart failure or disturbances in acid-base or electrolyte balance.

The solution does not contain glucose, so its administration may cause hypoglycaemia. Blood glucose levels should be monitored regularly.

Hemosol B0 contains bicarbonate and lactate (a precursor of bicarbonate), which may affect the patient's acid-base balance. If metabolic alkalosis develops or worsens during treatment with the solution, it may be necessary to reduce the infusion rate or discontinue administration.

Dosage

Commonly used flow rates for replacement solution in haemofiltration and haemodiafiltration are:

Adults: 500–3,000 ml/hour

Commonly used flow rates for dialysis solution (dialysate) in continuous haemodialysis are:

Adults: 500–2,500 ml/hour

Commonly used flow rates in adults are approximately 2,000 to 2,500 ml/h, corresponding to an approximate daily fluid volume of 48 to 60 L.

Paediatric population

The flow rate range for replacement solution in haemofiltration and haemodiafiltration and for dialysis solution (dialysate) in continuous haemodialysis is:

Children (from neonates to adolescents up to 18 years): 1,000 to 2,000 ml/h/1.73 m².

Flow rates up to 4,000 ml/h/1.73 m² may be required, especially in younger children (≤10 kg). In general, the absolute flow rate (in ml/h) in the paediatric population should not exceed the maximum adult flow rate.

Instructions for use and handling

The electrolyte solution (small compartment A) is added to the buffer solution (large compartment B) after breaking the breakable rod immediately before use to obtain the reconstituted solution.

Use only with appropriate extracorporeal renal replacement equipment.

Aseptic technique must be used throughout the handling and administration process.

Use the solution only if the overwrap is undamaged, all seals are intact, the breakable rod is unbroken, and the solution is clear. Squeeze the bag to ensure there are no leaks. If any leak is detected, discard the solution immediately, as sterility cannot be guaranteed.

The large compartment B has an injection port for adding any necessary drugs after reconstitution.

It is the physician's responsibility to assess the compatibility of any drug added to Hemosol B0 solution. This includes checking for possible changes in colour and/or precipitation, insoluble complexes or crystals. Before adding a drug, verify that it is soluble and stable in water within the pH limits of Hemosol B0 (the pH range of the reconstituted solution is 7.0 to 8.5). Additives may not be compatible. Refer to the instructions for use of the drug to be added.

Remove any liquid from the injection port, hold the bag vertically downward, add the drug through the injection port and mix thoroughly. The solution must be administered immediately. Introduction and mixing of additives must always be performed before connecting the solution bag to the extracorporeal circuit.

I Remove the bag from its overwrap immediately before use and discard other packaging materials. Open the seal by breaking the rod located between the two compartments of the bag. The rod will remain inside the bag (see figure I below).

II Ensure that all liquid from the small compartment A passes into the large compartment B (see figure II below).

III Rinse the small compartment A twice by moving the mixed solution back into this compartment and then back into the large compartment B (see figure III below).

IV Once the small compartment A is emptied, shake the large compartment B to ensure complete mixing of its contents. The solution is now ready for use and the bag may be hung on the equipment (see figure IV below).

V The dialysis or replacement line may be connected to either access port.

V.a If using the luer connector, remove the cap by twisting and pulling, then connect the male luer connector of the dialysis or replacement line to the female luer receptor on the bag by pushing and twisting. Ensure the connection is secure and tight. The connector will open. Check that fluid flows freely (see figure V.a below).

If the dialysis or replacement line is disconnected from the luer connector, the connector will close and solution flow will stop. The luer port is a needle-free port that can be cleaned.

V.b If using the injection port, first remove the cap by lifting it. The injection port is a site that can be disinfected with a swab. Then insert the spike through the rubber wall. Check that fluid flows freely (see figure V.b below).

The solution must be used immediately after removing the overwrap. If not used immediately, the reconstituted solution must be used within 24 hours, including treatment duration, after adding the electrolyte solution to the buffer solution.

The reconstituted solution is for single use only. Discard any unused solution immediately after use.

Disposal of unused medicine and all materials that have come into contact with it must be carried out in accordance with local regulations.

Sequence of four diagrams illustrating the steps of manipulating a medical bag through compression, rotation, and inversion to mix the contents

HEMOSOL B0 – PVC WITH LUER CONNECTOR AND BREAKABLE ROD