Accusol 35 Potassium 2 mmol/L solution for hemofiltration, hemodialysis and hemodiafiltration

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Accusol 35 Potassium 2 mmol/l, solution for haemofiltration, haemodialysis, and haemodiafiltration

Read the entire leaflet carefully before you are administered 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.
• If you experience any adverse reactions, consult your doctor, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Accusol 35 Potassium 2 mmol/l is and what it is used for
2. What you need to know before being administered Accusol 35 Potassium 2 mmol/l
3. How Accusol 35 Potassium 2 mmol/l is administered
4. Possible adverse reactions
5. How to store Accusol 35 Potassium 2 mmol/l
6. Contents of the pack and other information

1. What Accusol 35 Potassium 2 mmol/l is and what it is used for

Accusol 35 Potassium 2 mmol/l is a solution for hemofiltration, hemodialysis, and hemodiafiltration.

Accusol 35 Potassium 2 mmol/l is indicated in patients with acute or chronic renal failure.

It cleans waste products from the blood; corrects acidosis or alkalinity and abnormal blood electrolyte levels. As a replacement solution in hemodiafiltration and hemofiltration, it may also be used to supply electrolytes and water for hydration.

Accusol 35 solutions are supplied in a two-compartment (bicompartimental) bag that is free of PVC. A long seal (inter-chamber seal) separates the two chambers. Prior to use, the solutions in the two chambers of Accusol 35 must first be mixed by opening the long seal (inter-chamber seal), followed by opening the short SafetyMoon seal located near the access port.

Accusol 35 solutions must be used only under the supervision of a physician.

2. What you need to know before Accusol 35 Potassium 2 mmol/l is administered to you

The doctor will ensure that there is adequate blood access for the procedure and that there is no risk of bleeding.

Accusol 35 solutions are available in different concentrations of potassium and glucose. Blood levels of potassium and glucose will be carefully monitored to ensure that the most appropriate formulation of Accusol 35 is used.

Your doctor will not administer Accusol 35 Potassium 2 mmol/l if:

• you do not have adequate venous and/or arterial access
• you are at high risk of bleeding
• you have high blood bicarbonate levels
• you have excessively low blood potassium levels, unless you are simultaneously receiving potassium supplementation
• you have a medical condition in which blood acidity or alkalinity levels may worsen
• you have a kidney disorder in which waste products cannot be removed from the blood by hemofiltration.

Warnings and precautions

Accusol 35 Potassium 2 mmol/l must only be used by, or under the supervision of, a physician experienced in hemofiltration, hemodialysis, or hemodiafiltration techniques.

Your doctor will:

• measure the acidity, electrolyte levels, and waste product levels in your blood
• ensure that these levels are correct and monitor them closely during treatment
• ensure that your body's fluid balance is properly maintained
• monitor your blood glucose levels closely, especially if you are diabetic
• measure your blood potassium levels regularly
• ensure, before use, that the contents of both chambers are mixed by opening the long seal (the seal between the chambers), followed by opening the short SafetyMoon seal near the access port. If the physician administers an unmixed solution, your blood bicarbonate level may rise. This could cause adverse effects such as nausea, drowsiness, headache, disturbances in heart rhythm, and difficulty breathing.

Other medicines and Accusol 35 Potassium 2 mmol/l

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

The administration of Accusol 35 Potassium 2 mmol/l may affect the action of other medicines.

• If you are diabetic, your blood glucose level must be closely monitored. Your insulin dose will be adjusted as necessary, since this solution contains glucose.
• If you are taking vitamin D or other medications containing calcium, your blood calcium levels may be affected.
• If you are taking additional sodium bicarbonate, there is an increased risk of abnormal salt and alkali levels (alkalosis) in your blood.
• If you are taking heart medications called cardiac glycosides, you may require potassium supplementation. Your doctor will monitor you closely during treatment.

Pregnancy and breastfeeding

Inform your doctor if you are pregnant or breastfeeding. Your doctor must evaluate the benefits of using Accusol 35 Potassium 2 mmol/l against the potential risks.

3. How Accusol 35 Potassium 2 mmol/l is administered

Depending on your treatment, your doctor will administer Accusol 35 Potassium 2 mmol/l through the tubing of the dialysis machine.

The hemofiltration, hemodialysis, or hemodiafiltration treatment you receive will depend on your clinical condition, physical examination, laboratory test results, and response to therapy.

Your doctor will determine the appropriate formula and amount of Accusol 35 solution according to your clinical condition.

Dosage and frequency

Your doctor will decide and adjust the volume and rate of infusion of the solution to be administered.

The amount of fluid required will depend on how Accusol Potassium 2 mmol/l is used.

If you are an adult or elderly patient and

• you are being treated with Accusol 35 Potassium 2 mmol/l as a replacement solution due to chronic renal failure, you should be given 7 to 35 ml/kg/h or more
• you are being treated with Accusol 35 Potassium 2 mmol/l as a replacement solution due to acute renal failure, you should be given 20 to 35 ml/kg/h or more
• you are being treated with Accusol 35 Potassium 2 mmol/l as a dialysis solution due to chronic or acute renal failure, the amount of solution should be determined according to the frequency and duration of treatment

4. Possible adverse effects

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

Rare possible adverse effects of Accusol 35 Potassium 4 mmol/l (occurring in less than 1 in 1,000 patients) include:

??Low blood glucose levels (hypoglycaemia).

You may experience other adverse effects. These adverse effects may not all be due to the solutions or treatment. Possible adverse effects that may occur are:

??Decrease (hypovolaemia) or increase (hypervolaemia) in body fluid volume

??Decrease (hypotension) or increase (hypertension) in blood pressure

??Very low levels of phosphate in the blood (hypophosphataemia)

??Disturbance in blood alkali levels (alkalosis)

??Dizziness

??Vomiting

??Muscle cramps

??Bleeding disorder

??Infection

??Breathing difficulty, irregular breathing (caused by air bubbles in the bloodstream)

??Changes in levels of different blood salts (e.g. changes in sodium, potassium, calcium in blood)

??Increased blood clotting

Reporting of adverse effects

If you experience any adverse effects, consult your doctor, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines:

www.notificaRAM.es

5. Storage of Accusol 35 Potassium 2 mmol/l

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

Do not refrigerate or freeze.

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

Your doctor will not use Accusol 35 if the solution is not clear or if the container is damaged.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Name of the medicine

Accusol 35, solution for haemofiltration, haemodialysis and haemodiafiltration.

Composition of Accusol 35 solution:

The final 5000 ml solution results from mixing 3750 ml of solution 'A' with 1250 ml of solution 'B'.

Ionic composition of the final solution:

The other components are: water for injections, hydrochloric acid, sodium hydroxide and disodium phosphate dihydrate.

Appearance of Accusol 35 and contents of the pack

Accusol 35 is supplied in a cardboard box containing two 5-litre dual-chamber bags that are PVC-free.

Each bag is wrapped in an overpouch.

The solution in the bag is clear and colourless.

Marketing Authorization Holder:

Nikkiso Belgium
Industriepark 6
3300 Tienen
Belgium

Local Representative:

Palex Medical S.A.
Jesus Serra Santamans, 5
08174 Sant Cugat del Valles
Spain

Manufacturer:

Baxter Healthcare S.A.
Moneen Road
Castlebar
County Mayo – Ireland

or

Serumwerk Bernburg AG
Hallesche Landstrasse 105b
06406 Bernburg
Germany

Date of the most recent revision of this package leaflet: 07/2018

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

Accusol is a registered trademark of Nikkiso International Inc.