ACCUSOL 35 SOLUTION FOR HEMOFILTRATION, HEMODIALYSIS AND HEMODIAFILTRATION

Introduction

Leaflet: information for the user

Accusol 35, solution for hemofiltration, hemodialysis, and hemodiafiltration

Read this leaflet carefully before this medicine is administered to you, as 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.
• If you experience side effects, ask your doctor, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Accusol 35 is and what it is used for
2. What you need to know before Accusol 35 is administered to you
3. How Accusol 35 will be administered to you
4. Possible side effects
5. Storage of Accusol 35
6. Package contents and additional information

1. What Accusol 35 is and what it is used for

Accusol 35 is a solution for hemofiltration, hemodialysis, and hemodiafiltration.

Accusol 35 is indicated in patients with acute or chronic renal failure.

It cleans the blood of waste products; corrects acidosis or alkalinity and abnormal levels of salts in the blood. As a replacement solution in hemodiafiltration and hemofiltration, it can also be used as a source of salts and water for hydration.

The Accusol 35 solutions are presented in a two-compartment bag (bicompartimental) that does not contain PVC. A long seal (seal between the chambers) separates the two chambers. Before use, the solutions from the two Accusol 35 chambers must be mixed by opening the long seal (seal between the chambers), followed by opening the short SafetyMoon seal located near the access port.

Accusol 35 is especially indicated if you have a high level of potassium.

The Accusol 35 solutions should only be used under the supervision of a doctor.

2. What you need to know before Accusol 35 is administered to you

Your doctor will ensure that you have adequate blood access to perform the procedure and that there is no risk of bleeding.

The Accusol 35 solutions are available in different concentrations of potassium and glucose. The levels of potassium and glucose in your blood will be carefully checked to ensure that the most suitable Accusol 35 formulation is used.

Your doctor will not administer Accusol 35 to you

• if you do not have good access to your veins and/or arteries
• if you have a high risk of bleeding
• if you have a high level of bicarbonate in your blood
• if you have a very low level of potassium in your blood, unless you are receiving a potassium supplement at the same time
• if you have a clinical condition in which the levels of acidity or alkalinity in your blood may worsen
• if you have a renal disorder in which waste products cannot be removed from the blood by hemofiltration

Warnings and precautions

Accusol 35 should only be used by or under the supervision of a doctor with experience in hemofiltration, hemodialysis, or hemodiafiltration techniques.

Your doctor

• will measure the acidity, salt levels, and waste products in your blood
• will ensure that the levels are correct and will closely monitor them during treatment
• will ensure that a good fluid balance is maintained
• will closely monitor your blood glucose levels, especially if you are diabetic
• will regularly measure the level of potassium in your blood
• will ensure, before use, that the contents of both chambers are mixed by opening the long seal (seal between the chambers), followed by opening the short SafetyMoon seal located near the access port. If the doctor perfuses with an unmixed solution, your bicarbonate level in the blood may increase. This can cause side effects such as nausea, drowsiness, headache, heart rhythm disturbances, and difficulty breathing.

Other medicines and Accusol 35

Tell your doctor if you are taking, have recently taken, or may take any other medicine.

The administration of Accusol 35 may affect the action of other medicines.

• If you are taking vitamin D or other medicines that contain calcium, your calcium level in the blood may be altered.
• If you are taking additional sodium bicarbonate, there is a greater risk of abnormal salt and alkalinity levels (alkalosis) in your blood.
• If you are taking heart medicines called cardiac glycosides, you may need potassium supplements. Your doctor will closely monitor you during treatment.

Pregnancy and breastfeeding

Tell your doctor if you are pregnant or breastfeeding. The doctor will evaluate the benefits of using Accusol 35 against the risks.

3. How Accusol 35 will be administered to you

Depending on your treatment, your doctor will administer Accusol 35 through the tube 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 treatment.

Your doctor will determine the suitable formula and amount of Accusol 35 solutions for your clinical condition.

Dose and frequency

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

The amount of fluid needed will depend on the use of Accusol.

If you are an adult or elderly patient and

• are being treated with Accusol 35 as a replacement solution due to chronic renal failure, you should be administered 7 to 35 ml/kg/h or more
• are being treated with Accusol 35 as a replacement solution due to acute renal failure, you should be administered 20 to 35 ml/kg/h or more
• are being treated with Accusol 35 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The rare possible side effects of Accusol 35 Potassium 4 mmol/l (which occur in less than 1 in 1000 patients)include:

??Low blood glucose level (hypoglycemia).

You may experience other side effects. It is possible that these side effects are not all due to the solutions or treatment. The possible side effects that may occur are:

??Decrease (hypovolemia) or increase (hypervolemia) in body fluid volume

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

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

??Alterations in the level of alkalinity in the blood (alkalosis)

??Dizziness

??Vomiting

??Muscle cramps

??Bleeding disorder

??Infection

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

??Alteration of the levels of different salts in the blood (e.g., alteration of sodium, potassium, calcium in the blood)

??Increased blood coagulation

Reporting of side effects

If you experience side effects, ask your doctor, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines:

www.notificaRAM.es

5. Storage of Accusol 35

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

Do not refrigerate or freeze.

Do not use this medicine after the expiration date stated on the label and on the packaging after CAD. The expiration date is the last day of the month indicated.

Your doctor will not use Accusol 35 if the solution is not transparent or the packaging is damaged.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Medicine name

Accusol 35, solution for hemofiltration, hemodialysis, and hemodiafiltration.

Composition of the Accusol 35 solution:

The 5000 ml of final solution result from the mixture of 3750 ml of solution 'A' with 1250 ml of solution 'B'.

Ionic composition of the final solution:

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

Appearance of Accusol 35 and package contents

Accusol 35 is supplied in a cardboard box containing two 5-liter two-chamber bags that do not contain PVC.

Each bag is wrapped in an overbag.

The solution in the bag is transparent and colorless.

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 last revision of this leaflet: 07/2018

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

Accusol is a registered trademark of Nikkiso International Inc.