Package Insert: Information for the User

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

Read this package insert carefully before this medicine is administered to you because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor
• If you experience any adverse effects, consult your doctor, even if they are not listed in this package insert. See section 4.

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

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

3. How Accusol 35 Potassium 2 mmol/l will be administered to you

4. Possible adverse effects

5. Storage of Accusol 35 Potassium 2 mmol/l

6. Contents of the package and additional information

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

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

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.

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

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

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

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

Your doctor will not administer Accusol 35 Potasio 2 mmol/l

• if you do not have good access to veins and/or arteries
• if you have a high risk of bleeding
• if you have high bicarbonate levels in your blood
• if you have low potassium levels in your blood, unless you are also receiving potassium supplements simultaneously
• if you have a clinical condition in which blood acidity or alkalinity levels can worsen
• if you have a renal impairment in which waste products cannot be removed from the blood by hemofiltration.

Warnings and precautions

Accusol 35 Potasio 2 mmol/l should only be used by or under the supervision of a doctor experienced 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 you maintain a good balance of body fluids
• will closely monitor your blood glucose levels, especially if you are diabetic
• will regularly measure your potassium levels 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 the opening of the short SafetyMoon seal located near the access port. If the doctor performs the perfusion with an unmixed solution, your bicarbonate levels in the blood may increase. This can cause adverse effects such as nausea, drowsiness, headache, arrhythmias, and difficulty breathing.

Other medications and Accusol 35 Potasio 2 mmol/l

Inform your doctor if you are taking, have taken recently, or may need to take any other medication.

The administration of Accusol 35 Potasio 2 mmol/l may affect the action of other medications.

• If you are diabetic, your blood glucose levels should be strictly checked. Your insulin dose will be adjusted as needed since this solution contains glucose.
• If you are taking vitamin D or other medications containing calcium, your calcium levels in the blood may be altered.
• If you are taking additional sodium bicarbonate, there is a higher risk of abnormal salt and alkalinity levels in your blood.
• If you are taking heart medications called cardiac glycosides, you may need potassium supplements. Your doctor will perform a thorough check during treatment.

Pregnancy and breastfeeding

Inform your doctor if you are pregnant or breastfeeding. The doctor should evaluate the benefits of using Accusol 35 Potasio 2 mmol/l against the risks.

Depending on your treatment, your doctor will administer Accusol 35 Potasio 2 mmol/l through the dialysis machine's tube.

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

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

Amount and frequency

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

The amount of fluid needed will depend on the form of use of Accusol Potasio 2 mmol/l.

If you are an adult or elderly patient and

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

The rare possible adverse effects of Accusol 35 Potasio 4 mmol/l(which occur in fewer than 1 in 1000 patients)include:

??Low blood glucose (hypoglycemia).

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

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

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

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

??Alterations of blood alkalinity (alkalosis)

??Dizziness

??Vomiting

??Muscle cramps

??Bleeding disorder

??Infection

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

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

??Increased blood coagulation

Reporting Adverse Effects

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

www.notificaRAM.es

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

Do not refrigerate or freeze.

Do not use this medication after the expiration date that appears 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 container is damaged.

Medications should not be thrown down the drain or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need.This will help protect the environment.

Medication Name

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

Composition of Accusol 35 Solution:

The final 5000 ml solution is obtained by mixing 3750 ml of solution ‘A’ with 1250 ml of solution ‘B’.

Ionic Composition of the Final Solution:

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

Appearance of Accusol 35 and Packaging Contents

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

Each bag is wrapped in a pouch.

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

Responsible for Manufacturing:

Baxter Healthcare S.A.

Moneen Road

Castlebar

County Mayo – Ireland

or

Serumwerk Bernburg AG

Hallesche Landstrasse 105b

06406 Bernburg

Germany

Last Review Date of this Leaflet:07/2018

The detailed and updated information of this medication 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.