Accusol 35 Potassium 2 mmol/l

Leaflet attached to the packaging: Information for the user

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

You should carefully read the contents of the leaflet before using the medicine, as it contains

important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor. See section 4.

Table of contents of the leaflet:

• 1. What Accusol 35 Potassium 2 mmol/l is and what it is used for
• 2. Important information before using Accusol 35 Potassium 2 mmol/l
• 3. How to use Accusol 35 Potassium 2 mmol/l
• 4. Possible side effects
• 5. How to store Accusol 35 Potassium 2 mmol/l
• 6. Contents of the packaging 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 prescribed to patients with acute or chronic renal failure.
It cleans the patient's blood of unnecessary metabolic products; corrects acidity or alkalinity and salt concentration in the patient's blood. As a replacement fluid in hemodiafiltration and hemofiltration, it can also be used as a source of salts and water for hydration.
The Accusol 35 solutions are supplied in a two-chamber bag (not containing PCV). Both chambers are separated by a long seam (seam between chambers). Before use, both chambers of the Accusol 35 solution must be mixed by opening the long seam (seam between chambers), and then the short 'SafetyMoon' seam near the access port.
Accusol 35 solutions can only be used by a doctor or under their supervision.

2. Important information before using Accusol 35 Potassium 2 mmol/l

Before starting treatment, the doctor will ensure that the patient's vein and artery access is correct.
They will also ensure that the patient does not have a high risk of bleeding.
Accusol 35 solutions with different potassium and glucose concentrations are available. The potassium and glucose concentration in the patient's blood will be closely monitored to ensure that the most suitable Accusol 35 composition is used.

The doctor will not administer Accusol 35 Potassium 2 mmol/l to a patient:

• if access to the veins and/or arteries is incorrect.
• if there is an increased risk of bleeding.
• if there is a high concentration of bicarbonates in the blood.
• if the potassium concentration in the blood is too low, unless potassium supplementation is also being administered.
• in a clinical condition where the existing blood acidity or alkalinity may worsen.
• if, due to renal failure, metabolic products cannot be removed from the blood by hemofiltration.

Warnings and precautions

Accusol 35 Potassium 2 mmol/l can only be used by a doctor or under the supervision of a doctor with experience in hemofiltration, hemodialysis or hemodiafiltration techniques.

The attending physician:

• will control the acidity, salt concentration and concentration of unnecessary metabolic products in the blood;
• will ensure that these values are correct and closely monitored during treatment;
• will ensure the maintenance of proper fluid balance in the body;
• will carefully check the glucose concentration in the blood, especially if the patient has diabetes;
• will ensure regular monitoring of potassium concentration in the blood;
• will ensure that the contents of both chambers are mixed immediately before use by opening the long seam (seam between chambers), and then the short 'SafetyMoon' seam near the access port. If unmixed solutions are administered, the bicarbonate concentration in the blood may increase. This can cause side effects such as nausea, drowsiness, headache, irregular heartbeat and breathing difficulties.

Accusol 35 Potassium 2 mmol/l and other medicines

You should tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Taking Accusol 35 Potassium 2 mmol/l may affect other medicines and interact with them.

• If the patient has diabetes, the glucose concentration will be closely monitored. The insulin dose will be adjusted accordingly due to the glucose content in the solution.
• If the patient is taking vitamin D or calcium-containing medicines, the calcium concentration in the blood may change.
• If the patient is also taking sodium bicarbonate, there is an increased risk of abnormal salt and base concentrations (metabolic alkalosis) in the blood.
• If the patient is taking heart medicines, known as cardiac glycosides, additional potassium administration may be necessary. The attending physician will closely monitor the patient during treatment.

Pregnancy and breastfeeding

The patient should inform the attending physician if they are pregnant or breastfeeding.
The doctor will assess the benefit-risk balance of using Accusol 35 Potassium 2 mmol/l.

3. How to use Accusol 35 Potassium 2 mmol/l

Depending on the treatment method, the doctor will administer Accusol 35 Potassium 2 mmol/l using the dialysis device tubes.

Treatment with hemofiltration, hemodialysis or hemodiafiltration used in the patient will depend on
the clinical diagnosis, medical examination, laboratory test results and response to treatment.
The doctor will determine the appropriate composition and amount of Accusol 35 solutions according to the patient's clinical condition.

In what doses and how often to use?

The attending physician will determine and adjust the flow rate and volume of the solution to be used.
The required amount of fluid depends on the method of using Accusol 35 Potassium 2 mmol/l.
If the patient is an adult or elderly and

• is being treated for chronic renal failure with Accusol 35 Potassium 2 mmol/l as a replacement fluid, they should receive 7-35 ml/kg body weight/hour or more;
• is being treated for acute renal failure with Accusol 35 Potassium 2 mmol/l as a replacement fluid, they should receive 20-35 ml/kg body weight/hour or more;
• is being treated for chronic or acute renal failure with Accusol 35 Potassium 2 mmol/l as a dialysis solution, the amount of solution will depend on the frequency and duration of treatment.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible rare side effects (occurring in less than 1 in 1000 patients) of Accusol 35 Potassium 2 mmol/l may include:

• low glucose levels (hypoglycemia).

Other side effects may occur. Not all of them have to be a result of using the solutions or treatment. Potential side effects that may occur include:

• decrease (hypovolemia) or increase (hypervolemia) in fluid volume;
• decrease (hypotension) or increase (hypertension) in blood pressure;
• very low phosphate levels in the blood (hypophosphatemia);
• disturbances in base concentration in the blood (metabolic alkalosis);
• feeling of nausea;
• vomiting;
• muscle cramps;
• bleeding;
• infection;
• shortness of breath, irregular breathing (caused by air bubbles entering the blood);
• disturbances in the concentration of various salts in the blood (e.g. disturbances related to sodium, potassium, calcium in the blood);
• increased tendency to form blood clots.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Accusol 35 Potassium 2 mmol/l

The medicine should be stored out of sight and reach of children.
Do not store in the refrigerator or freeze.
Do not use this medicine after the expiry date stated on the label and carton after the words "Expiry date". The expiry date refers to the last day of the given month.
The doctor will not use Accusol 35 if the solution is not clear or the container is damaged.

6. Contents of the packaging and other information

Medicinal product name

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

Composition of Accusol 35 Potassium 2 mmol/l solution:

5000 ml of the final solution is obtained by mixing 3750 ml of solution "A" with 1250 ml of solution "B".

Ion composition of the final solution:

Other ingredients are: water for injections, hydrochloric acid, sodium hydroxide and disodium phosphate dihydrate.

What Accusol 35 Potassium 2 mmol/l looks like and what the pack contains

Accusol 35 is supplied in a carton containing two 5-liter two-chamber bags not containing PCV.
Each bag is packaged in an outer protective bag.
The solution in the bag is clear and colorless.

Marketing authorization holder:

Nikkiso Belgium
Industriepark 6
3300 Tienen
Belgium
Tel. (Belgium): +32 (0)16 781770
Tel. (Poland): +48 (00)800 1211465

Manufacturers:

Serumwerk Bernburg AG
Hallesche Landstrasse 105b
06406 Bernburg
Germany

Date of last revision of the leaflet: 19.09.2021

ACCUSOL is a trademark of Nikkiso Co., Ltd.
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The following information is intended for healthcare professionals only

LEAFLET FOR HEALTHCARE PROFESSIONALS

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

1. MEDICINAL PRODUCT NAME

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

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

This corresponds to the following ionic composition:
5000 ml of the final solution is obtained by mixing 3750 ml of solution "A" with 1250 ml of solution "B".
The pH of the final solution is between 7.0-7.5.
The number "35" in the name indicates the buffer concentration in the solution (bicarbonate = 35 mmol/l).

3. PHARMACEUTICAL FORM

Solution for hemofiltration, hemodialysis and hemodiafiltration.
Accusol 35 is a sterile, clear and colorless solution.

4. CLINICAL PARTICULARS

4.1. Therapeutic indications

Accusol 35 is indicated for the treatment of acute and chronic renal failure as a replacement solution in hemofiltration and hemodiafiltration and as a dialysis solution in hemodialysis and hemodiafiltration.

4.2. Dosage and administration

For hemofiltration, hemodialysis and hemodiafiltration.
Accusol 35 as a replacement solution
The volume of replacement solution administered to adult patients is determined by the ultrafiltration coefficient and is set individually to ensure proper fluid and electrolyte balance.
Adults:

• chronic renal failure: 7-35 ml/kg body weight/hour,
• acute renal failure: 20-35 ml/kg body weight/hour, Elderly: as for adults.

The above volume recommendations may be adjusted by the attending physician according to the patient's clinical condition.

Accusol 35 can be administered into the extracorporeal circulation in a pre- and post-dilution mode, as recommended by the doctor.
Accusol 35 as a dialysis solution
The type and volume of the prescribed dialysis solution depend on the treatment method, its frequency and duration; the choice is made by the doctor according to the patient's clinical condition.
Administration:

• Hemodialysis: through the dialyzer chamber.
• Hemofiltration: through the arterial or venous blood line.

After removing the outer protective bag, immediately open the long seam (seam between chambers) to mix both solutions, and then open the short 'SafetyMoon' seam (seam near the access port) to allow administration of the mixed solution. The bag should be connected to the patient's line and the access port opened. The solution should be used within 24 hours of mixing.

4.3. Contraindications

Contraindications related to the solution:

• hypokalemia, unless potassium supplementation is also being administered;
• metabolic alkalosis.

Contraindications related to hemofiltration, hemodialysis or hemodiafiltration, related to the technical procedure itself:

• renal failure accompanied by severe catabolism in patients with symptoms of uremia that do not respond to hemofiltration;
• inadequate blood flow at the vascular access site;
• if there is a high risk of bleeding due to the action of anticoagulant medicines.

4.4. Special warnings and precautions for use

• Accusol 35 can only be used by or under the supervision of a doctor with experience in hemofiltration, hemodialysis or hemodiafiltration techniques.
• Rarely, precipitation may occur after a few hours of treatment. In such a case, the Accusol 35 bag and the line set should be replaced immediately, and the patient should be closely monitored.
• Fluid balance should be carefully controlled.
• Acid-base balance parameters should be carefully controlled.
• Similarly, electrolyte balance parameters (chloremia, phosphatemia, calcemia, magnesemia and natremia) should be regularly controlled to detect any possible disturbances.
• Before starting and during treatment, the potassium concentration in the blood should be regularly controlled. In the event of hypokalemia or a gradual decrease in potassium concentration in the blood, potassium supplementation and/or the use of a replacement fluid with a higher potassium concentration may be indicated. In the event of hyperkalemia, it may be necessary to increase the filtration coefficient and/or use a replacement fluid with a lower potassium concentration, as well as implement appropriate procedures in an intensive care setting.
• The glucose concentration in the blood should be closely monitored, especially in patients with diabetes.
• If the long seam (seam between chambers) is not opened (i.e. only the short 'SafetyMoon' seam near the access port is opened) and the solution from the small chamber "B" is administered, metabolic alkalosis may occur. The most common subjective and objective clinical symptoms of alkalosis are: nausea, coma, headache, arrhythmia and respiratory failure.

4.5. Interactions with other medicinal products and other forms of interaction

When prescribing Accusol 35 Potassium 2 mmol/l, possible interactions between this treatment and other treatments related to other pre-existing conditions should be considered.

• The concentration in the blood of other medicinal products may change during hemodialysis, hemofiltration and hemodiafiltration.
• In patients taking cardiac glycosides, the serum potassium concentration should be closely monitored due to the increased risk of arrhythmia due to hypokalemia.
• The use of vitamin D and calcium-containing medicines may increase the risk of hypercalcemia (e.g. the use of calcium carbonate as a potassium-chelating agent).
• Additional sodium bicarbonate substitution may increase the risk of metabolic alkalosis.

4.6. Fertility, pregnancy and lactation

There are no clinical or preclinical data on the use of Accusol 35 in pregnancy and lactation. Accusol 35 can be used in pregnant and breastfeeding women only if necessary.

4.7. Effects on ability to drive and use machines

Not applicable.

4.8. Undesirable effects

The following undesirable effects come from reports of adverse events that occurred during clinical trials (see point (1) below) and were considered by the investigator to be related to Accusol, as well as from literature data (see point (2) below).
The frequency of occurrence was determined using the following criteria: very common (>1/10), common (>1/100 to <1>1/1,000 to <1>1/10,000 to <1>

• 1) Clinical trials

• 2) Literature data

The following undesirable effects reflect the types of undesirable effects that may occur during the use of hemofiltration and hemodialysis solutions.

• Undesirable effects related to treatment may include nausea, vomiting, muscle cramps, hypotension, bleeding, clotting, infection and air embolism.
• Undesirable effects related to the product may include metabolic alkalosis, electrolyte disturbances and/or fluid balance disturbances: hypophosphatemia, hypoglycemia, hypovolemia or hypervolemia, hypotension or hypertension.

Reporting suspected adverse reactions
After the medicinal product has been placed on the market, it is important to report suspected adverse reactions. This allows for the continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

4.9. Overdose

Overdose should not occur if fluid and electrolyte balance is regularly controlled as recommended in section 4.4. Overdose may lead to hypervolemia and electrolyte disturbances. These symptoms can be corrected by adjusting the ultrafiltration coefficient and the volume of the solution administered.
Electrolyte balance disturbances should be corrected according to their type.

5. PHARMACEUTICAL PARTICULARS

5.1. Incompatibilities

This medicinal product must not be mixed with other medicinal products, except for those mentioned in section 5.5.

5.2. Shelf life

Shelf life
24 months if the product is stored in the outer protective bag.
Shelf life after mixing
After removal from the outer protective bag and mixing, Accusol 35 should be used within 24 hours.

5.3. Special precautions for storage

Do not store in the refrigerator or freeze.

5.4. Nature and contents of container

Accusol 35 is stored in a two-chamber bag not containing PCV, made of a multi-layer film of polypropylene, polyamide and a mixture of polypropylene, SEBS and polyethylene (Clear-Flex). The two chambers are separated by a long seam (seam between chambers).
The large chamber "A" has a port for adding medicines, and the small chamber "B" has an access port for connecting to the appropriate administration set.
The two-chamber bag is supplied in a transparent outer protective bag made of copolymers.
The volume of the container after mixing is 5000 ml (3750 ml in the large chamber and 1250 ml in the small chamber).
Accusol 35 is available in cartons containing 2 units of 5000 ml.

5.5. Special precautions for disposal and preparation of the medicinal product for administration

Administration

• The product should be inspected for damage. Do not use if one of the bag's seams has been previously opened. If damaged, the container should be discarded.
• Do not administer if the solution is not clear.
• During the entire procedure, aseptic principles should be observed.
• Concomitantly administered medicines can be added to the solution through the medicine addition port in the large chamber. Before mixing, the compatibility of the solution with the added medicines should be checked. After adding any medicine, the product should be used immediately.
• After removing the outer protective bag, the long seam (seam between chambers) should be immediately opened to mix both solutions, and then the short 'SafetyMoon' seam (seam near the access port) should be opened to allow administration of the mixed solution. The bag should be connected to the patient's line and the access port opened. The solution should be used within 24 hours of mixing.
• Any unused solution should be discarded.
• For single use only. Accusol 35 should only be used with the appropriate equipment, allowing for control of the treatment process.

6. MARKETING AUTHORIZATION HOLDER

RESPONSIBLE FOR BATCH RELEASE

Nikkiso Belgium
Industriepark 6
3300 Tienen
Belgium
Tel. (Belgium): +32 (0)16 781770
Tel. (Poland): +48 (00)800 1211465

7. MARKETING AUTHORIZATION NUMBER

12261