Label: Information for the User

balance4.25% glucose, 1.25 mmol/l of calcium, peritoneal dialysis solution

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label. See section 4.

dialysisis used to clean the bloodvia the peritoneum in patients with End-stage Chronic Kidney Disease. This type of blood cleaning is known as peritoneal dialysis.

No usebalance4,25% glucose, 1.25 mmol/l of calcium

• if your blood potassium level is very low
• if your blood calcium level is very low
• if your body fluid volume is too low
• if your blood pressure is low
• if you have a known metabolic disorder called lactic acidosis

Do not start peritoneal dialysis if you have:

• abdominal region alterationssuch as

• open wounds, or after a surgical operation
• burns
• widespread skin inflammatory reactions
• peritonitis inflammation
• unhealed suppurating wounds
• umbilical, inguinal, or diaphragmatic hernias
• abdominal or intestinal tumors

• inflammatory bowel diseases
• intestinal function obstruction
• lung disease, especially pneumonia
• bloodstream infection caused by bacteria
• very high levels of blood fat
• blood accumulation of toxins from urine that cannot be removed through blood cleaning
• severe malnutrition and weight loss, especially if adequate protein nutrition is not possible.

Warnings and precautions

Inform your doctor immediately:

• in case ofhyperparathyroidism (elevated activity of the parathyroid gland). You may need to take calcium chelating agents containing additional phosphates and/or vitamin D.
• in case ofvery low calcium levels. You may need to take calcium chelating agents containing additional phosphates and/or vitamin D or use a peritoneal dialysis solution with a higher calcium concentration.
• in case ofsevere loss of electrolytes (salts) caused by vomiting and/or diarrhea.
• in case ofabnormal kidneys (polycystic kidneys)
• in case ofperitonitis inflammation, recognizable because the peritoneal dialysis solution that comes out of your peritoneum is cloudy and/or abdominal pain. Show your doctor the drainage solution bag.
• in case of severe abdominal pain, abdominal distension, or vomiting. This may be a sign of encapsulating peritoneal sclerosis, a complication of peritoneal dialysis treatment that can lead to death.

Peritoneal dialysis may causeprotein lossandwater-soluble vitamin loss.

It is recommended to follow a suitable diet or take dietary supplements to avoid nutritional deficiencies.

Your doctor should check your electrolyte balance, renal function, body weight, and nutritional status.

Due to the high glucose concentration inbalance 4.25% glucose, 1.25 mmol/l of calcium, it should be used with caution and under the supervision of your doctor.

Use ofbalancewith other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Peritoneal dialysis may alter the effect of some medications, so your doctor may need to change the dose for some of them, especially the following:

• heart failure medications, such as digoxin.

Your doctor will check your potassium level in the blood and, if necessary, take the necessary measures.

• medications that increase urine excretion, such as diuretics.
• medications administered orally andthat decrease blood sugar levelsor insulin.Regularly check your blood sugar levels. Diabetic patients may need to adjust their daily insulin dose.

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication. There are no adequate data on the use ofbalancein pregnant women or during lactation.

If you are pregnant or breastfeeding, you should only usebalanceif your doctor considers it absolutely necessary.

Driving and operating machines

The influence ofbalanceon the ability to drive or operate machines is negligible or insignificant.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Your doctor will determine the method, duration, and frequency of use, as well as the required volume of solution and the time of residence in the peritoneal cavity.

If you have tension in the abdominal region, your doctor may reduce the volume.

Continuous Ambulatory Peritoneal Dialysis (CAPD)

• Adults:The usual dose is between 2000 – 3000 ml of solution four times a day depending on body weight and renal function.

The solution is drained after a residence time of between 2 and 10 hours.

• Children:Your doctor will determine the required volume of dialysis solution based on tolerance, age, and body surface area.

The initial recommended dose is 600 – 800 ml/m2of body surface area four times a day (up to 1000 ml/m2at night).

Automated Peritoneal Dialysis (APD)

This system uses thesleeep•safeorSafe•Locksystem. The exchange of bags is controlled automatically by the cycler during the night.

• Adults:The usual prescription is 2000 ml (maximum 3000 ml) per exchange with 3-10 exchanges during the night and a cycler time of 8 to 10 hours, and one or two exchanges during the day.

• Children:The volume per exchange should be 800-1000 ml/m2(up to 1400 ml/m2) of body surface area with 5-10 exchanges during the night.

Usebalanceonly in the peritoneal cavity.

Use onlybalanceif the solution is transparent and the container is not damaged.

balanceis available in a double-chambered bag. Before using the solution in the two chambers, mix the solutions as described below.

Instructions for use:

sleeep•safesystemfor Continuous Ambulatory Peritoneal Dialysis (CAPD)

First, warm the bag with the solution to body temperature. This must be done using an appropriate bag warmer. A 2000 ml bag at an initial temperature of 22°C will require 120 minutes of warming time. You can find more detailed information in the instructions for your warmer. To warm the solution, do not use microwave ovens due to the risk of local overheating. The exchange of bags can be carried out after warming the solution.

1. Solution preparation

?Check the bag with the tempered solution (label, expiration date, transparency of the solution, integrity of the bag and overbag, integrity of the weld).?Place the bag on a solid surface.?Open the overbag of the bag and the disinfection cap seal.?Wash your hands with an antimicrobial washing solution.?Roll up the bag, which is placed horizontally on the overbag, from one of the lateral edges until the intermediate weld opens. The solutions from the two chambers are automatically mixed.?Now roll up the bag from the top edge until the lower triangular weld opens completely.?Check that all welds are completely open.?Check that the solution is transparent and that the bag has no leaks.

2. Bag exchange preparation

?Hang the bag with the solution on the upper hanger of the perfusion support, unwind the tubes from the bag with the solution, and place the DISC connector in the organizer. After unwinding the tubes from the drainage bag, hang the said bag on the lower hanger of the perfusion support.?Place the catheter connector in one of the two connections of the organizer.?Put the new disinfection cap on the free connection.?Disinfect your hands and remove the protective cap from the DISC connector.?Connect the catheter connector to the DISC connector.

3. Drainage flow

?Open the extension valve. The drainage flow begins.?

4. Purge

?Once the drainage flow is complete, purge the drainage bag with new liquid (approximately 5 seconds).?

5. Inflow flow

?Start the inflow flow by rotating the rotary switch to the?Position?

6. Safety passage

?Close the catheter extension by introducing the PIN into the catheter connector.?

7. Disconnection

?Remove the protective cap from the new disinfection cap and screw it onto the old one.?Unscrew the catheter connector from the DISC connector and screw it onto the new disinfection cap.

8. DISC connector closure

?Close the DISC connector with the open end of the used disinfection cap, which is placed in the right hole of the organizer.

9.Checkthe transparency and weight of thedialysate drainedand if the effluent is transparent, discard it.

sleeep•safesystemfor Automated Peritoneal Dialysis (APD)

During automated peritoneal dialysis (APD), the cycler warms the solution automatically.

sleeep•safesystemof 3000 ml

1. Solution preparation:see thesleeep•safesystemof 3000 ml

3.Remove the protective cap

4.Place the connector in the free port of the traysleeep•safe

5.The bag is ready to use with the equipmentsleeep•safe

sleeep•safesystemof 5000 and 6000 ml

1. Solution preparation

?Check the bag with the solution (label, expiration date, transparency of the solution, integrity of the bag and overbag, integrity of the weld).?Place the bag on a solid surface.?Open the overbag of the bag.?Wash your hands with an antimicrobial washing solution.?Unfold the intermediate weld and the connector of the bag.?Roll up the bag, which is placed horizontally on the overbag, from the diagonal edge towards the bag connector. The intermediate weld will open.?Continue until the small chamber weld also opens.?Check that all welds are completely open.?Check that the solution is transparent and that the bag has no leaks.

2. – 5.:see thesleeep•safesystemof 3000 ml.

Safe•Locksystem for Automated Peritoneal Dialysis (APD)

During automated peritoneal dialysis (APD), the cycler warms the solution automatically.

1. Solution preparation:see thesleeep•safesystemof 5000 and 6000 ml

2. Remove the protective cap from the connector of the connection line.

3. Connect the lines to the bag.

4. Break the internal stop by folding the line and the PIN more than 90° to both sides.

5. The bag is ready for use.

The bags are for single use and any remaining solution without use must be discarded.

After proper training,balancecan be used independently at home. Make sure to follow all the steps you learned during training and maintain the necessary hygiene conditions when exchanging bags.

Always check the turbidity of the dialysate drainage. See section 2.

If you use morebalancethan you should

If you infuse an excess of dialysis solution in the peritoneal cavity, it can be drained. In case of using too many bags, contact your doctor, as it may cause electrolyte and/or fluid imbalance.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to usebalance

Try to reach the prescribed total volume for each 24-hour period to avoid consequences that may put your life at risk. You should consult your doctor if you have any doubts.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

It may present the following side effects as a result of peritoneal dialysis treatment in general:

very common (may affect more than 1 in 10 people)

• peritoneal inflammation, which is indicated by cloudy dialysate solution drained from your peritoneum, abdominal pain, fever, discomfort, or, in very rare cases, blood infection.

Show your doctor the bag containing the drainage solution.

• skin inflammation at the catheter exit site or along the catheter length, recognizable by redness, swelling, pain, exudation, or scabs.
• abdominal wall hernia

Contact your doctor immediately if you experience any of these side effects.

Other side effects of treatment are the following:

common (may affect up to 1 in 10 people))

• problems with dialysate entry or exit
• feeling of abdominal stretching or fullness
• shoulder pain

uncommon (may affect up to 1 in 100 people))

• diarrhea
• constipation

very rare(may affect up to 1 in 10,000 people)

• blood infection

not known(the frequency cannot be estimated from the available data)

• respiratory difficulties
• discomfort
• encapsulating peritoneal sclerosis, whose symptoms may be abdominal pain, abdominal distension, or vomiting

It may present the following side effects when usingbalance:

very common(may affect more than 1 in 10 people)

• potassium deficiency

common (may affect up to 1 in 10 people))

• elevated blood sugar levels
• elevated blood lipid levels
• weight gain

uncommon (may affect up to 1 in 100 people))

• calcium deficiency
• low body fluid level, which may be recognized by rapid weight loss, decreased blood pressure, rapid pulse.
• high body fluid level, which may be recognized by fluid accumulation in tissues and lungs, high blood pressure, respiratory difficulties.
• dizziness

not known(the frequency cannot be estimated from the available data)

• increased parathyroid gland activity with potential bone metabolism disorders

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the bag and on the box after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature below 4°C.

The ready-to-use solution should be used immediately, within 24 hours after mixing.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

Composition ofbalance

- The active principles in one liter of ready-to-use solutionare

Calcium chloride dihydrate0.1838 g

Sodium chloride5.64 g

Solution of (S)-sodium lactate7.85 g

(3.925 g (S)-sodium lactate)

Magnesium chloride hexahydrate0.1017 g

Glucose monohydrate46.75 g

(42.5 g anhydrous glucose)

These amounts of active substance are equivalent to:

1.25 mmol/l calcium, 134 mmol/l sodium, 0.5 mmol/l magnesium, 100.5 mmol/l chloride, 35 mmol/l lactate, and 235.8 mmol/l glucose.

The other components are water for injection, hydrochloric acid, sodium hydroxide, and sodium bicarbonate.

Appearance of the product and contents of the package

The solution is transparent and colorless.

The theoretical osmolality of the ready-to-use solution is 509 mOsm/l, the pH is approximately 7.0.

balanceis available in double-chamber bags. One chamber contains the alkaline lactate sodium solution and the other chamber contains the acidic glucose solution with electrolytes.

balanceis available in the following application systems and package sizes:

Only some package sizes may be commercially available.

Marketing Authorization Holder:

Fresenius Medical Care Deutschland GmbH, Else-Kröner-Straße 1, 61352 Bad Homburg v.d.H. Germany

Manufacturer:

Fresenius Medical Care Deutschland GmbH, Frankfurter Straße 6-8, 66606 St. Wendel Germany

Local Representative:

Fresenius Medical Care España S.A.

C/ Ronda de Poniente, 8, ground floor, Parque Empresarial Euronova,

28760 Tres Cantos (Madrid)

Spain

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

See at the end of this multilingual package leaflet.

Last revision date of this package leaflet: 01/2020

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.