peritoneal dialysis fluid 

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What balance is and what it is used for 
2. What you need to know before using balance 
3. How to use the balance 
4. Possible side effects 
5. How to store the balance 
6. Package contents and other information 

1. What balance is and what is it used for

Balance is used in the purification of blood through the peritoneum ( the peritoneum) in patients with chronic renal failure. This type of blood purification is called peritoneal dialysis .

2. What you need to know before using balance

Do not use balance 1.5% glucose, 1.25 mmol / l calcium

  • if you have severe potassium deficiency in your blood
  • if you have severe calcium deficiency in your blood
  • if you have a metabolic disease called lactic acidosis

Peritoneal dialysis should not be started at

  • changes in the abdomen or in the abdominal cavity that include:
    • injuries or after surgery,
    • burns
    • widespread inflammation is of the skin
    • peritonitis
    • non-healing exuding wounds
    • umbilical hernia, groin hernia, or diaphragmatic hernia
    • the tumor is in the abdomen or intestines
  • inflammatory bowel diseases
  • tarmvred
  • pneumonia, in particular, pneumonia
  • blood poisoning caused by bacteria
  • extremely high-fat levels in the blood
  • cases of urinary intoxication in the blood that cannot be treated with peritoneal dialysis
  • severe malnutrition and weight loss especially when adequate protein intake through food is not possible

Warnings and cautions

Tell your doctor immediately

  • if you suffer from pathological thyroid hormone overproduction. It may be necessary to use phosphate binders that contain calcium and/or vitamin D.
  • If you have too low calcium levels. It may be necessary to use phosphate binders that contain calcium and/or vitamin D or to use peritoneal dialysis fluid with a higher calcium concentration.
  • if your electrolyte content (salinity) decreases sharply due to vomiting and/or diarrhea
  • if you suffer from large kidneys (polycystic kidneys)
  • if you have an inflammation of the abdominal cavity. This is characterized by cloudy discharge and/or abdominal pain. The drainage bag with the cloudy dialysate should be taken to your doctor.
  • if you have severe abdominal pain, swollen abdomen, or vomiting. This may be a sign of a condition called sclerosing peritonitis (EPS), a complication of peritoneal dialysis treatment that can be life-threatening.

Peritoneal dialysis can lead to the loss of protein you and water-soluble vitamins you. To avoid nutritional deficiencies, a good diet or nutritional supplement is recommended.

Electrolyte (salt) balance, kidney function, body weight, and nutritional status will be checked by your doctor.

Other drugs and balance

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

Peritoneal dialysis may affect the effectiveness of other medicines and your doctor may need to change their dosage. This is especially important for:

  • cardiac medicine, eg digitalis. 
    Your doctor will check your blood potassium level and take the necessary action if necessary.
  • medicines that increase urine production  e.g. diuretics ( diuretics ).
  • medications are taken by mouth and lowering blood sugar or insulin. Your blood sugar level should be measured regularly. Diabetics may need to adjust their daily dose of insulin

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. There is insufficient information on the use of balance during pregnancy or lactation. If you are pregnant or breastfeeding, only use balance if your doctor deems it absolutely necessary.

Driving and using machines

balance has no or negligible effect on the ability to drive and use machines.

3. How to use a balance

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Your doctor will adapt the method, how long and how often dialysis should take place and what volume is needed, and how long the solution should be kept in the abdominal cavity, to your needs.

If you experience tension in the abdominal cavity, your doctor may reduce the volume of dialysis.

Continuous outpatient peritoneal dialysis ( CAPD ):

  • Adults: The usual dose is 2000 – 3000 ml dialysis fluid four times a day, depending on body weight and kidney function. The solution is kept in the abdominal cavity for 2-10 hours, after which it is emptied.
  • Children: The doctor adjusts the volume of dialysis fluid needed depending on the child’s tolerance, age, and body surface area. The recommended starting dose is 600 – 800 ml / m 2 body surface area (up to 1000 ml / m 2 body surface area overnight) four times daily.

Automatic peritoneal dialysis (APD):

The sleep safe or safe lock system must be used for this. Bag changes are automatically checked by the machine during the night.

  • Adults: The usual dose is 2000 ml (maximum 3000 ml) per treatment period with 3-10 treatment periods during the night within a time period of 8-10 hours and one or two treatment periods during the day.
  • Children: The volume per treatment period should be 800-1000 ml / m 2 (up to 1400 ml / m 2 ) body surface area with 5-10 treatment periods overnight.

Use only balance in the abdominal cavity.

Only use balance if the solution is ready and the packaging is undamaged.

balance is provided in a double-chamber bag. The solutions in the two chambers must be mixed before use according to the instructions.

Handling instructions

stay safe system for continuous ambulatory peritoneal dialysis ( CAPD ):

The liquid bag must first be warmed to body temperature. Heating must be done with a dedicated hotplate. The heating time for a 2000 ml bag with an initial temperature of 22ºC is about 120 minutes. More detailed information can be found in the operating instructions for the hotplate. Microwave ovens must not be used for heating due to the risk of local overheating. After heating the liquid bag, the bag change can begin.

  1. Preparation of the solution
    • Check the heated liquid bag (label, expiration date, that the liquid is ready, that the bag and outer casing are intact and that the welds are intact).
    •  Place the bag on a firm surface.
    • Open the outer casing of the bag and open the packaging for the disinfection sleeve.
    • Wash hands with a disinfectant soap solution.
    • Roll up the bag, which is located on the outer cover, from one of the sides until the middle joint opens. The solutions in the two chambers are mixed automatically.
    • Then roll up the bag from the top edge until the joint in the lower triangle is completely open.
    • Check that all joints are fully open.
    • Check that the solution is ready and that the bag is not leaking.
  2. Preparation for bag change
    • Hang the liquid bag at the top of the drip stand, roll up the hose from the liquid bag, and place the flow selector in the holder. Roll up the hose to the drainage bag and hang the drainage bag at the bottom of the drip stand.
    • Place the catheter extension in one of the two holes in the holder.
    • Place the new disinfection sleeve in the second hole in the holder.
    • Disinfect your hands and remove the plug from the flow selector.
    • Connect the catheter extension to the flow selector.
  3. Outflow
    • Open the clamp on the catheter extension. The outflow begins. Mode “●”.
  4. Flushing
    • After the outflow is completed, turn the flow selector clockwise to the “●●” position. Flushing takes place from liquid bag to drainage bag (approx. 5 sec).
  5. Inflow
    • Start inflow by turning the flow selector to the position.
  6. Security measure
    • Turn the flow selector to the “●●●●” position, the catheter extension is then closed automatically by inserting a PIN into the catheter extension coupling.
  7. Disconnection
    • Remove the protective plug from the new disinfection sleeve and screw it onto the old disinfection sleeve.
    • Unscrew the catheter extension from the flow selector and screw the catheter extension onto the new disinfection sleeve.
  8. Closing the flow selector
    • Close the flow selector with the open end of the used disinfection sleeve protective plug, which is located in one of the two holes on the holder.
  9. Check the weight of the drained dialysis fluid and that it is not cloudy. The clear liquid is discarded.

sleep safe system for automatic peritoneal dialysis (APD):

During automatic peritoneal dialysis (APD), the fluid is automatically heated by the machine.

3000 ml sleep safe system :

  1. Preparation of the solution: see the stay safe system
  2. Roll up the hose from the bag.
  3. Remove the protective plug.
  4. Insert the coupling into the free compartment of the sleep safe machine.
  5. The bag is now ready to use together with the sleep safe set.

5000 and 6000 ml sleep safe system :

1. Preparation of the solution

  • Check the liquid bag before use (label, expiration date, that the liquid is ready, that the bag and outer casing are intact and that the welds are intact).
  • Place the bag on a firm surface.
  • Open the outer casing of the bag.
  • Wash hands with a disinfectant soap solution.
  • Unfold the middle seam and the attachment.
  • Roll up the bag, which is located on the outer casing, from the diagonal towards the coupling. The middle seam will open.
  • Continue until the weld seam on the small chamber also opens.
  • Check that all weld seams are fully open.
  • Check that the solution is ready and that the bag is not leaking

2– 5: see 3000 ml sleep safe system

Safe Lock system for automatic peritoneal dialysis (APD):

During automatic peritoneal dialysis (APD), the fluid is automatically heated by the machine.

  1. Preparation of the solution: see 5000 and 6000 ml sleep safe system
  2. Remove the protective plug on the connector from the contact channel.
  3. Connect the hoses to the bag
  4. Break the inner cover by bending the channel more than 90º in both directions.
  5. The bag is now ready for use.

Each bag is for single use and unused liquid must be discarded.

After adapted training in handling, balance can be used independently in the home. Be sure to follow all the procedures you learned during the workout. Aseptic technique must be maintained during the bag change to minimize the risk of infection .

Always check if the dialysate in the drainage bag is cloudy, see section 2.

If you have used too much balance

If too much dialysis solution is infused, it can easily be emptied into the drainage bag. However, if bag changes have occurred too often, you should contact your doctor as this may lead to dehydration and/or imbalance in electrolyte levels.

If you have forgotten to use the balance

Try to keep the prescribed total daily dose of the dialysis volume to avoid life-threatening consequences. Contact your doctor if you are unsure.

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

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

The following side effects may occur as a result of peritoneal dialysis treatment:

very common (may affect more than 1 user in 10):

  • peritonitis with signs of cloudy dialysate, abdominal pain, fever, general malaise, or, in very rare cases, sepsis. 
    The drainage bag with the cloudy dialysate should be taken to your doctor.
  • inflammation of the skin around the dialysis catheter (at the starting point and along the tunnel). Signs of this are redness, swelling, pain, fluid or scabs
  • hernia in the abdominal wall

At the slightest sign of these side effects, contact your doctor immediately.

Other side effects resulting from treatment are: 
common (may affect up to 1 in 10 people):

  • problems with inflow and outflow of the dialysis solution
  • dilated abdomen and feeling of bloating
  • pain in the shoulders

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

  • diarrhea
  • constipation

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

  • blood poisoning

has been reported (occurs in an unknown number of users)

  • breathing difficulties
  • general malaise
  • sclerosing peritonitis (EPS), possible symptoms may be abdominal pain, swollen abdomen, or vomiting.

The following side effects may occur when balancing is used:

very common,  (may affect more than 1 user in 10):

  • potassium deficiency

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

  • high blood sugar levels
  • elevated blood fat levels
  • weight gain

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

  • calcium deficiency
  • too low levels of body fluid, which can result in rapid weight loss, low blood pressure, increased heart rate
  • too high levels of body fluid which can result in water in tissues and lungs, high blood pressure, shortness of breath
  • dizziness

has been reported (occurs in an unknown number of users)

  • overactivity of the parathyroid gland, which can cause disorders in bone metabolism

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to keep balance

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

Do not use this medicine after the expiry date which is stated on the bag and carton after EXP. The expiration date is the last day of the specified month.

Store at least 4 ° C.

The reconstituted solution should be used immediately and within a maximum of 24 hours after mixing.

6. Contents of the packaging and other information

What balance contains

  • The active substances in 1 liter of reconstituted peritoneal dialysis fluid are:

Calcium chloride dihydrate 0.1838 g
Sodium chloride 5,640 g
Sodium (S) -lactate solution 7.85 g
(3.925 g sodium – (S) -lactate)
Magnesium chloride hexahydrate 0.1017 g
Glucose monohydrate 16.5 g
(15.0 g glucose anhydrous)

This corresponds to an electrolyte content of:

1.25 mmol / l calcium , 134 mmol / l sodium , 0.5 mmol / l magnesium , 100.5 mmol / l chloride, 35 mmol / l lactate and 83.2 mmol / l glucose .

  • The other ingredients are water for injections, hydrochloric acid, sodium hydroxide, and sodium bicarbonate.

What the medicine looks like and the contents of the pack

The solution is clear and colorless.

The theoretical osmolarity in a ready-mixed solution is 356 mOsm / l and the pH is about 7.0

balance is provided in a double-chamber bag. One chamber contains the alkaline sodium lactate solution, the other chamber contains the acidic glucose-based electrolyte solution.

balance is provided in the following packages and systems:

Stay safe Sleep safe Safe lock
4 bags of 2000 ml4 bags of 2500 ml4 bags of 3000 ml 4 bags of 3000 ml2 bags of 5000 ml2 bags of 6000 ml 2 bags of 5000 ml2 bags of 6000 ml

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder 
Fresenius Medical Care Deutschland GmbH, Else-Kröner-Strasse 1, 61352 Bad Homburg vdH, Germany

Manufacturer

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

Local representative

Fresenius Medical Care Sverige AB

SE-192 51 Sollentuna

Tel: + 46 8 594 776 00

This medicinal product is authorized under the European Economic Area under the names:

B, NL balance 1.5% glucose , 1.25 mmol / l calcium, solution for peritoneal dialysis
CZ balance 1.5% glucose, 1.25 mmol / l calcium, peritoneum dialysis dose
D, A, L balance 1.5% Glucose , 1.25 mmol / l Calcium, Peritoneal dialysis solution
DK balance 1.5% glucose, 1.25 mmol / l calcium, peritoneal dialysis fluid
E balance 1.5% glucose, 1.25 mmol / l calcium, solution for peritoneal dialysis
EST balance 1.5% glucose, 1.25 mmol / l calcium, peritoneal dialysis cell
F Neutravera glucose 1.5%, calcium 1.25 mmol / l, solution for peritoneal dialysis
NICE balance 1.5% glucose, 1.25 mmol / l calcium, peritoneaalidialyysineste
GB, M balance 1.5% glucose , 1.25 mmol / l calcium, solution for peritoneal dialysis
GR, CY balance 1.5% fluid , 1.25 mmol / l oxygen , Percipital fluid flow (fluid)
hrs balance 1.5% glucose, 1.25 mmol / l calcium , peritoneal dialysis
HR balance 1.5% glucose, 1.25 mmol / l calcium, utopian for peritoneum dialysis
IN balance 1.5% glucosio, 1.25 mmol / l calcium, solution for peritoneal dialysis
IS balance 1.5% glucose, 1.25 mmol / l calcium, peritoneal dialysis solution
LT balance 1.5% glucose, 1.25 mmol / l calcium, pesticides
LV balance 1.5% glucose, 1.25 mmol / l calcium, šķīdums peritoneālai dialīzei
N balance 1.5% glucose, 1.25 mmol calcium / l, peritoneal dialysis fluid
P balance 1.5% glucose, 1.25 mmol / l of calcium, solution for peritoneal dialysis
PL balance 1.5% from 1.5% glucose and gaseous 1.25 mmol / l, the dialysis rate is otrzewnowej
S balance 1.5% glucose, 1.25 mmol / l calcium, peritoneal dialysis fluid
SK balance 1.5% glucose , 1.25 mmol / l calcium, roztok na peritoneálnu dialýzu
SLO balance 15 mg / ml glucose, 1.25 mmol / l calcium, raztopina for peritoneal dialysis

Muhammad Nadeem

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