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 bicaVera is and what it is used for 
2. What you need to know before you use bicaVera 
3. How to use bicaVera 
4. Possible side effects 
5. How to store bicaVera 6. Contents of the pack 
and other ingredients information 

1. What bicaVera is and what it is used for

bicaVera is used for purifying the blood via the peritoneum ( peritoneum ) in patients with chronic renal failure. This type of blood purification is called peritoneal dialysis.

2. What you need to know before using bicaVera

Do not use bicaVera 1.5% Glucose, 1.25 mmol / l Calcium

  • if you have very low potassium levels in your blood
  • if you have very low calcium levels in your blood

Peritoneal dialysis treatment should not be started at

  • changes in the abdomen or in the abdominal cavity that include:
    • injuries or after surgery,
    • severe burns
    • widespread inflammation is of the skin
    • peritonitis
    • non-healing exuding wounds
    • umbilical, groin, or diaphragmatic hernia
    • the tumor is in the abdomen or intestines
  • inflammatory bowel diseases
  • tarmvred
  • if you have a lung disease, especially 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 your electrolyte content (salinity) decreases sharply due to vomiting and / or diarrhea
  • if you have an overproduction of parathyroid hormone or have low calcium levels in your blood. It may be necessary to use phosphate binders that contain calcium and / or vitamin D or to use a peritoneal dialysis fluid with a higher calcium concentration.
  • if you have an inflammation of the abdominal cavity . This is characterized by cloudy discharge, abdominal pain, fever, general malaise or, in very rare cases, sepsis. 
    The drainage bag with the cloudy dialysate should be taken to your doctor.
  • if you have polycystic kidneys (hereditary kidney disease)
  • if you have severe abdominal pain, swollen abdomen, or vomiting. This can be a sign of a condition called encapsulating peritoneal sclerosis, a complication of peritoneal dialysis treatment that can be fatal.

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

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

Other medicines and bicaVera

Tell 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 affect calcium levels, such as those that contain calcium or vitamin D.
  • Medicines that increase urine production, such as diuretics.
  • Medications are taken by mouth and lowering blood sugar or insulin. Your blood sugar level should be measured regularly.

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 from the use of bicaVera during pregnancy or breast-feeding. If you are pregnant or breast-feeding, only use bicaVera if your doctor considers it absolutely necessary.

Driving and using machines

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

3. How to use bicaVera

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 the 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 – 2500 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)

bicaVera sleep safe should 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 the only bicaVera in the abdominal cavity.

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

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

Handling instructions

Instructions for use for the stay safe system for continuous outpatient peritoneal dialysis ( CAPD )

The liquid bag must first be warmed to body temperature. The heating must be done with a dedicated hotplate. The heating time for a 2000 ml bag with an initial temperature of 22 ºC is about 2 hours (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 weld is 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, position “●”. The outflow begins.
  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 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. Close the clamp on the catheter extension.
  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 protective plug of the used disinfection sleeve, 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.

Instructions for use for the sleep safe system for automatic peritoneal dialysis (APD)

During automatic peritoneal dialysis (APD), the fluid is automatically heated by the sleep safe 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 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 (located on the outer casing), from the diagonal to 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

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

After adapted training in handling, bicaVera can be used independently at 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 Warnings and precautions ”.

If you use more bicaVera than you should

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

If you forget to use bicaVera

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, bicaVera 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 due to the 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

Has been reported (occurs in an unknown number of users): 

  • difficulty breathing due to the elevation of the diaphragm.
  • Encapsulating peritoneal sclerosis, possible symptoms may be abdominal pain, swollen abdomen, or vomiting.

The following side effects may occur when using bicaVera:

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 rapid weight gain
  • water in tissue and lungs
  • high blood pressure
  • breathing difficulties

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 store bicaVera

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.

bica Vera stays safe / sleep safe: Store at least 4 ° C.

bica Vera  sleep safe combo: Store at 5 ° C – 30 ° C

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

May only be used if the solution is ready and the packaging is undamaged.

6. Contents of the packaging and other information

Content declaration

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

Calcium chloride dihydrate 0.1838 g
Sodium chloride 5,786 g
Sodium bicarbonate 2,940 g
Magnesium chloride hexahydrate 0.1017 g
Glucose monohydrate 16.5 g
(equivalent to 15.0 g glucose )

This corresponds to an electrolyte content of:

1.25 mmol / l calcium , 134 mmol / l sodium , 0.5 mmol / l magnesium , 103.5 mmol / l chloride, 34 mmol / l bicarbonate and 83.25 mmol / l glucose .

The other ingredients in bicaVera are water for injections, hydrochloric acid, sodium hydroxide, and carbon dioxide.

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 357 mosm / l and the pH is about 7.4.

bicaVera is supplied in a double-chamber bag. One chamber contains the alkaline bicarbonate solution, the other chamber contains the acidic glucose-based electrolyte solution in a ratio of 1: 1.

bicaVera is a peritoneal dialysis fluid and is supplied in the following packages and systems:

stay safe4 bags of 2000 ml4 bags of 2500 ml sleep safe4 bags of 3000 ml2 bags of 5000 ml
sleep safe combo2 bags of 5000 ml + disinfection sleeve + sleep safe Set Plus

Not all pack sizes may be marketed.

Marketing Authorisation Holder

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

Manufacturer

bica Vera stay  safe / sleep safe :

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

bica Vera  sleep  safe combo :

Fresenius Medical Care Deutschland GmbH, Else-Kröner-Straße 1, 61352 Bad Homburg vdH, Germany

Muhammad Nadeem

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