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BICAVERA 1.5% GLUCOSE 1.75 MMOL/L CALCIUM SOLUTION FOR PERITONEAL DIALYSIS

Active substance(s): CALCIUM CHLORIDE / GLUCOSE MONOHYDRATE / MAGNESIUM CHLORIDE HEXAHYDRATE / SODIUM CHLORIDE / SODIUM HYDROGEN CARBONATE

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0875216_01_K001.qxp:0875216

02.07.2014

bicaVera
1.5% Glucose,
1.75 mmol/l Calcium
What is in this leaflet:
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 information

1.

What bicaVera is and what it is
used for

bicaVera is used for cleaning the blood via the
peritoneum in patients with end-stage chronic kidney
failure. This type of blood cleaning is called peritoneal
dialysis.

2.

What you need to know before
you use bicaVera

Do not use bicaVera 1.5% Glucose,
1.75 mmol/l Calcium
• if the level of potassium in your blood is very low
• if the level of calcium in your blood is very high

Peritoneal dialysis treatment must not be
started if you have

12:36 Uhr

Seite 5

Package leaflet:
Information for the user
bicaVera 1.5% Glucose, 1.75 mmol/l Calcium,
Solution for peritoneal dialysis
Read all of this leaflet carefully before you start using this medicine because it contains important
information for you.
• Keep this leaflet. 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 pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not
listed in this leaflet. See section 4.

Other medicines and bicaVera
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Because blood cleaning may influence the effects of
medicines, your doctor may need to change their
dosages, especially those of
• Medicines for heart failure, such as digitoxin.
Your doctor will check the level of potassium in
your blood and, if necessary, will take appropriate
measures.
• Medicines that influence calcium levels such as
those containing calcium or vitamin D.
• Medicines that increase the excretion of urine
such as hydrochlorothiazide.
• Medicines taken by mouth that lower blood sugar
levels or insulin. Your blood sugar level should be
measured regularly.

• alterations in the abdominal region such as
– injuries, or after surgery
– severe burns
– large, inflammatory skin reactions
– inflammation of the peritoneum
– non-healing, weeping wounds
– umbilical, inguinal or diaphragmatic hernias
– ulcers
• inflammatory bowel diseases
• intestinal obstruction
• lung diseases, particularly pneumonia
• blood poisoning caused by bacteria
• extremely high levels of fat in the blood
• poisoning due to urine products in the blood which
cannot be treated by blood cleaning
• severe malnutrition and loss of weight, particularly if
adequate intake of food containing proteins is not
possible.

Pregnancy, breast-feeding and fertility

Warnings and precautions

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

Inform your doctor immediately
• if you have a severe loss of electrolytes (salts)
due to vomiting and/or diarrhoea
• if you have an inflammation of the peritoneum,
recognisable by a cloudy dialysate, abdominal pain,
fever, feeling unwell or in very rare cases blood
poisoning. Please show the bag containing the
drained dialysate to your doctor.
Blood cleaning can lead to a loss of proteins and
water-soluble vitamins. An adequate diet or
nutritional supplements are recommended in order to
avoid deficiency states.
Your doctor will check your electrolyte (salt) balance,
blood cell counts, kidney function, bodyweight and
nutritional state.

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 taking this medicine.
There are no adequate data from the use of bicaVera in
pregnant women or during lactation period. If you are
pregnant or breast-feeding you should use bicaVera
only if your doctor considers this absolutely necessary.

Driving and using machines
When used as prescribed bicaVera does not impair
your ability to drive or operate machines.

3.

How to use bicaVera

Always use this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.

If tension in the abdominal region occurs the volume
must be reduced.

Continuous ambulatory peritoneal dialysis (CAPD):
• Adults: the usual dose is 2000–2500 ml solution
four times daily depending on bodyweight and
kidney function.
Bags are exchanged over 24 hours. After 2 –10 hours
retention time the solution is drained off.
• Children up to 18 years of age: The doctor will
determine the volume of dialysis solution required
depending on the age, height and bodyweight of the
child.
The recommended dose is 30–40 ml/kg bodyweight.
5

Automatic peritoneal dialysis (APD):
Bag exchange is controlled automatically by the
machine over night. For this the bicaVera sleep•safe
system is used.
Use bicaVera in the peritoneal cavity only.
Use bicaVera only if the solution is clear and the bag is
undamaged.
bicaVera is available in a double-chamber bag. Before
use the solutions in the two chambers must be mixed
as described.

Handling instructions
stay•safe® system for continuous ambulatory
peritoneal dialysis (CAPD):
The solution bag is first warmed to body temperature.
This should be done by using an appropriate heater
tray. The heating time for a 2000 ml bag with a starting
temperature of 22°C is approximately 120 min.
More detailed information can be obtained from the
operating instructions of the bag warmer. A microwave
oven must not be used to warm the solution due to the
risk of local overheating. After warming the solution you
can start with the exchange of the bags.

1. Preparation of the solution
 Place the bag on a solid surface.  Open the
overwrap of the bag and seal of the disinfection cap.
 Check the solution bag before use (label, expiry date,
clearness of the solution, integrity of the bag).  Wash
your hands with an antimicrobial washing lotion.  Roll
up the bag from one of the upper ends until the middle
seam opens. The solutions in the two chambers are
mixed automatically.  Then roll up the bag from the
upper edge, until the peel seam of the lower triangle
is completely opened.  The ready-to-use solution
should be used immediately, but within a maximum of
24 hours after mixing!

2. Preparation of the bag exchange
 Hang the solution bag on the upper hook of the
infusion pole, unroll the tubing line of the solution bag,
and place the DISC into the organizer. After unrolling
the tubing line to the drainage bag, hang the drainage
bag on the lower hook of the infusion pole and place
the disinfection cap into the organizer.  Place catheter
adapter into the organizer.  Disinfect your hands and
remove the protection cap of the DISC.  Connect
catheter adapter to the DISC.

3. Outflow
 Open the catheter clamp. The outflow starts.
 Position 䊉

0875216_01_K001.qxp:0875216

02.07.2014

4. Flush

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Possible side effects

 Flush the drainage bag with fresh solution
(approximately 5 seconds).  Position 䊉䊉

4.

5. Inflow

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

 Connect the solution bag with the catheter.
 Position 䊊䊎䊉

6. Security step
 Close the catheter adapter by putting in the PIN.
 Position 䊉䊉䊉䊉

7. Disconnection
 Remove the catheter adapter from the DISC and
screw the new disinfection cap to the catheter adapter.

8. Closure of the DISC
 Close the DISC with the open end of the protection
cap of the used disinfection cap, which is placed in the
right hole of the organizer.

9. Check the drained dialysate and dispose of it.
sleep•safe system for automatic peritoneal

dialysis (APD):
During automatic peritoneal dialysis (APD) the solution
is warmed automatically in the machine.

1. Preparation of the solution
see instructions on the stay•safe® system above

2. Unroll tubing of bag.
3. Remove the protection cap.
4. Insert connector in free sleep•safe tray port.
5. The bag is now ready for use with the
sleep•safe set.
Each bag should be used only once and any unused
solution remaining must be discarded.
After appropriate training, bicaVera can be used
independently at home. Ensure that you follow all the
procedures you learnt during training and maintain
hygienic conditions when exchanging bags.
Always check the drained dialysate for cloudiness. See
section 2. “Warnings and precautions”.

The following side effects may occur as a result of the
treatment:
• inflammation of the peritoneum with signs of
cloudiness of the drained dialysate, abdominal pain,
fever, feeling unwell or in very rare cases blood
poisoning.
Please show the bag containing the drained
dialysate to your doctor.
• inflammation of the skin at the catheter exit site or
along the length of the catheter, recognisable by
redness, swelling, pain, weeping or crusts.
• hernia of the abdominal wall.
Please contact your doctor immediately if you notice
any of these side effects.
Other side effects of the treatment are:
• problems with inflow or outflow of the dialysate
• diarrhoea
• constipation
• breathing difficulties
• sensation of stretching or fullness of the abdomen
• shoulder pain.
The following side effects may occur when bicaVera
is used:
• potassium deficiency
• calcium excess if the calcium intake is too high
• body fluid levels too low, which can be recognised
by rapid weight loss, low blood pressure, rapid pulse
• body fluid levels too high, which can be recognised
by water in the tissues and lung, high blood
pressure, breathing difficulties
• high blood sugar levels
• high blood fat levels
• weight gain.

Reporting of side effects

6.

Contents of the pack and other
information

What bicaVera contains
The active substances in one litre of the ready-to-use
solution are:
Glucose monohydrate
(equivalent to 15.0 g glucose)
Sodium chloride
Sodium hydrogen carbonate
Calcium chloride dihydrate
Magnesium chloride hexahydrate

16.5 g
5.786 g
2.940 g
0.2573 g
0.1017 g

These quantities of active substances are equivalent to:
83.25 mmol/l glucose, 134 mmol/l sodium,
1.75 mmol/l calcium, 0.5 mmol/l magnesium,
104.5 mmol/l chloride and 34 mmol/l hydrogen
carbonate.
The other ingredients of bicaVera are water for
injections, hydrochloric acid, sodium hydroxide, carbon
dioxide.

What bicaVera looks like and contents of the
pack
bicaVera is a solution for peritoneal dialysis. The
solution is clear and colourless.
The theoretical osmolarity of the ready-to-use solution
is 358 mOsm/l, the pH is about 7.40.
bicaVera is available in a double-chamber bag. One
chamber contains the alkaline sodium hydrogen
carbonate solution and the other the acidic glucosebased electrolyte solution in a ratio of 1:1.
bicaVera is available in the following application
systems and pack sizes per carton:
stay•safe®

sleep•safe

4 × 1500 ml bags
4 × 2000 ml bags
4 × 2500 ml bags
4 × 3000 ml bags

4 × 1500 ml bags
4 × 2000 ml bags
4 × 2500 ml bags
4 × 3000 ml bags

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 via:

Marketing Authorisation Holder

Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

Fresenius Medical Care Deutschland GmbH,
61346 Bad Homburg v.d.H., Germany

If you forget to use bicaVera

By reporting side effects you can help provide more
information on the safety of this medicine.

Manufacturer

Try to attain the volume of dialysate prescribed for
each 24-hour period in order to avoid the risk of
possibly life-threatening consequences. You should
check with your doctor if you are not sure.

5.

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

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

If you use more bicaVera than you should
If you allow too much solution to flow into the
peritoneal cavity, the excess can be drained off. If you
use too many bags please contact your doctor as this
can result in fluid and/or electrolyte imbalances.

How to store bicaVera

Not all pack sizes may be marketed.

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

Distributed in the UK by
Fresenius Medical Care (UK) Ltd, Nunn Brook Road,
Huthwaite, Nottinghamshire, NG17 2HU

Do not use this medicine after the expiry date which is
stated on the bag and carton.

This medicinal product is authorised in the
Member States of the EEA under the following
names:

Do not store bicaVera below 4 °C.

See end of this multilingual package leaflet.

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

This leaflet was last revised in 06/2014

Do not use this medicine if you notice that the solution
is not clear or the bag is damaged.

6

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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