Skip to Content

BICAVERA 2.3% GLUCOSE 1.25 MMOL/L CALCIUM SOLUTION FOR PERITONEAL DIALYSIS

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

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

bicaVera

2.3 % Glucose,
1.25 mmol/l Calcium

Package leaflet:
Information for the user

bicaVera 2.3 % Glucose, 1.25 mmol/l Calcium,
Solution for peritoneal dialysis

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 2.3 % Glucose,
1.25 mmol/l Calcium

• if the level of potassium in your blood is very low
• if the level of calcium in your blood is very low
• if the volume of your body fluids is too low
• if you have low blood pressure

Peritoneal dialysis treatment must not be
started if you have

• 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
– tumours in the abdomen or bowel
• 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 peritoneal dialysis
• severe malnutrition and loss of weight, particularly if
adequate intake of food containing proteins is not possible.

Warnings and precautions

Inform your doctor immediately
• if you have a severe loss of electrolytes (salts)
due to vomiting and/or diarrhoea.
• if you have a low calcium level in your blood,
it may be necessary to take additional calciumcontaining phosphate binders and/or vitamin D. If
this is not possible a peritoneal dialysis solution with
a higher calcium concentration may be necessary.
• 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.
• if you have polycystic kidneys.
Peritoneal dialysis 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, body weight and
nutritional state.

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 peritoneal dialysis 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 diuretics.
• Medicines taken by mouth that lower blood sugar
levels or insulin. Your blood sugar level should be
measured regularly.

Pregnancy and breast-feeding
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

bicaVera has no or negligible influence 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. Check with your doctor or
pharmacist if you are not sure.
Your doctor will determine the method, duration and
frequency of use and the required volume of solution
and dwell time in the peritoneal cavity.
If tension in the abdominal region occurs your doctor
may reduce the volume.
Continuous ambulatory peritoneal dialysis (CAPD)
• Adults: The usual dose is 2000 - 2500 ml solution
four times daily depending on body weight and
kidney function.
After 2-10 hours dwell time the solution is drained off.
• Children: The doctor will determine the volume
of dialysis solution required depending on the
tolerance, age and body surface area of the child.
The recommended initial dose is 600-800 ml/m2
(up to 1000 ml/m2 overnight) body surface area four
times daily.

Automatic peritoneal dialysis (APD)
For this the bicaVera sleep•safe system is used. Bag
exchange is controlled automatically by the sleep•safe
cycler overnight.
• Adults: The usual prescription is 2000 ml (maximum
3000 ml) per exchange with 3-10 exchanges
overnight and time on the cycler 8 to 10 hours, and
at daytime one or two exchanges.
• Children: The volume per exchange should be
800-1000 ml/m2 (up to 1400 ml/m2) body surface
area with 5-10 exchanges overnight.
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
For use of the 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 bag
warmer. 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
 Check the warmed solution bag (label, expiry date,
clearness of the solution, bag and overwrap not
damaged, peel seams intact).  Place the bag on a
solid surface.  Open the overwrap of the bag and the
packaging of the disinfection cap.  Wash your hands
with an antimicrobial washing lotion.  Roll up the bag,
which is lying on the overwrap, from one of the side
edges until the middle seam opens. The solutions in
the two chambers are mixed automatically.  Now roll
up the bag from the upper edge until the peel seam
of the lower triangle is completely open.  Check that
all peel seams are completely open.  Check that the
solution is clear and that the bag is not leaking.
2. Preparation of the bag exchange
 Hang the solution bag in the upper hole 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 in the lower hole of the infusion pole.  Place
catheter connector into one of the two inserts of the
organizer.  Place the new disinfection cap into the
other free insert.  Disinfect your hands and remove
the protection cap of the DISC.  Connect catheter
connector to the DISC.

5

K003_bicaVera_EU_2.3Gl_1.25Ca_PIL_0875244-01.indd 5

08.09.16 10:10

3. Outflow
 Open the clamp on the extension. The outflow starts.
 Position
4. Flush
 After completion of outflow flush fresh solution into the
drainage bag (approximately 5 seconds).  Position
5. Inflow
 Start inflow by turning the control switch to
 Position
6. Safety step
 Close the catheter extension by introducing the PIN
into the catheter connector.
 Position
 Close the clamp on catheter extension.
7. Disconnection
 Remove protection cap from the new disinfection
cap and screw it onto the old one.  Screw the
catheter connector off the DISC and screw the catheter
connector to the new disinfection cap.
8. Closure of the DISC
 Close the DISC with the open end of the used
disinfection cap, which has remained in the right hole
of the organizer.
9. Check the drained dialysate for clarity and weight
and if the effluent is clear discard it.
For use of the sleep• safe system for automatic
peritoneal
dialysis (APD)
During automated peritoneal dialysis (APD) the solution
is warmed automatically by the cycler.
3000 ml sleep•safe system
1. Preparation of the solution: see stay•safe system
2. Unroll tubing of bag.
3. Remove the protection cap.
4. Insert bag connector in free tray port of the
sleep•safe cycler.
5. The bag is now ready for use with the
sleep•safe set.
5000 ml sleep•safe system
1. Preparation of the solution
 Check the solution bag (label, expiry date, clearness
of the solution, bag, and overwrap not damaged, peel
seams intact).  Place the bag on a solid surface.
 Open the overwrap of the bag.  Wash your hands
with an antimicrobial washing lotion.  Unfold middle
peel seam and bag connector.  Roll up the bag,
which is lying on the overwrap, from the diagonal end
towards the bag connector. The middle peel seam
will open.  Continue until the peel seam of the small
chamber opens as well.  Check that all peel seams
are completely open.  Check that the solution is clear
and that the bag is not leaking.
2-5.: see 3000 ml sleep•safe system
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”.

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 the
peritoneal dialysis treatment in general:
very common (may affect more than 1 in 10 people):
• 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:
common (may affect up to 1 in 10 people):
• problems with inflow or outflow of the dialysate
• sensation of stretching or fullness of the abdomen
• shoulder pain
uncommon (may affect up to 1 in 100 people):
• diarrhoea
• constipation
not known (frequency cannot be estimated from
available data):
• breathing difficulties due to elevation of the
diaphragm.
The following side effect may occur when bicaVera is
used:
very common (may affect more than 1 in 10 people):
• potassium deficiency
common (may affect up to 1 in 10 people):
• high blood sugar levels
• high blood fat levels
• weight gain
uncommon (may affect up to 1 in 100 people):
• calcium deficiency
• 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 rapid weight gain
• water in the tissues and lung
• high blood pressure
• breathing difficulties
not known (frequency cannot be estimated from
available data):
• overactive parathyroid with potential disturbances of
bone metabolism

Reporting of side effects

If you use more bicaVera than you should

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:
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.

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.

5.

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

6.

Contents of the pack and other
information

What bicaVera contains
The active substances in one litre of the ready-to-use
solution are:
Calcium chloride dihydrate
Sodium chloride
Sodium hydrogen carbonate
Magnesium chloride hexahydrate
Glucose monohydrate
(equivalent to 22.73 g glucose)

0.1838 g
5.786 g
2.940 g
0.1017 g
25.0 g

These quantities of active substances are equivalent to:
1.25 mmol/l calcium, 134 mmol/l sodium, 0.5 mmol/l
magnesium, 103.5 mmol/l chloride, 34 mmol/l
hydrogen carbonate and 126.1 mmol/l glucose.
The other ingredients of bicaVera are water for
injections, hydrochloric acid, sodium hydroxide, carbon
dioxide.

What bicaVera looks like and contents of the pack
The solution is clear and colourless.
The theoretical osmolarity of the ready-to-use solution
is 399 mOsm/l, the pH is about 7.4.
bicaVera is a solution for peritoneal dialysis and
available in a double-chamber bag. One chamber
contains the alkaline sodium hydrogen carbonate
solution and the other the acidic glucose-based
electrolyte solution in a ratio of 1:1.
bicaVera is available in the following application
systems and pack sizes per carton:
stay•safe®
4 × 2000 ml bags
4 × 2500 ml bags

sleep•safe
4 × 3000 ml bags
2 × 5000 ml bags

Not all pack sizes may be marketed.

Marketing Authorisation 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 (UK) Ltd,
Tel.: 0044 (0) 1623 445 100

This medicinal product is authorised in the
Member States of the EEA under the following
names:
See end of this multilingual package leaflet.

This leaflet was last revised in 08/2016

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 expiry
date refers to the last day of that month.
Do not store bicaVera below 4 °C.
The ready-to-use solution should be used immediately,
but within a maximum of 24 hours after mixing.
Do not use this medicine if you notice that the solution
is not clear or the bag is damaged.

6

K003_bicaVera_EU_2.3Gl_1.25Ca_PIL_0875244-01.indd 6

08.09.16 10:10

Dieses Arzneimittel ist in den Mitgliedsstaaten des Europäischen Wirtschaftsraumes (EWR) unter den folgenden Bezeichnungen zugelassen:
This medicinal product is authorised in the Member States of the EEA under the following names:
Dit geneesmiddel is geregistreerd in lidstaten van de EEA onder de volgende namen:
Este medicamento está autorizado en los estados miembros del Espacio Económico Europeo con los siguientes nombres:
Este medicamento é autorizado nos Estados Membros da EEA, sob os seguintes nomes:
Ce médicament est autorisé dans les Etats membres de l'Espace Economique Européen sous les noms suivants :
Questo medicinale è autorizzato negli Stati Membri dello Spazio Economico Europeo con le seguenti denominazioni:

B
A





bicaVera 2,3 % glucose, 1,25 mmol/l calcium, oplossing voor peritoneale dialyse
B

bicaVera 2,3 % Glucose, 1,25 mmol/l Calcium, Peritonealdialyselösung
bicaVera 2,3 % glucose, 1,25 mmol/l calcium, Roztok pro peritoneální dialýzu

bicaVera 2,3% glucose, 1,25 mmol/l calcium, Peritonealdialysevæske
bicaVera Glucosa 2,3% Calcio 1,25 mmol/l solución para diálisis peritoneal
B

bicaVera 2,3 % glucose, 1,25 mmol/l calcium, solution pour dialyse péritonéale

bicaVera 2,3 % glukoosi, 1,25 mmol/l kalsium, peritoneaalidialyysineste
bicaVera 2.3% Glucose, 1.25 mmol/l Calcium, Solution for peritoneal dialysis
bicaVera 2,3% γλυκόζη, 1,25 mmol/l ασβέστιο, Διάλυμα περιτοναϊκής διαπίδυσης (κάθαρσης)
bicaVera 2,3 % Glucosio, 1,25 mmol/l Calcio, Soluzione per dialisi peritoneale


bicaVera 2,3 % glikoze, 1,25 mmol/l kalcijs, šķīdums peritoneālai dialīzei

bicaVera 2,3% Glucose, 1,25 mmol/l Calcium, kviðskilunarlausn
bicaVera 2,3 % glukose, 1,25 mmol/l kalsium, peritonealdialysevæske


bicaVera z 2,3% glukozą i wapniem 1,25 mmol/l

bicaVera 2,3% Glucose 1,25 mmol/l Cálcio, Solução para diálise peritoneal
bicaVera 2,3 % Glucose, 1,25 mmol/l Calcium, peritonealdialysvätska

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

K003_bicaVera_EU_2.3Gl_1.25Ca_PIL_0875244-01.indd 20

08.09.16 10:10

Expand Transcript

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.

Hide