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CAPD/DPCA 19 SOLUTION FOR PERITONEAL DIALYSIS

Active substance(s): CALCIUM CHLORIDE DIHYDRATE / GLUCOSE MONOHYDRATE / MAGNESIUM CHLORIDE HEXAHYDRATE / SODIUM CHLORIDE / SODIUM LACTATE SOLUTION

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CAPD/DPCA 19

Package Leaflet:
Information for the user
CAPD/DPCA 19
solution for peritoneal dialysis

What is in this leaflet:
1. What CAPD/DPCA 19 is and what it is used for
2. What you need to know before you use
CAPD/DPCA 19
3. How to use CAPD/DPCA 19
4. Possible side effects
5. How to store CAPD/DPCA 19
6. Contents of the pack and other information

1.


What CAPD/DPCA 19 is and
what it is used for

CAPD/DPCA 19 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 CAPD/DPCA 19

Do not use CAPD/DPCA 19
• if the level of potassium in your blood is very low
• if the level of calcium in your blood is very low
• if you suffer from disorders of lactate metabolism
• if you have fructose metabolism disorders
(hereditary fructose intolerance)
• 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 blood cleaning
• 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 an overactive parathyroid or a low
calcium level in your blood. It may be necessary
to take additional calcium-containing phosphate
binders and/or vitamin D. If this is not possible a
peritoneal dialysis solution with a higher calcium
concentration should be used.

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.

• 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.
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.
CAPD/DPCA 19 contains 22.73 g glucose in 1000 ml
solution. Depending on the dosage instructions and the
pack size used up to 68.2 g glucose (CAPD, 3000 ml
stay•safe®) or 113.65 g glucose (APD, 5000 ml
sleep•safe) are supplied to the body with each bag.
This should be taken into account in patients with
diabetes mellitus.
Due to the high glucose concentration CAPD 19 should
be used cautiously and under monitoring by your
doctor.

Other medicines and CAPD 19
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.

It is unknown whether CAPD/DPCA 19 substances/
metabolites are excreted in human milk. Breastfeeding is not recommended for mothers on peritoneal
dialysis.

Driving and using machines
CAPD/DPCA 19 has no or negligible influence on the
ability to drive or use machines.

3.



How to use CAPD/DPCA 19

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 2000-3000 ml solution
four times daily depending on body weight and
kidney function.
After 2-10 hours dwell time the solution is drained off.

Because peritoneal dialysis may influence the effects
of medicines, your doctor may need to change their
dosages, especially those of:

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

• 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.

The recommended initial dose is 600-800 ml/m2
(up to 1000 ml/m2 overnight) body surface area four
times daily.

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 CAPD/DPCA 19 in
pregnant women or during lactation period. If you are
pregnant you should not use CAPD/DPCA 19 unless
your doctor considers this absolutely necessary.

Automated peritoneal dialysis (APD):
Bag exchange is controlled automatically by the
machine over night. For this the CAPD/DPCA
sleep•safe system is used.
• 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 8001000 ml/m2 (up to 1400 ml/m2) body surface area
with 5-10 exchanges overnight.
Use CAPD/DPCA 19 in the peritoneal cavity only.
Use CAPD/DPCA 19 only if the solution is clear and the
bag is undamaged.

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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 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. Check the solution bag (label, expiry date,
clearness of the solution, bag and overwrap not
damaged) ➧ open the overwrap of the bag and the
packaging of the disinfection cap.
 2. Clean your hands with an antimicrobial washing
solution.
 3. Place the DISC into the organiser (suspend solution
bag from the upper hole of the infusion pole ➧
unroll the line “solution bag-DISC” ➧ place the
DISC into the organiser ➧ place drainage bag into
lower holder of the infusion pole).
 4. Place catheter extension into one of the two inserts
of the organiser. ➧ Place the new disinfection cap
into the other free insert.
 5. Disinfect your hands and remove protection cap of
the DISC.
 6. Connect catheter extension to the DISC.
 7. Open the clamp on extension ➧ position "" ➧
outflow procedure starts.
 8. After completion of the outflow: Flush ➧ position
"" ➧ flush fresh dialysate to the drainage bag
(approx. 5 seconds).
 9. Inflow ➧ position "" ➧ connect the solution
bag with the catheter.
10. Security step ➧ position "" ➧ close
catheter extension by putting in the PIN.
11. Disconnection ➧ remove the protection cap from
the new disinfection cap and screw it onto the old
one ➧ unscrew the catheter extension from the
DISC and screw the catheter extension onto the
new disinfection cap.
12. Close the DISC with the open end of the used
disinfection cap (which has remained in the right
hole of the organizer).
13. Check the drained dialysate for clarity and weight
and if the effluent is clear discard it.

procedures you learnt during training and maintain
hygienic conditions when exchanging bags.
Always check the drained dialysate for cloudiness. See
section 2.

If you use more CAPD/DPCA 19 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.

If you forget to use CAPD/DPCA 19
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
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
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 streching or fullness of the abdomen
• shoulder pain
uncommon (may affect up to 1 in 100 people):

• 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 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.

5.


How to store CAPD/DPCA 19

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 CAPD/DPCA above 25 °C. Do not
refrigerate or freeze.
The solution must be used immediately after opening.

6.


Contents of the pack
and other information

What CAPD/DPCA 19 contains
The active substances in one litre solution are:
Calcium chloride dihydrate
0.1838 g
Sodium chloride
5.786 g
Sodium-(S)-lactate-solution
7.85 g
(3.925 g Sodium-(S)-lactate)
Magnesium chloride hexahydrate
Glucose monohydrate
(22.73 g glucose)
Fructose up to 1.1 g

0.1017 g
25.0 g

• diarrhoea
• constipation

These quantities of active substances are
equivalent to:

sleep•safe system for automated peritoneal
dialysis (APD):

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

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

• breathing difficulties due to elevation of the
diaphragm.

1.25 mmol/l calcium, 134 mmol/l sodium,
0.5 mmol/l magnesium, 102.5 mmol/l chloride,
35 mmol/l (S)-lactate and 126.1 mmol/l glucose.

1. Preparation of the solution

The following side effect may occur when CAPD/
DPCA 19 is used:

 Check the solution bag (label, expiry date, clearness
of the solution, bag and overwrap not damaged).
 Place the bag on a solid surface.  Open the
overwrap.  Wash your hands with an antimicrobial
washing lotion.  Check whether the solution is clear
and that the bag is not leaking.

very common (may affect more than 1 in 10 people):
• potassium deficiency
common (may affect up to 1 in 10 people):

2. Unroll tubing of bag.

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

3. Remove the protection cap.

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

4. Insert connector in free sleep•safe tray port.

• calcium deficiency
• body fluid levels too low, which can be recognised by
rapid weight loss
• dizziness
• low blood pressure
• rapid pulse
• body fluid levels too high which can be recognised
by rapid weight gain

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, CAPD/DPCA 19 can be used
independently at home. Ensure that you follow all the

The other ingredients of CAPD/DPCA 19 are water for
injections, hydrochloric acid, sodium hydroxide.

What CAPD/DPCA 19 looks like and contents
of the pack
The solution is clear and colourless to slightly yellow.
The theoretical osmolarity of the solution is 399 mOsm/l,
the pH is about 5.5.
CAPD/DPCA 19 is available in the following
application systems and pack sizes per carton:
stay•safe®
sleep•safe
6 * 1500 ml bags
2 * 5000 ml bags
4 * 2000 ml bags
4 * 2500 ml bags
4 * 3000 ml bags
Not all pack sizes may be marketed.

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Marketing Authorisation Holder
Fresenius Medical Care Deutschland GmbH
61346 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 11/2015

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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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