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PERITONEAL DIALYSIS SOLUTION CAPD/DPCA 4

Active substance(s): CALCIUM CHLORIDE DIHYDRATE / DEXTROSE MONOHYDRATE FOR PARENTERAL USE / MAGNESIUM CHLORIDE HEXAHYDRATE / SODIUM CHLORIDE / SODIUM LACTATE SOLUTION

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CAPD/DPCA 2
CAPD/DPCA 3
CAPD/DPCA 4

Package Leaflet:  
Information for the user

CAPD/DPCA 2, CAPD/DPCA 3, CAPD/DPCA 4,  
solution for peritoneal dialysis

In this package leaflet CAPD/DPCA 2, CAPD/DPCA 3,
and CAPD/DPCA 4 are referred to as “CAPD/DPCA”
only.

Read all of this leaflet carefully before you start using this medicine.

In this leaflet:

• If you have any further questions, ask your doctor or pharmacist.

1. What CAPD/DPCA is and what it is used for

• T his medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their
symptoms are the same as yours.

2. Before you use CAPD/DPCA
3. How to use CAPD/DPCA
4. Possible side effects

• K eep this leaflet. You may need to read it again.

• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.

5. How to store CAPD/DPCA
6. Further information

1.

What CAPD/DPCA is and what it
is used for

CAPD/DPCA 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.

Before you use CAPD/DPCA

Do not use CAPD/DPCA

• if the level of potassium in your blood is very low
• if the level of calcium in your blood is very high

In addition, do not use CAPD/DPCA 3

• if the volume of your body fluids is too low
• if you have low blood pressure

Peritoneal dialysis treatment should not be
started in the case of

• 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
• a disorder of metabolism known as lactic acidosis
• 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

Take special care with CAPD/DPCA
Inform your doctor immediately if you have
• a severe loss of electrolytes due to vomiting and/
or diarrhoea
• 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 balance, blood
counts, kidney function, body weight and nutritional
state.

Using other medicines
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription.
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 digoxin.
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,
as hydrochlorothiazide.
• 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 you should use
CAPD/DPCA only if your doctor considers this
absolutely necessary, because there is only limited
experience in these groups.

Driving and using machines
No special precautions are required.

3.

How to use CAPD/DPCA

Always use CAPD/DPCA exactly as your doctor has told
you. You should check with your doctor or pharmacist if
you are not sure.
Use CAPD/DPCA in the peritoneal cavity only.
Your doctor will determine the method, duration and
frequency of use and the required volume of solution
and retention time in the peritoneal cavity.
If tension in the abdominal region occurs the volume
must be reduced.

4

Continuous ambulatory peritoneal dialysis (CAPD):
• Adults: the usual dose is 2,000 ml solution four
times daily depending on body weight and kidney
function. Smaller or larger doses can be administered
as appropriate (dose given merely as a guide, dosage
must be adjusted for the individual patient).
Bags are exchanged over 24 hours. After 4 – 8 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 body weight.
The recommended dose is 30 – 40 ml/kg body weight.
Automatic peritoneal dialysis (APD):
Bag exchange is controlled automatically by the
machine over night. For this, the CAPD/DPCA
sleep•safe system or the CAPD/DPCA Safe•Lock
system is used.
Use CAPD/DPCA only if the solution is clear and the
bag is undamaged.
Each CAPD/DPCA bag should be used only once and
any unused solution remaining must be discarded.
After appropriate training, CAPD/DPCA 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 “Take special care …”.

If you use more CAPD/DPCA 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
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 stop using CAPD/DPCA
If you stop the blood cleaning without starting an
alternative treatment, there can be life-threatening
consequences.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

2. Preparation of the bag exchange

An additional active substance is:

4.

Possible side effects

Like all medicines, CAPD/DPCA can cause side effects,
although not everybody gets them.
The following side effect occurs when CAPD/DPCA is
used:
very common, more than 1 in 10 persons treated
• potassium deficiency
Side effects of CAPD/DPCA with unknown frequency
are:
• 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

CAPD/DPCA 2
Glucose monohydrate
equivalent to 15.0 g glucose (83.2 mmol/l)
CAPD/DPCA 3
Glucose monohydrate
equivalent to 42.5 g glucose (235.8 mmol/l)
CAPD/DPCA 4
Glucose monohydrate
equivalent to 22.73 g glucose (126.1 mmol/l)

16.5 g

46.75 g

25.0 g

• weight gain
The following side effects occur as a result of the
treatment:
very common, more than 1 in 10 persons treated
• inflammation of the peritoneum with signs of
cloudiness of the drained dialysate, abdominal pain,
fever, feeling unwell or in very rare cases blood
poisoning.
• 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 due to elevation of the
diaphragm
• sensation of stretching or fullness of the abdomen
• shoulder pain

 Open the catheter extension clamp. The outflow
starts.  Position 

What CAPD/DPCA looks like and contents of
the pack

 After completion of outflow fill the tube between
solution bag and DISC completely with fluid by
flushing fresh solution into the drainage bag
(approx. 5 seconds).  Position 

The solution is clear and colourless to slightly
yellowish.

stay•safe®
6 bags each containing 1,500 ml
4 bags each containing 2,000 ml
4 bags each containing 2,500 ml
sleep•safe
2 bags each containing 5,000 ml
2 bags each containing 6,000 ml
Safe•Lock
2 bags each containing 5,000 ml
2 bags each containing 6,000 ml
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Fresenius Medical Care (UK) Limited,
Nunn Brook Road, Huthwaite, Sutton-in-Ashfield,
Nottinghamshire. NG17 2HU.
Fresenius Medical Care (SA) (Pty) Ltd,
2 Tonetti Street, Stand 7, Growthpoint Business Park,
Halfway House 1685, Tel: 27(0) 11 545 0200

If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor or pharmacist.

Reg Number (South Africa):
36/34/0276 (CAPD/DPCA 2 stay•safe® 2000 ml)
36/34/0277 (CAPD/DPCA 3 stay•safe® 2000 ml)
36/34/0278 (CAPD/DPCA 4 stay•safe® 2000 ml)

5.

Reg Number (Botswana):
BOT0700900 (CAPD/DPCA 2 stay•safe®)
BOT0700919 (CAPD/DPCA 3 stay•safe®)
BOT0700916 (CAPD/DPCA 4 stay•safe®)

How to store CAPD/DPCA

Keep out of the reach and sight of children.
Do not store CAPD/DPCA above 25°C. Do not
refrigerate or freeze.
Do not use CAPD/DPCA after the expiry date printed on
the bag and carton.

6.

Further information

What CAPD/DPCA contains

The active substances contained in one litre of
each CAPD/DPCA solution are:
Sodium chloride
Sodium (S)-lactate solution
(equivalent to 3.925 g sodium
(S)-lactate)
Calcium chloride dihydrate
Magnesium chloride hexahydrate

5.786 g
7.85 g

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

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 2,000 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

0.2573 g
0.1017 g

These quantities of active substances are equivalent to:
134 mmol/l sodium ions, 1.75 mmol/l calcium ions,
0.5 mmol/l magnesium ions, 103.5 mmol/l chloride
ions and 35 mmol/l lactate ions.

3. Outflow

The other ingredients of CAPD/DPCA are:
Water for injections, hydrochloric acid, sodium
hydroxide

CAPD/DPCA is available in the following application
systems and pack sizes per carton:

• high blood fat levels

 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 and place the
disinfection cap into the organizer.   Place catheter
connector into the organizer.  Disinfect your hands
and remove the protection cap of the DISC.  Connect
catheter connector to the DISC.

 Check the warmed solution bag (label, expiry date,
clearness of the solution, bag and over wrap 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.  Check that the
solution is clear and that the bag is not leaking.
5

4. Flush

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 
7. Disconnection
 Remove protection cap from the new disinfection
cap and screw it to 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 protection
cap of the used disinfection cap, which is placed in the
right hole of the organizer.
9. Check the drained dialysate for clarity and weight
and if the effluent is clear discard it.
sleep•safe system and Safe•Lock system for
automatic peritoneal dialysis (APD):
During automatic peritoneal dialysis (APD) the solution
is warmed automatically by the machine.
sleep•safe system
1. Preparation of the solution
 see stay•safe® system
2. Unroll tubing of solution bag.
3. Remove the protection cap.
4. Insert bag connector in free tray port of the cycler.
5. The bag is now ready for use with the
sleep•safe set.
Safe•Lock system
1. Preparation of the solution
 see stay•safe® system
2. Remove protective cap of the connector from
the connecting line.
3. Connect lines to the bag.
4. Break the inner lock by bending the line and the
PIN by more than 90° to both sides.
5. The bag is now ready for use.

Date of last revision: 11/2010
For UK:
For South Africa: Schedule 1
For Botswana: Schedule 2

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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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