Skip to Content

CAPD/DPCA 19 SOLUTION FOR PERITONEAL DIALYSIS

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

View full screen / Print PDF » Download PDF ⇩
Transcript
CAPD/DPCA 17

Package Leaflet:
Information for the user
CAPD/DPCA 17
solution for peritoneal dialysis

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

In this leaflet:

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This 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.
• 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.

1. What CAPD/DPCA is and what it is used for
2. Before you use CAPD/DPCA
3. How to use CAPD/DPCA
4. Possible side effects
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 17
• 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)

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
- 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.

Take special care with CAPD/DPCA
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.
• 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.

Continuous ambulatory peritoneal dialysis (CAPD):

Your doctor will check your electrolyte (salt) balance,
blood cell counts, kidney function, body weight and
nutritional state.

• 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 of the
child.
The recommended dose is 30 – 40 ml/kg bodyweight.

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 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.

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
When used as prescribed CAPD/DPCA does not impair
your ability to drive or operate machines.

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.
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.

• Adults and elderly: the usual dose is 2000 - 3000
ml solution four times daily depending on body
weight and kidney function.
Bags are exchanged over 24 hours. After 2-10 hours
retention time the solution is drained off.

Automatic peritoneal dialysis (APD):
Bag exchange is controlled automatically by the
machine over night. For this the CAPD/DPCA
sleep•safe system is used.
Use CAPD/DPCA in the peritoneal cavity only.
Use CAPD/DPCA only if the solution is clear and the
bag is undamaged.

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. Check the solution bag (label, expiry date,
clearness of the solution, bag and over wrap not
damaged) – open the over wrap and package 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 adapter into the organiser.
  5. Disinfect your hands and remove protection cap of
the DISC.
  6. Connect catheter adapter to the DISC.
  7. Open the catheter clamp - position “” - outflow
procedure starts.
  8. Flush - position “” – flush fresh dialysate to
the drainage bag (approx. 5 seconds).

5
0870066_06_K006.indd 5

21.03.2013 10:43:52 Uhr

  9. Inflow - position “” – connect the solution
bag with the catheter.
10. Security step - position “” –close catheter
adapter by putting in the PIN.
11. Disconnection (remove catheter adapter from the
DISC) – screw the new disinfection cap to the
catheter adapter.
12. Close the DISC. Close the DISC with the open end
of the protection cap of the used disinfection cap
(placed in the right hole of the organizer).
13. Checking the drained dialysate and disposal.
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
 Check the solution bag (label, expiry date, clearness
of the solution, bag and over wrap not damaged). 
Place the bag on a solid surface.  Open the over
wrap.  Wash your hands with an antimicrobial
washing lotion.  Check whether the solution is clear
and that the bag is not leaking.

The following side effects may occur as a result of
the treatment:
very common:
• 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:
• problems with inflow or outflow of the dialysate
• sensation of streching or fullness of the abdomen
• shoulder pain

6.


FURTHER INFORMATION

What CAPD/DPCA contains
The active substances in one litre solution are:
Glucose monohydrate
16.5 g
(equivalent to 15.0 g glucose)
Fructose up to 0.75 g
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

0.1838 g
0.1017 g

These quantities of active substances are
equivalent to:

uncommon:

83.2 mmol/l glucose, 134 mmol/l sodium,
1.25 mmol/l calcium, 0.5 mmol/l magnesium,
102.5 mmol/l chloride and 35 mmol/l lactate.

2. Unroll tubing of bag.

• diarrhoea
• constipation

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

3. Remove the protection cap.

not known:

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

• breathing difficulties due to elevation of the
diaphragm
The following side effect may occur when CAPD/
DPCA is used:

What CAPD/DPCA looks like and contents of
the pack

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 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 with CAPD/DPCA”

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
In order to avoid the risk of possibly life-threatening
consequences, you should contact your doctor.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

4.


POSSIBLE SIDE EFFECTS

very common:
• potassium deficiency
• high blood sugar levels
• high blood fat levels
• weight gain

4 * 2000 ml bags

uncommon:
• calcium defciency
• 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
• water in the tissues and lung
• high blood pressure
• breathing difficulties
not known:
• overactive parathyroid with potential disturbances of
bone metabolism.

Like all medicines, CAPD/DPCA can cause side effects,
although not everybody gets them.

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.

The assessment of the side effects is based on the
following frequencies:



very common:

occurs in more than 1 in 10
persons treated

HOW TO STORE CAPD/DPCA

Keep out of the reach and sight of children.

common:

occurs in more than 1 in 100
persons treated

Do not use CAPD/DPCA after the expiry date printed on
the bag and carton.

uncommon:

occurs in more than 1 in 1,000
persons treated

Do not store CAPD/DPCA above 25°C. Do not
refrigerate or freeze.

rare:

occurs in more than 1 in 10,000
persons treated

The solution must be used immediately after first
opening.

very rare:

not known:

The theoretical osmolarity of the solution is
356 mosm/l, the pH is about 5.5.
CAPD/DPCA is available in the following
application systems and pack sizes per carton:
stay•safe®
sleep•safe
6 * 1500 ml bags
2 * 5000 ml bags

common:

5.

CAPD/DPCA is a solution for peritoneal dialysis. The
solution is clear and colourless to slightly yellow.

occurs in 1 or fewer of 10,000
persons treated; includes isolated
cases

4 * 2500 ml bags
4 * 3000 ml bags
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Fresenius Medical Care Deutschland GmbH,
61346 Bad Homburg v.d.H., Germany
Fresenius Medical Care (SA) (Pty) Ltd,
2 Tonetti Street, Stand 7, Growthpoint Business Park,
Halfway House 1685, Tel: 27(0) 11 545 0200
Reg Number (South Africa):
36/34/0143 (CAPD/DPCA 17 stay·safe 2000 ml,
sleep·safe 5000 ml)
36/34/0144(CAPD/DPCA 18 stay·safe 2000 ml,
sleep·safe 5000 ml)
36/34/0145(CAPD/DPCA 19 stay·safe 2000 ml,
sleep·safe 5000 ml)
Reg Number (Botswana):
BOT0700901 (CAPD/DPCA 17 stay·safe)
BOT0700917 (CAPD/DPCA 18 stay·safe)
BOT0700918 (CAPD/DPCA 19 stay·safe)

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

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 March 2013
For South Africa: Schedule 1
For Botswana: Schedule 2

cannot be estimated from the
available data
6

0870066_06_K006.indd 6

21.03.2013 10:43:53 Uhr

Expand view ⇕

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