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.

•    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.

1WHAT 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.

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.

Your doctor will check your electrolyte (salt) balance, blood cell 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 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.

Continuous ambulatory peritoneal dialysis (CAPD):

•    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.

•    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. 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).

9. Inflow - position “OQ#” - 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

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

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, 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.

POSSIBLE SIDE EFFECTS

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

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

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 uncommon:

•    diarrhoea

•    constipation not known:

•    breathing difficulties due to elevation of the diaphragm

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

very common:

•    potassium deficiency common:

•    high blood sugar levels

•    high blood fat levels

•    weight gain 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.

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.

HOW TO STORE CAPD/DPCA

Keep out of the reach and sight of children.

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

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

The solution must be used immediately after first opening.

FURTHER INFORMATION 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.

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

What CAPD/DPCA looks like and contents of the pack

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

The theoretical osmolarity of the solution is 356 mosm/l, the pH is about 5.5.

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):

B0T0700901 (CAPD/DPCA 17 stay-safe)

B0T0700917 (CAPD/DPCA 18 stay-safe)

B0T0700918 (CAPD/DPCA 19 stay-safe)

Manufacturer

Fresenius Medical Care Deutschland GmbH, Frankfurter StraBe 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

0870066_06_K006.indd 6 21.03.2013 10:43:53 Uhr

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