Package Leaflet:

CAPD/DPCA 19    ser

CAPD/DPCA 19

solution for peritoneal dialysis

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.

IWhat 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.

•    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.

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 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.

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.

•    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/m¹ (up to 1000 ml/m¹ overnight) body surface area four times daily.

Automated peritoneal dialysis (APD):

Bag exchange is controlled automatically by the machine over night. For this the CAPD/DPCA sleeps 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/m¹ (up to 1400 ml/m¹) 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.

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) I 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 I unroll the line “solution bag-DISC" I place the DISC into the organiser I place drainage bag into lower holder of the infusion pole).

4.    Place catheter extension into one of the two inserts of the organiser. I 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 I position "•" I outflow procedure starts.

8.    After completion of the outflow: Flush I position "••" I flush fresh dialysate to the drainage bag (approx. 5 seconds).

9.    Inflow I position "03d" I connect the solution bag with the catheter.

10.    Security step I position "••••" I close catheter extension by putting in the PIN.

11.    Disconnection I remove the protection cap from the new disinfection cap and screw it onto the old one I 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.

Possible side effects

•    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.

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.

Contents of the pack . and other information

These quantities of active substances are equivalent to:

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.

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.

Marketing Authorisation Holder

Fresenius Medical Care Deutschland GmbH 61346 Bad Homburg v.d.H., Germany

Manufacturer

Fresenius Medical Care Deutschland GmbH, Frankfurter StraBe 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

0870068_08-D-GB-NL-E-P-GR-F-I_K003.indd 7 27.05.16 11:00

1

   Unroll tubing of bag.

2

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

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

3

   Preparation of the solution

D Check the solution bag (label, expiry date, clearness of the solution, bag and overwrap not damaged).

D Place the bag on a solid surface. D Open the overwrap. D Wash your hands with an antimicrobial washing lotion. D Check whether the solution is clear and that the bag is not leaking.

4

   Remove the protection cap.

5

   Insert connector in free sleep^safe tray port.

6

   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

7

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):

•    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 CAPD/ DPCA 19 is used:

very common (may affect more than 1 in 10 people):

•    potassium deficiency

common (may affect up to 1 in 10 people):

8

   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

•    dizziness

•    low blood pressure

•    rapid pulse

•    body fluid levels too high which can be recognised by rapid weight gain